Biosafety level

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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 specified these levels.[2] In the European Union, the same biosafety levels are defined 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 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.

History[edit]

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 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 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.[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 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.[6]

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

Levels[edit]

Biosafety level 1[edit]

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.[7] 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.[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]

Biosafety level 2[edit]

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:

  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.[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 difficult to contract via aerosol in a lab setting.[10] Examples include Hepatitis A, B, and C viruses, human immunodeficiency virus (HIV), pathogenic Escherichia coli, Staphylococcus aureus, Salmonella, Plasmodium falciparum, and Toxoplasma gondii.[10][11]

Biosafety level 3[edit]

Researcher at US Centers for Disease Control, Atlanta, Georgia, working with influenza virus under biosafety level 3 conditions, with respirator inside a biosafety cabinet (BSC).

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.[8] It includes various bacteria, parasites and viruses that can cause severe to fatal disease in humans but for which treatments exist, such as Yersinia pestis (causative agent of plague), Francisella tularensis, Leishmania donovani, 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, rabies virus, chikungunya, yellow fever virus, and West Nile 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, specially designed hoods, 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 (P2) 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[edit]

The Galveston National Laboratory BSL-4 (P4) lab on the Campus of the University of Texas Medical Branch

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 virus, Crimean-Congo hemorrhagic fever, and various other hemorrhagic diseases. This level is also used for work with agents such as smallpox that are considered contagious enough to require the additional safety measures, regardless of vaccination availability. When dealing with biological hazards at this level the use of a positive pressure personnel suit, with a segregated air 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 from opening at the same time. All air and water service going to and coming from a biosafety level 4 (or P4) 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 are 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, even if compromised, would severely inhibit 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.

  • Regular inspection of positive pressure suits to locate any leaks[12]

  • SPECT machine at BSL-4 imaging facility that separates subjects with pathogens from the machines.[1]

  • 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

  • Effluent decontamination system of a BSL-4 lab of NIAID

List of BSL-4 facilities[edit]

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

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 (GAO-08-108T [13]). This represents a very conservative estimate of the number of facilities in the US in 2007. Approximately 36% of these laboratories are located in academia. Only 15 BSL-4 facilities were identified in the U.S. in 2007, including nine at federal labs.[13]

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

Name Location Date
established		 Description
National Service of Healthcare and Agriculture Quality (SENASA) Buenos Aires, Argentina Diagnostic laboratory for Foot-and-mouth disease.[14]
Korea Centers for Disease Control and Prevention (KCDC) Osong, Cheongwon county, North Chungcheong province, South Korea 2013
University of Melbourne - Doherty Institute for Infection and Immunity Melbourne, Victoria, Australia 2014 Diagnostic reference lab.[15][16]
Australian Animal Health Laboratory Geelong, Victoria, Australia 1985 Large diagnostic and research lab equipped with two BSL-4 animal rooms.[17][16]
National High Security Laboratory Victoria, North Melbourne, Australia Operates under the auspice of the Victoria Infectious Diseases Reference Laboratory.[18]
National Microbiology Laboratory Winnipeg, Manitoba, Canada 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.[19]
Wuhan Institute of Virology of the Chinese Academy of Sciences Wuhan, Hubei, China 2003 Wuhan Institute of Virology already hosts a BSL3 laboratory. A distinct BSL4 facility was built and delivered in 2015, and became the first maximum safety laboratory in China. The technical design of this BSL4 laboratory was realized by the French biocontainment expert Thierry Morand.
Biological Defense Center Těchonín, Pardubice, Czech Republic 1971, rebuilt 2003-2007 Located at the Centrum biologické ochrany (Biological Defense Center)[20]
Laboratoire P4 Jean Mérieux Lyon, Rhône-Alpes, France 1999-03-05 Jean Mérieux laboratory is the result of a cooperation between Pasteur Institute and INSERM. The technical design of this BSL4 laboratory constructed in 1999 was realized by the French biocontainment expert Thierry Morand.
Laboratoire de la DGA Essonne, Vert-le-Petit, France 2013-10-24 The Laboratoire de la DGA [1] is part of the Ministry of Defence.
Centre International de Recherches Médicales de Franceville Gabon This facility is operated by a research organization supported by both Gabonese (mainly) and French governments, and is West Africa's only P4 lab (BSL-4).[21]
Robert Koch Institute Berlin, Germany The facility was licensed for construction by City of Berlin on November 30, 2008.
Bernhard Nocht Institute for Tropical Medicine Hamburg, Germany
Friedrich Loeffler Institute on the Isle of Riems Germany, Isle of Riems (Greifswald) 2010 Deals especially with virology
Philipps University of Marburg Marburg, Germany 2008 The facility is licensed to work with genetically modified organisms
Országos Epidemiológiai Központ - National Center for Epidemiology Budapest, Hungary 1998 Division of Virology operates three WHO National Reference Laboratories. The BSL-4 biosafety laboratory provides a modern means to process dangerous imported zoonotic viral pathogens that can spread between humans.[22]
High Security Animal Disease Laboratory (HSADL) Bhopal, India 1998 This facility deals especially to zoonotic organisms and emerging infectious disease threats.
Centre for Cellular and Molecular Biology Hyderabad, India 2009 National Bio-Safety Level-4 Containment Facility for Human Infectious Diseases & Clinical Research Facility in Regenerative Medicine [23][24]
All India Institute of Medical Sciences New Delhi, India 1993 Conducts studies on major pathogenic organisms. Has contributed in discovering new strains & vaccines.
Microbial Containment Complex Pune, India 2012 Bio-Safety Level-IV Laboratory established by ICMR with support from Department of Science & Technology
Azienda Ospedaliera Ospedale Luigi Sacco Milan, Lombardy, Italy A university hospital located in the city's Polo Universitario; it contains two special vehicles for the safe transportation of infectious patients.
Istituto Nazionale per le Malattie Infettive Rome, Lazio, Italy 1936 (1997) The "National Institute of Infectious Diseases" used to operate within the Lazzaro Spallanzani hospital; the facility is now independent and is home to five BSL-3 labs as well as a single BSL-4 laboratory, which was completed in 1997.[25]
National Institute for Infectious Diseases Musashimurayama, Tokyo, Japan 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 Tsukuba, Ibaraki, Japan This is a non-operating BSL-4 facility.
Cantacuzino Microbiological Research Institute (INCDMI) Bucharest, Romania [26]
"Dr. Carol Davila" Central Military Hospital Bucharest, Romania [27]
State Research Center of Virology and Biotechnology VECTOR Koltsovo, Novosibirsk Oblast, Russia It is one of two facilities in the world that officially hold smallpox. The other Russian BSL-4 facilities have been dismantled.
National Institute for Communicable Diseases Johannesburg, South Africa 1976 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.
The Swedish BSL-4 Laboratory[28] Solna, Sweden 2001 Located at the Public Health Agency of Sweden premises, this is the only BSL-4 facility in the Nordic region. The facility also houses a BSL-3 laboratory.[29][30][31]
University Hospital of Geneva Switzerland
Spiez Laboratory Spiez, Switzerland
Kwen-yang Laboratory (昆陽實驗室) Center of Disease Control Taiwan Part of the Department of Health, Taiwan.
Preventive Medical Institute of ROC Ministry of National Defense Taiwan
Health Protection Agency's Centre for Infections Colindale, United Kingdom Located in the Viral Zoonosis unit.[citation needed]
National Institute for Medical Research London, United Kingdom [32]
Institute for Animal Health Pirbright, United Kingdom [citation needed]
Institute for Animal Health Compton Laboratory Compton, United Kingdom [33][not in citation given]
Defence Science and Technology Laboratory Porton Down, United Kingdom [citation needed]
Health Protection Agency Porton Down, United Kingdom Special Pathogens Reference Unit.[citation needed]
Health Protection Agency Porton Down, United Kingdom Botulism.[citation needed]
Francis Crick Institute[34][not in citation given] London, United Kingdom Under construction. The UKCMRI will not work on Human Hazard Group 4 agents.
Centers for Disease Control and Prevention Atlanta, Georgia, United States Currently operates in two buildings. One of two facilities in the world that officially hold smallpox.
Georgia State University Atlanta, Georgia, United States Is an older design "glovebox" facility.
National Bio and Agro-Defense Facility (NBAF), Kansas State University Manhattan, Kansas, United States Under construction. Facility to be operated by the Department of Homeland Security, and replace the Plum Island Animal Disease Center (which is not a BSL-4 facility). Planned to be operational by 2015, but likely delayed.
National Institutes of Health (NIH) Bethesda, Maryland, United States Located on the NIH Campus, it currently only operates with BSL-3 agents.
Integrated Research Facility Fort Detrick, Maryland, United States This facility is operated by National Institute of Allergy and Infectious Diseases (NIAID), focuses on the development of prevention and treatment options of human diseases.
National Biodefense Analysis and Countermeasures Center (NBACC) Fort Detrick, Maryland, United States Under construction, it will be operated for the Department of Homeland Security.
US Army Medical Research Institute of Infectious Diseases (USAMRIID) Fort Detrick, Maryland, United States 1969 Old building
US Army Medical Research Institute of Infectious Diseases (USAMRIID) Fort Detrick, Maryland, United States 1969 New building, currently under construction
National Emerging Infectious Diseases Laboratory (NEIDL), Boston University Boston, Massachusetts, United States Under construction by Boston University, building and staff training complete, waiting for regulatory approval.
NIAID Rocky Mountain Laboratories Hamilton, Montana, United States National Institute of Allergy and Infectious Diseases
Kent State University, Kent Campus Kent, Ohio, United States Operates as a clean lab at level 3 for training purposes. Scheduled for conversion to a hot level 4 lab in response to a bioterrorism event in the USA.
Galveston National Laboratory, National Biocontainment Facility Galveston, Texas, United States Opened in 2008, facility is operated by the University of Texas Medical Branch.[35]
Shope Laboratory Galveston, Texas, United States Operated by the University of Texas Medical Branch (UTMB).
Texas Biomedical Research Institute San Antonio, Texas, United States 1999 The only privately owned BSL-4 lab in the US.[36]

See also[edit]

Notes and references[edit]

  1. ^ a b "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.
  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.
  5. ^ Manuel S. Barbeito; Richard H. Kruse. "A History of the American Biological Safety Association". American Biological Safety Association. 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. Retrieved 2009-02-11. 
  7. ^ a b c d e "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. 30–59. Retrieved 2 April 2016. 
  8. ^ a b c d Richmond JY. "The 1, 2, 3's of Biosafety Levels" (PDF). Retrieved 2 April 2016. 
  9. ^ "Health & Safety Manual - Biological Safety". Columbia University Environmental Health and Safety. Retrieved 2 April 2016. 
  10. ^ a b "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. 22–28. 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. 123–289. Retrieved 9 April 2016. 
  12. ^ Seligson, Susan (7 March 2013). "Video Offers Glimpse of Biosafety Level 4 Lab Science webcast "threads the NEIDL"". BU Today. Retrieved 5 December 2014. 
  13. ^ a b "Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States" (pdf). Oct 4, 2007. 
  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. 60–62. Retrieved 3 April 2016. 
  15. ^ "Members: The Doherty Institute for Infection and Immunity". Global Virus Network. Retrieved 3 April 2016. 
  16. ^ a b 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. ^ Ministerstvo obrany - Centrum biologické ochrany Těchonín
  21. ^ "Centre International de Recherches Medicales de Franceville" (in French). CIRMF. Retrieved 30 September 2014. 
  22. ^ "Hungarian National Center for Epidemiology" (PDF). 
  23. ^ "Maximum Containment Facilities – Sense and Nonsense, Risks and Benefits" (pdf). 
  24. ^ Stone laid for stem cell research lab in Hyderabad | Business Line
  25. ^ Storia dell'Istituto
  26. ^ "Microbial Culture Collection of "Cantacuzino" Institute Present and perspectives of development" (pdf). 
  27. ^ Spitalul Militar Central – Bucuresti - harta, adresa, contact, panorama
  28. ^ "P4-laboratoriet vid Folkhälsomyndigheten" (in Swedish). Public Health Agency of Sweden. Retrieved 8 October 2014. 
  29. ^ "Superlabbet kan diagnostisera ebola" (in Swedish). Aftonbladet. 15 August 2014. Retrieved 7 October 2014. 
  30. ^ "Beredda på viruskatastrofer" (in Swedish). LabTech Magazine. 21 May 2014. Retrieved 7 October 2014. 
  31. ^ "På rundtur i världens säkraste labb" (in Swedish). Life Science Sweden. 16 November 2013. Retrieved 7 October 2014. 
  32. ^ "Deadly secrets of the pathogen labs". The Times (London).  (Subscription required.)
  33. ^ "Jobs March 2014 SAPO 3-4 Officer". Pirbright (Compton). 
  34. ^ "House of Commons - UK Centre for Medical Research and Innovation (UKCMRI) - Science and Technology Committee". Retrieved 30 September 2014. 
  35. ^ "Galveston National Laboratory Fact Sheet". Retrieved 30 September 2014. 
  36. ^ "About Texas Biomed: Biosafety Level 4 Laboratory". Texas Biomedical Research Institute. Retrieved 3 April 2016. 

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