Uncertified PC1 facilities are managed at the local level by IBC liaison officers or facility managers and are not inspected by the IBC.
Certified PC1 or PC2 facilities are inspected annually by the University Recombinant DNA Monitoring Committee. At the present time, The Australian National University has no certified PC1 facilities. Inspection dates will be announced several weeks prior to the inspections. Annual Inspection Checklists used in ANU inspections are available below.
Current OGTR PC2 Facility guidelines can be found on the OGTR website.
For a PC2 Certified Facility, the Facility Manual should contain:
- Copies of relevant OGTR PC2 documents, including Guidelines for Certification of the appropriate Physical Containment Level 2 Facility (2013) and Guidelines for the Transport, Storage and Disposal of GMOs 2011. These should be an accessible resource, so that all lab members understand what is required
- Copies of applications for NLRDs and DNIRs
- Copies of NLRD approval letters from the IBC
- Copies of Licences or Licence variations issued by the OGTR
- In the case of a DNIR, a signed and dated record of those informed of the licence conditions. This record must be revised each time a licence variation is issued. Please remember that this includes all staff who may come in contact with GMOs from the dealing i.e. autoclave, animal and plant technicians
- Training Records: Recorded signatures of those trained in OGTR requirements and authorised to work in the facility. This should include completion dates for The Australian National University Biological Safety Course and Gene Technology Practices Course. Ensure the list is up-to-date and names are removed or crossed out when appropriate
- Additional Training: If the IBC or OGTR has requested additional training for lab workers, evidence of this training must be documented in the Facility Manual
- Standard Operating Procedures for local area GM waste transport, sterilisation and spill procedures
- Documented reporting mechanism to inform the IBC of any accident involving a GMO. Unintentional releases should be advised first to the IBC Secretary who will advise the OGTR
- Backflow risk assessment for the facility/building
- Protocols for experimental procedures involving GMOs together with completed risk assessments (ANU preference).
All research groups working within PC2 certified labs must abide by PC2 facility requirements. Groups with exempt or PC1 dealings must meet PC2 facility requirements. Copies of exempt dealings are not required in the Facility Manual of a PC2 lab.
Certified PC1 and PC2 facilities may be 'spot checked' by the OGTR without notice.