Technical Review of the Gene Technology Regulations

Page last updated: 18 May 2018

The Gene Technology Regulator (the Regulator) has initiated a technical review of the Gene Technology Regulations 2001 (the Technical Review) to bring the legislation up-to-date with current science. Technological developments have out paced the legislation, and it is now necessary to clarify whether organisms developed using several new technologies are subject to regulation as genetically modified organisms (GMOs).

The Regulator previously consulted on four options for how these new technologies could be regulated. The Regulator has now consulted on proposed amendments, which were developed after considering issues raised in first-round submissions, scientific understanding, potential risks, regulatory burden implications, whether regulatory burden would be commensurate with risk, and the policy intent of the Gene Technology Act 2000.

The proposed amendments include confirming the regulated status of some site-directed nuclease techniques (SDN-2 and SDN-3, which include the use of CRISPR/Cas9), and excluding one class of site-directed nuclease techniques (SDN-1) from regulation. Details of the Technical Review proposals, including a consultation regulation impact statement and an exposure draft of proposed amendments, are available on the Office of the Gene Technology Regulator website.

The central consideration of the Technical Review is to ensure that new technologies are regulated in a manner commensurate with the risks they pose. Organisms modified by SDN-1, which would be excluded from regulation, present no different risk than organisms carrying naturally occurring genetic changes. Organisms modified using SDN-1 cannot be distinguished from natural mutants, and there is no evidence that they pose risks that warrant regulation.

Some submitters were concerned that changes to the regulation of GMOs could impact food labelling and safety assessment. Food regulation is a separate matter to the Regulator’s review, and any future changes to the Gene Technology Regulations would not change the pre-market approval or labelling requirements for genetically modified foods and ingredients in Standard 1.5.2 – Food produced using gene technology in the Australia New Zealand Food Standards Code (the Code), which is administered by Food Standards Australia New Zealand (FSANZ). FSANZ has commenced a separate review to consider how the Code applies to food derived using new technologies. Information about the FSANZ review is available on the FSANZ website.

The Office of the Gene Technology Regulator is now considering issues raised in submissions on the draft amendments, which will be taken into account in finalising the amendment proposals.

Date Reviewed: 18 May 2018