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Gene Technology Amendment Regulations 2011

Gene Technology Amendment Regulations 2011

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 amend the Gene Technology Regulations 2001.

These amendments are 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 will enhance the effectiveness of the Regulations and assist user compliance by making them clearer and easier to understand. The Amendment Regulations have changes in scheduling of some Exempt dealings; scheduling of some 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


Link to supporting material

(note that updates will occur periodically)
Questions and Answers - The Gene Technology Amendment Regulations 2011 (RTF 165 KB)
Questions and Answers - The Gene Technology Amendment Regulations 2011 (PDF 126 KB)

Some implications of the Gene Technology Regulations 2011 for regulated organisations (RTF 209 KB)
Some implications of the Gene Technology Regulations 2011 for regulated organisations (PDF 153 KB)

Guidance for making Records of Assessment of NLRDs (RTF 227 KB)
Guidance for making Records of Assessment of NLRDs (PDF 157 KB)

Model Form - Records of Assessment Notifiable Low Risk Dealings (NLRDs) (RTF 210 KB)
Model Form - Records of Assessment Notifiable Low Risk Dealings (NLRDs) (PDF 128 KB)

Guidance tables for the classification of contained dealings with viral vectors as at 1 September 2011 (updated) (RTF 322 KB)
Guidance tables for the classification of contained dealings with viral vectors as at 1 September 2011 (updated) (PDF 194 KB)

Guidance tables on the changes to the classification of contained dealings with viral vectors 1 September 2011 (updated) (RTF 430 KB)
Guidance tables on the changes to the classification of contained dealings with viral vectors 1 September 2011 (updated) (PDF 196 KB)

Guidance flowchart for the classification of contained dealings with viral vectors as at 1 September 2011 (RTF 1.1 MB)
Guidance flowchart for the classification of contained dealings with viral vectors as at 1 September 2011 (PDF 104 KB)

Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors (RTF 233 KB)
Guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors (PDF 115 KB)

Factsheet - Changes to the Conduct of Notifiable Low Risk Dealings (RTF 259 KB)
Factsheet - Changes to the Conduct of Notifiable Low Risk Dealings (PDF 173 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) (RTF 243 KB)

Application form for licence for dealings with a GMO not involving intentional release (DNIR) of the GMO into the environment (updated form) (DOC 767 KB)



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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