1. Persons undertaking dealings in the facility with GMOs requiring PC2 containment must comply with these Behavioural Requirements.
Non-GMOs, exempt dealings and PC1 dealings in the facility
2. Persons undertaking work in the facility on non-GMOs, exempt dealings or dealings which may be undertaken in a PC1 facility must comply with these Behavioural Requirements unless:
- procedures are implemented to ensure that non-GMOs, exempt dealings or dealings which may be undertaken in a PC1 facility, are not cross-contaminated with GMO dealings requiring containment in a PC2 facility;
- the above procedures are documented; and
- the primary and any secondary container used to transport any organism out of the facility must be free of contamination with GMOs prior to being transported out of the facility.
NOTE: Means of preventing cross-contamination could include physical separation of the work, or separation by working at different times and ensuring any contaminated surfaces are decontaminated prior to
working with a different organism.
Doors and windows
3. Entry to and exit from the facility must be through the anteroom.
4. Dedicated “Emergency Only” exits must not be used to enter nor exit the facility except in an emergency.
5. Except during the entry and exit of personnel, supplies and/or equipment, doors of the facility must be closed while procedures with GMOs are being conducted. Entrance doors into the facility must remain
locked, or the facility must be otherwise secured, when facility personnel are not in attendance.
6. Windows must be closed and locked or otherwise secured while GM animals or animals containing GMOs are in the facility.
Handling of animals
7. Handling of the GM animals or animals containing GMOs, and any experimental procedures conducted on the animals, must be carried out in a way that minimises the chance of escape of the animals and exposure of people to
8. When not being handled, the GM animals or animals containing GMOs must be kept in containers or cages designed to prevent the escape of the animals being contained.
- NOTE: The facility physical boundaries of the facility alone are not sufficient for containment.
9. Decontamination must be undertaken in accordance with Section 3.1 of the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs as in force from time to time unless otherwise approved in writing by the
10. All decontamination procedures conducted inside the facility must be carried out by trained personnel.
11. GM animals, animals containing GMOs or any waste containing GMOs must be decontaminated prior to disposal if the method of disposal is not also the method of decontamination.
- NOTE: Where appropriate, visual inspection of the container(s) may be used to confirm whether decontamination is necessary (e.g. in the case of macroscopic GMOs which are visible to the naked eye)
12. Equipment, pens, cages or bedding contaminated with or suspected to be contaminated with GMOs must be decontaminated before being removed from the facility, except if they are being transported for the purposes of
decontamination in accordance with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, and other relevant guidelines issued by the Regulator.
Escape/Spills of GMOs
13. If a GM animal or animal containing GMOs escapes within the facility, the animal must be captured and returned to its container or cage, or euthanised.
14. Documented procedures must be in place to decontaminate any spills involving GM sperm, GM ova, GM embryos, GM micro-organisms or animal tissue containing GM micro-organisms inside the facility. The procedures must
be made available to the Regulator if requested.
15. If a spill of GM sperm, GM ova, GM embryos, GM micro-organisms or animal tissue containing GMOs occurs inside the facility, the spills procedures must be implemented to decontaminate the spill as soon as reasonably
16. In the event of the escape, unintentional release, spill, leak or loss of GMOs outside of the facility:
- efforts must be implemented as soon as reasonably practicable to locate and/or retrieve the GMOs and return the GMOs to containment or render them non-viable; and
- the incident must be reported to the Regulator as soon as practicable.
17. All animals or cages/containers of animals must be labelled so as to indicate that they are GMOs or contain GMOs. Cages or containers must be labelled to enable identification of the animals being contained and
to indicate the number of animals in the containers. Large animals must be clearly marked so they can be readily identified (e.g. with a tattoo, permanent tag, microchip or permanent brand).
18. A documented system of accounting for the number of animals in the facility must be used. The documentation must be made available to the Regulator if requested.
Removal and storage of GMOs
19. Transport and storage of all GMOs, animals containing GM micro-organisms, GM sperm, GM ova, GM embryos or animal tissue containing GMOs outside of the facility must be conducted in accordance with the Regulator’
Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time and other relevant guidelines issued by the Regulator.
20. All cultures of GMOs being stored inside the facility must be sealed during storage to prevent dissemination of the GMOs.
- NOTE: The type of container necessary to prevent the GMOs from escaping will vary depending on the type of organisms being stored.
AnteroomTop of page
21. Dealings with GMOs, other than transport, must not be undertaken in the anteroom.
Dealings involving GM micro-organisms
If any of the dealings proposed to be conducted in the facility will involve GM micro-organisms, the behavioural training must encompass the following requirements in addition to all other requirements listed:
22. If any proposed dealings in the facility with GM micro-organisms will produce aerosols containing Risk Group 2 GM micro-organisms, then they must be performed in a biological safety cabinet or other equipment specifically
approved in writing by the Regulator that is designed to contain aerosols.
NOTE: Procedures with GM micro-organisms such as centrifuging and vortexing in sealed tubes are not required to be performed in a biological safety cabinet, provided that the tubes are only opened in a biological safety
23. Where any Class I or Class II biological safety cabinet is installed and used for procedures with GM micro-organisms, it must be used and decontaminated in accordance with the requirements of AS 2252.4.
Personal protective equipment
24. The following personal protective equipment must be worn by personnel undertaking dealings with GM micro-organisms in the facility:
- protective clothing to afford protection to the arms and front part of the body; and
- NOTE: A rear-fastening gown is preferable.
- disposable gloves, when dealing with GM viral vectors or GM micro-organisms which fit into the classification of Risk Group 2 organisms, as described in AS/NZS 2243.3.
- NOTE: Consideration should be given to the wearing of appropriate forms of eye protection.
25. If the work in the facility involves GM micro-organisms, or there is contact with GMOs that could persist on the clothing or equipment, then personal protective equipment must be removed before leaving the facility and disposed of or stored in designated storage or hanging provisions.
26. Personal protective equipment, with the exception of gloves, may be worn if moving directly to another containment facility, certified to at least PC2 by the Regulator, that is directly connected to the facility or is connected by a
corridor, stairs or other space that is not a public thoroughfare and in which there is negligible risk of the release of the GMOs or of cross-contamination should other personnel be encountered or contacted in the corridor.
The general conditions relating to decontamination also apply to GM micro-organisms (see paragraphs 9, 10, 11 & 12).
27. Work benches and surfaces where procedures involving GM micro-organisms have taken place must be decontaminated when the dealings are completed. Equipment directly used in procedures involving GM
micro-organisms must be decontaminated when the dealings are completed.
28. Carcasses of animals containing GM micro-organisms must be decontaminated prior to disposal if the method of disposal is not also the method of decontamination.
29. Personal protective equipment contaminated with or suspected to be contaminated with GM micro-organisms must be taken off as soon as practicable and decontaminated prior to reuse or disposal. Protective clothing that
has not been contaminated with GM micro-organisms may be washed using normal laundry methods. Gloves must be disposed of after use and prior to exiting the facility.
30. Persons who have been performing procedures with GMOs in the facility must decontaminate their hands before leaving the facility.
NOTE: This may include the use of soap and water, if appropriate. If wash basins are to be used, the use of hand-operated taps is not acceptable, as they are a ready source of contamination. Soap and other
decontamination agents should be dispensed from hands-free dispensers.
31. All containers of GM micro-organisms must be clearly labelled. Any unlabelled material must be treated as a GMO and handled in accordance with these requirements.
NOTE: Labelling enables the separation of GM work from non-GM work and enhances the control of GMOs within the facility.