The Commonwealth Gene Technology Amendment Regulations 2011 commenced on 1 September 2011. All dealings with GMOs must be conducted following the Commonwealth’s Gene Technology Regulations 2001 (as amended in 2011) or, where applicable, corresponding State/Territory legislation.
The Gene Technology Amendment Regulations 2011 amended the Gene Technology Regulations 2001.
These amendments were the outcome of a review initiated by the Gene Technology Regulator (the Regulator). The proposals for amendment were made in response to suggestions from regulated organisations, as well as operational experience gained in the Office of the Gene Technology Regulator (OGTR), regarding a number of provisions that might be improved. The Amendment Regulations were finalised, taking into account feedback received during the consultation.
The amendments relate to technical and operational matters that have enhanced the effectiveness of the Regulations and assisted user compliance by making them clearer and easier to understand. The Amendment Regulations changed the scheduling of some Exempt and Notifiable Low Risk Dealings (NLRDs); classification of some viral vectors; oversight and timeframes of NLRDs; as well as other minor administrative matters.
The Amendment Regulations 2011 also require transport, storage and disposal of GMOs as part of NLRDs to be undertaken in accordance with the Guidelines for Transport, Storage and Disposal of GMOs issued by the Gene Technology Regulator on 2 June 2011. These new guidelines also commenced on 1 September 2011.
Links to the amended regulations
- The Gene Technology Amendment Regulations 2011 (commencement 1 September 2011)
- The Gene Technology Regulations 2001 (current compilation)
Please note: Symbols for LD50 values
Some devices may read symbols incorrectly in Word and possibly HTML and PDF. The Greek letter ‘mu’ is used in five provisions (LD50) in the Gene Technology Regulations 2001 as part of a recognised international symbol indicating ‘micrograms’. This symbol is usually displayed correctly. However, some devices may display it incorrectly, making units read as ‘mg’ (milligrams), which significantly changes the meaning of the legislation. ‘mg’ is not used in the Gene Technology Regulations 2001. The definitive legal PDF versions, where the problem will not occur on most devices, can be accessed from the ‘Download’ tab on ComLaw web page linked above.
Links to supporting material(note that updates will occur periodically)
- Explanatory Statement for the Gene Technology Amendment Regulations 2011
- Guidelines for the Transport, Storage and Disposal of GMOs (commenced on 1 September 2011)
Some implications of the Gene Technology Regulations 2011 for regulated organisations (HTML)
Guidance for making Records of Assessment of NLRDs (HTML)
Model Form - Records of Assessment Notifiable Low Risk Dealings (NLRDs) (HTML)
List of host/vector systems classified as 'exempt' - updated 1 September 2011 (HTML)
Guidance tables for the classification of contained dealings with viral vectors as at 1 September 2011 (updated) (HTML)
Guidance flowchart for the classification of contained dealings with viral vectors as at 1 September 2011 (HTML)
Guidance tables on the changes to the classification of contained dealings with viral vectors 1 September 2011 (updated) (HTML)
Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors (HTML)
Factsheet - Changes to the Conduct of Notifiable Low Risk Dealings
PDF 63 KB
DOCX 66 KB
Request to surrender DNIR licence where dealings have been assessed as an NLRD (update of the previous form 'Combined NLRD Notification & Surrender of DNIR licence) (HTML)
Application form for licence for dealings with a GMO not involving intentional release (DNIR) of the GMO into the environment (HTML)
Questions regarding the Gene Technology Amendment Regulations 2011 may be directed to the Office of the Gene Technology Regulator using the contact details below.
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