Biosafety Risk Assessment / Risk Groups
The biological risk assessmenrt process is used to identify the hazardous characteristics of an infectious or potentially infectious agent or material, if known; the activitties that can result in a person's exposure to an agent; the likelyhood that such exposure will cause a laboratory associated infection (LAI); and the probable consequences of such an infection. The information identified by risk assessment will provide a guide for the selection of the appropriate mitigations, including the application of Biosafety Levels and good microbiological practices, safety equipment, and facility safeguards that can prevent LAIs. Risk Assessments should be performed prior to beginning work with a biohazardous agent or at any time when a change occurs to exsisting procedures, protocols and SOP's. A six-step approach to risk assessment is summarized below.
- Identify hazardous characteristics of the agent and perform an assessment of the inherent risk (i.e. what is the agent Risk Group?) Risk Group classifications indicate the specific hazards associated with a particular bacteria, virus, or other biohazard. Risk Group classifications are based on an agent's capability to infect and cause disease in a susceptible host, severity of disease, and the availability of preventative measures and effective treatments. Other items of concern include possible routes of transmission of infection, infectious dose, host range, genetic characteristics of the agent. Consult the references listed below for your agent(s).
- Identify laboratory procedure hazards. Procedures that produce aerosols, working with sharps, working with animals (zoonotic diseases), working with large/concentrated volumes of biohazardous agent(s), working with cell cultures derived from human/primate cultures or materials (bloodborne diseases) as well as many other procedures carried out in a typical laboratory can have varying levels of risk associated with them.
- Determine the appropriate BSL and select additional precautions indicated by the risk assessment The selection of the appropriate BSL and any additional laboratory precautions require a comprehensive understanding of the practices, safety equipment, and facility safeguards described in the BMBL 6th ed.
- Review the selected safeguards with a biosafety professional, subject matter expert, and the IBC or equivalent resource This review is strongly recommended and may be required by regulatory or funding agencies.
- Evaluate the proficiencies of the staff regarding safe practices and the integrity of safety equipment Laboratory directors or principal investigators should ensure that laboratory personnel have acquired the technical proficiency in the use of microbiological practices and safety equipment required for safe handling of the agent(s). This includes the ability to recognize hazards and how to handle emergency situations and obtain assistance if necessary.
- Regularly revisit and verify risk management strategies and determine if changes are necessary This includes a regular update of biosafety manuals and SOPs when changes in procedures or equipment occur.
Click for more on Biological Risk Assessment (Section II - BMBL 6th ed.)
Learn more about Hazard Reviews and Safety Protocols
References - Biological Agent Risk Groups
- American Biological Safety Association Risk Group Classification for Infectious Agents.
- CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition - Agent Summary Statements
- NIH Guidelines for Research Involving Recombinant and/or Synthetic DNA Molecules
- Public Health Agency of Canada Pathogen Safety Data Sheets