GMO Containment 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.
A certified facility can be identified by the OGTR signage on the facility entrance door.
The IBC may approve certain exempt dealings be conducted in non-certified facilities, such as standard ‘PC1’ research or teaching laboratories.
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 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.
Requesting a new facility certification
To request an area be certified as a physical containment facility by the OGTR:
- Refer to https://www.ogtr.gov.au/resources/publications/explanatory-information-guide-physical-containment-levels-and-facility-types to determine the type of facility and level of containment required
- Contact the IBC Secretary firstname.lastname@example.org (08) 8313 6105 to arrange a pre-certification inspection.
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 this form to request changes to a facility certification.
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 work should be completed within one week. If the duration of work is expected to extend beyond a week, the certified area should either be suspended or varied to remove the work site(s).
- External perimeter breach: Work that only breaches a small area of the facility perimeter, e.g. less than one square metre at a time. Examples of minor works include the removal of a ceiling tile to conduct repairs, or penetration of a perimeter wall to install electrical cables. The work site(s) must be securely covered when not being worked on.
- Internal work: Examples 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 starting work, the work site(s) must be inspected by the Facility Manager to ensure that all GMOs have been removed or correctly stored.
- All users of the facility must be notified in 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.
Use this form to request approval for minor works in a certified facility.
Personnel must confirm that they fully understand the behavioural requirements for working in OGTR certified facilities by completing a record of their training. The Facility Manager must keep a record of those trained, which will be made available to the OGTR if requested.
Facility Managers should ensure that all personnel are adequately trained before commencing work in a certified facility and that records of training are maintained. The IBC maintains a register of all training for which a form is completed and sent to the IBC. The following 'Record of Training' forms should be routinely completed and forwarded as indicated.
Record of Training form
Please select from the following three Record of Training forms depending on which campus you are working at:
- Record of training - North Terrace and Adelaide Health and Medical School (AHMS)
- Record of training - Roseworthy Campus
- Record of training - Waite Campus
Note that some facilities have specific training requirements applied by the OGTR. Where this applies, a facility-specific Record of Training will be provided by the Facility Manager and must be completed in addition to the standard conditions defined in the above documents.
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 this link
Working in non-university PC2 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.
Physical containment level 1 (PC1)
Physical containment level 2 (PC2)
- Guidelines for Certification of a Physical Containment Level 2 Animal Facility February 2013
- Guidelines for Certification of a Physical Containment Level 2 Aquatic Facility February 2013
- Guidelines for Certification of a Physical Containment Level 2 Constant Temperature Room August 2011
- Guidelines for Certification of a Physical Containment Level 2 Invertebrate Facility March 2013
- Guidelines for Certification of a Physical Containment Level 2 Laboratory March 2013
- Guidelines for Certification of a Physical Containment Level 2 Large Grazing Animal Facility February 2014
- Guidelines for Certification of a Physical Containment Level 2 Plant Facility March 2013