Information on the current 2016-17 Technical Review of the Gene technology Regulations 2001 can be found on the Regulations Review page.
Information on the current Review of the Gene Technology Scheme (2017) can be found on the Department of Health’s Review of the Scheme page.
The 2011 review of the Gene Technology Act 2000
An independent review of the Act was conducted for the Gene Technology Ministerial Council (now known as the Legislative and Governance Forum on Gene Technology, LGFGT) in 2011. The review concluded that the Act is working well and that, “The Office of the Gene Technology Regulator (OGTR) is operating in an effective and efficient manner” and that “The OGTR is providing a rigorous, highly transparent regulatory system.”
The Gene Technology Amendment Act 2015 implements minor and technical recommendations of the 2011 Review as agreed by all governments in 2013 by:
- removing a restriction on licence variations to broaden the circumstances in which stakeholders can vary licences rather than apply for new licences;
- updating the matters the regulator must consider before a GMO dealing can be declared a notifiable low risk dealing in the Regulations;
- discontinuing quarterly reporting to the Minister on activities under the Act;
- elaborating on activities allowed under an inadvertent dealings licence, to ensure reasonable activities are explicitly authorised;
- changing newspaper advertising requirements for notifying the public of consultations on licence application assessments;
- removing the requirement to include genetically modified products authorised by other agencies on the Record of GMO and GM Product Dealings; and
- clarifying wording.
More information on this review is available from the LGFGT Secretariat and via the Department of Health website
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The 2006 statutory review of the Gene Technology Act 2000In 2005-06 the independent statutory review of the Gene Technology Act 2000 and the Intergovernmental Gene Technology Agreement 2001 was conducted (the Statutory Review). The Statutory Review found that the Act and the national regulatory scheme had worked well in the five years following introduction, and that no major changes were required. However, it suggested a number of minor changes, aimed at improving the operation of the Act at the margin.
The Gene Technology Amendment Act 2007 and the Gene Technology Amendment Regulations 2007 implement the changes as agreed in the State, Territory and Australian Governments' Response to the recommendations of the Statutory Review. These amendments commence on 1 July 2007, amending the Gene Technology Act 2000 and the Gene Technology Regulations 2001, respectively. Changes to various guidelines issued by the Regulator have also resulted from implementation of the agreed recommendations.
More information related to the independent Statutory Review is available from the Australian Government Web Archive.
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The Regulator's review of the Gene Technology Regulations 2001In 2008 the Gene Technology Regulator (the Regulator) initiated a review of the Regulations in response to suggestions from regulated organisations, as well as the operational experience of the OGTR, regarding a number of provisions that might be improved.
This review led to the Gene Technology Amendment Regulations 2011, which commenced on 1 September 2011, amending the Gene Technology Regulations 2001.
The Amendment Regulations 2011 introduced 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.
A list of questions and answers relating to the Amendment Regulations 2011 can be found at the Gene Technology Amendment Regulations 2011 Q&A webpage.
Links to legislation, guidelines and supporting information for the Amendment Regulations 2011 can be found at the Gene Technology Amendment Regulations 2011 webpage.
Links to current legislation is provided on the OGTR Legislation page.
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