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

• Contact the Secretary of the University Recombinant DNA Monitoring Committee to arrange an inspection of the 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 at OGTR
  • 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 attended (or registered for) the Biological Safety training course and have undertaken the online Gene Technology Practices training course
• One or two members 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 inspectors will send the inspection report and checklist to the Secretary of the University Recombinant DNA Monitoring Committee who will advise of any non-compliant issues that need to be addressed in order for the facility to meet the regulatory guidelines. The researcher or facility manager will be asked to provide, in writing, a detailed response outlining measures taken to rectify the identified problems.  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 Secretary, signed by the Chair of the Committee and sent to the OGTR. Note: The making of a false or misleading statement may be punished by imprisonment or a fine under the Gene Technology Act 2000.

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 Secretary of the IBC. The IBC secretary will send a copy of the letter to the facility manager. Facility signs will be issued by the OGTR at the time of certification. In the event that PC1 or PC2 signs on certified facilities need replacing, advise the IBC secretary of the room number and the type of sign required and replacement signs will requested from the OGTR.