New facility certification

Certification of a Physical Containment (PC) Facility

Exempt dealings require PC1 containment but do not require facility certification. Work in uncertified PC1 facilities must be carried out in accordance with the Australian/New Zealand Standard, Safety in laboratories, Part 3: Microbiological safety and containment. Uncertified PC1 facilities are not inspected by the IBC.

If you are undertaking research work that is part of a Notifiable Low Risk Dealing or a Licenced Dealing, your work must be carried out in the appropriate facility (either a PC1 or PC2 facility) that has been certified by the OGTR. The Accredited Organisation must complete an application form and submit the form to the Regulator. The IBC Secretary undertakes this process on behalf of the Accredited Organisation.

How to apply for Inspection & Certification of a Facility

• New facilities can be submitted through the Research Ethics Management System (REMS).
  • Facilities need to be submitted under the local College, or School 'team'. For more informaiton please contact the rDNA officer 
• You will be required to complete a desktop audit prior to the inspection of the proposed facility
• To prepare your facility for inspection:
  • Download the appropriate ANU inspection checklists:
    • PC2 Laboratory Checklist
    • PC2 Superlab Checklist & Discrete Research Area within PC2 Superlab Checklist
    • PC2 Animal Checklist
    • PC2 Plant Checklist
    • PC2 Building Support Checklist
    • PC2 Constant Temperature Room Checklist
  • Current OGTR PC2 Facility Guidelines can be found on the OGTR website
  • Familiarise yourself with the OGTR Guidelines for the Transport, Storage and Disposal of GMOs
  • Ensure that supervisors and staff working on Notifiable Low Risk Dealings (NLRDs) or Licences (DNIRs or DIRs) in the facility have completed the Biological Safety and Gene Technology Practices training course on Pulse
• A delegate of the University Recombinant DNA Monitoring Committee will inspect the facility on an arranged date
• The researcher or facility manager and Liaison Officer must be present at the time of inspection to answer any questions the inspector/s may have about the facility, the staff and their understanding of the regulatory requirements
• The inspection report will be sent to you via REMS with any actions required in order for the facility to meet the regulatory guidelines. The researcher or facility manager will be asked to provide a revised applicaiotn.  There may be a requirement for a follow up inspection.

When the Committee is satisfied that the facility meets the regulatory guidelines, the certification application will be completed by the rDNA officer and will be submitted to the OGTR. 

Documentation for Inspection & Certification of a Facility

The documentation included with The Australian National University certification application is as follows:

1. A facility diagram or floor plan of the facility; and
2. The completed application checklist

Regulation 14 provides that certification applications are decided within 90 working days of receipt of the application, unless the period is extended because the Regulator has sought additional information from the applicant. The OGTR sends a copy of the certification letter to the delegate or the CEO of the Accredited Organisation, and to the Chair and rDNA officer. 

Facility signs and certification instruments will be issued by the OGTR at the time of certification and will be attached to the facility in REMS for use in the local area.