Reform recommended for genetic modification regulations

Australia’s gene technology regulator, Dr Raj Bhula, has proposed reducing regulations around gene editing techniques such as CRISPR, following a 12-month technical review into the current regulations.

If approved, the reforms are expected to have wide-ranging benefits for agriculture research, speeding up the research and commercialisation of disease-, salt- or drought-resistant crops, as well as high-yielding varieties.

The most radical change put forward by the regulator is that some of the more efficient and newer genetic technologies, known as gene editing, would not be considered ‘genetic modification’. As Dr Bhula told the ABC, “With gene editing you don’t always have to use genetic material from another organism; it is just editing the [existing] material within the organism.

“All of our regulatory frameworks and laws have been established based on people putting unrelated genetic material into another organism, whereas this process is just manipulation within the organism and not introducing anything foreign.”

Under current legislation, a genetically modified organism (GMO) is broadly defined as an organism that has been modified by gene technology, and is subject to heavy regulation. Dr Bhula told the ABC that new technologies, rather than inserting a foreign gene, involve editing an existing gene to speed up the development of an organism that would usually happen over time.

The change in regulation will also have ramifications for the medical research sector, which Dr Bhula said had also been considered in the review. The regulatory framework has to take into consideration protection of human health as well as the environment. “When you are looking for a very specific outcome with human health, it’s good to proceed with caution, but with plants you can see the outcomes or breed out the effects you don’t want in the final product,” Dr Bhula told the ABC.

This means that while many agriculture products made using CRISPR technology are close to commercialisation, its applications for solving human health problems are far off. They are nonetheless highly anticipated, given CRISPR has the potential to disable the genes that help cancers and HIV dodge the immune system; however, genetic differences between patients mean the technology is not yet foolproof.

The Office of Gene Technology Regulator said it does not expect consumers to be upset with any decision, provided any food produced with new methods was labelled as such in supermarkets. The OGTR conducted a community awareness survey and found that some of the opponents were more concerned about not having a choice when purchasing GM products, Dr Bhula told the ABC.

Dr Clovis Palmer, head of the Immunometabolism and Inflammation Laboratory at the Burnet Institute, believes Dr Bhula is underestimating Australia’s reaction, calling her proposal “dramatic” and saying she should expect to face “fierce opposition and generate a robust debate, since technically removing a portion of a gene is still considered ‘genetic modification’”.

“Biological processes are a consequence of genes working together within a network, so modification of gene within that network are likely to have unintended and sometimes deleterious consequences,” Dr Palmer said.

“The gene editing technology in question is a process that allows laboratory researchers to ‘cut out’ portions of a gene from cells grown in the lab or in some cases completely removing a particular gene and then observing the consequences.

“The technology is still in its infancy and should continue to be highly scrutinised under rigorous federal authorities that govern GMOs.”

The National Association for Sustainable Agriculture Australia (NASAA), which represents organic farmers, is unsurprisingly opposed to the reforms, saying they could damage the reputation of the sector.

“The Australian standard is very clear from our perspective — GMOs of any kind and organics simply don’t mix,” said NASAA General Manager Mark Anderson.

“It would be a slippery slope should the door ever open to genome editing within our current regulatory framework. The integrity of our iconic national brand certification would risk irreversible damage.

“New types of genetic modification coming about now should be included and regulated in the same way the old GM organisms have been.

“Creating another class of GM organisms that aren’t regulated in the same way puts a lot of risk on Australian organic farmers.”

Dr Caitlin Byrt, from the ARC Centre of Excellence in Plant Energy Biology, has argued in favour of the reforms, stating, “The food our children eat in the future will have a different DNA sequence to the food we eat today.

“We are on a trajectory for increases in drought frequency, which will result in a decline in crop productivity. To protect future food security we require crop varieties that can maintain productivity in a climate with limited rainfall and higher temperatures. The development of crop varieties with improved performance in hot and dry conditions can only be achieved by modifying the genome.”

Dr Byrt noted that the genome can be modified using one of four methods: plant breeding; genetic transformation; genome editing; and mutating the genome using chemicals or radiation to change the sequence of the DNA.

“We are more likely to achieve improvements in our crop varieties if we enable plant biologists to choose the most appropriate method to achieve the desired change in DNA sequence,” she said.

Professor Michael Jones, director of the WA State Agricultural Biotechnology Centre, has meanwhile claimed that “all the food we eat … has been genetically modified over time, first by early farmers then more systematically using Mendelian genetics, cytogenetic transfer of chromosome segments, wide crosses, chemical and irradiation mutagenesis, molecular marker-assisted breeding and more recently by transgenic technologies”.

“It is a scientific paradox that we know less about what new genetic combinations occur in conventional plant breeding, which is unregulated, than we do for new breeding technologies, which are highly regulated,” he said.

“With 20 years’ experience of the safe use of GM crops … it’s time to bring gene technology regulations up to date. Varieties developed by harsh mutagenic treatments are grown without regulation and are often labelled as non-GM in organic stores.

“Gene editing is a major advance which allows changes in specific genes to be made much more precisely than conventional mutagenesis. As a result, gene technology regulations are now out of date and no longer fit for purpose.

“If there is no introduced DNA, or the changes are the same as those resulting from current unregulated breeding technologies, then the products should not be regulated as GMOs. That would be a real game changer for Australian crop improvement.”

The changes are currently open for consultation, and will ultimately need to be signed off by Commonwealth and state and territory governments, and passed in federal parliament.

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