Skip to main content Skip to navigation
Office of Research Assurances Institutional Biosafety Committee

Risk assessments

Identify and mitigate risk, and document regulatory compliance

When to perform a risk assessment

  • When planning a research project
  • When making a significant change to a research project, such as:
    • New employees
    • New infectious or potentially infectious agent
    • New procedures or techniques
    • New equipment
    • Relocation of activities
    • During or after renovations
  • Upon renewal of your Biosafety Approval Form (BAF)

Factors affecting risk

When performing a risk assessment, consider—and carefully document—the following factors:

Agent characteristics

Use the information below to assess the risks of a specific biological agent. If you are using HeLa or HEK 293 cell lines, examine the risk management information specific to those agents.

Personnel factors

  • Level of training and experience (in general, and specific to the procedure or agent)
  • Competency level and demonstration of diligence
  • Health status
  • Use of personal protective equipment
  • Allergies (determines vaccination restrictions)
  • Availability of prophylaxis and first aid

Experimental factors

  • Aerosol generating activities (pipetting, vortexing, centrifuging, etc.)
  • Potential for self-inoculation (recapping needles, disposal of sharps, etc.)
  • Concentration of samples
  • Nature of sample (clinical, pure culture, previously manipulated)
  • Volume of pathogen
  • Animal use (species, potential viral shredding, bites, scratches)
  • Cell line characteristics
  • Toxin production
  • Vector use
  • Contingency plan (exposure, spill, accidental release, equipment failure)
  • Techniques (cryogenics, cell sorting, etc.)
  • Decontamination procedures

Environment: Work area, laboratory, and facility

Factors considered are modes of transmission, environmental stability, and spread of contaminated material. In the laboratory, consider the following issues:

  • Level of containment (required, available)
  • Factors affecting containment (air flow, pressurization, certification)
  • Impact of external activities (construction, traffic flow, new routes of egress)
  • Biosecurity (access and inventory control)
  • Lab facility conditions (clean, non-porous benches, etc.)
  • Availability and status of emergency support (first aid, eye wash, spill kit, etc.)
  • Housekeeping and trades personnel (training, procedures)
  • Access by the public (students, visitors, trade personnel)

Equipment

Can equipment increase risk of exposure or spill? Consider the following:

  • Equipment maintenance (frequency and status)
  • Periodic decontamination (incubators, centrifuge etc.)
  • Training and correct operation of equipment (compliance with manufacturers’ recommendations)
  • Equipment-specific hazards (centrifuges, homogenizer, autoclaves)
  • Standard operating procedures
  • Ventilation considerations
  • Location within lab or adjoining labs

How to assess risks of a specific biological agent

In each category below, Risk Level 1 represents minimal risk. At the opposite end of the scale, Risk Level 4 represents very high potential risk to health or the environment (including risks with economic impacts).

When using a biological agent, consider each factor listed below. Assign a risk level to each. Enter this information into the WSU risk assessment grid (pdf) to help determine when engineering and procedural controls should be implemented to reduce risk.

If you are using HeLa or HEK 293 cell lines, visit the pages that supply information specific to those agents.

Pathogenicity/virulence

Risk level 1

Unlikely to cause disease

Low individual and community risk

Risk level 2

Mild or moderate disease

Moderate individual risk

Low community risk

Any pathogen that can cause disease, but under normal circumstances is unlikely to be a serious hazard to a healthy laboratory worker, the community, livestock, or the environment

Risk level 3

Serious livestock, poultry or wildlife disease

High individual risk

Low community risk

Any pathogen that usually causes serious disease or can result in serious economic consequences or does not ordinarily spread by causal contact from one individual to another

Risk level 4

Severe livestock, poultry or wildlife disease

High individual risk

High community risk

Also causes human disease

Any pathogen that usually produces very serious and often fatal disease, often untreatable and may be readily transmitted form one individual to another, or from animal to human or vice-versa, directly or indirectly, or by casual contact

Infectious dose

Risk level 1

Not applicable (not known to cause disease in healthy adults)

Risk level 2

Variable or high (1,000-5,000 organisms or greater)

Risk level 3

Medium (10 –1,000 organisms)

Risk level 4

High (1-10 organisms)

Mode of transmission/route of infection

Risk level 1

Not applicable (not known to cause disease in normal healthy adult plants or animals)

Risk level 2

Primary exposure hazards are through ingestion, inoculation and mucous membrane route (not generally through the airborne route)

Risk level 3

May be transmitted through airborne route, direct contact, vectors

Risk level 4

Readily transmitted, potential for aerosol transmission

Ability to spread/transmission/communicability

Risk level 1

Not applicable (not known to cause disease in normal healthy adult plants or animals)

Risk level 2

If released from the laboratory, risk of geographical spread is limited or very limited; risk of transmission is relatively limited

Risk level 3

Geographical risk of spread if released from the laboratory is moderate; direct animal to animal or human to human transmission occurs relatively easily; transmission between different animal species may readily occur

Risk level 4

Geographical risk of spread if released from the laboratory is widespread

Environmental stability

Risk level 1

Not applicable

Risk level 2

Short term survival (days); can survive under ideal conditions

Risk level 3

Resistant (days to months)

Risk level 4

Highly resistant (months to years), e.g. spores

Host range

Risk level 1

Not applicable (not known to cause disease)

Risk level 2

Infects a limited number of species

Risk level 3

Infects multiple species

Risk level 4

Infects many species of animals/plants

Endemicity

Risk level 1

Enzootic

Risk level 2

Generally enzootic (some low-risk exotics, zoonotics or reportable diseases)

Risk level 3

Exotic, zoonotic, or enzootic, but subject to official control

Risk level 4

Exotic

Economic aspects of introduction and/or release into the environment of the public

Risk level 1

No economic and/or clinical significance

Risk level 2

Limited economic and/or clinical significance

Risk level 3

Severe economic and/or clinical significance

Risk level 4

Extremely severe economic and/or clinical significance

Availability of prophylactic and therapeutic treatments

Risk level 1

Not applicable (not known to cause disease)

Risk level 2

Effective treatment and preventive measures are available

Risk level 3

Prophylactic and/or treatments may or may not be readily available (or of limited benefit)

Risk level 4

Prophylactic and/or treatments are not usually available

Disease transmission vectors

Risk level 1

Not applicable (not known to cause disease)

Risk level 2

Does not depend on vectors or intermediate hosts for transmission; may depend on vectors or intermediate hosts for transmission

Risk level 3

May depend on vectors or intermediate hosts for transmission

Risk level 4

May depend on vectors or intermediate hosts for transmission

r/sNA

Risk level 1

The r/sNA is a risk group 1 organism; modifications have not changed the risk

Risk level 2
  • The r/sNA is a risk group 2 organism; modifications have not changed the risk
  • r/sNA from risk group 2 or 3 organism is transferred into risk group 1 organism: but not the whole genome.
  • r/sNA from risk group 4 organism is transferred into risk group 1 organism (only after demonstration of a totally and irreversible defective fraction of the organism genome is present in the r/sNA.
  • The r/sNA is a risk group 3 or 4 organism; however, the modification has resulted in proven attenuation.
Risk level 3
  • The r/sNA is a risk group 3 organism and modifications have not changed the risk
  • The r/sNA is based on a risk group 2 organism, however, the modifications have increased the risk group to a 3.
Risk level 4
  • The r/sNA is a risk group 4 organism; modifications have not changed the risk
  • r/sNA from risk group 4 organisms is transferred into a risk group 1 organism, without being able to demonstrate a lack of virulence or pathogenicity.
Considerations when working with r/sNA

Consider the effect of the modification on all previous 10 risk factors; plus, NIH Guidelines provide standard risk group assessment based on the modifications. A comprehensive look at the effect of the modification is required.

  • Does the inserted material increase virulence or decrease the effectiveness of any anti-infective agents?
  • Does the inserted gene encode a known toxin or a relatively uncharacterized toxin?
  • Does the modification have the potential to alter the host range or cell tropism of the virus?
  • Does the modification have the potential to increase the replication capacity of the virus?
  • Does the inserted gene encode a known oncogene?
  • Does the inserted gene have the potential for altering the cell cycle?
  • Does the viral DNA/RNA integrate into the host genome?
  • What is the probability of generating replication–competent viruses?
  • If the modification has resulted in a form of attenuation, how extensively has this strain been utilized without incident and/or has the attenuation been proven in animal models?
  • Does the modification have an effect of increasing or decreasing the efficacy of available treatment or prophylaxis?