Review of the Gene Technology Regulations
The Gene Technology Regulator is currently undertaking a review of the Gene Technology Regulations 2001 (the Regulations).
The review is consistent with the Regulator's roles and functions under the Gene Technology Act 2000 and recommendation 6.1 of the 2006 Statutory Review of the Gene Technology Act 2000 and the Gene Technology Agreement
The Gene Technology Regulator has released the Draft Gene Technology Amendment Regulations 2010 for public consultation in accordance with section 142 of the Act.
Submission on the proposed amendments should be received by 18 June 2010:
Office of the Gene Technology Regulator, MDP 54, GPO box 9848 CANBERRA ACT 2601 (www.ogtr.gov.au)
Telephone: 1800 181 030 Facsimile: (02) 6271 4202 E-mail: ogtr@health.gov.au
Amendments are proposed in five areas based on feedback from regulated and other organisations and operational experience of the OGTR: classification of dealings with GMOs as exempt; classification of dealings with GMOs as Notifiable Low Risk Dealings (NLRDs); classification of dealings with GMOs involving viral vectors; oversight of NLRDs; and timeframes and other administrative matters.
A comprehensive consultation package has also been prepared to assist interested individuals and groups to understand the changes proposed in the Draft Amendment Regulations and to participate in the consultation process. This package includes and overview paper, a discussion paper addressing each of the five areas of amendment, and an unofficial compilation of the proposed amendments with the current Regulations to allow the changes to be read in context.Top of page
Invitation to make submissions (RTF 161 KB)
Invitation to make submissions (PDF 43 KB)
Draft Gene Technology Amendment Regulations 2010 (PDF 336 KB)
Overview of the proposals for amendment (RTF 226 KB)
Overview of the proposals for amendment (PDF 75 KB)
Discussion papers for the five areas of proposed amendment:
Classification of exempt dealings (RTF 276 KB)
Classification of exempt dealings (PDF 79 KB)
Classification of Notifiable Low Risk Dealings (NLRDs) (RTF 269 KB)
Classification of Notifiable Low Risk Dealings (NLRDs) (PDF 73 KB)
Classification of dealings involving viral vectors (RTF 547 KB)
Classification of dealings involving viral vectors (PDF 123 KB)
Oversight of NLRDs (RTF 293 KB)
Oversight of NLRDs (PDF 72 KB)
Timeframes and administrative matters (RTF 210 KB)
Timeframes and administrative matters (PDF 55 KB)
Questions and Answers on the current review of the Regulations (RTF 36 KB)
Questions and Answers on the current review of the Regulations (PDF 20 KB)
An unofficial compilation of the proposed amendments (RTF 624 KB)
An unofficial compilation of the proposed amendments (PDF 190 KB)
Matters raised in submissions will be taken into account in finalising the Amendment Regulations. The Regulator will then recommend to the Gene Technology Ministerial Council (GTMC) that the Regulations be amended. Following GTMC agreement, finalised Amendment Regulations will be submitted for consideration by the Executive Council and making by the Governor General. If agreed, it is anticipated that Amendment Regulations will come into force in early 2010. Top of page
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