Facility Management

Facility Types

The OGTR provides guidance on the requirements for hte containment requirements of Dealings involving GMOs. The purpose of certification is to satisfy the Regulator that the containment facility has the capacity to:

prevent release of GMOs into the environment;
protect persons outside the facility from exposure to GMOs; and
protect the safety of people working with GMOs inside the facility.

There are four levels of physical containment (PC). For more information on PC levels, please see the Guide to Physical Containment Levels and Facility Types on the OGTR website.

The ANU does not currently have any PC1, PC3 or PC4 facilities.

Facility Inspections

OGTR certified facilities at ANU are managed through the Research Ethics Management System (REMS)

Certified PC2 facilities are inspected annually by the University Recombinant DNA Monitoring Committee. The ANU currently has no certified PC1 facilities.

The rDNA officer arranges annual inspections which may be conducted in an announced or unannounced manner. Inspections are conducted in line with the OGTR Annual Inspection Checklists. Areas will be informed of inspection outcomes and followup inspections may be conducted at any time without notice to monitor compliance.

Facility Manual

Certified Facilities must ensure that the following information is accessible to users and can be provided to OGTR upon request. This information can be kept online or in a manual:

Guidelines for Certification of the appropriate Physical Containment Level 2 Facility
Guidelines for the Transport, Storage and Disposal of GMOs.
NLRDs and DNIRs approved for use in the facility
Licences or Licence variations issued by the OGTR
For DNIRs - 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 for those trained in OGTR requirements and authorised to work in the facility.
- If the IBC or OGTR has requested additional training for lab workers, evidence of this training must be documented
Procedures for local area GM waste transport, sterilisation and spill procedures
Documented reporting mechanism to inform the IBC of any incident involving a GMO.
Backflow risk assessments for the facility/building
Protocols and Risk Assessments for experimental procedures involving GMOs

Where spacial and procedural separation has not been established and approved by the rDNA committee, all persons working within PC2 certified facilities must abide by PC2 facility requirements (including work with exempt or PC1 dealings).

Certified facilities may be subject to inspections by the OGTR without notice.