Biosafety

A wide range of biological agents - and materials that might reasonably contain hazardous biological agents - are in use across the University. Policies have been developed to ensure that such agents are reported and logged, and that any risks to workers, the general population, and the environment are minimised. These safeguards include (in summary):

• Each work group must complete the online Biohazard Training (Biosafety 1) on Blackboard.
• Each work group must maintain an inventory of the infectious agents that it uses or holds.
• Risk Group 1 agents do not require specific project approvals, but should be used with normal laboratory precautions.
• Work with Risk Group 2 agents should be reported to the Biological Safety Office for assessment. These agents may require approval from the Institutional Biosafety Committee, depending on the work being done and the laboratory space that it will be done in.
• All work with Risk Group 3 agents must be approved by the Institutional Biosafety Committee prior to the commencement of work, unless it is already approved as a "dealing with a GMO".
• No Risk Group 4 agents may be used at UWA.
• Work with infectious agents that is not approved under the gene technology regulatory system, or takes place in facilities that are not certified by the OGTR or Department of Agriculture and Water Resources (formerly AQIS), can only be conducted in facilities that meet a set of University requirements (based on the Australian Standards).

1. Does my facility need to be certified?

A facility will need to be internally certified by the University if it is to be used for work with hazardous biological agents UNLESS:

• it is currently certified by the OGTR or approved as a QAP by the Department of Agriculture (formerly AQIS)

AND

• is certified to the level required for the highest risk agent you will use (e.g. work with Risk Group 2 organisms must be conducted in a PC2 certified facility).
• An internally certified facility will display University-issued stickers on all entrances to the facility.

2. How do I get my facility certified?

If certification is required, there are a number of things you should do prior to the University inspection of the facility:

• Check the list of certification requirements.
  
• Check that your facility meets the requirements, and rectify any non-compliances that you observe (the Biosafety Office can help with ideas of how to rectify non-compliances).
• Ensure that training records, standard operating procedures (SOPs) or safe work procedures (SWPs) and risk assessments are current and complete.
• Notify your department of your intention to get the facility internally certified.
• Send an email to the Biosafety Office, stating your intention and readiness to have your laboratory internally certified.

3. University inspection and approval

The University inspection, conducted by representatives of the Institutional Biosafety Commitee, will take between 30 and 60 minutes.

• Ensure that some of the research personnel who will use the facility are present at the time of inspection.
• Ensure that copies of training records, SOPs, risk assessments and relevant certificates (e.g. for autoclaves or biosafety cabinets) are available.
• If the application is approved, the Biosafety Office will provide certification signs which are to be displayed at the entrances to the facility.

4. Continued approval

• The facility must continue to comply with internal certification requirements
• The facility will be inspected annually by representatives of the Institutional Biosafety Commitee.
• In addition to scheduled annual inspections, internally certified facilities can be inspected by the representatives of the Institutional Biosafety Committee without prior notice.

5. Surrendering a certification

When a facility no longer needs to be internally certified, the certification can be cancelled or 'surrendered'. Before a certification can be surrendered:

• All infectious material must be destroyed or moved to another certified facility
• The facility must be decontaminated - this usually means swabbing surfaces with a disinfectant that is effective against the agents that were used in the facility
• After the surrender of a certification:
  1. No work with biological agents can be conducted in the facility
  2. All internal certification signs must be removed from the entrances

Keeping a biological inventory

University Policy requires that each research group maintains a list of the infectious agents (bacteria, viruses and biological material that might reasonably be expected to contain bacteria or viruses) that it handles, uses or stores. The level of detail required should be dictated by a risk assessment. For example, a reference collection may not need to include the details of each strain if the level of risk is similar for each isolate. Different requirements apply for infectious agents that belong to different risk groups (as defined in AS/NZS 2243.3. Safety in laboratories: Microbiological safety and containment).

Risk Group 2 agents*

• must be included on the research or work group inventory
• may require extra reporting, depending on the risk analysis

Risk Group 3 agents

• must be included on the research or work group inventory
• new Risk Group 3 agents must be reported to the Biosafety Office via a Biological Hazard Risk Asessment form
• project approval must be granted before work using Risk group 3 agents can commence

Risk Group 4 agents

• the University does not have any facilities that meet PC4 containment requirements
• any intention to acquire a Risk Group 4 agent must be reported to the Office for Research Ethics and Integrity

*Biological Material (such as sewage, cell lines, blood, blood products or tissues) that might reasonably be expected to contain infectious agents should be treated as Risk Group 2 Agents and have the same reporting requirements as these.

Annual reports

Annual reports for biological hazard research that has been assessed by the Institutional Biosafety Committee will be requested in August each year.