Office of the Gene Technology Regulator

The Office of the Gene Technology Regulator, supports the Gene Technology Regulator (the Regulator), and is a part of the Australian Government Department of Health and Ageing. The Office was established under the Commonwealth Gene Technology Act 2000 (the Act). This legislation sets forth a nationally consistent regulatory system for gene technology in Australia.

In Australia, all dealings with live and viable genetically modified organisms (GMOs), including import, are illegal unless authorised under the Act.

The OGTR has developed a range of documents to provide organisations and interested parties with guidance on monitoring and compliance activities under the Act.

Under the Act, the Regulator may issue technical and procedural guidelines in relation to GMOs (under section 27 of the Act), in relation to certification of facilities to specified containment levels (section 90) and in relation to accreditation of organisations (section 98). The Act, the Gene Technology Regulations 2001 (the Regulations) or instruments issued by the Regulator can require compliance with these guidelines in conducting dealings with GMOs or in obtaining and maintaining certification or accreditation.

To ensure the necessary approvals or authorisations are obtained prior to importation, the OGTR is working closely with the Australian Quarantine and Inspection Service (AQIS) especially in relation to GM seeds/grains.

The Regulator is an independent statutory office holder responsible for administering the Gene Technology Act 2000 (the Act) and corresponding state and territory laws. The Regulator is appointed by the governor-general only with the agreement of the majority of all jurisdictions.

Dr Raj Bhula is the Gene Technology Regulator, appointed for a period of five years commencing 18 July 2016. . She is responsible for administering the national regulatory system for gene technology as set out in the Act. The OGTR staff are part of the Department of Health.

Dr Bhula comes from a background of over 20 years of experience in the regulation of pesticides in Australia. She worked as the Executive Director of Scientific Assessment and Chemical Review at the Australian Pesticides and Veterinary Medicines Authority and Program Manager Pesticides for almost 10 years. Dr Bhula has had experience in representing Australia at international expert committees such as the Codex Committee for Pesticide Residues and contributed to technical groups of the OECD Working Group on Pesticides. Much of this work has included the development of technical policy and risk assessment methodologies.

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