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Version 1.1– issued 30 March 2007These guidelines contain the requirements for certification of a Physical Containment Level 1 (PC1) Facility issued pursuant to section 90 of the Gene Technology Act 2000 (the Act).
These guidelines apply to facilities containing dealings that are required to be conducted in a PC1 facility certified by the Gene Technology Regulator (the Regulator).
Once a facility is certified, the certification instrument imposes conditions on the facility pursuant to section 86 of the Act.
The conditions of certification, attached to this document, detail the usual conditions that will apply to a PC1 Facility. 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.
A list of the Australian/New Zealand standards that are referenced in the requirements and conditions is also attached to this document.
A separate document - Explanatory Information on Guidelines for Certification of Physical Containment Facilities - contains details about the process of certification.
Requirements for Certification
Section 90 of the Gene Technology Act 2000
These are the requirements for the certification of a PC1 Facility issued under section 90 of the Gene Technology Act 2000 (the Act) and, as applicable, corresponding State legislation. These requirements apply to applications for certification of PC1 Facilities received on or after the day on which these guidelines take effect.
To be granted certification, a facility must meet each of the requirements for certification of a PC1 Facility, unless the facility receives a written exemption from meeting a particular requirement from the Regulator or a delegate of the Regulator.
DefinitionsUnless defined otherwise in these guidelines, words and phrases used in the guidelines have the same meaning as in the Act and the Gene Technology Regulations 2001.
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).
Particulate matter, solid or liquid, small enough to remain suspended in air.
Pressure steam steriliser.
dealing or deal with
In relation to a GMO, means the following:
- conduct experiments with the GMO;
- make, develop, produce or manufacture the GMO;
- breed the GMO;
- propagate the GMO;
- use the GMO in the course of manufacture of a thing that is not the GMO;
- grow, raise or culture the GMO;
- import the GMO;
A physical or chemical process which kills or renders non-viable the GMOs being dealt with in the facility, but does not necessarily result in sterility.
- ecosystems and their constituent parts;
- natural and physical resources; and
- the qualities and characteristics of locations, places and areas.
The whole of the space that is to be certified by the Regulator to a specific level of containment.
Genetically Modified Organism.
Physical Containment Level 1.
The container directly surrounding the GMO.
Able to contain and prevent the escape/release of all GMOs or GM reproductive material (including pollen or gametes), including during standard transport conditions.
The container immediately surrounding the primary container.
The Gene Technology Regulator.
Able to maintain integrity under all reasonably expected conditions of transport such as pressures, forces, impacts, temperatures and moisture.
General requirements1. The applicant must be able to demonstrate a capacity to comply with the conditions of certification that will be generally applied to a certified PC1 Facility. These conditions are attached to this document.
Facilities and fittings requirementsWhat ‘Facilities and fittings requirements’ must be met?
|If the facility will contain dealings with GM animals only, the facility must comply with the requirements in the following sections:||Facilities and fittings (A) & (B)|
|If the facility will contain dealings with GM micro-organisms only, the facility must comply with the requirements in the following sections:||Facilities and fittings (A) & (C)|
|If the facility will contain dealings with GM micro-organisms within an animal(s), the facility must comply with the requirements in the following sections:|
Note: if the involves GM micro-organisms within a non-GM animal, the animal must be treated as if it were GM.
|Facilities and fittings (A), (B) & (C)|
|If the facility will contain dealings with non-GM plants that contain or host GMOs, the facility must comply with the requirements in the following sections:||Facilities and fittings (A), (C) & (D)|
A) Requirements for all facilities containing dealings with GMOs
2. The facility to be certified must be 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 dealings with GMOs will be conducted.
B) Requirements for facilities containing dealings with GM animals
3. Doors, and windows that are able to be opened, must be lockable. Windows that are able to be opened must be screened to prevent the entry or exit of arthropods.
4. Except when persons are entering or exiting the facility, doors of the facility must be closed while GM animals are contained there. Windows and doors must be locked when facility personnel are not in attendance.
5. The facility boundaries (doors, walls, floors, ceilings etc.) must be designed to prevent the escape of the GM animals being contained.
6. Any openings in the facility walls, ceiling or roof, such as air vents, must be screened with rodent proof mesh.
7. If the facility has drainage exits, they must be fitted with barriers (e.g. floor wastes or mesh) to prevent rodents or any other animals from entering the facility via the drains and to prevent the escape of animals from the facility. Where a dealing being conducted in the facility involves animals containing a GMO capable of being transmitted by arthropods, the drains must also be designed to prevent arthropods from entering or leaving the facility via the drains (e.g. by use of liquid traps permanently filled with water, or by a mesh that acts as a barrier to both arthropods and rodents).
C) Requirements for facilities containing dealings with GM micro-organisms
8. Floors and benches in the facility must be cleanable, easily decontaminated and resistant to damage by the cleaning agents and/or disinfectants that will be used in the facility.
9. The facility must 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 GM micro-organisms. Alternatives to wash basins, such as dispensers filled with decontaminant solutions, are considered suitable.
10. Designated storage or hanging provisions for protective clothing must be available within the facility.
D) Requirements for facilities containing dealings with non-GM plants that contain or host GMOs
11. Transparent sections may be used in walls, doors and ceilings if required.
12. All boundaries of the facility must be rigid and durable, must be suitable for the environment in which the facility is located, and must withstand expected wear and tear without risking loss of containment. Any transparent sections of the facility boundary must made of glass, polycarbonate sheeting or other similar durable material. All boundaries must be impact resistant or must be protected from impact.
NOTE: ‘Impact resistant’ or ‘protected’ refers to the ability of the boundaries to withstand exposure to events such as hailstones, wind-borne debris, birds and objects displaced by equipment or machinery such as lawnmowers.
13. The facility must be designed to prevent the entry of surface run-off water.
14. Any openings in the walls, ceiling or roof, such as windows, vents and air-conditioning or ventilation inlets and outlets, must be screened or filtered at the containment boundary to prevent entry or exit of arthropods and, where applicable, the escape of any arthropod vectors used for pollination. The screening material must be of a material mechanically strong enough to withstand the airflow load, remain undamaged with regular cleaning, and resist corrosion.
15. If the facility has drainage exits, they must be fitted with a barrier such as mesh, grilles or floor wastes, to prevent entry of rodents and arthropods.
General conditions of certification
Facilities and fittings conditions1. The certification holder must ensure that the physical attributes of the facility and fittings are maintained so that the relevant ‘Facilities and fittings requirements’ for certification continue to be met.
NOTE: If the type of dealings change, the certification holder must ensure the ‘Facilities and fittings requirements’ applicable to the new dealings are met. For example, if the facility was originally used for dealings with micro-organisms and will now be used for dealings with animals, then any unlockable doors would need to be modified so they are lockable.
2. If the certification holder is not the owner of the facility and does not have the authority to maintain the facility and fittings, the certification holder must notify the Regulator in writing if the owner of the facility is incapable of carrying out, or refuses to carry out, or otherwise does not carry out, any maintenance required to continue to meet the ‘Facilities and fittings requirements’.
3. Each access door to the facility must be labelled with a PC1 sign as supplied by the OGTR so that persons entering the facility are able to clearly see they are entering a certified PC1 facility. Emergency only exits must not be used except in emergencies.
NOTE: Signs do not need to be displayed on or next to the outside of dedicated “emergency only” exits. Signs may be stuck onto removable fixtures, such as backing boards or plastic frames, which must be secured to the door or adjacent wall and must not be transferred to any other location.
Obligations of the holder of certification in respect of users of the facility4. While any dealings with GMOs are being conducted in the facility, the certification holder must ensure that access to the facility is restricted to authorised persons.
5. For purposes of the previous condition, an authorised person is:
- A person who:
- intends to undertake dealings, and has been notified of and trained in the PC1 behavioural conditions listed below, and
- has agreed to comply with those behavioural conditions, and
- has not been excluded from the facility by the certification holder on the direction of the Regulator; or
- An individual, or class of person, who does not intend to undertake dealings and has the permission of the certification holder, its representative or the facility manager, to enter the facility.
7. If the Regulator directs the certification holder to admit a person or class of person to the facility subject to conditions, the certification holder must only admit the person or class of person subject to those conditions.
8. Before admitting a person or class of person subject to conditions, the certification holder must notify the person of any conditions that would apply to them.
9. The Regulator or a person authorised by the Regulator must, at all reasonable times, be allowed to enter the facility for the purposes of auditing or monitoring the conditions applying to the facility and any dealings being conducted in it.
Behavioural conditions relating to dealings conducted in the facility
|If the facility will contain dealings with GM animals not containing micro-organisms, the conditions in the following sections must be complied with:||Behavioural conditions (A) & (B)|
|If the facility will contain dealings with GM micro-organisms, the conditions in the following sections must be complied with:||Behavioural conditions (A) & (C)|
|If the facility will contain dealings with GM micro-organisms within an animal(s), the conditions in the following sections must be complied with:|
Note: if the dealing involves GM micro-organisms within a non-GM animal, the animal must be treated as if it were GM.
|Behavioural conditions (A), (B) & (C)|
|If the facility will contain dealings with non-GM plants that contain or host GMOs, the conditions in the following sections must be complied with:||Behavioural conditions (A), (C) & (D)|
A) Conditions for all dealings with GMOs
10. Non-GMOs used in the facility while a GMO dealing is occurring are subject to these conditions unless:
- procedures are implemented to ensure that dealings with GMOs do not result in the unintentional cross-contamination of non-GM work;
- the above procedures are documented; and
- prior to removal from the facility, all primary containers and any secondary containers are decontaminated.
11. GMOs requiring PC1 containment must not be removed from the facility unless:
- they are to be transported to another containment facility certified by the Regulator to at least PC1;
- they are to be transported to another location for storage;
- they are to be transported to another location to be decontaminated prior to disposal;
- written permission has been given by the Regulator for transport to another destination within Australia; or
- subject to obtaining any required permits, they are to be transported to the Australian border for export.
Incineration must 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.
AS/NZS 2243.3 is a recommended source of information when selecting chemical disinfectant agents.
13. All GMOs and waste contaminated with GMOs being transported outside of the facility, including transport to storage outside the facility, must be transported in accordance with any transport guidelines and other relevant guidelines, issued by the Regulator and as in force from time to time.
14. GMOs or organisms containing GMOs may be stored outside the facility in a storage unit (freezer, fridge, controlled temperature room or other container). Access to the storage unit must be restricted or controlled to prevent unintentional release of GMOs into the environment.
15. In the case of Notifiable Low Risk Dealings, the notifying organisation must authorise the storage of GMOs outside of the facility.
16.GMOs or organisms containing GMOs being stored outside the facility must be stored in a labelled, sealed, unbreakable primary container to prevent the escape or release of the GMO.
17. Any real or suspected unintentional release of GMOs from the facility, including a spill or escape, must be reported to the Regulator as soon as reasonably possible.
B) Conditions for all dealings involving animals
18. Except during the entry and exit of personnel, supplies, or equipment, doors of the facility must be closed while dealings involving animals are contained there. Windows and doors must be locked when facility personnel are not in attendance.
19. When not being handled, the animals involved in dealings must 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.
20. All animal 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 marked so that they can be identified (eg. with a tattoo, permanent tag, microchip or permanent brand). A system of accounting for the animals in the facility must be used.
21. Handling of the animals involved in dealings and any experimental procedures conducted on the animals must be carried out in a way that minimises the chance of escape.
22. If an animal involved in dealings escapes within the facility, trapping devices must be used to capture the animal and the animal must be returned to its container or cage or euthanased.
C) Conditions for all dealings with GM micro-organisms (including plants and animals containing GMOs)
23. Precautions must be taken to minimise the production of aerosols where procedures involving GMOs are carried out on an open bench.
24. All cultures of GMOs must be labelled.
NOTE: Labelling assists the separation of GM work from non-GM work and enhances the control of GMOs within the facility.
25. All cultures of GMOs being stored inside the facility must 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.
26. If any spills of GMOs occur outside the facility, the contaminated surfaces must be decontaminated as soon as reasonably possible.
27. A supply of disinfectants effective against the GMOs used in the facility must be available in the facility for decontamination purposes. Containers of disinfectants, including any solutions for decontaminating hands, must be clearly labelled with the contents and, where necessary, the expiry date. Solutions must not be used after the expiry date.
28. Persons performing procedures with GMOs in the facility must wear protective clothing to protect the front part of the body from exposure to the GMOs.
29. Protective clothing must be removed before leaving the facility and disposed of or stored in the designated storage or hanging provisions. This condition does not apply if moving directly to another containment facility, certified to at least PC1 by the Regulator, that is directly connected to the facility or is connected by a corridor that is not a public thoroughfare and in which there is negligible risk of cross-contamination should other personnel be encountered or contacted in the corridor.
30. Protective clothing contaminated or suspected to be contaminated with GMOs must 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.
31. Work benches, surfaces and equipment where procedures involving GMOs have taken place must 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.
32. GMOs must be decontaminated prior to disposal.
33.Carcasses of animals containing GMOs must be decontaminated by autoclaving, incineration or any other method approved in writing by the Regulator.
34. Liquid and solid wastes potentially containing GMOs must be decontaminated prior to disposal.
35. Any equipment that is, or may be, contaminated with GMOs must be decontaminated prior to being removed from the facility.
36. 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.
D) Conditions for all dealings with non-GM plants that contain or host GMOs
37. Any effluent waste containing GMOs, including run off, must be decontaminated prior to release from the facility.
38. All plants and containers containing GMOs or GM material must be labelled. This may be achieved by labelling plants, containers or trays as relevant.
NOTE: Labelling enables the separation of GM work from non-GM work and enhances the control of GMOs within the facility.
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 in force or existing from time to time.
‘AS/NZS’ followed by a number or other identification is a reference to the Australian New/Zealand Standard so numbered or identified, as in force or existing from time to time.
Safety in laboratories
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