Risk Assessment Process
The concept of "biosafety levels" (BSL) is the basis for laboratory practices designed to prevent laboratory acquired infections. CDC/NIH identifies four levels of containment. Levels are designated in ascending order, by degree of protection provided to personnel, the environment, and the community. Protection is accomplished through proper containment.
Containment is achieved by a combination of laboratory practices and techniques, safety equipment, and facility considerations as outlined by CDC/NIH in Biosafety in Microbiological and Biomedical Laboratories (BMBL). Required containment measures for a given protocol will depend on the results of a risk assessment of the work to be done with a specific agent. Protocols for all work at Biosafety Level 2 and above must be approved by the IBC.
The principal investigator or laboratory director is responsible for assessing risks in order to determine the necessary biosafety level practices (containment) required to perform a task with a specific organism. This should be done in close collaboration with the Institutional Biosafety Committee (IBC) and/or the department of Environmental Health and Safety's biosafety professionals in order to ensure compliance with established guidelines and regulations.
Steps to perform a biological risk assessment:
- Identify biohazardous materials to be used in research protocol.
- Identify the protocol's specific risk factors for exposure to the identified hazards. This includes modes of infectious transmission for the organism (inhalation, ingestion, etc.), steps in the protocol that may create an exposure risk (use of sharps, creation of aerosols, injecting animals, etc.), and the possible consequences of an accidental exposure.
- Review available resources for health hazards, laboratory hazards, handling procedures, and recommended precautions.
- MSDS sheets
- Section VIII of Biosafety in Microbiological and Biomedical Laboratories (BMBL) Agent Summary Statements addressing safety precautions
- Risk Group Classifications for Infectious Agents (includes bacteria, virus, fungi, and parasites) provides a basis for determining biosafety level
- From information gathered in Step 3, determine appropriate biosafety level.
- For a summary of biosafety procedures and equipment for all biological agents, see Summary of Recommended Biosafety Levels for Infectious Agents
- For a summary of biosafety procedures and equipment for all biological agents involving animals, see Summary of Recommended Biosafety Levels for Activities in Which Experimentally or Naturally Infected Vertebrate Animals Are Used
- Identify specific exposure control measures that will be implemented to reduce each exposure risk as identified in Step 2. Incorporate these exposure control measures into written Standard Operating Procedures (SOPs).