Biosafety level

A biosafety level is a set of biocontainment precautions required to

isolate dangerous biological agents in an enclosed laboratory facility.
The levels of containment range from the lowest biosafety level 0
(BSL-0) to the highest at level 4 (BSL-4). In the United States, the
Centers for Disease Control and Prevention (CDC) have specified
these levels.[2] In the European Union, the same biosafety levels are
defined in a directive.[3] In Canada the four levels are known as
Containment Levels.[4] Facilities with these designations are also
sometimes given as P1 through P4 (for Pathogen or Protection level),
as in the term "P3 laboratory".

At the lowest level of biosafety, precautions may consist of regular

hand-washing and minimal protective equipment. At higher biosafety
levels, precautions may include airflow systems, multiple
containment rooms, sealed containers, positive pressure personnel
suits, established protocols for all procedures, extensive personnel
training, and high levels of security to control access to the facility
.

Essential features of abiosafety level 4 (BSL-4)

Contents laboratory[1]

1 History
2 Levels
2.1 Biosafety level 1
2.2 Biosafety level 2
2.3 Biosafety level 3
2.4 Biosafety level 4
3 List of BSL-4 facilities
4 Safety concerns
5 See also
6 References
7 External links

History
The first prototype Class III (maximum containment) biosafety cabinet was fashioned in 1943 by Hubert Kaempf Jr., then a U.S.
Army soldier, under the direction of Dr. Arnold G. Wedum, Director (1944–69) of Industrial Health and Safety at the United States
Army Biological Warfare Laboratories, Camp Detrick, Maryland. Kaempf was tired of his MP duties at Detrick and was able to
, the H.K. Ferguson Co.[5]
transfer to the sheet metal department working with the contractor

On 18 April 1955, fourteen representatives met at Camp Detrick in Frederick, Maryland. The meeting was to share knowledge and
experiences regarding biosafety, chemical, radiological, and industrial safety issues that were common to the operations at the three
principal biological warfare (BW) laboratories of the U.S. Army.[6] Because of the potential implication of the work conducted at
biological warfare laboratories, the conferences were restricted to top level security clearances. Beginning in 1957, these conferences
were planned to include non-classified sessions as well as classified sessions to enable broader sharing of biological safety
information. It was not until 1964, however, that conferences were held in a government installation not associated with a biological
warfare program.[7]

Over the next ten years, the biological safety conferences grew to include representatives from all federal agencies that sponsored or
conducted research with pathogenic microorganisms. By 1966 it began to include representatives from universities, private
laboratories, hospitals, and industrial complexes. Throughout the 1970s, participation in the conferences continued to expand and by
1983 discussions began regarding the creation of a formal organization.[7] The American Biological Safety Association (ABSA) was
officially established in 1984 and a constitution and bylaws were drafted the same year. As of 2008, ABSA includes some 1,600
members in its professional association.[7]

Levels

Biosafety level 1
Biosafety level 1 (BSL-1) is suitable for work with well-characterized agents which
do not cause disease in healthy humans. In general, these agents should pose
minimal potential hazard to laboratory personnel and the environment.[8] At this
level, precautions are limited relative to other levels. Laboratory personnel must
wash their hands upon entering and exiting the lab. Research with these agents may
be performed on standard open laboratory benches without the use of special
containment equipment. However, eating and drinking are generally prohibited in
laboratory areas.[8] Potentially infectious material must be decontaminated before
disposal, either by adding an appropriate disinfectant, or by packaging for
decontamination elsewhere.[8] Personal protective equipment is only required for
circumstances where personnel might be exposed to hazardous material.[8] BSL-1
laboratories must have a door which can be locked to limit access to the lab,
CDC technician dons an older-model however it is not necessary for BSL-1 labs to be isolated from the general
positive-pressure suit before entering
building.[9]
one of the CDC’s earlier maximum
containment labs.
This level of biosafety is appropriate for work with several kinds of microorganisms
including non-pathogenic Escherichia coli, Bacillus subtilis, Saccharomyces
cerevisiae and other organisms not suspected to contribute to human disease.[10] Due to the relative ease and safety of maintaining a
BSL-1 laboratory, these are the types of laboratories generally used as teaching spaces forhigh schools and colleges.[9]

Biosafety level 2
At this level, all precautions used at Biosafety Level 1 are followed, and some additional precautions are taken. BSL-2 differs from
BSL-1 in that:

Laboratory personnel have specific training in handling pathogenic agents and are directed by scientists with
advanced training.
Access to the laboratory is limited when work is being conducted.
Extreme precautions are taken with contaminated sharp items.
Certain procedures in which infectious aerosols or splashes may be created are conducted inbiological safety
cabinets or other physical containment equipment.[8]
Biosafety level 2 is suitable for work involving agents of moderate potential hazard to personnel and the environment.[9] This
includes various microbes that cause mild disease to humans, or are difficult to contract via aerosol in a lab setting.[11] Examples
include Hepatitis A, B, and C viruses, human immunodeficiency virus (HIV), pathogenic Escherichia coli, Staphylococcus aureus,
Salmonella, Plasmodium falciparum, and Toxoplasma gondii.[11][12]
Biosafety level 3
Biosafety level 3 is appropriate for work involving microbes which can cause
serious and potentially lethal disease via the inhalation route.[8] This type of work
can be done in clinical, diagnostic, teaching, research, or production facilities.[9]
Here, the precautions undertaken in BSL-1 and BSL-2 labs are followed, as well as
additional measures including:

All laboratory personnel are provided medical surveillance and of

fered
relevant immunizations (where available) to reduce the risk of an
accidental or unnoticed infection.[8]
All procedures involving infectious material must be done within a
biological safety cabinet.[8]
Laboratory personnel must wear solid-front protective clothing (i.e.
gowns that tie in the back). This cannot be worn outside of the
laboratory and must be discarded or decontaminated after each use. [8]

A laboratory-specific biosafety manual must be drafted which details

how the laboratory will operate in compliance with all safety
requirements.[8]
In addition, the facility which houses the BSL-3 laboratory must have certain
Researcher at US Centers for
features to ensure appropriate containment. The entrance to the laboratory must be Disease Control, Atlanta, Georgia,
separated from areas of the building with unrestricted traffic flow.[8] Additionally, working with influenza virus under
the laboratory must be behind two sets of self-closing doors (to reduce the risk of biosafety level 3 conditions, with
aerosols escaping).[9] The construction of the laboratory is such that it can be easily respirator inside a biosafety cabinet
cleaned. Carpets are not permitted, and any seams in the floors, walls, and ceilings (BSC).

are sealed to allow for easy cleaning and decontamination.[8] Additionally, windows
must be sealed, and a ventilation system installed which forces air to flow from the
"clean" areas of the lab to the areas where infectious agents are handled.[8] Air from the laboratory must be filtered before it can be
recirculated.[8]

Biosafety level 3 is commonly used for research and diagnostic work involving various microbes which can be transmitted by
aerosols and/or cause severe disease. These include Francisella tularensis, Mycobacterium tuberculosis, Chlamydia psittaci,
Venezuelan equine encephalitis virus, Eastern equine encephalitis virus, SARS coronavirus, Coxiella burnetii, Rift Valley fever virus,
Rickettsia rickettsii, several species of Brucella, chikungunya, yellow fever virus, and West Nile virus.[12]

Biosafety level 4
Biosafety level 4 (BSL-4) is the highest level of biosafety precautions, and is
appropriate for work with agents that could easily be aerosol-transmitted within the
laboratory and cause severe to fatal disease in humans for which there are no
available vaccines or treatments.[8] BSL-4 laboratories are generally set up to be
either cabinet laboratories or protective-suit laboratories.[8] In cabinet laboratories,
all work must be done within a class III biosafety cabinet.[8] Materials leaving the
cabinet must be decontaminated by passing through an autoclave or a tank of
disinfectant.[8] The cabinets themselves are required to have seamless edges to allow
for easy cleaning. Additionally the cabinet and all materials within must be free of
[8] In a protective-suit The Galveston National Laboratory
sharp edges in order to reduce the risk of damage to the gloves.
BSL-4 lab on the Campus of the
laboratory, all work must be done in a class II biosafety cabinet by personnel
University of Texas Medical Branch
wearing a positive pressure suit.[8] In order to exit the BSL-4 laboratory, personnel
must pass through a chemical shower for decontamination, then a room for
removing the positive-pressure suit, followed by a personal shower.[8] Entry into the BSL-4 laboratory is restricted to trained and
[8]
authorized individuals, and all persons entering and exiting the laboratory must be recorded.
As with BSL-3 laboratories, BSL-4 laboratories must be separated from areas that receive unrestricted traffic. Additionally airflow is
tightly controlled to ensure that air always flows from "clean" areas of the lab to areas where work with infectious agents is being
performed.[8] The entrance to the BSL-4 lab must also employ airlocks to minimize the possibility that aerosols from the lab could be
removed from the lab. All laboratory waste, including filtered air, water, and trash must also be decontaminated before it can leave
the facility.[8]

Biosafety-level-4 laboratories are used for diagnostic work and research on easily transmitted pathogens which can cause fatal
disease. These include a number of viruses known to cause viral hemorrhagic fever such as Marburg virus, Ebola virus, Lassa virus,
Crimean-Congo hemorrhagic fever. Other pathogens handled at BSL-4 include Hendra virus, Nipah virus, and some Flaviviruses.
Additionally, poorly characterized pathogens which appear closely related to dangerous pathogens are often 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.[12] This level is also
used for work with Variola virus, the causative agent of smallpox, though this work can only be done at the World Health
Organization approved facilities at the Centers for Disease Control and Prevention in Atlanta, U.S.A., as well as the State Research
Center of Virology and Biotechnologyin Koltsovo, Russia.[13]

Regular inspection of positive-pressure SPECT machine at BSL-4 imaging

suits to locate any leaks[14] facility that separates subjects with
pathogens from the machines.[1]

The circular containment tube Air Pressure Resistant (APR) door to

separates the patient table in the "hot" separate the hot and cold zones
zone (pathogen present) from the
"cold" zone around thisMRI machine.
 Working inside a BSL-4 lab with air Inside a Class III biological safety
hoses providing positive air pressure. cabinet with an aerosol control platform

Effluent decontamination system of a

BSL-4 lab of NIAID

List of BSL-4 facilities

According to the U.S. Government Accountability Office (GAO) report published on October 4, 2007, a total of 1,356 CDC/USDA
registered BSL-3 facilities were identified throughout the United States.[15] Approximately 36% of these laboratories are located in
[15]
academia. 15 BSL-4 facilities were identified in the U.S. in 2007, including nine at federal labs.

The following is a list of existing BSL-4 facilities worldwide.

 Date
Name Location Description
established
National Service
of Healthcare and Diagnostic laboratory for Foot-and-mouth
Buenos Aires,
Agriculture
Argentina disease.[16]
Quality
(SENASA)
University of
Melbourne –
Melbourne,
Doherty Institute
Victoria, Australia
2014 Diagnostic reference lab.[17][18]
for Infection and
Immunity
Large diagnostic and research lab
Australian Animal Geelong, Victoria,
1985 equipped with two BSL-4 animal
Health Laboratory Australia
rooms.[18][19]

National High Operates under the auspice of the Victoria

Melbourne,
Security Infectious Diseases Reference
Victoria, Australia
Laboratory Laboratory.[20]
Located at the Canadian Science Centre
National for Human and Animal Health, it is jointly
Winnipeg,
Microbiology operated by the Public Health Agency of
Manitoba, Canada
Laboratory Canada and the Canadian Food
Inspection Agency.[21]

Wuhan Institute Wuhan Institute of Virology has existed

of Virology of the since 1956 and already hosted BSL3
Wuhan, Hubei,
Chinese 2015 laboratories. A BSL4 facility was
China
Academy of completed in 2015, and became the first
Sciences BSL-4 laboratory in China.[22]
Těchonín, Located at the Centrum biologické ochrany
Biological 1971, rebuilt
Pardubice Region,
Defense Center 2003-2007 (Biological Defense Center)[23]
Czech Republic

Jean Mérieux Lyon, Metropolis of Built and owned by the Fondation Mérieux.
1999
BSL-4 Laboratory Lyon, France Since 2004, operated by INSERM.[24]
Laboratoire de la Vert-le-Petit,
2013 Operated by the Ministry of Defense.[25]
DGA Essonne, France
Centre This facility is operated by a research
International de Franceville, Haut- organization supported by both Gabonese
Recherches Ogooué Province, (mainly) and French governments, and is
Médicales de Gabon
West Africa's only P4 lab (BSL-4).[26]
Franceville
Robert Koch
Berlin, Germany 2015 Diagnostic and experimental lab facility.[27]
Institute

Bernhard Nocht Part of the Leibniz Center Infection.

Hamburg,
Institute for National reference lab for tropical
Germany
Tropical Medicine viruses.[28]
Isle of Riems,
Greifswald, Focus on animal viral diseases and
Friedrich Loeffler
Mecklenburg- 2010
Institute diagnostics.[29]
Vorpommern,
Germany
Philipps Marburg, Hesse, 2008 Focuses on hemorrhagic fever viruses.[30]
University of Germany
Marburg

Országos Division of Virology operates three WHO

Epidemiológiai National Reference Laboratories. The
Központ – Budapest, Hungary 1998 BSL-4 biosafety laboratory provides a
National Center modern means to process dangerous
for Epidemiology imported zoonotic viral pathogens.[31]
High Security This facility deals especially to zoonotic
Animal Disease Bhopal, Madhya organisms and emerging infectious
1998
Laboratory Pradesh, India
disease threats.[32]
(HSADL)
Centre for National BSL-4 Containment Facility for
Hyderabad,
Cellular and 2009
Telangana, India Human Infectious Diseases.[33]
Molecular Biology
Microbial Run by the National Institute of
Pune,
Containment 2012
Maharashtra, India Virology.[34]
Complex
The "National Institute of Infectious
Diseases" used to operate within the
Istituto Nazionale
Lazzaro Spallanzani hospital; the facility is
per le Malattie Rome, Lazio, Italy 1997
now independent and is home to five BSL-
Infettive
3 labs as well as a single BSL-4 laboratory,
which was completed in 1997.[35]
Located at National Institute for Infectious
National Institute
Musashimurayama, Diseases, Department of Virology I. Built in
for Infectious 2015
Tokyo, Japan 1981; operated at BSL-3 until 2015 due to
Diseases
opposition from nearby residents.[36]
Institute of
Physical and Facility completed in 1984 but not
Tsukuba, Ibaraki
Chemical 1984 operated as BSL-4 due to local
Prefecture, Japan
Research opposition.[37]
(RIKEN)
State Research
Center of Virology Koltsovo, One of two WHO-approved facilities for
and Novosibirsk Oblast,
work on variola virus.[13]
Biotechnology Russia
(VECTOR)
National Institute
Johannesburg,
for [38]
Gauteng, South 2002
Communicable
Africa
Diseases
The only BSL-4 facility in the Nordic
Public Health
Solna, Stockholm region. Constructed for research and
Agency of 2001
County, Sweden diagnostics of hemorrhagic fever
Sweden
viruses.[39]
University Geneva, Canton of "Glove box" type laboratory; primarily for
Hospital of Geneva,
handling clinical samples.[40]
Geneva Switzerland
Spiez Laboratory Spiez, Canton of 2013 Run by Federal Office for Civil Protection
Bern, Switzerland and the Federal Department of Defence,
[41]
 Civil Protection and Sports.[41]
Part of the University of Zurich. Primary
Institute of Zurich, Canton of
purpose is diagnostics of highly pathogenic
Medical Virology Zurich, Switzerland
viruses.[41]
Taipei National
Institute of
Defense University, [42]
Preventive
Taipei, Republic of
Medicine
China
Department of Health laboratory.
Health Protection Colindale, Greater
Diagnostics for various viral diseases.[43]
Agency's Centre London, United
Part of the European Network of Biosafety-
for Infections Kingdom
Level-4 Laboratories.[44]

National Institute Mill Hill, Greater Medical Research Council laboratory.

for Medical London, United Research and diagnostics for highly
Research Kingdom pathogenic viruses.[43]
Biotechnology and Biological Sciences
Institute for Pirbright, Surrey,
Research Council laboratory. Research on
Animal Health United Kingdom
highly pathogenic animal diseases.[43]
Defence Science Porton Down, Ministry of Defense laboratory. Focuses on
and Technology Wiltshire, United
protection from biological weapons.[43]
Laboratory Kingdom
Department of Health laboratory.
Centre for Diagnostics and research for
Porton Down,
Emergency
Wiltshire, United haemorrhagic fever viruses.[43] Part of the
Preparedness
Kingdom European Network of Biosafety-Level-4
and Response
Laboratories.[44]
Camden, Greater Has BSL-4 space but does not work on
Francis Crick
London, United 2015
Institute human pathogens.[45]
Kingdom
National Institute Department of Health and Home Office
Potters Bar,
for Biological laboratory. Develop assays and reagents
Hertfordshire,
Standards and
United Kingdom for research on virulent pathogens.[43]
Control

Veterinary Addlestone, Department for Environment, Food and

Laboratories Surrey, United Rural Affairs laboratory. Diagnostics and
Agency Kingdom research for animal diseases.[43]
Private lab. Produces vaccines against
Merial Animal Pirbright, Surrey,
foot and mouth disease and bluetongue
Health United Kingdom
disease.[43]

Centers for Currently operates in two buildings. One of

Atlanta, Georgia,
Disease Control two facilities in the world that officially hold
United States
and Prevention smallpox.[13]
Georgia State Atlanta, Georgia,
1997 Research focus on B virus.[46]
University United States

National Bio and Under construction. Facility to be operated

Agro-Defense Manhattan, by the Department of Homeland Security,
2022
Facility (NBAF), Kansas, United and replace the Plum Island Animal
(expected)
Kansas State States Disease Center. Expected to be
University operational by 2022-2023.[47]
 National Institutes Bethesda, Located on the NIH Campus, it currently
of Health (NIH) Maryland, United only operates with BSL-3 agents.[48]
States
Fort Detrick, Operated by NIAID. Focuses on animal
Integrated
Maryland, United
Research Facility models of human diseases.[49]
States
National
Biodefense Fort Detrick, Operated by the Department of Homeland
Analysis and Maryland, United Security. Focus on potential bioterrorism
Countermeasures States threats.[50]
Center
US Army Medical
Research Run by the U.S. Army. Research focuses
Fort Detrick,
Institute of on biological threats to the U.S.
Maryland, United 1969
Infectious
States military.[51][52]
Diseases
(USAMRIID)
National
Emerging
Infectious Boston, Focus on potential threats to public
Diseases Massachusetts,
health.[53]
Laboratory United States
(NEIDL), Boston
University

Rocky Mountain Hamilton, Montana, NIAID laboratory. Focus on vector-borne

1928
Laboratories United States diseases.[54]
Galveston
National
Laboratory, Galveston, Texas, Opened in 2008, facility is operated by the
National United States University of Texas Medical Branch.[55]
Biocontainment
Facility

Galveston, Texas, Operated by the University of Texas

Shope Laboratory 2004
United States Medical Branch.[56]
Texas Biomedical San Antonio, The only privately owned BSL-4 lab in the
Research Texas, United 1999
US.[57]
Institute States

Centers for A BSL 3/4 facility that operates in

Disease Control Fort Collins, connection with some of CSU's biomedical
and Prevention, Colorado, United research programs. The Fort Collins,
Division of Vector States Colorado location specializes in arboviral
Borne Diseases and bacterial diseases.[58]

Safety concerns
A North Carolina Mosquito & Vector Control Association (NCMVCA) study highlighted safety concerns. In the United States
laboratories can be funded by federal, state, private, non-profit, or academically. The last accounts for 72% of the funding. There is
no central monitoring agency accountable for monitoring laboratories and standards vary according to funding, the age of the
[59]
laboratory, and is dependent on the size and whether it is SA approved.
High-containment labs that are registered with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of
Agriculture's (USDA) Select Agent Program must adhere to Department of Defense standards.[60] No single federal agency,
according to 12 agencies' responses to a GSA survey, has the mission to track the overall number of BSL-3 and BSL-4 labs in the
[61]
United States. This means no agency is responsible for determining the risks associated with the proliferation of these labs.

See also
Aeromedical Isolation Team
Biosafety
Biocontainment
Biological hazard
Hazmat suit
Laboratory Response Network
Safety engineering
Security engineering
Select agent

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External links
Biosafety in Microbiological and Biomedical Laboratories CDC
Federation of American Scientists: Biosafety Level 3 and 4 Labs

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