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.
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.
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 faciltiies 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.
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.
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.
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.