Gene-edit deregulation proposal

Australia’s gene technology regulator has proposed a bold shake-up of rules surrounding genetic engineering processes, potentially loosening constraints on research and development within the sector.

The key recommendation from Ray Bhula, who occupies an independent statutory position within the ambit of the federal Department of Health, is a change to the definition of “genetic modification” to exclude the use of gene editing techniques such as CRISPR.

At present, any procedure deemed to involve genetic modification is very tightly regulated. Bhula says this is because until recently GM procedures involved introducing genetic material from one species into the genome of another.

This is not the case with gene editing.

“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,” Bhula told broadcaster ABC.

“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.”

The proposal, should it survive community consultation and win subsequent approval of state and federal governments, is likely to result in the fast-tracking of a range of editing-based projects in medical and agricultural areas.

Opposition to the proposal, however, is expected to be loud and prolonged, with even some in experts in the field expressing caution.

“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,” says Clovis Palmer, head of the Immunometabolism and Inflammation at the Burnet Institute in Melbourne, Victoria.

“The technology is likely to have significant long-term benefits in medicine and agriculture but current claimed benefits are perhaps overemphasised. The technology is still in its infancy and should continue to be highly scrutinized under rigorous federal authorities that govern GMOs.”

Other experts, however, saw merit in the proposal.

“The food our children eat in the future will have a different DNA sequence to the food we eat today,” says Caitlyn Byrt from ARC Centre of Excellence in Plant Energy Biology at the Waite Research Institute, University of Adelaide, in South Australia.

“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.”

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