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 & windows
3. If the facility has an anteroom, entry to and exit from the facility must be through the anteroom.
4. Dedicated “Emergency Only” exits must not be used to enter or 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. Any windows must remain closed and locked, or otherwise secured, while procedures with GMOs are being conducted or when facility personnel are not in attendance.
Handling of Invertebrates
7. Handling of the GM invertebrates or invertebrates containing GMOs, and any experimental procedures conducted on the invertebrates, must be carried out in a way that minimises the chance of escape of the invertebrates and exposure of people to GMOs.
8. When not being handled, the GM invertebrates or invertebrates containing GMOs must be kept in containers or cages designed to prevent the escape of the invertebrates and contain any micro-organisms being contained.
- NOTE: The physical boundaries of the facility alone are not sufficient for containment.
9. If any proposed dealings in the facility with GM micro-organisms will produce aerosols containing Risk Group 2 GM micro-organisms, then these dealings must be performed in either 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 does not need to be performed in a biological safety cabinet, provided that the tubes are only opened in a biological safety cabinet.
Personal protective equipment
11. The following personal protective equipment must be worn by personnel undertaking dealings involving 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 GMOs which fit into the classification of Risk Group 2 organism, as described in AS/NZS 2243.3.
- NOTE: Consideration should be given to the wearing of appropriate forms of eye protection.
13. 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.
14. 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.
15. 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 Regulator.
16. All decontamination procedures conducted inside the facility must be carried out by trained personnel.
17. GM invertebrates, invertebrates 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).
19. Equipment contaminated with or suspected to be contaminated with GMOs must be decontaminated before being removed from the facility, except if the equipment is 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.
20. Personal protective equipment contaminated with or suspected to be contaminated with GMOs must be taken off as soon as practicable and decontaminated prior to reuse or disposal. Protective clothing that is known to be not contaminated with GMOs may be washed using normal laundry methods. Gloves must be disposed of after use and prior to exiting the facility.
21. Persons who have been performing procedures in the facility that involve GM micro-organisms or who have had hand contact with any stage of the life cycle of GMOs that could persist on the hands after exit from 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.
Escape/Spills of GMOs
22. If a GM invertebrate or invertebrate containing GMOs escapes within the facility, the invertebrate must be captured and returned to its container or cage, or euthanised.
23. Documented procedures must be in place to decontaminate any spills involving GMOs inside the facility. The procedures must be made available to the Regulator if requested.
24. If a spill of GMOs or any material containing GMOs occurs inside the facility, the spills procedures must be implemented to decontaminate the spill as soon as reasonably practicable.
25. 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.
27. All GM invertebrates, invertebrates containing GM micro-organisms or other GM material must be identifiable as a GMO. This may be achieved by labelling containers. Anything that cannot be identified as a GMO or a non-GMO 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.
Removal and storage of GMOs
28. Transport and storage of all GMOs outside of the facility, must be conducted 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.
29. 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.
30. Dealings with GMOs, other than transport, must not be undertaken in any anteroom.