Biosafety level

Kaempf Jr., then a U.S. Army soldier, under the direction

of Dr. Arnold G. Wedum, Director (194469) 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 transfer to the sheet metal department working
with the contractor, the H.K. Ferguson Co.[4]
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.[5]
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 nonclassied sessions as well as classied 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.[6]
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.[6] The American Biological Safety Association (ABSA) was ocially 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.[6]

Essential features of a biosafety level 4 (BSL-4) laboratory[1]

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 1 (BSL-1) to
the highest at level 4 (BSL-4). In the United States, the
Centers for Disease Control and Prevention (CDC) have
specied these levels.[2] In the European Union, the same
biosafety levels are dened in a directive.[3] 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 equip- 2 Levels
ment. At higher biosafety levels, precautions may include
airow systems, multiple containment rooms, sealed containers, positive pressure personnel suits, established pro- 2.1 Biosafety level 1
tocols for all procedures, extensive personnel training,
and high levels of security to control access to the facility. 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
1 History
environment.[7] At this level, precautions are limited relative to other levels. Laboratory personnel must wash their
The rst prototype Class III (maximum containment) hands upon entering and exiting the lab. Research with
biosafety cabinet was fashioned in 1943 by Hubert these agents may be performed on standard open labo1

LEVELS

Laboratory personnel have specic 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 in
biological safety cabinets or other physical containment equipment.[7]
Biosafety level 2 is suitable for work involving agents
of moderate potential hazard to personnel and the
environment.[8] This includes various microbes that
cause mild disease to humans, or are dicult to contract via aerosol in a lab setting.[10] Examples include Hepatitis A, B, and C viruses, human immunodeciency virus (HIV), pathogenic Escherichia coli,
Staphylococcus aureus, Salmonella, Plasmodium falciparum, and Toxoplasma gondii.[10][11]

2.3 Biosafety level 3

CDC technician dons an older-model positive-pressure suit before
entering one of the CDCs earlier maximum containment labs.

ratory benches without the use of special containment

equipment. However, eating and drinking are generally
prohibited in laboratory areas.[7] Potentially infectious
material must be decontaminated before disposal, either
by adding an appropriate disinfectant, or by packaging for
decontamination elsewhere.[7] Personal protective equipment is only required for circumstances where personnel
might be exposed to hazardous material.[7] BSL-1 laboratories must have a door which can be locked to limit
access to the lab, however it is not necessary for BSL-1
labs to be isolated from the general building.[8]
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.[9] Due to the relative ease and safety
of maintaining a BSL-1 laboratory, these are the types
of laboratories generally used as teaching spaces for high
schools and colleges.[8]

2.2

Biosafety level 2

Researcher at US Centers for Disease Control, Atlanta, Georgia,

working with inuenza virus under biosafety level 3 conditions,
with respirator inside a biosafety cabinet (BSC).

At this level, all precautions used at Biosafety Level 1

are followed, and some additional precautions are taken. Biosafety level 3 is appropriate for work involving microbes which can cause serious and potentially lethal disBSL-2 diers from BSL-1 in that:

2.4

Biosafety level 4

ease via the inhalation route.[7] This type of work can be

done in clinical, diagnostic, teaching, research, or production facilities.[8] 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 oered relevant immunizations
(where available) to reduce the risk of an accidental
or unnoticed infection.[7]
All procedures involving infectious material must be
done within a biological safety cabinet.[7]
Laboratory personnel must wear solid-front protective clothing (i.e. gowns that tie in the back). This The Galveston National Laboratory BSL-4 lab on the Campus of
cannot be worn outside of the laboratory and must the University of Texas Medical Branch
be discarded or decontaminated after each use.[7]
A laboratory-specic biosafety manual must be
cabinet.[7] Materials leaving the cabinet must be decondrafted which details how the laboratory will opertaminated by passing through an autoclave or a tank of
ate in compliance with all safety requirements.[7]
disinfectant.[7] The cabinets themselves are required to
have seamless edges to allow for easy cleaning. AdditionIn addition, the facility which houses the BSL-3 labora- ally the cabinet and all materials within must be free of
tory must have certain features to ensure appropriate con- sharp edges in order to reduce the risk of damage to the
tainment. The entrance to the laboratory must be sepa- gloves.[7] In a protective suit laboratory, all work must be
rated from areas of the building with unrestricted trac done in a class II biosafety cabinet by personnel wearing
ow.[7] Additionally, the laboratory must be behind two a positive pressure suit.[7] In order to exit the BSL-4 labsets of self-closing doors (to reduce the risk of aerosols oratory, personnel must pass through a chemical shower
escaping).[8] The construction of the laboratory is such for decontamination, then a room for removing the posithat it can be easily cleaned. Carpets are not permitted, tive pressure suit, followed by a personal shower.[7] Entry
and any seams in the oors, walls, and ceilings are sealed into the BSL-4 laboratory is restricted to trained and auto allow for easy cleaning and decontamination.[7] Addi- thorized individuals, and all persons entering and exiting
tionally, windows must be sealed, and a ventilation system the laboratory must be recorded.[7]
installed which forces air to ow from the clean areas of
the lab to the areas where infectious agents are handled.[7] As with BSL-3 laboratories, BSL-4 laboratories must be
Air from the laboratory must be ltered before it can be separated from areas that receive unrestricted trac. Additionally airow is tightly controlled to ensure that air alrecirculated.[7]
ways ows from clean areas of the lab to areas where
Biosafety level 3 is commonly used for research and work with infectious agents is being performed.[7] The
diagnostic work involving various microbes which can entrance to the BSL-4 lab must also employ airlocks to
be transmitted by aerosols and/or cause severe disease. minimize the possibility that aerosols from the lab could
These include Francisella tularensis, Mycobacterium tu- be removed from the lab. All laboratory waste, including
berculosis, Chlamydia psittaci, Venezuelan equine en- ltered air, water, and trash must also be decontaminated
cephalitis virus, Eastern equine encephalitis virus, before it can leave the facility.[7]
SARS coronavirus, Coxiella burnetii, Rift Valley fever
virus, Rickettsia rickettsii, several species of Brucella, Biosafety level 4 laboratories are used for diagnostic work
chikungunya, yellow fever virus, and West Nile virus.[11] 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 hemor2.4 Biosafety level 4
rhagic fever. Other pathogens handled at BSL-4 include
Biosafety level 4 (BSL-4) is the highest level of biosafety Hendra virus, Nipah virus, and some Flaviviruses. Adprecautions, and is appropriate for work with agents that ditionally, poorly characterized pathogens which appear
could easily be aerosol-transmitted within the laboratory closely related to dangerous pathogens are often handled
and cause severe to fatal disease in humans for which at this level until sucient data are obtained either to conthere are no available vaccines or treatments.[7] BSL-4 rm continued work at this level, or to work with them
laboratories are generally set up to be either cabinet labo- at a lower level.[11] This level is also used for work with
ratories or protective suit laboratories.[7] In cabinet labo- Variola virus, the causative agent of smallpox, though
ratories, all work must be done within a class III biosafety this work can only be done at the World Health Orga-

nization-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 Biotechnology in
Koltsovo, Russia.[12]
Regular inspection of positive pressure suits to locate any leaks[1]
SPECT machine at BSL-4 imaging facility that separates subjects with pathogens from the machines.[2]
The circular containment tube separates the patient
table in the hot zone (pathogen present) from the
cold zone around this MRI machine.
Air Pressure Resistant (APR) door to separate the
hot and cold zones
Working inside a BSL-4 lab with air hoses providing
positive air pressure.
Inside a Class III biological safety cabinet with a
aerosol control platform

Hazmat suit
Laboratory Response Network
Safety engineering
Security engineering
Select agent

5 References
[1] Integrated Research Facility. niaid.nih.gov. NIAID.
Retrieved 14 November 2014.
[2] Richmond JY, McKinney RW (editors) (1999). Biosafety
in Microbiological and Biomedical Laboratories (4th ed.).
ISBN 0-7881-8513-6.
[3] Council Directive 90/679/EEC of 26 November 1990 on
the protection of workers from risks related to exposure
to biological agents at work, OJ No. L 374, p. 1.

Euent decontamination system of a BSL-4 lab of

NIAID

[4] Covt, Norman M. (1997), A History of Fort Detrick,

Maryland, 3rd edition. Kaempf retired from Fort Detrick in 1994, having completed more than 50 years service. He was chief of the mechanical branch, Directorate
of Engineering and Housing.

1. ^ Seligson, Susan (7 March 2013). Video Oers

Glimpse of Biosafety Level 4 Lab Science webcast
threads the NEIDL"". BU Today. Retrieved 5 December 2014.

[5] Manuel S. Barbeito; Richard H. Kruse. A History of the

American Biological Safety Association. American Biological Safety Association. Retrieved 2008-08-14.

2. ^ Cite error: The named reference irf was invoked

but never dened (see the help page).

[6] American Biological Safety Association Collection :

NAL Collections : National Agricultural Library. United
States Department of Agriculture: National Agricultural
Library. 2009-02-11. Retrieved 2009-02-11.

List of BSL-4 facilities

This list is incomplete; you can help by expanding it.

[7] Section IV-Laboratory Biosafety Level Criteria.

Biosafety in Microbiological and Biomedical Laboratories,
5th ed. (PDF). U.S. Department of Health and Human
Services. December 2009. pp. 3059. Retrieved 2 April
2016.

According to the U.S. Government Accountability Oce [8]

(GAO) report published on October 4, 2007, a total of
1,356 CDC/USDA registered BSL-3 facilities were iden- [9]
tied throughout the United States.[13] Approximately
36% of these laboratories are located in academia. 15
BSL-4 facilities were identied in the U.S. in 2007, in[10]
cluding nine at federal labs.[13]
The following is a list of existing BSL-4 facilities worldwide.

REFERENCES

See also
Aeromedical Isolation Team
Biosafety
Biocontainment
Biological hazard

Richmond JY. The 1, 2, 3s of Biosafety Levels (PDF).

Retrieved 2 April 2016.
Health & Safety Manual - Biological Safety. Columbia
University Environmental Health and Safety. Retrieved 2
April 2016.
Section III-Principles of Biosafety. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. (PDF).
U.S. Department of Health and Human Services. December 2009. pp. 2228. Retrieved 9 April 2016.

[11] For a list of infectious agents and the recommended

biosafety level at which they should be studied, see Section VIII-Agent Summary Statements. Biosafety in Microbiological and Biomedical Laboratories, 5th ed. (PDF).
U.S. Department of Health and Human Services. December 2009. pp. 123289. Retrieved 9 April 2016.
[12] Section VIII-Agent Summary Statements. Biosafety
in Microbiological and Biomedical Laboratories, 5th ed.
(PDF). U.S. Department of Health and Human Services.
December 2009. p. 219. Retrieved 4 May 2016.

[13] High-Containment Biosafety Laboratories: Preliminary

Observations on the Oversight of the Proliferation of
BSL-3 and BSL-4 Laboratories in the United States
(pdf). United States Government Accountability Oce.
Oct 4, 2007. Retrieved 26 May 2016.
[14] Risk Analysis:Risk of Importing Foot-and-Mouth Disease in Susceptible Species and Products from a region of
Patagonia, Argentina (PDF). U.S. Department of Agriculture, National Import Export Services, Veterinary Services. January 2014. pp. 6062. Retrieved 3 April 2016.
[15] Members: The Doherty Institute for Infection and Immunity. Global Virus Network. Retrieved 3 April 2016.
[16] Racaniello V (14 July 2014). Visiting biosafety level-4
laboratories. Virology Blog. Retrieved 3 April 2016.
[17] Committee on Anticipating Biosecurity Challenges of the
Global Expansion of High-Containment Biological Laboratories (15 December 2011). 8: Requirements for and
Challenges Associated with BSL-4 Labs (Plenary Session)". Biosecurity Challenges of the Global Expansion
of High-Containment Biological Laboratories. National
Academies Press (US). ISBN 9780309225755. Retrieved
3 April 2016.
[18] Laboratories: High Security/Quarantine. Victorian Infectious Diseases Reference Laboratory. Retrieved 8
April 2016.
[19] National Microbiology Laboratory (NML) Overview.
Public Health Agency of Canada. Retrieved 8 April 2016.
[20] China Inaugurates the First Biocontainment Level 4 Laboratory in Wuhan. Wuhan Institute of Virology, Chinese Academy of Sciences. 3 February 2015. Retrieved
9 April 2016.

[30] Bio-containment Laboratory. National Institute of High

Security Animal Diseases, India. Retrieved 20 April
2016.
[31] Stone laid for stem cell research lab in Hyderabad. The
Hindu. Retrieved 25 April 2016.
[32] NIV Prune lab gets BSL-4. The Hindu. Retrieved 24
April 2016.
[33] Storia dell'Istituto (in Italian). IRCCS Lazzaro Spallanzani. Retrieved 1 May 2016.
[34] Deadly disease lab opens amid local fears. Japan Times.
15 October 2015. Retrieved 1 May 2016.
[35] Bio lab handling highly dangerous agents to open in suburban Tokyo. The Mainichi. 3 August 2015. Retrieved
4 May 2016.
[36] South Africa National Institute for Communicable Diseases. African National Public Health Institutes. Retrieved 4 May 2016.
[37] P4-laboratoriet vid Folkhlsomyndigheten
Swedish). Public Health Agency of Sweden.
trieved 8 October 2014.

(in
Re-

[38] Cherpillod, P. Management of suspect viral hemorrhagic fever patient in Geneva. Schweizerische Union fur
Labormedizin. Retrieved 10 May 2016.
[39] Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological)
and Toxin Weapons and on their Destruction (PDF).
Switzerland Federal Department of Defence, Civil Protection, and Sports. 2016. Retrieved 10 May 2016.

[21] Biological Defence Department at Techonin. Ministry

of Defense & Armed Forces of the Czech Republic. Retrieved 9 April 2016.

[40] Case of SARS reported in a laboratory research worker

in Taiwan. Eurosurveillance. 18 December 2003. Retrieved 18 May 2016.

[22] Jean Mrieux BSL-4 Laboratory. Fondation Mrieux.

Retrieved 11 April 2016.

[41] Davison N; Lentzos F (2012). E8: High-Containment

Laboratories-UK Case Study. Biosecurity Challenges
of the Global Expansion of High-Containment Biological
Laboratories. pp. 176177. ISBN 978-0-309-22575-5.
Retrieved 26 May 2016.

[23] Inauguration du laboratoire biologique P4 de la DGA

(in French). Ministre de la Dfense. Retrieved 11 April
2016.

[26] Bernhard Nocht Institute for Tropical Medicine (BNI)".

Heinrich Pette Institute. Retrieved 16 April 2016.

[42] Nisii, Carla; Castilletti, Concetta; Raoul, Herv; Hewson, Roger; Brown, David; Gopal, Robin; Eickmann,
Markus; Gunther, Stephan; Mirazimi, Ali; Koivula, Tuija; Feldmann, Heinz; Di Caro, Antonino; Capobianchi,
Maria R.; Ippolito, Giuseppe (2013). Biosafety Level-4
Laboratories in Europe: Opportunities for Public Health,
Diagnostics, and Research. PLoS Pathogens 9 (1):
e1003105. doi:10.1371/journal.ppat.1003105. PMC
3547859. PMID 23349630.

[27] Friedrich Loeer Institute, Germany. Caverion. Retrieved 16 April 2016.

[43] Ewen Callaway (6 June 2013). London biomedical hub

sets its research agenda. Nature. Retrieved 26 May 2016.

[28] Philipps-University Marburg. Philipps-University Marburg. Retrieved 16 April 2016.

[44] Operating a BSL-4 Laboratory in a University Setting.

Tradeline. 16 December 2003. Retrieved 28 May 2016.

[29] Division of Virology.

Orszgos Epidemiolgiai
Kzpont. Retrieved 16 April 2016.

[45] Leveraging the National Bio and Agro-defense Facility.

Kansas State University. Retrieved 28 May 2016.

[24] Centre International de Recherches Medicales de

Franceville (in French). CIRMF. Retrieved 30 September 2014.
[25] Das Hochsicherheitslabor im Robert Koch-Institut.
Robert Koch Institut. Retrieved 16 April 2016.

[46] An Integrated Research Facility: Questions and Answers. National Institute of Allergy and Infectious Diseases. Retrieved 28 May 2016.
[47] Integrated Research Facility Overview. National Institute of Allergy and Infectious Disease. Retrieved 28 May
2016.
[48] National Biodefense Analysis and Countermeasures
Center. Department of Homeland Security. Retrieved
28 May 2016.
[49] USAMRIID: Biodefense Solutions to Protect our Nation. U.S. Army Medical Department. Retrieved 28 May
2016.
[50] USAMRIID Biological Safety. U.S. Army Medical Department. Retrieved 28 May 2016.
[51] National Emerging Infectious Diseases Laboratories:
About - Mission and Safety. Boston University. Retrieved 28 May 2016.
[52] Rocky Mountain Labs Overview. National Institute for
Allergy and Infectious Disease. Retrieved 28 May 2016.
[53] Galveston National Laboratory Fact Sheet. Retrieved
30 September 2014.
[54] Center for Biodefense and Emerging Infectious Diseases:
Safety and Biocontainment. UTMB Health. Retrieved
28 May 2016.
[55] About Texas Biomed: Biosafety Level 4 Laboratory.
Texas Biomedical Research Institute. Retrieved 3 April
2016.

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

EXTERNAL LINKS

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Biosafety level Source: https://en.wikipedia.org/wiki/Biosafety_level?oldid=725088466 Contributors: Mbecker, Dmd3e, Dominus,

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