Biosafety Risk Assessment
Risk assessment is one of the two keys principles of biosafety. It is the process used to identify the hazardous characteristics of an infectious organism, the activities that could allow exposure, the likelihood of becoming infected after exposure, and the consequences to the worker of an infection. This risk assessment provides the framework for the selection of appropriate containment (biosafety level, microbiological practices, safety equipment, facility safeguards).
So how do you perform a risk assessment? This is the responsibility of both the PI and the IBC. The PI, through the IBC application, submits his risk assessment and resulting containment recommendations. The IBC will then evaluate the application and independently verify the PI’s conclusions.
The BMBL provides a 5-step approach to risk assessment in Section 2.
- Identify agent hazards and perform an initial assessment of risk. Some things to consider include: virulence and pathogenicity of the agent, method of transmission and communicability, environmental stability etc. Recombinant DNA work also requires analysis of the source DNA, the vector used, the host and possible effects of an expressed protein. Two references are Control of Communicable Diseases Manual and the NIH Guidelines.
- Identify laboratory procedure hazards. Any manipulation that can cause an aerosol is considered hazardous. Also the concentration, quantity of the agent as well as equipment (e.g. sharps etc.) factor into the analysis of lab procedures. Working with animals can present with its own set of hazards such as bites and scratches.
- Make a final determination of the appropriate biosafety level and select additional precautions indicated by the risk assessment.
- Evaluate the proficiencies of staff regarding safe practices and the integrity of safety equipment. The individual worker is the most important defense against biohazards. Technical proficiency in the use of microbiological practices, the proper use of equipment (BSCs, sharps etc.) and other safety devices (PPE) and the willingness to accept responsibility for the safety of one’s self and others is the key to ensuring a safe work environment.
- Review the risk assessment with a biosafety professional, subject matter expert (SME), and the IBC. This is always helpful and in the case of some funding agencies (NIH Guidelines) required.
For complete information, consult the BMBL and the NIH Guidelines.
NIH http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html