3.1 Requirements for the Disposal of PC1 & PC2 GMOsPart 3.1 applies to the decontamination or disposal of GMOs or waste containing GMOs, and the decontamination of equipment involved in procedures with GMOs related to:
- NLRDs that are assessed as being able to be conducted in authorised PC1 facilities by Part 1 of Schedule 3 of the Regulations; or
- NLRDs that are assessed as being able to be conducted in authorised PC2 facilities by Part 2 of Schedule 3 of the Regulations; or
- any other dealings that are permitted, in writing, by the Regulator to be decontaminated and disposed of under this Part of these guidelines.
Other regulations may need to be complied with for the disposal of GMOs including, where relevant, State, Territory or Local Government regulations.
Notice that item to be disposed of is a GMO
3.1.1 A person or accredited organisation supplying the GMO for disposal must label the material in a manner capable of notifying any other handler of the material that the item to be disposed of is, or contains a GMO.
Decontamination Prior to Disposal
3.1.2 GMOs, or non-GM organisms containing GMOs, must be rendered non-viable prior to disposal if the method of disposal is not also the method of decontamination.
3.1.3 Any wastes containing GMOs must be decontaminated prior to disposal if the method of disposal is not also the method of decontamination.
3.1.4 Decontamination and disposal of GMOs must only be undertaken by a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs.
3.1.5 Following use for transport or storage, the primary container, and any secondary container that is not itself a storage unit, must be decontaminated prior to reuse of the container or its 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 easy to see).
3.1.6 A person who personally conducts the decontamination process must ensure the requirements outlined below, for the respective method of decontamination, are complied with.
3.1.7 Decontamination may be effected by autoclaving using a combination of temperature and time that has been validated as effective for the decontamination of the GMOs.
3.1.8 The temperature and time controls of an autoclave used for decontaminating GMOs must be calibrated by a qualified person at least once every 12 months to determine the actual temperature and time at which the autoclave runs as compared to the autoclave gauges. The results of each year’s calibration must be kept for the previous 5 years and made available to the Regulator if requested.
- NOTE: Calibration does not necessarily require adjustment of the autoclave controls. If the autoclave cannot be adjusted and is significantly out, then the set temperature, for example, can be adjusted to compensate the difference by using the data from the calibration.
- thermocouples or resistance thermometers, to ensure that the required temperature has been achieved; or
- chemical indicators which use a combination of moisture, heat and time and which progressively change colour with the time exposed at the specified temperature; or
- biological indicators such as spore strips; or
- enzyme indicators.
The results of each month’s monitoring tests must be kept for the previous 12 months and made available to the Regulator if requested.
- NOTE: Autoclaving is considered the most reliable means of decontamination, however, it is recognised that this method is not applicable in all situations. The reliability of autoclaves is predicated on correct usage and monitoring of the process. AS/NZS 2243.3:2010, Section 10.6, is a recommended source of guidance on using autoclaves.
3.1.11 Decontamination may be effected by incineration in a high temperature, high efficiency incinerator that has been approved by the relevant government authority in the jurisdiction where the incinerator is located.
3.1.12 Decontamination may be effected by any other heat-based equipment using a combination of temperature and time that has been validated as effective for the decontamination of the GMOs.
3.1.13 If using other heat-based equipment for decontaminating GMOs the temperature and time controls of the equipment must be calibrated by a qualified person at least once every 12 months to determine the actual temperature and time at which the equipment runs as compared to the equipment gauges. The results of each year’s calibration must be kept for the previous 5 years and made available to the Regulator if requested.
3.1.14 Decontamination may be effected by any chemical decontamination agent that has been validated as effective for the decontamination of the GMOs.
- NOTE: AS/NZS 2243.3:2010, Appendix F, is a recommended source of information when selecting and using chemical decontamination agents.
3.1.15 Decontamination of GM plant material that does not contain any GM micro-organisms may also be effected by composting of the GM plant material, along with soil and other associated material, provided:
- the process is validated as effective for killing and/or decomposing the GM plant material;
- the composting occurs in a dedicated concrete bay;
- the concrete bay is not in a site that is prone to flooding or storm surges;
- the concrete bay is free of any gaps or cracks that could be penetrated by the plants being composted;
- the surface of the concrete bay is able to be easily cleaned and decontaminated;
- access to the concrete bay is restricted to a person or class of persons mentioned in an IBC’s record of assessment as having the appropriate training and experience to deal with the GMOs;
- all seeds have been removed from the GM plant material prior to placing in the concrete bay;
- the concrete bay is protected from entry by animals that would be able to distribute any undecomposed GM plant material beyond the concrete bay;
- the concrete bays containing composting GM plant material are monitored every month for volunteer GM plant growth;
- any volunteer GM plants are removed and destroyed;
- monitoring continues until six months has passed, after the last addition of GM plant material to the bay, without the emergence of any volunteer GM plants.
- all seeds have been removed from the GM plant material prior to shredding it;
- shredding has been validated as effective in rendering the GM plant material non-viable.
3.1.17 Decontamination may only occur by any other method if approved in writing by the Regulator.
3.1.18 Decontamination of GMOs must not be performed using:
- decontamination equipment that is defective;
- any heat based decontamination equipment for which the results of each month’s monitoring tests for the previous 12 months and the results of each year’s calibration are not available to the Regulator;
- chemical decontamination agents that are past their expiry date; or
- any method that has not been validated as effective for the decontamination of the GMOs.
3.2 Requirements for the Disposal of PC3 & PC4 GMOsPart 3.2 applies to GMOs that require containment in a PC3 or PC4 facility certified by the Regulator.
3.2.1 Prior to disposal, the GMOs to which Part 3.2 applies must be decontaminated inside a relevant facility certified by the Regulator, unless otherwise permitted, in writing, by the Regulator.
3.2.2 Requirements for the decontamination of the GMOs to which Part 3.2 applies will be those applied by the licence or other authority issued by the Regulator that permits the conduct of the dealing and/or by the guidelines for certification of the relevant facility, issued by the Regulator.
This publication is available as a downloadable document.
When accessing large documents (over 500 KB in size), it is recommended that the following procedure be used:
- Click the link with the RIGHT mouse button
- Choose "Save Target As.../Save Link As..." depending on your browser
- Select an appropriate folder on a local drive to place the downloaded file
Attempting to open large documents within the browser window (by left-clicking)
may inhibit your ability to continue browsing while the document is
opening and/or lead to system problems.
To view PDF (Portable Document Format) documents, you will need to have a PDF reader installed on your computer. A number of PDF readers are available through the Australian Government Information Management Office (AGIMO) Web Guide website.