Containment requirements that must be met in order for a Physical Containment Level 2 (PC2) Aquatic 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 Aquatic 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 Aquatic 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 Aquatic 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 of 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.|
|autoclave||Pressure steam steriliser.|
|bunding||An embankment or barrier to contain potential spillage. For example the provision of a low wall around potential spillage areas.|
|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 aquatic organisms (including zygotes or gametes) being transported or stored, and able to remain closed during all reasonably expected conditions of transport and storage.|
|secondary container||The container immediately surrounding the primary container.|
|the Regulator||The Gene Technology Regulator.|
|viable||Micro-organisms, cells and cell cultures:
Facility and fittings requirements
1. If the facility is located in an area prone to flooding or storm surges, an assessment of the risks of GMOs escaping in a flood or storm surge event must be undertaken. The risk assessment must take into consideration the GMOs kept in the facility; the consequences and likelihood of flooding or storm surges; and details of any facility design features that may mitigate such risks. If this assessment establishes a greater than negligible risk then, a risk management plan must be developed to manage the risks of escape of GMOs as a result of the flood or storm surge. Consideration must include the availability of resources needed to implement the risk management plan during such events. The risk management plan must be made available to the Regulator on request.
- NOTE: Persons planning an aquatic facility in an area prone to flooding or storm surges and who intend to apply for certification by the Regulator are encouraged to contact the OGTR prior to or during the planning phase.
The risk management plan may include, for example, removal or destruction of GMOs, and decontamination of all water in the primary containers, secondary containers and effluent treatment system, well before inundation occurs.
- mainstream flooding (an event where water from a creek, river, lake, estuary or coastal waters overflows the natural or artificial banks of the principal watercourses in a catchment);
- flash flooding (flooding that occurs within six hours of the rain which causes the flooding); and
- stormwater flooding (local runoff exceeding the capacity of an urban stormwater drainage system).
For the purposes of these guidelines, the determination of whether the location of the facility is prone to flooding or storm surges depends on the expected frequency of these events. The facility will be regarded as being prone to flooding if the floor of the facility would be inundated by a 100 year Average Recurrence Interval (ARI) flood or storm surge event. (This equates to a 1 in 100 year flood level, or an Annual Exceedance Probability (AEP) of 1%.) If it is not possible to obtain the 100 year ARI flood level from the relevant local authority, then the highest ARI or Defined Flood level used by that authority will be taken to be the level for determining if the location is prone to flooding or storm surges.
For facilities prone to flooding or storm surges, details about the flooding should include the likely effective warning time of the facility prior to inundation and possible hazards that might prevent the implementation of any risk management procedures (such as staff being unable to reach the facility prior to inundation). Applicants should expect the Regulator to seek further details during the assessment of the application.
3. 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.
5. Secondary containment must be provided to retain and decontaminate any spillage of water from:
- breakage, leakage or overflow from primary container(s); or
- overflow or leakage from aquarium water circulation systems that could contain GMOs.
- the volume, as a percentage, as determined below, of the primary containers inside the secondary containment area;
- the estimate of the total volume of any potential overflow or leakage from aquarium water circulation systems that could contain GMOs;
- the volume of any disinfectant that might be used to decontaminate the retained spillage; and
- additional capacity to prevent any expected general fluid movement from splashing over the top of the secondary containment.
- where the number of primary containers is ten or less, the volume of the largest container;
- where the number of primary containers is greater than ten, the total volume of 10% of the containers using the volume of the largest containers (e.g. for 28 containers, the largest 3 containers).
- NOTE: In facilities where the total volume of water to be retained is sufficiently small relative to the floor area of the facility, such that water cannot flow out of the facility, there may be no need for secondary containment.
6. The facility must be fitted with sufficient primary containers (e.g. tanks) to contain the aquatic organisms to be kept in the facility. If there is any likelihood of the production of aerosols containing viable GMOs (such as the larvae of bivalves and some crustaceans or GM micro-organisms) or reproductive material, then the aerosols must be prevented from escaping the primary container.
- NOTE: Options that may achieve this could include the use of sealed primary containers or filtering any exhaust air and water.
8. If the facility has drainage exits, including hand basins, they must be fitted with barriers (e.g. screens), suitable for preventing escape of the GMOs and GM reproductive material, or a mechanism to decontaminate all effluent by heat or chemical treatment, before the effluent is discharged.
- NOTE: The facility may be constructed so that the effluent from drainage exits and other liquid effluent from the facility is filtered through or decontaminated by the same system.
Discharge into municipal sewers of effluent that has not been filtered or decontaminated is not permitted and must not occur in any circumstance for species that might survive passage through the sewer and treatment plants.
10. If any proposed dealings in the facility will involve GM micro-organisms, or there will be hand contact with GMOs that could persist on the hands, then the facility must contain either a dedicated wash basin fitted with taps of the hands-free operation type or some other means of decontaminating hands.
- 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 hands free dispensers filled with decontaminant solutions, are considered suitable.
- NOTE: The requirement for access to open spaces is to allow for easier decontamination of spills and to prevent persistence of GM micro-organisms on the floor.
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 in relation to backflow prevention requirements for water supplied to the facility, 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.
The water supply to an aquatic facility may come from more than one source. There may be, for example, a dedicated supply for the aquarium systems and a municipal, potable or supply for wash-up and use by facility staff.
Cross-connection might occur with the municipal system in cases such as a hose being used for cleaning out secondary containment (eg. floor bunding) or a floor-drain sump falling into effluent water.
If the water supply is a dedicated supply, such as a storage tank dedicated for use inside the facility, then back-siphonage is unlikely and would not need a backflow prevention device. However, if back-pressure from any pumps attached to the dedicated water supply might force water back into the tank and the pressure is sufficient to cause overflow from the tank, backflow protection would be necessary.
Dealings involving GM micro-organisms
Where any of the dealings conducted in the facility involve GM micro-organisms, the facility must meet the following conditions in addition to all other conditions listed:
15. Eyewash equipment (either plumbed eyewash equipment or single-use packs of sterile eye irrigation fluids) must be provided within the facility.
- NOTE: The Regulator does not require the placement of more than one piece of eyewash equipment in the facility. Consideration should be given to the provision of appropriate forms of eye protection.
- walls, floors including any bunding, doors, windows and benches;
- furniture, including seating; and
- any other surfaces, where contamination is likely to occur or where decontamination is required.
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 Aquatic 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.