A new regulatory scheme for gene technology within Australia

The Interim Office of the Gene Technology Regulator (IOGTR) was established as a branch of the Therapeutic Goods Administration in May 1999. The Health portfolio identified two primary functions of the IOGTR:

• To work with representatives of State and Territory Governments, other Commonwealth agencies, existing regulators, and non-government organisations to develop and implement a new national regulatory system for genetically modified organisms (GMOs); and
• Pending the establishment of this new system, to provide support and, where necessary direction, to the current voluntary administrative arrangements for GMOs, including providing support for the Genetic Manipulation Advisory Committee.

The key objectives of the IOGTR have ensured that the Interim Office has had a demanding work schedule over the past 23 months, in the lead up to 21 June 2001, when the new national regulatory scheme will be operational.

The IOGTR undertook an extensive consultation process with State and Territory governments, local governments, industry and members of the public, that resulted in the Gene Technology Bill 2000 being introduced into Parliament on 22 June 2000. The Gene Technology Act 2000 was passed by the Commonwealth Parliament on 8 December 2000, and received Royal Assent on 21 December 2000. It will come into force, along with complementary regulations, on 21 June 2001. Complementary State legislation, and an Inter-Governmental Agreement, will ensure a truly national scheme.

The Gene Technology Act 2000:

• Creates the office of the Gene Technology Regulator (GTR);
• Prohibits all dealings with GMOs unless the dealing is exempt, a notifiable low risk dealing, a licensed dealing, or a registered dealing;
• Establishes a system for the GTR to assess dealings with live and viable GMOs ranging from contained work to general releases of GMOs into the environment;
• Establishes three advisory committees to assist the GTR and provide advice to the Ministerial Council; and
• Imposes accountability of decisions.

Once operational, the Office of the Gene Technology Regulator will interface with other regulators, such as the TGA and the Australian New Zealand Food Authority (ANZFA), as well as State and Territory governments, to ensure a nationally consistent regulatory scheme.

On 21 June 2001, the Interim Office of the Gene Technology Regulator will become the Office of the Gene Technology Regulator. The Department recognises the continued efforts of all officers within the IOGTR and congratulates them on a job well done.

For further information contact:

The Office of the Gene Technology Regulator
Website: http://www.ogtr.gov.au
Email: ogtr@health.gov.au
Phone: 02 6271 4207
Fax: 02 6271 4202
Free Call: 1800 181 030