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.
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