Gene technology is advancing at a rapid rate, particularly with the advent of new gene editing techniques.
These new breeding techniques do not currently fit neatly into Australia’s gene technology regulatory framework, so this framework is being re-examined to determine how to approach new techniques. A regulatory approach that is commensurate with risk will provide the necessary protection against negative social, environmental and health impacts, while supporting the development of precision gene editing technologies.
The Academy of Science and ATSE have developed a joint submission to the Office of the Gene Technology Regulator (OGTR) in response to its discussion paper: ‘Options for Regulating new technologies’. The Academies share the view that the gene technology regulatory framework needs to recognise that regulations must be commensurate with risk. Extensive genetic variations have been introduced by a range of previously available breeding techniques that have historically been accepted without a need for regulation, such as chemical mutagenesis. On this basis, organisms produced by techniques that are analogous to these mutagenesis techniques, such as several forms of gene editing, present the same risks as those developed using conventional breeding methods. Regulations should be focussed on regulating new gene editing techniques that integrate foreign or large pieces of DNA, or utilise methods such as gene drives and RNA interference, where the level of risk may be higher.
The Academies’ key recommendations include:
- Support of the fourth option presented by the OGTR to deal with gene editing techniques: exclude certain new technologies from regulation on the basis of the outcomes they produce;
- Regulations must be proportional to risk;
- The definition of ‘foreign’ nucleic acid to be further defined as ‘non-homologous DNA sequences from non-sexually compatible species’; and
- Emphasising the need for a nuanced approach to regulations in relation to gene drives and RNA interference.