Containment requirements that must be met in order for a Physical Containment Level 2 (PC2) Invertebrate Facility to be certified by the Gene Technology Regulator (the Regulator).
Section 90 of the Gene Technology Act 2000
These are the requirements for the certification of a PC2 Invertebrate 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 PC2 Invertebrate 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 PC2 Invertebrate Facility, unless the facility receives a written exemption from meeting a particular requirement from the Regulator or a delegate of the Regulator. Additional conditions may also be imposed on the facility by the Regulator or delegate to the Regulator.
Definitions and acronyms
Unless defined otherwise in this document, words and phrases used in this document have the same meaning as in the Act and the Gene Technology Regulations 2001 (the 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.
|aerosol||Suspension in air of finely dispersed solids and/or liquids.|
|anteroom||An area or room between a pair of doors through which access is gained to the work area inside a facility.|
The anteroom must not be used for performing any dealings other than transport of GMOs.
|autoclave||Pressure steam steriliser.|
|dealing or deal with||In relation to a GMO, means the following:|
|decontamination||A physical or chemical process which removes, kills or renders non-viable the GMOs used. In the case of micro-organisms this may not necessarily result in sterility.|
|facility||The whole of the space that is to be certified by the Regulator to a specific level of containment.|
|GMO||Genetically modified organism.|
|micro-organism||An organism too small to be viewed by the unaided eye, including bacteria, fungi, viruses and some multicellular organisms. For the purposes of these guidelines, this definition includes replication defective viral vectors.|
|OGTR||Office of the Gene Technology Regulator.|
|PC2||Physical Containment Level 2.|
|personal protective equipment||Any devices or equipment, including clothing, designed to be worn or held by a person on its own, or part of a system, to protect against exposure to GMOs.|
|pest||An unwanted organism that could cause cross-contamination within the facility or compromise containment of the GMO.|
|primary container||The container directly surrounding the GMO.|
|risk group 2 organism||An organism that satisfies the criteria in AS/NZS 2243.3 for classification as Risk Group 2|
|sealed||Able to contain all GMOs or the reproductive material of GM plants or GM aquatic organisms (including pollen or gametes) being transported or stored, and able to remain closed during all reasonably expected conditions of transport and storage.|
|the Regulator||The Gene Technology Regulator.|
|viable||Micro-organisms, cells and cell cultures:
|work area||Any area inside a facility that is not performing the function of an anteroom. |
Dealings with GMOs other than transport, storage and disposal may only take place in the work area and any dealings with GMOs in the work area are subject to the conditions on the certification instrument.
Facility and fittings requirements
1. The facility to be certified must be a fully enclosable space bounded by walls, doors, windows, floors and ceilings. The facility doors and windows must be lockable or otherwise able to be secured.
- NOTE: The walls, doors, windows, floors and ceilings form the physical containment barrier of the facility where dealings with GMOs will be conducted. This barrier protects all spaces outside the facility, including internal spaces of buildings in which a certified facility is located, and the environment.
- walls, floors, doors, windows and benches;
- furniture, including seating; and
- any other surfaces, where contamination is likely to occur or where decontamination is required.
4. Any openings in the walls, ceiling or roof must be filtered or screened at the facility boundary to prevent the entry or exit of animals, including invertebrates. The filter or screen must be of a material mechanically strong enough to withstand any airflow load, remain undamaged with regular cleaning, and resist corrosion and penetration by animals, including invertebrates.
5. The facility must have a dedicated anteroom, except if the facility is only to house GM Drosophila (Sophophora) melanogaster that are not infected with GM micro-organisms.
6. If the only GM work conducted in the facility involves non-infected Drosophila (Sophophora) melanogaster, the function of the anteroom may be fulfilled by other rooms or corridors (whether or not certified by the Regulator), provided the doors and windows of these other areas are closed or screened with fine mesh capable of preventing the entry or exit of animals, including invertebrates. Any space serving as the anteroom, must have measures in place to monitor and control escaped Drosophila (Sophophora) melanogaster.
- NOTE: Measures for monitoring and for controlling invertebrates may include using traps, regular monitoring, and accounting procedures for live and trapped invertebrates and methods for attracting invertebrates away from doors. Procedures should be documented.
8. If the facility has drainage exits, including hand basins, they must be fitted with barriers (e.g. screens, water traps) suitable for preventing the escape of GMOs and to prevent the movement either in or out of the facility, of animals, including invertebrates, via the drains.
9. Open spaces between and under benches, cabinets and equipment in the facility must be accessible for decontamination.
- NOTE: The requirement for access to open spaces is to allow for easier decontamination of spills and to prevent persistence of GMOs on the floor or harbourage of invertebrates.
- NOTE: Decontamination of hands is considered an important means of preventing unintentional release of GMOs and protecting the health of facility personnel. If wash basins are to be used, the provision of hand-operated taps is not acceptable, as they can be a source of contamination.
Alternatives to wash-basins, such as dispensers filled with decontaminant solutions, are considered suitable.
- NOTE: The Regulator does not require the placement of more than one piece of eyewash equipment in the facility.
Consideration should be given to providing appropriate forms of eye protection.
Where a Class I or Class II biological safety cabinet is installed, it must be installed in accordance with the requirements of AS 2252.4.
13. Where the facility complies with AS/NZS 2243.3 in relation to backflow prevention requirements for water supplied to the facility no backflow prevention assessment is required.
14. Where the facility does not comply with AS/NZS 2243.3 an assessment must be undertaken to determine whether backflow prevention on the water supplied to the facility is necessary.
- NOTE: Consideration should be given in the assessment to the potential hazards of the GMOs that are proposed to be dealt with in the facility; the presence of cross-connections, devices or systems that may cause contamination of a water supply connected directly or indirectly to any part of a water service; and the likelihood of a backflow event.
Documentation which demonstrates the backflow prevention assessment, and any backflow prevention measures implemented, must be kept and made available to the Regulator if requested.
- NOTE: AS/NZS 3500.1 specifies the requirements and methods for the prevention of contamination of potable water within the water service and the water main, and provides for the selection and installation of backflow prevention devices.
16. Strategies must be in place to prevent the entry or exit of animals, including invertebrates to the facility via the anteroom.
17. To monitor for the presence of escaped invertebrates, the work area(s) must be fitted with at least one invertebrate trap effective for capturing the GMOs and invertebrates being contained in the facility.
Capacity to comply with certification conditions
18. The applicant must be able to demonstrate a capacity to comply with the conditions of certification that will generally be applied to a certified PC2 Invertebrate Facility. These conditions are found in Part B of this document.
Information required with application forms
19. In addition to identifying the rooms to be certified, the floor plans for the facility submitted with the application must clearly identify rooms or spaces that are lifts, toilets, bathrooms, kitchens, lunch rooms and offices with carpets.
- NOTE: The Regulator would not usually certify the above rooms or spaces as part of the certified facility.