Gene Technology Amendment Regulations 2006

The Gene Technology Amendment Regulations 2006 were signed by the Governor-General on 30 November 2006 and were tabled in both houses of the Australian Parliament on 5 December 2006. As a disallowable instrument, a senator or member of the House of Representatives may give notice of a motion to disallow within 15 sitting days of tabling. This period will expire before the commencement of the Amendment Regulation. However if a disallowance motion is moved, the chamber then has a further 15 sitting days to resolve the motion. If passed, a motion of disallowance would have the effect of repealing the Amendment Regulations and reviving all of the 2001 Regulations. 

These regulations are due to commence on 31 March 2007. 

The Gene Technology Amendment Regulations 2006 amend the Gene Technology Regulations 2001.

These amendments are the outcome of a review initiated by the Gene Technology Regulator in response to suggestions from regulated organisations, as well as the operational experience of the Office of the Gene Technology Regulator, regarding a number of provisions that might be improved. They clarify areas of confusion and provide greater flexibility in relation to information requirements for notifications and licence applications. The list of host/vector systems permitted for exempt dealings has been expanded. Certain types of contained dealings have also been reclassified based on current understanding of the associated risks. 

These changes reduce the regulatory burden of the regulations and streamline their operation, while maintaining the policy objectives of the regulatory system.  

Obsolete provisions relating to the transitional arrangements from the former voluntary scheme, overseen by the Genetic Manipulation Advisory Committee (GMAC), to the current regulatory scheme under the Gene Technology Act 2000 are also removed.

Commencement

The delayed commencement (31 March 2007, subject to disallowance) is intended to allow time for States with corresponding legislation, under the Gene Technology Act 2000, to make changes to their own legislation to maintain consistency of the regulatory scheme. States with corresponding regulations have indicated that they expect to have their own amendments made by 31 March 2007.

Links to the new regulations

The Gene Technology Amendment Regulations (commencement date 31 March 2007, subject to disallowance)

Compilation of the Gene Technology Amendment Regulations 2006 with the Gene Technology Regulations 2001 (commencement date 31 March 2007, subject to disallowance)

Links to supporting material

Explanatory Statement to the Gene Technology Amendment Regulations 2006

Guidance on classification of contained dealings involving viral vectors according to the Gene Technology Amendment Regulations 2006 with the Gene Technology Regulations 2001

Some implications of the Gene Technology Amendment Regulations 2006 for regulated organisations

Questions regarding the implications of the Gene Technology Amendment Regulations 2006 may be directed to the Office of the Gene Technology Regulator using the contact details below.

OGTR
PO Box 100 (MDP 54)
Woden ACT 2606
Web site: www.ogtr.gov.au
Email: ogtr@health.gov.au
Telephone: 1800 181 030
Fax: + 61 2 6271 4202