Clarifying the regulation of genome editing in Australia: situation for genetically modified organisms

• Published in: Transgenic research Vol. 28; no. Suppl 2; pp. 151 - 159
• Main Author: Thygesen, Peter
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.08.2019; Springer Nature B.V
• Subjects: Animal Genetics and Genomics; Biomedical and Life Sciences; Biomedical Engineering/Biotechnology; European Union; Food, Genetically Modified; Gene Editing - trends; Genetic Engineering; Genetic Engineering - trends; Genetically engineered organisms; Genetically modified organisms; Genome editing; Genomes; Humans; Life Sciences; Molecular Medicine; Mutagenesis; Nuclease; Oligonucleotides; Organisms, Genetically Modified - genetics; Plant Genetics and Genomics; Proceedings Paper; Regulation; Reviews; Transgenics; Australia
• ISSN: 0962-8819; 1573-9368
• DOI: 10.1007/s11248-019-00151-4

Australia’s gene technology regulatory scheme (GT Scheme) regulates activities with genetically modified organisms (GMOs, organisms modified by gene technology), including environmental releases. The scope of regulation, i.e. what organisms are and are not regulated, is set by the Gene Technology Act 2000 (GT Act) and GT Regulations 2001 (GT Regulations). The GT Act gives broad, overarching definitions of ‘gene technology’ and ‘GMO’ but also provides for exclusions and inclusions in the GT Regulations. Whether organisms developed with genome editing techniques are, or should be, regulated under countries’ national GMO laws is the subject of debate globally. These issues are also under active consideration in Australia. A technical review of the GT Regulations was initiated in 2016 to clarify the regulatory status of genome editing. Proposed draft amendments are structured around whether the process involves introduction of a nucleic acid template. If agreed, amendments would exclude from regulation organisms produced using site directed nuclease (SDN) 1 techniques while organisms produced using oligonucleotide mutagenesis, SDN-2 or SDN-3 would continue to be regulated as GMOs. The review of the GT Regulations is still ongoing and no legislative changes have been made to the GT Regulations. A broader policy review of the GT Scheme was undertaken in 2017–2018 and as a result further work will be undertaken on the scope and definitions of the GT Act in light of ongoing developments.