Biosafety Levels and Risk Groups
Each level of containment describes the microbiological practices, safety equipment and facility safeguards for the corresponding level of risk associated with a particular agent.
Biosafety Level 1 (BL1):
|Practices, safety equipment, and facilities are appropriate for undergraduate and secondary educational training and teaching laboratories, and for other facilities in which work is done with defined and well characterized strains of viable microorganisms not known to cause disease in healthy adult humans. Bacillus subtilis and Infectious Canine Hepatitis Virus are representative of those microorganisms meeting these criteria. |
Many agents not ordinarily associated with disease processes in humans are, however, opportunistic pathogens and may cause infection in the young, the aged, and immunodeficient or immunosuppressed individuals. Vaccine strains which have undergone multiple in vivo passages should not be considered avirulent simply because they are vaccine strains.
Biosafety Level 1 represents a basic level of containment that relies on standard microbiological practices with no special primary or secondary barriers recommended, other than a sink for handwashing.
Biosafety Level 2 (BL2):
Practices, equipment, and facilities are applicable to clinical, diagnostic, teaching and other facilities in which work is done with the broad spectrum of indigenous moderate-risk agents present in the community and associated with human diseases of varying severity. With good microbiological techniques, these agents can be used safely in activities conducted on the open bench, provided the potential for producing splashes or aerosols is low. Hepatitis B virus, the Salmonella spp., and Toxoplasma spp. are representative of microorganisms assigned to this containment level.
Biosafety Level 2 is appropriate when work is done with any human-derived blood, bodily fluids, or tissues where the presence of an infectious agent may be unknown. (Laboratory personnel working with human-derived materials should refer to the Bloodborne Pathogen Standard (187) for specific, required precautions). Primary hazards to personnel working with these agents relate to accidental percutaneous or mucous membrane exposures, or ingestion of infectious materials. Extreme precaution with contaminated needles or sharp instruments must be emphasized. Even though organisms routinely manipulated at BSL2 are not known to be transmissible by the aerosol route, procedures with aerosol or high splash potential that may increase the risk of such personnel exposure must be conducted in primary containment equipment, or devices such as a BSC or safety centrifuge cups. Other primary barriers should be used as appropriate, such as splash shields, face protection, lab coats, and gloves. Secondary barriers such as handwashing and waste decontamination facilities must be available to reduce potential environmental contamination.
Biosafety Level 3 (BL3):
Practices, safety equipment, and facilities are applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents with a potential for aerosol transmission, and which may cause serious and potentially lethal infection. Mycobacterium tuberculosis, St. Louis encephalitis virus, and Coxiella burnetii are representative of microorganisms assigned to this level. Primary hazards to personnel working with these agents relate to autoinoculation, ingestion, and exposure to infectious aerosols.
At Biosafety Level 3, more emphasis is placed on primary and secondary barriers to protect personnel in contiguous areas, the community, and the environment from exposure to potentially infectious aerosols. For example, all laboratory manipulations should be performed in a BSC or other enclosed equipment, such as a gas-tight aerosol generation chamber. Secondary barriers for this level include controlled access to the laboratory and a specialized ventilation system that minimizes the release of infectious aerosols from the laboratory.
Biosafety Level 4 (BL4):
Practices, safety equipment, and facilities are applicable for work with dangerous and exotic agents, which pose a high individual risk of life-threatening disease, which may be transmitted via the aerosol route, and for which there is no available vaccine or therapy. Additionally, agents with a close or identical antigenic relationship to Biosafety Level 4 agents should also be handled at this level. When sufficient data are obtained, work with these agents may continue at this level or a lower level. Viruses such as Marburg or Congo-Crimean hemorrhagic fever are manipulated at Biosafety Level 4.
The primary hazards to personnel working with Biosafety Level 4 agents are respiratory exposure to infectious aerosols, mucous membrane exposure to infectious droplets, and autoinoculation. All manipulations of potentially infectious diagnostic materials, isolates, and naturally or experimentally infected animals pose a high risk of exposure and infection to laboratory personnel, the community, and to the environment.
The laboratory worker's complete isolation of aerosolized infectious materials is accomplished primarily by working in a Class III BSC or a full-body, air-supplied positive-pressure personnel suit. The Biosafety Level 4 facility itself is generally a separate building or completely isolated zone with complex, specialized ventilation and waste management systems to prevent the release of viable agents to the environment.
Risk Group Classifications of Biological Agents
Risk Group 1 (RG1)
Agents are not associated with disease in healthy adult humans.
Risk Group 2 (RG2)
Agents are associated with human disease that are rarely serious, and for which preventive or therapeutic interventions are often available.
Risk Group 3 (RG3)
Agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
Risk Group 4 (RG4)
Agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.
See NIH guidelines for a specific list of agents per risk group.