These notes are provided as guidance only to persons conducting exempt dealings pursuant to regulation 6 of the Gene Technology Regulations 2001 (the Regulations) as in force from 1 July 2007 and/or pursuant to any applicable corresponding law.

Exempt dealings are dealings described in Schedule 2, Part 1 of the regulations. The only further legislative requirement for exempt dealings is that they do not involve an intentional release of the GMO into the environment, or a retroviral vector that is able to transduce human cells.

Note that a dealing with a GMO listed as an exempt dealing will cease to be exempt from licensing if the GMO is intentionally released.

These Guidance Notes, which are effectively equivalent to those for facilities certified by the Regulator to Physical Containment Level 1 (PC1), may be of assistance to organisations or persons in determining how to undertake exempt dealings to satisfy themselves with regard to avoiding intentional release. Please note that these Guidance Notes are not Guidelines for Certification of a PC1 Facility.

A list of the Australian/New Zealand standards that are referenced in the Guidance Notes is also attached to this document.

Explanatory Information

Guidance Notes for the Containment of Exempt Dealings

This document comprises Guidance Notes for the containment of exempt dealings as described in regulation 6 of the Regulations as in force from 1 July 2007.

The Guidance Notes are only applicable to exempt dealings conducted under the Gene Technology Act 2000 (the Act). They do not provide comprehensive guidance for laboratory safety, good laboratory practice or broader occupational health and safety issues, nor do they provide comprehensive guidance for laboratory design and construction. For these purposes, refer to AS/NZS 2243.3:2002 and AS/NZS 2982.1:1997.

Containment of Exempt Dealings

Definitions and acronyms

Unless defined otherwise in these Guidance Notes, words and phrases used in these Guidance Notes have the same meaning as in the Act and Regulations.

Words in the singular include the plural and words in the plural include the singular.

Where any word or phrase is given a defined meaning, any other part of speech or other grammatical form in respect of that word has a corresponding meaning.

Where a word in the text is bolded, it indicates that the word has been defined (see below).

aerosolParticulate matter, solid or liquid, small enough to remain suspended in air.
autoclavePressure steam steriliser.
dealing or deal withIn relation to a GMO, means the following:
  1. conduct experiments with the GMO;
  2. make, develop, produce or manufacture the GMO;
  3. breed the GMO;
  4. propagate the GMO;
  5. use the GMO in the course of manufacture of a thing that is not the GMO;
  6. grow, raise or culture the GMO;
  7. import the GMO;
  8. transport the GMO;
  9. dispose of the GMO;
and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of the paragraphs (a) to (i).
decontaminationA physical or chemical process that removes, kills or renders non-viable the GMOs being dealt with in the facility, but does not necessarily result in sterility.
  1. ecosystems and their constituent parts;
  2. natural and physical resources; and
  3. the qualities and characteristics of locations, places and areas.
exempt dealingA dealing conducted pursuant to regulation 6 of the Regulations.
facilityThe laboratory or other work area within which exempt dealings are contained.
GMGenetically Modified.
GMOGenetically Modified Organism.
primary containerThe container directly surrounding the GMO.
sealedAble to contain and prevent the escape/release of all GMOs or GM reproductive material, including during standard transport conditions.
unbreakableAble to maintain integrity under all reasonably expected conditions of transport such as pressures, forces, impacts, temperatures and moisture.
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Which parts of these Notes are applicable?

If you are conducting exempt dealings with GM micro-organisms or tissue cultures only, you should refer to:Part 1 (A) and Part 2 (A)
If you are conducting exempt dealings with animals containing GM micro-organisms, you should refer to:Parts 1 (A) & (B) and Parts 2 (A) & (B)

Part 1 – Facilities and fittings

A) Exempt dealings with GMOs

1. Exempt dealings with GMOs should be conducted in a facility that is a fully enclosable space bounded by walls, doors, windows, floors and ceilings.
    NOTE: The walls, doors, windows, floors and ceilings form the physical containment barrier around the area where exempt dealings with GMOs will be conducted.
2. Floors and benches in the facility should be cleanable, easily decontaminated and resistant to damage by the cleaning agents and/or disinfectants that will be used in the facility.

3. The facility should contain either a wash basin or some other means of decontaminating hands.
    NOTE: Decontamination of hands is considered an important means of preventing unintentional release of GMOs. Alternatives to wash basins, such as dispensers filled with decontaminant solutions, are considered suitable.
4. If the facility has drainage exits, they should be fitted with barriers such as mesh, grilles or floor wastes, to prevent entry of rodents and invertebrates.

B) Exempt dealings with animals containing GMOs

5. Doors and windows that are able to be opened should be lockable. Windows that are able to be opened should be screened to prevent the entry or exit of arthropods.

6. The facility boundaries (doors, walls, floors, ceilings etc.) should be designed to prevent the escape of the animals containing GMOs.

7. Any openings in the facility walls, ceiling or roof, such as air vents, should be screened with rodent-proof mesh.

8. If the facility has drainage exits, they should be fitted with barriers (e.g. floor wastes or mesh) to prevent rodents or any other animal from entering the facility via the drains and to prevent the escape of animals containing GMOs from the facility.
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Part 2 – Behavioural conditions

A) Exempt dealings with GMOs

9. Access to the facility should be restricted to persons authorised to enter.

10. Dedicated “emergency only” exits should not be used except in emergencies.

11. Persons performing procedures with GMOs in the facility should wear protective clothing to protect the front part of the body from exposure to the GMOs.

12. Protective clothing should be removed and disposed of, or stored, before leaving the facility.
    NOTE: Consideration should be given to the provision of hooks or other storage for protective clothing.
13. Protective clothing contaminated or suspected to be contaminated with GMOs should be removed as soon as reasonably possible and decontaminated prior to reuse. Protective clothing that has not been contaminated with GMOs may be washed using normal laundry methods.

14. Precautions should be taken to minimise the production of aerosols where procedures involving GMOs are carried out on an open bench.

15. All cultures of GMOs should be labelled.
    NOTE: Labelling assists the separation of GM work from non-GM work and enhances the control of GMOs within the facility.
16. GMOs should be decontaminated prior to disposal.

17. Liquid and solid wastes potentially containing GMOs should be decontaminated prior to disposal.

18. Work benches, surfaces and equipment where procedures involving GMOs have taken place should be decontaminated when the procedures are completed.
    NOTE: This is to minimise any persistence of GMOs inside the facility and minimise cross-contamination with any other work.
19. Any equipment that is, or may be, contaminated with GMOs should be decontaminated prior to being removed from the facility.

20. Decontamination can be achieved by any method effective in rendering the GMO non-viable, including autoclaving or other heat treatment; chemical treatment; or incineration.

Incineration should be performed in a high temperature, high efficiency incinerator that has been approved by the relevant government authority in the jurisdiction where the incinerator is located.
    NOTES: Decontamination can take place in the facility or at another location.
21. A supply of disinfectant(s) effective against the GMOs used in the facility should be available in the facility for decontamination purposes. Containers of disinfectant(s), including any solutions for decontaminating hands, should be clearly labelled with the contents and, where necessary, the expiry date. Solutions should not be used after the expiry date.
    NOTES: AS/NZS 2243.3:2002 is a recommended source of information when selecting chemical disinfectant agents.
22. All cultures of GMOs being stored inside the facility should be sealed during storage to prevent dissemination of the GMOs.
    NOTE: The type of containment necessary to prevent the GMOs from escaping will vary depending on the type of GMO being stored.
23. Persons who have been performing procedures with GMOs in the facility should decontaminate their hands before leaving the facility.
    NOTE: This may include the use of soap and water, if appropriate.
24. GMOs may be stored outside the facility in a storage unit (freezer, fridge, controlled temperature room or other container) provided that: (a) access to the storage unit is restricted or controlled to prevent unintentional release of GMOs into the environment and that the GMOs are stored in a labelled, sealed, unbreakable primary container to prevent the escape or release of the GMO.

25. If any spills of GMOs occur outside the facility, the contaminated surfaces should be decontaminated as soon as reasonably possible.
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B) Exempt dealings with animals containing GMOs

26. Except during the entry and exit of personnel, supplies and/or equipment, doors of the facility should be closed while procedures with animals containing GMOs are being conducted. Windows and doors should be locked when facility personnel are not in attendance.

27. Handling of and any experimental procedures conducted on the animals containing GMOs should be carried out in a way that minimises the chance of escape.

28. When not being handled, the animals containing GMOs should be kept in containers or cages designed to prevent the escape of the animals being contained.
    NOTE: The facility physical boundaries alone are not sufficient for containment.
29. All animal cages or containers should be labelled. Cages or containers must be labelled to enable identification of the animals containing GMOs and to indicate the number of animals in the containers. Large animals containing GMOs should be clearly marked so that they can be readily identified (eg. with a tattoo, permanent tag, microchip or permanent brand). Some documented system of accounting for the animals containing GMOs in the facility should be used.

30. If an animal containing GMOs escapes within the facility, trapping devices should be used to capture the animal and the animal should be returned to its container or cage or euthanased.

Standards referenced in this document

‘AS’ followed by a number or other identification is a reference to the Australian Standard so numbered or identified.

‘AS/NZS’ followed by a number or other identification is a reference to the Australian New/Zealand Standard so numbered or identified.

AS/NZS 2243.3:2002Safety in laboratories
Part 3: Microbiological aspects and containment facilities
AS/NZS 2982.1:1997Laboratory design and construction
Part 1: General requirements

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