RISK LEVELS |
Risk assessment is a process used to identify the hazardous characteristics of a known infectious or potentially infectious agent or material, the activities that can result in a person’s exposure to an agent and the probable consequences of such an exposure. Risk assessment is an important responsibility for directors and principal investigators of microbiological and biomedical laboratories. The institutional biosafety committee (IBC), animal care and use committees (ACUC), biological safety professionals, and laboratory animal veterinarians share in this responsibility. Laboratory principal investigators should use risk assessment to alert their staffs to the hazards of working with infectious agents and to the need for developing proficiency in the use of selected safe practices and containment equipment. The selection of an appropriate biosafety level begins by establishing the classification of the non-modified virus. Among the recombinant viruses now routinely developed are adenoviruses, alphaviruses, retroviruses, vaccinia viruses, herpesviruses, and others designed to express heterologous gene products. However, the nature of the genetic modification and the quantity of virus must be carefully considered when selecting the appropriate biosafety level for work with a recombinant virus. |
Risk Group 1 |
Suitable for work involving well-characterized agents not known to cause disease in healthy adult humans, and of minimal potential hazard to lab personnel and the environment |
Ø Open bench tops acceptable with good standard microbiological practices |
Ø Laboratory not necessarily separated |
Ø Special containment equipment or facility design not required |
Ø Lab personnel have specific training |
Ø Additional requirements may be needed |
Risk Group 2 |
(Similar to Level 1) Suitable for work involving agents of moderate potential hazard with the following additional precautions: |
Ø Lab personnel are specifically trained to handle pathogenic agents (includes an up-to-date laboratory manual specific to your operations and protocols) |
Ø Lab access limited when work is conducted |
Ø Precautions are taken with contaminated sharp items (needles, scalpels, etc.) |
Ø Certain procedures require primary containment |
Risk Group 3 |
Applicable to clinical, diagnostic, teaching, research or production facilities where work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure via the inhalation route: |
Ø Lab personnel have very specific training |
Ø Lab personnel may be required to complete DOJ/FBI security clearance for access to labs holding Select Agents, as defined by 42 CFR 73, “Possession, Use, and Transfer of Select Agents and Toxins” |
Ø Primary containment devices are required and employed |
Ø Appropriate personal protective equipment and clothing are required |
Ø Lab has special engineering and design features |
Ø No open bench work occurs |
Ø Immunization and medical surveillance protocols are required |
Risk Group 4 |
Required for work with dangerous and exotic agents which pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease: |
Ø Laboratory access is strictly controlled |
Ø Lab personnel may be required to complete DOJ/FBI security clearance for access to labs holding Select Agents, as defined by 42 CFR 73, “Possession, Use, and Transfer of Select Agents and Toxins” |
Ø Special facility design features are required |
Ø All activities are confined to a Class III biological safety cabinet or Class II used by workers wearing one-piece positive pressure personnel suits ventilated by a life support system |
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