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A biosafety level is the level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed facility. The levels of containment range from the lowest biosafety level 1 to the highest at level 4. In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels.[1] In the European Union, the same biosafety levels are defined in a directive.[2]

Contents

History

The first prototype Class III cabinet was fashioned in 1943 by Hubert Kaempf, 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, Fort 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.[3]

On 18 April 1955, fourteen representatives met in 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[4][5] Because of the potential implication of the work conducted at biological warfare laboratories, the conferences was restricted to top level security clearances. Begininning in 1957, these conferences were planned to include non-classified sessions as well 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.[6]

Over the first 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 grew to include representatives from universities, private laboratories, hospitals, and industrial complexes. Throughout the 1970s participations in the conferences continued to grow, and by 1983 discussions began considering the creation of a formal organization.[6]

The American Biological Safety Association (ABSA) was officially established in 1984, and a constitution and bylaws were drafted in 1984. As of 2008, ABSA has grown to include 1,600 members in its professional association.[6]

Rationale

Biocontainment can be classified by the relative danger to the surrounding environment as biological safety levels (BSL). As of 2006, there are four safety levels. These are called BSL1 through BSL4, with one anomalous level BSL3-ag for agricultural hazards between BSL3 and BSL4. Higher numbers indicate a greater risk to the external environment. See biological hazard.

At the lowest level of biocontainment, the containment zone may only be a chemical fume hood. At the highest level the containment involves isolation of the organism by means of building systems, sealed rooms, sealed containers, personal isolation equipment commonly referred to as "space suits" and elaborate procedures for entering the room, and decontamination procedures for leaving the room. In most cases this also includes high levels of security for access to the facility, ensuring that only authorized personnel may be admitted to any area that may have some effect on the quality of the containment zone. This is considered a hot zone.

Levels

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Biosafety level 1

This level 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 (CDC,1997).[7]

It includes several kinds of bacteria and viruses including canine hepatitis, non-pathogenic Escherichia coli, as well as some cell cultures and non-infectious bacteria. At this level precautions against the biohazardous materials in question are minimal, most likely involving gloves and some sort of facial protection. 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. Usually, contaminated materials are left in open (but separately indicated) rubbish receptacles. Decontamination procedures for this level are similar in most respects to modern precautions against everyday microorganisms (i.e., washing one's hands with anti-bacterial soap, washing all exposed surfaces of the lab with disinfectants, etc.). In a lab environment all materials used for cell and/or bacteria cultures are decontaminated via autoclave. 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

This level is similar to Biosafety Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment.[7] It includes various bacteria and viruses that cause only mild disease to humans, or are difficult to contract via aerosol in a lab setting, such as C. difficile, hepatitis A, B, and C, influenza A, Lyme disease, dengue fever, Salmonella, mumps, measles, HIV,[8] scrapie, MRSA, and VRSA. Genetically modified organisms have also been classified as level 2 organisms, even if they pose no direct threat to humans. This designation is used to limit the release of modified organisms into the environment. Approval by the FDA is required to release these organisms. An example is genetically modified food crops. BSL-2 differs from BSL-1 in that:

  1. laboratory personnel have specific training in handling pathogenic agents and are directed by scientists with advanced training;
  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

This level 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 after inhalation.[7] It includes various bacteria and viruses that can cause severe to fatal disease in humans, but for which vaccines or other treatment exist, such as Mycobacterium tuberculosis, Bacillus anthracis, West Nile virus, Venezuelan equine encephalitis virus, Eastern equine encephalitis virus, Hendra virus, SARS coronavirus, Salmonella typhi, Coxiella burnetii, Rift Valley fever virus, Rickettsia rickettsii, and yellow fever virus.

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. This is considered a neutral or warm zone.

All procedures involving the manipulation of infectious materials are conducted within biological safety cabinets or other physical containment devices, or by personnel wearing appropriate personal protective clothing and equipment. The laboratory has special engineering and design features.

It is recognized, however, that some existing facilities may not have all the facility features recommended for Biosafety Level 3 (i.e., double-door access zone and sealed penetrations). In this circumstance, an acceptable level of safety for the conduct of routine procedures, (e.g., diagnostic procedures involving the propagation of an agent for identification, typing, susceptibility testing, etc.), may be achieved in a biosafety level 2 facility, providing

  1. the filtered exhaust air from the laboratory room is discharged to the outdoors,
  2. the ventilation to the laboratory is balanced to provide directional airflow into the room,
  3. access to the laboratory is restricted when work is in progress, and
  4. the recommended Standard Microbiological Practices, Special Practices, and Safety Equipment for Biosafety Level 3 are rigorously followed.

The decision to implement this modification of biosafety level 3 recommendations is made only by the laboratory director.

Biosafety level 4

This level is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections, agents which cause severe to fatal disease in humans for which vaccines or other treatments are not available, such as Bolivian and Argentine hemorrhagic fevers, Marburg virus, Ebola virus, Lassa fever, Crimean-Congo hemorrhagic fever, Smallpox, and other various hemorrhagic diseases. When dealing with biological hazards at this level the use of a Hazmat suit and a self-contained oxygen supply is mandatory. The entrance and exit of a Level Four biolab will contain multiple showers, a vacuum room, an ultraviolet light room, and other safety precautions designed to destroy all traces of the biohazard. Multiple airlocks are employed and are electronically secured to prevent both doors opening at the same time. All air and water service going to and coming from a biosafety level 4 lab will undergo similar decontamination procedures to eliminate the possibility of an accidental release.

Agents with a close or identical antigenic relationship to Biosafety Level 4 agents are handled at this level until sufficient data is 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 qualified 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. Building protocols for preventing contamination often use negatively pressurized facilities, which, if compromised, would severely inhibit the containment of an outbreak of aerosol pathogens.

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 Biosafety Level 4 laboratory has special engineering and design features to prevent microorganisms from being disseminated into the environment. The laboratory is kept at negative air pressure, so that air flows into the room if the barrier is penetrated or breached. Furthermore, an airlock is used during personnel entry and exit.

List of BSL-3 and BSL-4 facilities

Name Location Level Established Discontinued Description
Virology Laboratory of the Queensland Department of Health Australia, Queensland, Coopers Plains 4
Australian Animal Health Laboratory Australia, Victoria, Geelong 4
Infectious Diseases Unit, St.John's Research Institute India, Bangalore 3
All India Institute of Medical Sciences India, New Delhi 1-4 1993 One of the premier research institute & conducts studies on major pathogenic organisms. Has been contributed in discovering novel strains & vaccines.
National JALMA Institute for Leprosy & Other Mycobacterial Diseases (NCJILOMD), Agra India, Agra 3 2002 This facility deals with the Mycobacterial strains & their pathogenicity & epidemiology.
National High Security Laboratory Australia, Victoria, North Melbourne 4 National High Security Laboratory Operates under the auspice of the Victoria Infectious Diseases Reference Laboratory.
Curtin University of Technology Australia, Western Australia, Bentley 3
Fundação Oswaldo Cruz Brazil, Rio de Janeiro 3 It is unclear whether this facility operates as a BSL-4. Brazil doesn't have any BSL-4 facilities[citation needed]
University of São Paulo Brazil, São Paulo 3 It is unclear whether this facility operates as a BSL-4. Brazil doesn't have any BSL-4 facilities[citation needed]
Instituto Adolf Lutz Brazil 3
Instituto Butantan Brazil 3
British Columbia Centre for Disease Control Canada, British Columbia 3 The British Columbia Centre for Disease Control, operates three biosafety level 3 labs.
National Microbiology Laboratory Canada, Manitoba, Winnipeg 4 Located at the Canadian Science Centre for Human and Animal Health, it is jointly operated by the Public Health Agency of Canada and the Canadian Food Inspection Agency.
Centre National de Biologie Expérimentale Canada, Quebec, Laval 3 Located at the Institut national de la recherche scientifique.
Vaccine and Infectious Disease Organization (VIDO) Canada, Saskatchewan, Saskatoon 2 1975 N/A University of Saskatchewan's Vaccine and Infectious Disease Organization is a pre-eminent research institute investigating the pathogenesis of infectious diseases and the development of effective therapeutic and prophylactic methods to control infectious diseases of humans and animals.
Canada, Ontario, Toronto 4 This facility never opened due to community opposition in the 1990s.
Center of Biological Protection Czech Republic 4 Located at the Centrum biologické ochrany Těchonín (Center of Biological Protection)[9]
National Institute for Health and Welfare Finland, Hermanni, Helsinki 3 Document from National Institute for Health and Welfare that mentios the facility.[10]
National Institute for Health and Welfare Finland, Tilkanmäki, Helsinki 3 Document from National Institute for Health and Welfare that mentios the facility.[10]
Laboratoire P4 Jean Mérieux France, Rhône-Alpes, Lyon 4 1999-03-05 Jean Mérieux laboratory is a co-operation between the Pasteur Institute and INSERM. Note that in France, it is P4 for Pathogen or Protection level 4.[11]
Centre International de Recherches Médicales de Franceville Gabon 4 This facility is operated by a research organization supported by the French government, operates West Africa's only BSL-4 lab.[12]
Robert Koch Institute Germany, Berlin 4 The facility was licenced for construction by City of Berlin on November 30, 2008.
Bernhard Nocht Institute for Tropical Medicine Germany, Hamburg 4
Philipps University of Marburg Germany, Marburg 4 2008 The facility is licenced to work with genetically modified organisms
Wehrwissenschaftliches Institut für Schutztechnologien Germany, Munster 3
Friedrich Loeffler Institute on Island Riems Germany, Island Riems 4 2010 Deals especially with virology
Evangelismos Greece, Athens 3 2003
Crete University, Pagne hospital, Clinical bacteriology lab Greece, Heraklion 3 2003
High Security Animal Disease Laboratory (HSADL) India, Bhopal 4 1998 This facility deals especially to zoonotic organisms and emerging infectious disease threats.
Institute of Tropical Disease (ITD) Indonesia, East Java, Surabaya 3 2008 Operated by Institute of Tropical Disease - Airlangga University, Build Cooperation with Japan.
Azienda Ospedaliera Ospedale Luigi Sacco Italy, Lombardy, Milano 4 A university hospital in Polo Universitario; it contains two special vehicles for transporting infectious persons.
Istituto Nazionale Malattie Infettive Italy, Rome, Rome 4 This facility, (trans.) National Institute of Infectious Diseases, operates within the Lazzaro Spallanzani Hospital.
Institute for Medical Research (IMR), Ministry of Health Malaysia, Kuala Lumpur 3 This facility is able to conduct research and tests on acarology, bacteriology, medical entomology, parasitology and virology.
National Institute for Infectious Diseases Japan, Kantō, Tokyo 3 Located at National Institute for Infectious Diseases, Department of Virology I; this lab has the potential of operating as a BSL-4, however it is limited to perform work on only BSL-3 agents due to opposition from local residents and communities.
Institute of Physical and Chemical Research Japan, Kantō, Tsukuba This is a non-operating BSL-4 facility.
Netherlands National Institute for Public Health and the Environment (RIVM) Netherlands, Bilthoven 3 - 4 2009 Currently under construction, it is planned to be finished by the end of 2009. It is planned to operate as a BSL 3 and a BSL 4 facility.
Wuhan Institute of Virology of the Chinese Academy of Sciences People's Republic of China, Hubei, Wuhan 3 - 4 2010 (P4) Wuhan Institute of Virology already hosts a BSL-3 laboratory. A distinct BSL-4 facility is currently being built based on P4 standards, the original technology for confinement developed by France.[13][14] It will be the first at level 4 in China, under the direction of Shi Zhengli.[15]
State Research Center of Virology and Biotechnology VECTOR Russia, Novosibirsk Oblast, Koltsovo 1 - 4 It is one of two facilities in the world that officially hold smallpox. The other Russian BSL-4 facilities have been dismantled.
Defence Science Organization (DSO) Singapore 4 Defence Science Organization goal is to conduct autopsies during a potential deadly epidemic outbreak. Singapore also has a mobile BSL-4 autopsy facility, perhaps the only one of its kind in the world.[16]
National Institute for Communicable Diseases South Africa, Johannesburg 4 National Institute for Communicable Diseases of Special Pathogens Unit is one of only two BSL-4 facilities in Africa but the only suit laboratory on the continent.
National Public Health Laboratory (NPHL), Ministry of Health Malaysia, Sungai Buloh, Selangor 3 The NPHL is established to develop laboratory-based surveillance systems for infectious diseases of epidemic and pandemic potential as part of an early warning system and response strategies for outbreaks of infectious diseases.
Swedish Institute for Infectious Disease Control Sweden, Solna 4 Swedish Institute for Infectious Disease Control is Scandinavia's P4 facility.
Institute of Virology and Immunoprophylaxis (IVI) Switzerland, Mittelhäusern 4 2007-02-01 This facility only deals with animal diseases which do not transmit to humans, and is the only P4 facility where complete isolation suits are not used.
High Containment Laboratory DDPS (SiLab) Switzerland, Spiez 4 Under construction, it will start operations in 2010. This laboratory will comply with BSL-4 standards.
Preventive Medical Institute of ROC Ministry of National Defense Republic of China (Taiwan) 4
Kwen-yang Laboratory (昆陽實驗室) Center of Disease Control Republic of China (Taiwan) 4 Part of the Department of Health Republic of China.
Health Protection Agency's Centre for Infections United Kingdom, Colindale 4 Located in the Viral Zoonosis unit.
National Institute for Medical Research United Kingdom, London 4
Defence Science and Technology Laboratory United Kingdom, Porton Down 4
United Kingdom 4 Under construction.
Centers for Disease Control and Prevention United States of America, Georgia, Atlanta 4 Currently operates in two buildings. One of two facilities in the world that officially hold smallpox.
George Mason University Biomedical Research Laboratory United States of America, Virginia, Manassas 3 This facility is currently under construction on a 10-acre site adjacent to George Mason University's Prince William Campus. It is scheduled to be fully operational in the Spring of 2010.
Georgia State University United States of America, Georgia, Atlanta 4 Is an older design "glovebox" facility.
Integrated Research Facility United States of America, Maryland, Fort Detrick 4 Under construction. This facility will be operated by National Institute of Allergy and Infectious Diseases (NIAID), it is planned to begin operating at 2009 at the earliest.
National Biodefense Analysis and Countermeasures Center (NBACC) United States of America, Maryland, Fort Detrick 4 Under construction, it will be operated for the Department of Homeland Security.
National Institutes of Health (NIH) United States of America, Maryland, Bethesda 4 Located on the NIH Campus, it currently only operates with BSL-3 agents.
US Army Medical Research Institute of Infectious Diseases (USAMRIID) United States of America, Maryland, Fort Detrick 4 Old building
US Army Medical Research Institute of Infectious Diseases (USAMRIID) United States of America, Maryland, Fort Detrick 4 New building, currently under design construction
National Emerging Infectious Diseases Laboratory (NEIDL) United States of America, Massachusetts, Boston 4 Under construction by Boston University, building and staff training complete, waiting for regulatory approval.
NIAID Rocky Mountain Laboratories United States of America, Montana, Hamilton 4 Under construction, it is planned to begin operation in 2009 at the earliest.
Stony Brook University Centers for Molecular Medicine Center for Infectious Diseases United States of America, New York, Stony Brook 3 1999 Operated by State University of New York at Stony Brook, a BSL-3 facility studying Borrelia burgdorferi (Lyme Disease), Yersinia pestis (Bubonic plague) and Francisella tularensis (Rabbit fever)
University of Cincinnati United States of America, Ohio, Cincinnati 3 University of Cincinnati Medical Sciences Building
Battelle Memorial Institute United States of America, Ohio, West Jefferson 3
Galveston National Laboratory, National Biocontainment Facility United States of America, Texas, Galveston 4 Opened in 2008, facility is operated by the University of Texas Medical Branch.[17]
Shope Laboratory United States of America, Texas, Galveston 4 Operated by the University of Texas Medical Branch (UTMB).
Southwest Foundation for Biomedical Research United States of America, Texas, San Antonio 4 The only privately-owned BSL-4 lab in the US.
Division of Consolidated Laboratory Services United States of America, Virginia, Richmond 4 This facility is part of the Department of General Services of the Commonwealth of Virginia. It is so called "surge" BSL-4 capacity.
National Bio and Agro-Defense Facility (NBAF) United States of America, Kansas State University, Manhattan, Kansas 4 Facility to be operated by the Department of Homeland Security, and replace the Plum Island Animal Disease Center. Planned to be operational by 2014.
Plum Island Animal Disease Center United States of America, New York, Plum Island 3-ag Facility scheduled to be replaced by the National Bio and Agro-Defense Facility. Researches zoonotic pathogens only.
Saint Louis University Doisy Research Building United States of America, Missouri, St. Louis 3 Saint Louis University's new center for biomedical research. Monkeypox is the primary BSL-3 agent studied.
University of California, Berkeley United States of America, California, Berkeley 3 The UC Berkeley BSL3 Facility is currently housed in a single location but will be expanded in 2011 to include a second site (in a building under construction).
University of California, Los Angeles United States, California, Los Angeles 3
Instituto Nacional de Tecnologia Agropecuaria, Buenos Aires Argentina, Buenos Aires, Castelar 3-A Instituto de Virologia (CICVyA)
Veterinary Research Institute (VRI), Department of Veterinary Services Malaysia, Ipoh, Perak 3 This facility created a breakthrough in identifying the Nipah virus, which is classified internationally as a BSL-4 agent.
University of Malaya Malaysia, Kuala Lumpur 3 2010

Popular culture

The beginning of the movie Outbreak (1995) walks the audience through each biosafety level, giving examples of diseases in each category; unfortunately, the diseases used are often incorrectly categorized, and numerous egregious violations of biosafety level protocol are witnessed. The introduction to the book The Hot Zone is similar to the beginning of Outbreak.

A fictitious Biosafety Level 5 is referenced in the video game Pariah, which takes place in the year 2520. It is described by the protagonist Jack Mason—a doctor with military training who works for a government organization called the Transgenic Control Commission—as a biosafety protocol which calls for the release of nuclear weapons in order to sterilize a location where it is believed that a hopelessly catastrophic disease outbreak is imminent. The novel by Michael Crichton called The Andromeda Strain references a functionally identical biosafety protocol under the name of "Directive 7-12".

See also

References

  1. ^ Richmond JY, McKinney RW (editors) (1999). Biosafety in Microbiological and Biomedical Laboratories (4th ed. ed.). ISBN 0-7881-8513-6. http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm. 
  2. ^ 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.
  3. ^ Covert, 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.
  4. ^ Manuel S. Barbeito; Richard H. Kruse. "A History of the American Biological Safety Association". American Biological Safety Association. http://www.absa.org/abohist1.html. Retrieved 2008-08-14. 
  5. ^ "Biosafety History,Recombinant DNA Molecules,Hybrid Organisms,NIH Guidelines,Bacillus Subtilis". Molecular-Plant-Biotechnology.info. http://www.molecular-plant-biotechnology.info/biosafety/biosafety-history.htm. Retrieved 2008-08-14. 
  6. ^ a b c "American Biological Safety Association Collection : NAL Collections : National Agricultural Library". United States Department of Agriculture: National Agricultural Library. 2009-02-11. http://riley.nal.usda.gov/nal_display/index.php?info_center=8&tax_level=4&tax_subject=158&topic_id=1982&level3_id=6419&level4_id=10967&level5_id=0&placement_default=0&test. Retrieved 2009-02-11. 
  7. ^ a b c The 1, 2, 3's of Biosafety Levels
  8. ^ "Routine diagnostic work with clinical specimens can be done safely at Biosafety Level 2, using Biosafety Level 2 practices and procedures. Research work (including co-cultivation, virus replication studies, or manipulations involving concentrated virus) can be done in a BSL-2 facility, using BSL-3 practices and procedures. Virus production activities, including virus concentrations, require a BSL-3 facility and use of BSL-3 practices and procedures", see Recommended Biosafety Levels for Infectious Agents.
  9. ^ Ministerstvo obrany - Centrum biologické ochrany Těchonín
  10. ^ a b [1]
  11. ^ English presentation of Jean Mérieux P4 laboratory
  12. ^ CIRMF
  13. ^ French subcontractor release and programme profile page
  14. ^ Information on Wuhan Institute of Virology and timeline
  15. ^ Don Burke's Global Health Blog - Wuhan, China
  16. ^ Chong, Peter (2006). ""Mobile Biosafety Level-4 Autopsy Facility - An Innovative Solution" - Conference Paper Abstract". http://www.absa.org/conf49abstracts.html#22. 
  17. ^ Galveston National Laboratory Fact Sheet

External links


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