GMO Containment Facilities
Certified facilities
Certain work with genetically modified organisms (GMOs) must be undertaken in facilities that are certified by the Office of the Gene Technology Regulator (OGTR). Facilities are certified by the Regulator if they are satisfied that they meet the containment requirements set out in the relevant guidelines.
There are four levels of containment established by the OGTR guidelines. These are in ascending order of the stringency of containment requirements:
- Physical containment level 1 (PC1)
- Physical containment level 2 (PC2)
- Physical containment level 3 (PC3)
- Physical containment level 4 (PC4)
For PC2 level containment, there are specific types of facilities for plant, animal, invertebrate, aquatic and large grazing animal containment.Ìý
A certified facility can be identified by the OGTR signage on the facility entrance door.
Non-certified facilities
The IBC may approve certain exempt dealings be conducted in non-certified facilities, such as standard ‘PC1’ research or teaching laboratories.
The Regulator has releasedÌý. These notes are provided asÌýguidance onlyÌýto persons conducting exempt dealings and may be of assistance in determining how to undertake exempt dealings with regard to avoiding intentional release. The guidance notes do not replace IBC advice on exempt dealings.
Exempt dealings can also be undertaken in facilities of a higher level of containment, eg. in PC2 facilities.
Certified facility guidelines
Some facility certifications may have exemptions to certain conditions, or alternative conditions, approved by the Regulator. You must comply with any standard operating procedures for a certified facility you are working in.
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Requesting a new facility certification
To request an area be certified as a physical containment facility by the OGTR:
- Refer to to determine the type of facility and level of containment required
- Contact the IBC Secretary ibc@adelaide.edu.au (08) 8313 6105 to arrange a pre-certification inspection.
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Requesting changes to certification
Types of changes:
- varying a certification to add or remove rooms
- suspending a certification
- lifting a suspension
- surrendering a certification
Use to request changes to a facility certification.
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Requesting approval to undertake minor repair or maintenance work in a certified facility
Some minor works to an OGTR certified facility may be undertaken without suspending or varying the certification. Minor works must meet the criteria below, and the Research Compliance Officer must notify the OGTR at least 24 hours before commencement of the work.
The following criteria must be met:
- Short duration, e.g. 1–2 whole days or 2–3 hours per day over several days. All workÌýshould be completed within one week. If the duration of workÌýis expected to extend beyond a week, the certified area should either be suspended or varied to remove the work site(s).
- External perimeter breach:ÌýWork thatÌýonly breaches a small area of the facility perimeter, e.g. less than one square metre at a time. Examples of minor works includeÌýthe removal of a ceiling tile to conduct repairs, or penetration of a perimeterÌýwall to install electrical cables. The work site(s) must be securely covered when not being worked on.
- Internal work:ÌýExamples of minor works may include installation of light fittings, installation of power points, re-painting walls, or repair of water damage. There is no limit to the size of internal work. Please note that if the works will result in a change to the floor plan (i.e. adding/removing rooms within the existing certified area), then a suspension and/or variation will be required.
- Access to the work site(s) must be restricted while work is undertaken (e.g. using signs), and doors are to remain closed except during entry and exit.
- Prior to startingÌýwork, the work site(s) must be inspected by the Facility Manager to ensure that all GMOs have been removedÌýor correctly stored.
- All users of the facility must be notifiedÌýin advance and informed that no dealings with GMOs can be undertaken at the work site(s) for the duration of work. Dealings with GMOs must be isolated from the work site(s), e.g. behind closed doors.
Following completion of minor works
The facility must be inspected for compliance with the current guidelines by the Research Compliance Officer, who will then notify the OGTR.
After the OGTR are notified that the facility complies, dealings with GMOs can recommence in the facility.±«²õ±ðÌýÌýto request approval for minor works in a certified facility.
All persons who access an OGTR certified facility must receive training in the behavioural conditions relevant to that class of facility and must provide a signed and dated record of training to the Facility Manager. This requirement applies to all personnel entering the facility, including visitors and contractors (e.g., maintenance staff, cleaners, and other service providers) who must be inducted and complete a Record of Training form.
Online OGTR PC2 Facility Training
The IBC provides an online training module for research staff and students covering the requirements for working in OGTR certified PC2 facilities, available for self-enrolment through MyUni using . Ìý
The online course must be completed by all research staff and students working in OGTR certified facilities. The IBC maintains a register of all personnel who have completed this training, which is made available to Facility Managers upon request. Ìý
The Facility Manager must ensure that all personnel are adequately trained before commencing work and keepÌýcopies of the signed and dated Record of Training, which will be made available to the OGTR if requested. A signed copy should also be returned to the IBC using the link supplied within the Record of Training form.
Record of Training form
Please select from the followingÌýRecord of Training forms depending onÌýat the class of persons working in the facility:
- Record of training for research staff and students
- Record of training for supervised visitors
- Record of training for contractors
Note that some facilities have specific training requirements applied by the OGTR or IBC. Where this applies, a facility-specific induction and Record of Training will be provided by the Facility Manager.
How to submit a Record of Training
Provide a copy of the above Record of Training to the Facility Manager for each PC2 facility you will be working in, and also submit a copy to the IBC using .
Working in non-university PC2 facilities
×îÐÂÌÇÐÄVlog 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.
Physical containment level 1 (PC1)
- ÌýMarch 2007Ìý
Physical containment level 2 (PC2)
- ÌýFebruary 2013Ìý
- ÌýFebruary 2013Ìý
- ÌýAugust 2011Ìý
- ÌýMarch 2013Ìý
- ÌýMarch 2013Ìý
- ÌýFebruary 2014Ìý
- ÌýMarch 2013Ìý
Contact us
For regulatory compliance or Institutional Biosafety Committee enquiries contact E:Ìýibc@adelaide.edu.au
Contact
- Amanda Highet
Ìý