The Australian Academy of Science supports the responsible and ethical use of biotechnology, including gene technologies, to produce genetically modified plants and animals for use in Australian agriculture and medicine.
The Academy supports a regulatory scheme for gene technology that is proportional to the risk being managed, and which provides benefits that outweigh the costs of regulation.
Australian science has a key role to assist in global food security and health. Gene technology can play a role in the alleviation of malnutrition, enhancing agricultural sustainability and food security worldwide.
The regulatory environment for gene technology must be proportionate with its risks. The lack of full certainty in an environment of manageable risk should not be used as the reason to postpone measures where genetic modification can legitimately be used to address environmental or public health issues.
Gene technology is regulated in Australia by the Office of the Gene Technology Regulator, under the Gene Technology Act 2000. Genetically modified foods are also regulated by Food Standards Australia New Zealand (FSANZ). Such foods require mandatory pre-market approval (including a food safety assessment) and are subject to mandatory labelling requirements.
Gene technology is the process of introducing or modifying the genetic material of an organism in order to introduce new genetic traits, suppress existing ones or otherwise affect the expression of genes. It is conceptually similar to traditional selective breeding techniques, but involves a technological intervention to modify the organism’s genome directly rather than selecting for preferred traits in breeding. The term may include the introduction of new genes, modification of existing genes, or altering the expression of genes by, for example, modifying the interaction of the gene with cellular machinery.
Gene technology is integral to biotechnology and an important tool in modern biology. Australia has a strong position in global bioscience and is a significant contributor to advances in gene technology. The technology is being harnessed to gain fundamental insights into the molecular basis of life and has enabled the production of GM cotton and canola, the first broadacre GM crops to be released commercially in Australia. Coupled with existing breeding and production systems, gene technology and scientific innovation can deliver improved financial and environmental outcomes for the agricultural sector.
Recent advances in genetic technologies have greatly increased the range of options available to breeders. Of particular note is the CRISPR/Cas9 system, which allows precise, targeted changes to the genome of living cells, many of which will indistinguishable from changes brought about using conventional methods but will be obtained with greater precision and in a more timely manner. The Academy strongly supports transparency, scrutiny and safety of genetic research. The outcomes of these new applications should be scientifically evaluated with respect to public safety and environmental impacts well in advance any public release.
The Australian regulatory framework for gene technology was established at a time when the technology was new, the risks were poorly defined, and there were few commercial products. Consequently, the focus was on ensuring the safety of new work in research facilities and tightly controlled small scale trials. However, the field is now significantly more developed and it is possible to state with much greater accuracy the level of risk posed by different applications of gene technology.
There is therefore a need to implement a responsive and efficient regulatory framework that can address changes in gene technology as they occur, and which applies a level of regulation commensurate with the actual rather than perceived risks. Present regulatory structures can be unduly onerous, and present a large barrier to commercialising new gene modification applications.
The Academy takes the position that there are efficiencies to be gained in the legislative and regulatory framework by developing an exemption model for organisms with genetic modifications indistinguishable from those produced by non-genetic modification techniques, and by streamlining risk assessment processes for low-risk procedures or well-studied organisms.
The Academy also recommends a regulatory scheme that is able to adapt to new technological developments, through clear definitions that focus on research outcomes rather than the technology used to achieve them.
Synthetic gene drives have the potential to solve intractable problems in public health, environmental conservation and agriculture, they may also have the potential to cause negative environmental and human health effects. Gene drives are designed to spread genetic constructs rapidly throughout a population, and thus may produce genetic and ecological changes in target and non-target species. Accordingly, the Academy takes the view regulation of gene drives requires special consideration, as it is difficult to predict the outcomes of deployment at this early stage of research and development.
Initial gene drive development will mostly involve laboratory-contained research and development projects. The appropriate level of containment will depend on the organism involved and the potential for the gene drive system being developed to spread and persist in the environment. For example, drives with a slow rate of propagation have different containment implications compared to drives that might rapidly spread from a low initial frequency.
This position paper was subject to expert review by the Australian Academy of Science and authorised by the Academy Council at its meeting of 11 October 2018.
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