This section outlines the guidelines & application process for a GMO facility to be certified, and requirements for maintaining the certification of existing facilities.
About Physical Containment Facilities
Certain dealings with GMOs must be conducted within physical containment facilities that are certified by the OGTR. The purpose of certification is to satisfy the GT Regulator that the containment facility protects persons outside the facility from exposure to GMOs and prevents release of GMOs into the environment. The GT Regulator also imposes conditions of certification that require certain procedures to be followed to ensure the safety of people working inside containment facilities with GMOs.
Physical Containment Levels & Types
There are four levels of containment established by the OGTR Guidelines. These are in ascending order of the stringency of containment requirements, which reflect the level of risk:
- Physical Containment Level 1 (PC1)
- Physical Containment Level 2 (PC2)
- Physical Containment Level 3 (PC3)
- Physical Containment Level 4 (PC4)
There are several facility types, depending upon the nature of work undertaken in the facility. These include laboratory, plant containment, animal containment, arthropod, aquatic, large grazing animal containment, etc.a11677
Facilities may be certified if the Regulator is satisfied that they meet the containment requirements set out in the relevant OGTR Guidelines for the Certification of Facilities/Physical Containment Requirements.
Most OGTR certified facilities are PC2 level, however, the OGTR can also certify facilities at the PC1 level as is required for certain GMO dealings. This sometimes creates confusion as facilities in general and the facilities in which exempt dealings are usually undertaken are referred to as 'PC1' by the OGTR. Thus, there are both 'PC1 facilities' and 'certified PC1 facilities'.
A certified facility can be identified by the OGTR signage on the facility entrance door.
Facilities for Exempt Dealings
There are no specific facility requirements for exempt dealings other than the requirement that they do not involve an intentional release of the GMOs into the environment, or a retroviral vector that is able to transduce human cells.
The Regulator has released Guidance Notes for the Containment of Exempt Dealings . These notes are provided as guidance only to persons conducting exempt dealings and may be of assistance in determining how to undertake exempt dealings with regard to avoiding intentional release.
The facilities where exempt dealings are undertaken:
- are generally referred to as PC1 facilities;
- do not require approval by the IBC or certification by the OGTR;
- do not require IBC or OGTR signage on the facility door;
- do not require IBC or OGTR inspection.
Exempt dealings can also be undertaken in facilities of a higher level of containment, eg. in PC2 facilities.
Facilities for Notifiable & Licence Dealings
Notifiable and licence dealings can only be undertaken in facilities that have been certified by the OGTR.
Most NLRD and DNIR dealings will be undertaken in a PC2 level of containment facility. Some NLRDs are appropriate to be undertaken in a PC1 facility which has been certified by the OGTR. Your NLRD or DNIR dealing must be undertaken in a PC2 facility unless another level of containment has been specifically approved for the dealing.
Note that, investigators must seek a variation to their dealing approval to allow them to undertake work in a facility which has not been listed on their application, ie. prior approval is required for each facility in which these dealings are undertaken.
Variations to an approved dealing can be sought by contacting the IBC Secretary with the relevant details.
Working in External Facilities
University personnel working physically within another organisation's premises/facility should check with the IBC of the other organisation to determine the requirements for investigators.
Personnel should be aware of the necessity to follow the rules, regulations or policies of another IBC if working in another organisation's premises or facilities and thereby the requirement to meet both organisation's compliance protocols
The requirements for each facility type at different physical containment levels are set out in the following documents:
- Guide to Physical Containment Levels and Facility Types
- Explanatory Information on Guidelines for Certification of Physical Containment Facilities
The facility types most relevant to research work within the university are listed below:
Facility types most relevant to the University
Facility Types Relevant to the University of Adelaide
PC1 Certified facility
PC2 Large grazing animal facility
PC2 Animal facility
PC2 Aquatic organism facility
PC2 Invertebrate facility
PC2 Constant Temperature Room
PC2 Plant facility
For other facility types refer to the OGTR website.
Note: The Guidelines for Certification of a Physical Containment Level 1 Large Grazing Animal Facility version 2.1 were revoked on 11 February 2014.
- Training requirements working with OGTR certified facilities
- Current* guidelines for the Transport, Storage and Disposal of GMOs.
Follow the steps (17) below when applying to certify a GMO facility.
Area to determine type of facility and level of containment required for the GMO work which will be undertaken in the facility. Refer to:
|2||Area to nominate a 'Facility Manager'|
|3||Area to ensure that facility meets the criteria listed in the relevant OGTR Facility Guidelines (discuss with IBC Secretary if necessary)|
Area to complete:
Ensure all attachments are in order (including the floorplan). A copy of Standard Operating Procedures or the Facility Manual also need to be submitted with the application form.
If relevant, apply to the OGTR for a declaration that specified information is confidential commercial information by completing the OGTR form:
|6||Area to forward completed forms (ie as indicated at 4. and 5. above) to IBC Secretary.|
|7||IBC Secretary to arrange to undertake an inspection of the facility - during the inspection the IBC Secretary, accompanied by the Facility Manager, will complete the relevant OGTR checklist.|
|8||Any issues arising during inspection to be addressed by area.|
|9||Application for certification to be endorsed by IBC prior to submitting to OGTR.|
OGTR will issue an 'identifier' (in the form Cert xxxx/200y) upon receipt of application.
|11||OGTR will advise IBC Secretary of any issues requiring clarification or attention.|
|12||As required, IBC Secretary will liaise with area to complete application process.|
|13||The application is assessed by the OGTR. Applications are decided within 90 working days of receipt of the application by the OGTR, unless the period is extended because the Regulator has sought additional information from the applicant.|
|14||OGTR will issue an 'instrument of certification' to the applicant organisation and will forward appropriate door signage and facility practice signage.|
|15||IBC Secretary will confirm with Facility Manager that GMO dealings may now commence within the certified facility.|
|16||IBC will maintain a register of certified facilities.|
|17||IBC Secretary will liaise with the Facility Manager on any issues of relevance which arise.|
At all times, certified facilities must meet the requirements specified in their certification instrument and the relevant OGTR facility guidelines.
Suspension of the OGTR certification can be made by written request to the OGTR (via the IBC). Another written request is made to arrange reinstatement of the PC2 status. Confirmation of the reinstatement of the PC2 status must be obtained from the OGTR before any GMO work requiring PC2 level containment can be undertaken in the facility.
Requirements during the suspension period:
- all OGTR signage must be covered or removed;
- no work with GMOs requiring PC2 level containment is to be carried out;
- any GMOs remaining within the facility must be stored in accordance with OGTR guidelines.
To surrender a facility certification, written advice must be given to the OGTR (via the IBC).
Requirements upon surrender:
- the facility must be thoroughly cleaned with appropriate decontamination processes for the particular work that has been undertaken in the facility;
- all GMOs must be removed and destroyed or stored appropriately;
- all OGTR signage must be removed from the facility.
In order to reinstate a surrendered certification, a new application for certification must be completed and submitted.
Institutional Biosafety Committee Inspections
The University's Institutional Biosafety Committee (IBC) undertakes an annual inspection of each certified facility according to the OGTR Guidelines which are current at the time.
The Facility Manager will be contacted to arrange a suitable time, and accompany the IBC Inspector throughout the inspection.
There is an OGTR check list to be completed and authorised at the time of inspection. Prior to the inspection, the Facility Manager should review the OGTR Guidelines and ensure that each of their facilities complies with the general and relevant specific conditions for certification. In addition, the Facility Manager should ensure that all of the required documentation is available and in order.
Any issues requiring corrective action that are identified at the time of inspection are notified to the Facility Manager for execution. Certification can only be maintained if corrective actions are completed and the facility meets the requirements specified in the certification instrument.
The IBC also undertakes random spot inspections to monitor the ongoing status of facilities.
The Monitoring and Compliance Section of the OGTR conduct routine monitoring inspections of certified physical containment facilities. These monitoring inspections are either 'announced inspections' or 'spot inspections'.
- 'Announced Inspections' - the IBC Secretary is notified approximately 5 working days prior and an agreed time is arranged
- 'Spot Inspections' - no notification provided; OGTR Officers will arrive and contact a person in authority to notify them of the intended inspection
Under the Act, if an OGTR Officer arrives to undertake an inspection, you must allow the inspector to enter premises for the purpose of auditing, monitoring and checking compliance. Please assist the OGTR Inspectors with their work.
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