Risk Assessment and Standard Operating Procedures (SOP) Development

Risk Assessment:


A thorough risk assessment determines the proper safety and containment precautions given the intrinsic risk of the hazard(s), procedures, and health of laboratory workers.

The risk assessment is a guide for the selection of appropriate controls and practices, safety equipment, and facility safeguards. The risk assessment will be used to alert others to the hazards of working in the lab and to the need for developing proficiency in the use of safe practices and containment equipment. Successful control of hazards in the laboratory also protects persons not directly associated with the laboratory, such as other occupants in the building, infrequent visitors (e.g., facilities services), and the public.

Risk assessments generally begin with the question, “Is the material that I’m working with capable of causing human disease, injury, or environmental harm?”  If so, the PI should work with the BSO to determine the best safety practices and level of containment to reduce the chance of accidental exposure or release of infectious agents, recombinant agents/organisms, or other relevant hazard. If you are unsure, contact the Biosafety Office for guidance.

Basic considerations for the risk assessment are listed below:

  • Assess the risk of the agent itself (e.g., host, vector). See Appendix B of the NIH Guidelines, the ABSA Risk Group Database, or the Canadian Pathogen Safety Data Sheets for risk group level for the biological agents known to infect human as well as selected animal agents that may pose theoretical risks if inoculate into humans.
  • Assess the risk caused by the manipulation of the agent. Agent factors to be considered:
    • Virulence
    • Pathogenicity
    • Infectious dose
    • Environmental stability
    • Route of transmission
    • Communicability
    • Operations
    • Quantity
    • Availability of vaccine or treatment
  • Assess the risk associated with the gene(s) to be transferred. What's the nature of the gene(s) to be transferred? Does the transgene encode either a potentially oncogenic gene product or a toxin molecule?
    Note: It is not possible to completely ensure that a replication-deficient virus will not gain back genes to become replication-competent.
    • Viral vectors do not need to be replication-competent.
    • It is possible for a "gene of interest" to be acquired by viruses or cells not expected to be associated with the gene.
  • Assess the risk of chemicals, radioactive materials, procedures, and equipment in additional to biological hazards
  • Based on the risk assessment, determine the required level of physical and biological containment (BSL 1, 2, 3) in accordance with NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules.
  • Determine the mitigation to minimize the risk to people and the environment
  • A Risk Assessment matrix and other helpful risk assessment documents are available on the Biosafety Teams site.

Risk Reduction for Biohazardous Agents

Once the Risk Group (RG) and other procedural factors are determined, basic considerations for risk reduction include:

Risk awareness

  • Risk assessments are performed and communicated
  • Materials and procedures are reviewed by the IBC as required
  • Containment recommendations are implemented
  • Standard Operating Procedures (SOPs) are developed and communicated

Control of materials

  • Containment requirements per the risk assessment are followed
  • Materials are labeled and securely stored per risk assessment
  • Biohazard inventory is documented, maintained, and controlled
  • Secondary containment is used for storage and transport of biohazards

Good Practices

  • Follow prescribed personal & lab hygiene principles, also known as Standard Microbiological Practices 
  • Wear and maintain personal protective equipment (PPE) per the risk assessment and manufacturers recommendations
  • Communicate hazards via door placard, biohazard labels, etc.
  • Segregate and dispose biohazardous wastes per Biosafety Office guidelines
  • Decontamination must be routine and effective based on the risk assessment and prudent practices
  • Post, communicate, and follow emergency response procedures (spills, personal exposures, injuries, etc.)

Restriction of Access

  • Follow prescribed laboratory security procedures per institutional policy
  • Secure storage equipment in common areas and placard with content owners name and contact information

SOP Development

Keeping in mind the above Biosafety Level determination, select the appropriate microbiological practices and laboratory techniques to be used for your specific research. Incorporate this information in written lab-specific Standard Operating Procedures (SOPs).