Macquarie University has both OGTR certified facilities and approved arrangement sites (AAS). Different facility types are available (microorganisms, plants, fish and animals) and all have restricted access. For entry into these facilities please see the relevant Facility Manager.
Available AASs at the University range from QC1 - QC2.
Users of quarantine facilities are now required to complete a Fit and Proper Persons Self Declaration prior to having their access granted.
Available OGTR Certified facilities range from PC1 - PC2.
Containment levels for GMOs
Facilities in which only exempt dealings are conducted do not need to be OGTR certified but must meet some minimum containment requirements.
Facilities where Notifiable Low Risk Dealings (NLRD) and Dealings NOT involving Intentional Release (DNIR) are conducted must be certified by the OGTR before any work commences.
The type of certified facility (laboratory or animal facility) and the level of containment (PC1 or PC2) must be suited to the type of GMO and the activities being conducted (see table below).
|GMO Dealing Class||Required Facility|
|Exempt Dealing||Do not need to be conducted within a containment facility|
|NLRD 1.1||OGTR-certified PC1 (at least)|
|NLRD 2.1||OGTR-certified PC2 (at least)|
|NLRD 2.2||OGTR-certified PC3 (at least)|
Certification, suspension or surrender of a facility
Facility certification requests are to be sent to the IBC Secretariat. The process will involve completing an application form, providing a detailed floor plan of the area to be certified, inspection by the Biosafety Advisor and IBC and final sign off from the DVC(R). The completed application package will then be sent to the OGTR for approval. Please note that the OGTR may take up to 90 working days to make a decision on an application.
Please see the procedure for certification of a physical containment facility for more detailed information. Facilities that have been certified by the OGTR must have restricted access and display signage on all facility entrances.
Variations, suspensions and surrenders of certificates can be organised through the IBC Secretariat. Please notify the secretariat via email and ensure that the areas to be closed have been cleared of all GMOs and are decontaminated.
Managing a certified facility
What records need to be in place for IBC annual inspection?
Facility managers must ensure that the facility has current, documented procedures in place. This may include:
- Facility certification letter and any approved variations
- Register of authorised personnel
- Facility induction records
- Hard copies of IBC approved Risk Assessments
- Pest Control
- Autoclave validation record
- Restricted access and after hours arrangements
- Safe work procedures for spills
For QAPs, additional paperwork will be required. This may include:
- Facility certification letter
- Copy of all current Import permits
- Destruction records
- Quarantine Training certificates
All certified facilities must continue to comply with the relevant certification requirements. All certified facilities will be inspected by the Biosafety Advisor and the IBC at least annually. Certified PC and QC facilities can be inspected by the relevant government body without prior notice.