Change in the wind for definition of 'GM'

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As technological advances blur the distinction between conventional and gene-modified organisms, Australian ‘genetic engineering’ regulations are under review – potentially untying some of the regulation that could otherwise impede new crop improvement discoveries.

Crops, animals and microbes developed using technologies that do not use externally sourced DNA should not be defined as a gene-modified organism (GMO) or be subject to GM regulations, according to a review by the Office of the Gene Technology Regulator (OGTR).

This recommendation, from the OGTR’s interim technical review, would relate to organisms modified using new technologies such as gene editing and RNAi gene silencing.

A DNA-cutting protein (the scissors) allows researchers to 'edit' their genes (and their traits) as the genome self-repairs.

Gene editing in canola is one such application currently under investigation by Dr Brian Jones at the University of Sydney in a GRDC research investment. Dr Jones is using the technique to introduce a change in a canola gene that rescripts the gene to mimic a mutation associated with improved yield and water use efficiency.

“These techniques have finally given us the tools we need to apply the accumulated insights into how genetic diversity affects crop performance,” Dr Jones told GroundCover™ in 2016 when the project was finishing.

“Field and laboratory studies on breeding material, landraces, wild relatives and model plant systems have produced a mountain of detailed insights about important variations in single genes, or gene networks, and how their application could benefit agriculture.

Single gene variations that bring benefits to growers have been identified in all our major crop species and gene editing allows us for the first time to use that knowledge directly to help develop improved varieties,” he said.

The OGTR recommendations do not automatically become policy without consideration by the Legislative and Governance Forum on Gene Technology.

They do, however, trigger a round of stakeholder consultation on draft amendments before legislative changes are made.

The OGTR says the technical review is intended to provide an interim solution while broader policy considerations associated with new technologies are progressed through the Review of the National Gene Technology Scheme.

Gene editing is a new technology that uses an organism’s own DNA-repair enzymes to rescript the DNA code to correct faulty genes (a procedure already underway in human medical trials) or unlock beneficial traits in livestock and plants. A detailed explanation of this technology was featured in GroundCover™ issue 123. July–August 2016.

From its inception, gene editing has blurred the distinction between conventional and GM breeding strategies. Unlike GM technology, gene editing leaves no trace of the molecules used to make the modification. In addition, when no externally sourced DNA is added to the genome, the gene-edited organism is indistinguishable from its conventional counterparts, a situation that has triggered regulatory reviews of GM regulation worldwide.

Professor of Innovation in Agriculture and director of the Queensland Alliance for Agriculture and Food Innovation, Professor Robert Henry, says that the technologies under review are likely to be of great value to the grains industry by allowing accelerated genetic improvement of grain crops.

“We may see the realisation of much of the benefit that was anticipated, but not delivered by GM technology (other than for herbicide and pesticide resistance),” Professor Henry says.

The recently completed technical review revolved around an OGTR discussion paper that canvassed four options for how the new technology could be regulated. The aim was to ensure that new technologies are regulated in a manner commensurate with risk levels.

In the OGTR’s discussion paper the technologies under review are referred to as ‘site-directed nuclease techniques’ and ‘oligonucleotide-directed mutagenesis’. The discussion paper states that: “As the legislation does not address technologies and techniques specifically in all cases, it has become apparent that it is not clear whether organisms produced using these techniques meet the definition of ‘genetically modified organism’ in the Gene Technology Act 2000 (the GT Act).”

The four options under review are:

  1. No amendment to the gene technology regulations.
  2. Regulate certain new technologies.
  3. Regulate some new technologies based on the process.
  4. Exclude certain new technologies from regulation on the basis of the outcomes they produce.

The interim finding is that option 3 “best supports the effectiveness of the legislative framework at this time”.

Under option 3, organisms modified “using site-directed nucleases without templates to guide genome repair” would not be regulated as GMOs. This opens the way for gene-editing technology as long as a ‘template’ is not used to insert DNA at the modified gene. If a template is used, the resulting organisms are GMOs.

RNAi (a technique generally used to silence genes that was developed in Australia) would also avoid classification as GM provided the RNA “cannot give rise to changes to genomic sequence and cannot be translated into proteins”.

RNAi techniques that involve “inserting sequences into the genome or use of viral vectors” would continue to result in GMOs, which are subject to regulation.

More information:

Office of the Gene Technology Regulator
1800 181 030
ogtr@health.gov.au