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Version 2.1– Effective 9 August 2011The guidelines (Part A) contain the requirements for certification of a Physical Containment Level 2 (PC2) Constant Temperature Room issued pursuant to section 90 of the Gene Technology Act 2000 (the Act) and, as applicable, corresponding State legislation.
Certification of PC2 Constant Temperature Rooms is intended to apply to standalone constant temperature rooms where genetically modified organisms (GMOs) that require containment in a PC2 facility are cultured or grown in controlled temperature conditions, either constant or fluctuating.
If a constant temperature room is part of another PC2 facility, currently or proposed to be, certified by the Gene Technology Regulator (the Regulator) to PC2, then it is not necessary to separately certify the constant temperature room.
The scope of dealings to be conducted with GMOs in facilities certified under these guidelines is also intended to be limited to procedures which produce no aerosols containing GMOs. Therefore, conditions generally will be applied to the certification of PC2 Constant Temperature Rooms specifying that all GMOs requiring containment in a PC2 facility certified by the Regulator, must remain within primary containment at all times, except for:
- Genetically modified (GM) animal tissue cultures which do not contain any GM micro-organisms
- GM multi-cellular plant tissue cultures which do not contain any GM micro-organisms
- whole GM plants which:
are contained within a plant growth cabinet that is screened to prevent the escape of seeds and pollen.
- do not contain any GM micro-organisms;
- do not contain any pollen, seed or other propagule; or
Once a facility is certified, the certification instrument imposes conditions on the facility pursuant to section 86 of the Act. The conditions of certification (Part B), detail the usual conditions that will apply to a PC2 Constant Temperature Room. Individual certification conditions may differ from these in some respect but generally an applicant can expect that their conditions will closely follow those published here. Once issued, the conditions may be varied by the Gene Technology Regulator as necessary and appropriate.
A list of the Australian/New Zealand Standards that are referenced throughout this document is also attached.
A separate document - Explanatory Information on Guidelines for Certification of Physical Containment Facilities - contains details about the process of certification. This document can be downloaded from the OGTR website.