Looking forward – responsible research into gene drive organisms
But what are GDOs and why do we need them?
GDOs are organisms that have been genetically engineered to spread a desired trait through a population.
This area of synthetic biology can be integral to solving multifaceted problems associated with pest species. It is a rapidly evolving but complex and new area of synthetic biology that is being advanced in laboratories globally.
GDOs can provide many benefits to widespread problems currently faced by societies. For instance, they can be used for the suppression of pest populations, which, in turn, can contribute to maintaining biodiversity, conserving threatened species, improving agricultural productivity, and supporting advances in human and animal health and wellbeing.
By way of an example, there is the challenge of eliminating major threats to human health by reducing the viability of and/or creating resistance to various pathogens in mosquitoes. This includes work in Aedes spp., which are major vectors of dengue, chikungunya and Zika viruses; and Anopheles spp., which are major vectors of malaria parasites.
There is also a risk that climate change impacts could increase the geographic distribution of mosquitos that carry such deadly pathogens. For example, there are concerns that if Aedes albopictus (Asian tiger mosquito), which is currently present in the Torres Strait Islands, were to increase its distribution to the Australian mainland, local transmission could have further impacts on human health. A. albopictus is a highly invasive mosquito and a major vector of arbovirus. In cases such as these, GDOs can provide a solution to reduce the threat of increased transmission.
Responsible research into GDOs
Researchers working on GDOs globally are seeking some standardised guidelines and regulations for future trials of GDOs, to support ongoing work in synthetic biology that is helping to solve such complex national challenges. Individual researchers and their organisations already have their own stringent safeguards associated with work in synthetic biology and, in particular, in work around GDOs. But there is currently an absence of standardised national and international guidelines for field trials.
A multidisciplinary group of GDO developers, ecologists, conservation biologists, experts in social science, ethics and policy have recently called for a need for well-developed criteria for field trials to help assess and manage any potential impacts.
Such commitments are considered to be necessary for best practice and responsible conduct of field trials that are both localised and non-localised (but ecologically isolated). Standardised practices in this case can ensure improved collaboration with scientists globally, further advances in GDO research to solve complex problems, and considered, responsible, high-quality practices in this emerging science.
You can learn more about the promotion of responsible conduct in future field trials of GDOs in a recently published paper in Science.
Why aren’t these national/international regulations already in place?
National and international regulations are constantly evolving to adapt to new technologies, such as gene drives and other synthetic biology technologies. Australia has been at the forefront, having included new regulations on laboratory research on gene drives in its most recent review of the Gene Technology Act.
What does it mean that they aren’t?
Changes to regulatory frameworks cannot be expected to keep pace with fast-moving technologies, which means there will often be a period when research on new technologies will be occurring in the absence of technology-specific regulations. Under these circumstance, scientific communities will often put in place a community of practice to ensure that their research is conducted in a responsible fashion.
Are field trials currently taking place that are unsafe, or that could have significant negative impacts?
No field trials with GDOs are currently taking place, and probably will not occur for at least 3-4 years and when appropriate protocols/safeguards are in place.
What are the type of safeguards covering the responsible conduct of GDO field trials in Australia?
GDO field trials cannot be conducted in Australia without approval from the relevant regulatory bodies, led by the Office of the Gene Technology Regulator. If GDO trials are viewed as being on the horizon in Australia, then we would expect any necessary changes to the existing regulations would be proposed as part of the next review of the Gene Technology Act.
What commitments does CSIRO make to GDO field trials?
If CSIRO were to conduct GDO field trials in the future, we would commit to conducting these trials with full transparency, using all available safeguards to ensure that risks are minimised. Of course, CSIRO would follow all national and international regulations that are in place at the time of the trials. If regulatory frameworks are incomplete, CSIRO would follow any standards and practices to which it has committed – such as those outlined in the Science paper.
Who/what organisation/s takes on the responsibility for the development of national and international commitments?
In Australia, everyone in the community has the opportunity to comment on proposed changes to the Gene Technology Act during public consultation periods. Many research organisations and other stakeholders in Australia, including CSIRO, will normally provide a formal institutional submission as part of this period of consultation. CSIRO researchers also routinely discuss and advise regulatory agencies on new technologies that on the horizon. For example, in 2016, CSIRO invited researchers and regulators to a gene drive symposium and roundtable discussion to consider potential gaps in the current regulations in advance of the 2019 review of the Gene Technology Act.