biosafety level 4

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Biosafety level

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. In the European Union, the same biosafety levels are defined in a directive. However, in USAMRIID (United States Army Research Institute of Infectious Diseases) classify agents the range from the lowest biosafety level 0 to the highest level 4 without level 1.

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 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.

History

On 18 April, 1955, 14 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.

Levels

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).

It includes several kinds of bacteria and viruses including canine hepatitis, Escherichia coli, varicella (chicken pox), 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. 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. diff, hepatitis A, B, and C, influenza A, Lyme disease, dengue fever, Salmonella, mumps, Bacillus subtilis, measles, HIV, scrapie.

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; and
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 as a result of exposure by the inhalation route. Includes various bacteria and viruses that can cause severe to fatal disease in humans, but for which vaccines or other treatment exist, such as anthrax, West Nile virus, Venezuelan equine encephalitis, Eastern equine encephalitis, SARS, tuberculosis, typhus, Rift Valley fever, Rocky Mountain spotted fever, yellow fever.

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

the exhaust air from the laboratory room is discharged to the outdoors,
the ventilation to the laboratory is balanced to provide directional airflow into the room,
access to the laboratory is restricted when work is in progress, and
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 are 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, smallpox (there is a vaccine), Marburg virus, Ebola virus, Lassa fever, Crimean-Congo hemorrhagic fever, 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 uses negatively pressurized facilities, which, 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. 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 biosafety 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	-	-	-
National High Security Laboratory	Australia, Victoria, North Melbourne	4	-	-	National High Security Laboratory Operates under the auspice of the Victoria Infectious Diseases Reference Laboratory.
Fundação Oswaldo Cruz	Brazil, Rio de Janeiro	4	-	-	It is unclear whether this facility operates as a BSL-4.
University of São Paulo	Brazil, São Paulo	4	-	-	-
Instituto Adolf Lutz	Brazil	3	-	-	-
Instituto Butantan	Brazil	3	-	-	-
National Microbiology Laboratory	Canada, Manitoba, Winnipeg	4	-	-	Located at the Canadian Science Centre for Human and Animal Health, it belongs to the Public Health Agency of Canada.
-	Canada, Ontario, Toronto	4	-	-	This facility never opened due to community opposition in the 1990s.
National Centre for Foreign Animal Disease	Canada	4	-	-	Belongs to the Canadian Food Inspection Agency.
Center of Biological Protection	Czech Republic	4	-	-	Located at the Centrum biologické ochrany Těchonín (Center of Biological Protection)
Jean Mérieux	France, Lyon	4	-	-	Note that in France, it is P4 for Pathogen or Protection level 4.
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.
Robert Koch Institute	Germany, Berlin	4	-	-	The facility was licenced for construction by City of Berrlin on 30 November 2008.
Bernhard Nocht Institute for Tropical Medicine	Germany, Hamburg	4	-	-	-
Philipps University of Marburg	Germany, Marburg	4	01-2008	-	The facility is licenced to work with genetic modified organisms
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 preform work on only BSL-3 agents. It faces community opposition.
Institute of Physical and Chemical Research	Japan, Kantō, Tsukuba	-	-	-	This is a non-operating BSL-4 facility.
High Security Animal Disease Laboratory (HSADL)	India, Bhopal	4	-	-	This facility deals especially to zoonotic organisms and emerging infectious disease threats.
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.
Netherlands National Institute for Public Health and the Environment (RIVM)	Netherlands, Bilthoven	3 - 4	2009	-	Currently underconstruction, it is planned to be finish end of 2009. It is planned to operated as a BSL 3 and a BSL 4 facility.
State Research Center of Virology and Biotechnology VECTOR	Russia, Novosibirsk Oblast, Koltsovo	1 - 4	-	-	It is one of two facilities which officially hold smallpox. The other Russian BSL-4 facilities has 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.
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.
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	-	Located in Teaching Hospital of Geneva this facility is the only publically known laboratory in Switzerland to be classed as having BSL-4 agents. This facility only deals with animal diseases which do not transmit to humnas, 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	-	-	-
Chemical and Biological Defence Establishment	United Kingdom, Porton Down	4	-	-
-	United Kingdom	4	-	-	Underconstruction.
Centers for Disease Control and Prevention	United States of America, Georgia, Atlanta	4	-	-	Currently operates in two buildings.
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	3	-	-	Located on the NIH Campus, it currently only operates 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	-	-	Underconstruction by Boston University
NIAID Rocky Mountain Laboratories	United States of America, Montana, Hamilton	4	-	-	Under construction, it is planned to begin operation in 2009 at the earliest.
National Biocontainment Facility	United States of America, Texas, Galveston	4	-	-	Is a new facility underconstruction by the University of Texas Medical Branch.
Shope Laboratory	United States of America, Texas, Galveston	4	-	-	Operated by the University of Texas Medical Branch (UTMB). A new building is under construction
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	4	-	-	Operated by the Department of Homeland Security, it was shortlisted July 2007. The final site selection is planned to be in mid to late 2008.