Questions and Answers
What are the Gene Technology Amendment Regulations 2011?The Gene Technology Amendment Regulations 2011 (the Amendment Regulations) commenced on 1 September 2011. The Amendment Regulations introduced changes to the Gene Technology Regulations 2001 (the Regulations).
The Regulations support the operation of the Gene Technology Act 2000 (the Act), providing technical details such as the requirements for undertaking laboratory-based work with genetically modified organisms (GMOs). The Regulations list specified GMO dealings as exempt dealings or notifiable low risk dealings (NLRDs), or as requiring licensing.
Why did the Regulations change?The changes ensured that the classification and regulation of dealings with GMOs remains commensurate with risk and up to date with current scientific understanding. This assists users to better understand and comply with their legislative obligations and supports the effective and efficient operation of the regulatory scheme for GMOs.
What was the scope of the changes?The changes were technical in nature, primarily relating to conduct of contained GMO work such as laboratory research. They did not alter the policy settings of the GMO regulatory scheme. The substantive changes include: classification of GMO dealings as exempt dealings or NLRDs; classification of GMO dealings involving viral vectors; and the oversight and timeframes of NLRDs.
Did the changes relate to the environmental release of GMOs?The changes did not relate to the requirements for environmental release of GMOs. The changes primarily related to conduct of contained GMO work such as laboratory research.
How were the amendments developed?The Gene Technology Regulator conducted a review in line with his functions under the Act. Proposals for amendment were developed based on feedback received from regulated stakeholders and experts, and on the operational experience of the Office of the Gene Technology Regulator (OGTR).
Was there consultation on the amendments?Yes. Extensive consultation on the proposed amendments was conducted in May-June 2010 with the public, regulated organisations, the Gene Technology Technical Advisory Committee (GTTAC) and relevant government agencies and departments, including all States and Territories. The Amendment Regulations were finalised, taking into account feedback received during the consultation.
Who approved the changes?The Gene Technology Ministerial Council, which includes representation from States, Territories and the Commonwealth, approved the Amendment Regulations as required by the intergovernmental Gene Technology Agreement 2001. The Amendment Regulations 2011 were made by the Administrator of the Commonwealth of Australia on 2 June 2011.
Did the changes relax regulatory oversight for GMOs?No. Some GMO dealings are now subject to higher classification and requirements. The Amendment Regulations continue to require oversight of work with GMOs that is commensurate with risk. The requirements for conducting NLRDs were updated to improve clarity of roles and responsibilities of organisations and institutional biosafety committees. Some GMO dealings were reclassified and require lesser levels of authorisation, in line with current scientific understanding of risks. There were transitional provisions for GMO dealings already being undertaken and now subject to increased classification.
Are these changes to the Regulations related to the current 2011 review of the Gene Technology Act 2000?No. The independent review of the Act was initiated by the Gene Technology Ministerial Council and was not undertaken by the Gene Technology Regulator or the OGTR. For further information about the review of the Act, contact GTMC.Secretariat@health.gov.au
Where can I get a copy of the Amendment Regulations?A copy of the Amendment Regulations and associated Explanatory Statement are available on the ComLaw website and can also be accessed via the OGTR’s website.
If you have any questions please contact the OGTR on 1800 181 030 or email@example.com.