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Recent changes to gene technology regulation in Australia

On 31 March and 1 July 2007, two sets of changes to Australia's gene technology legislation came into effect, resulting from the finalisation of two separate review processes. Information on these processes is provided on the OGTR Legislation Review Process web page.

Links to new/amended legislation

The Gene Technology Act 2000 (compilation incorporating amendments up to Act No. 99 of 2007)

Gene Technology Amendment Act 2007 (commencement 1 July 2007)

The Gene Technology Regulations 2001 (compilation incorporating amendments up to SLI 2007 No. 128) (commencement 1 July 2007). These are the complete regulations in force from 1 July 2007.

The Gene Technology Amendment Regulations 2007 (SLI 2007 No. 128, commencement 1 July 2007). These amend the Gene Technology Regulations 2001 as in force on the commencement date.

The Gene Technology Amendment Regulations 2006 (commencement 31 March 2007). These amend the Gene Technology Regulations 2001 as in force on the commencement date. Further amendments have since been made.

Links to all current Australian gene technology legislation, including corresponding State laws, are also provided on the OGTR website.Top of page

Explanatory Statements

Explanatory Statements were produced during the development each of the legislative amendments:

General information on recent changes to gene technology regulation

Summary of Regulatory Changes for Institutional Biosafety Committees - posted 29 June 2007 (RTF 112 KB)
Summary of Regulatory Changes for Institutional Biosafety Committees - posted 29 June 2007 (PDF 69 KB)

Presentation made to Institutional Biosafety Committees on changes to the Gene Technology Act and regulations - posted 29 June 2007 (PPT 1.8 MB)

Information on changes to classification of dealings (as Exempt, NLRD, DNIR, DIR) and guidelines

What dealings with GMOs are classified as 'exempt' – updated 29 June 2007 (RTF 411 KB)
What dealings with GMOs are classified as 'exempt' – updated 29 June 2007 (PDF 191 KB)

Requirements for Exempt dealings – updated 29 June 2007 (RTF 995 KB)
Requirements for Exempt dealings – updated 29 June 2007 (PDF 191 KB)

What dealings are classified as NLRDs (PC1 and PC2) – updated 25 October 2007 (RTF 107 KB)
What dealings are classified as NLRDs (PC1 and PC2) – updated 25 October 2007 (PDF 57 KB)

Changes to DNIRs and NLRDs - posted 29 June 2007 (RTF 105 KB)
Changes to DNIRs and NLRDs - posted 29 June 2007 (PDF 30 KB)

Changes to DIRs - updated 29 June 2007 (RTF 103 KB)
Changes to DIRs - updated 29 June 2007 (PDF 31 KB)

Changes to Accreditation - posted 25 May 2007 (RTF 175 KB)
Changes to Accreditation - posted 25 May 2007 (PDF 28 KB)

Links to current guidelines and application and notification forms issued by the Regulator can be found on the OGTR Forms and Guidelines web page.Top of page

Other changes

Some other changes introduced by the amended legislation relate to:

Variation of GMO licences - Applications for variation of a licence to deal with a GMO now have a statutory timeframe of 90 days within which the Regulator must vary, or refuse to vary, the licence. The circumstances in which the Regulator can vary a licence have also been clarified. (Regulation 11A of the amended Regulations and section 71 of the amended Act).

Inadvertent dealings - the Regulator has been given the power to issue a licence for disposal of a GMO to persons who find themselves inadvertently dealing with an unlicensed GMO, to allow a person who has unintentionally come into possession of a GMO to dispose of the GMO without breaching the Act. (Sections 10(1), 40A, 46A, 49, 56, 57, 60 of the amended Act). If you need more information on this provision please contact the OGTR using the contact details at the bottom of this page.

Emergency powers - Emergency powers have been introduced to the Act, giving the Minister the ability to expedite the approval of a dealing with a GMO in an emergency, increasing the responsiveness of the regulatory system. Guidelines for emergency response have been issued by the Gene Technology Ministerial Council.

Gene Technology Advisory Committees - The Gene Technology Ethics and Community Consultative Committee (GTECCC) will be established, combining the functions of the current Gene Technology Ethics Committee (GTEC) and the Gene Technology Community Consultative Committee (GTCCC). More information on the Gene Technology Advisory Committees is available on the OGTR Gene Technology Committees web page.

Further details and explanation of these changes can be found in the relevant legislation and Explanatory Statements, links for which are provided on the OGTR Legislation Review Process web page.Top of page