Comment: Molecular scissors tied up in legal knots

NGT, which stands for ‘new genomic technique’, is the latest abbreviation to do the rounds in plant breeding circles.

We have been familiar with GMO – genetically modified organism – for some years. It most commonly results from transgenesis, the introduction of genetic material from one living thing into another. Each GMO has one or more traits not naturally found in the original organism.

But NGTs, like Crispr-Cas9, are fundamentally different. They do not only involve the introduction of foreign DNA.

Instead, their distinctive potential lies in their use as ‘molecular scissors’ to modify specific DNA sequences within an organism’s existing genome. Others meanwhile involve cisgenesis – the transfer of genes from the same or a closely related species.

For those NGTs which don’t involve the introduction of foreign DNA, it can be argued that they are akin to natural, spontaneous mutagenesis – the process by which an organism’s genetic information changes through mutation.

They can modify an existing genome, for example by reversing a naturally occurring mutation, or switching inherent but dormant traits back on.

And the range of characteristics potentially targeted by NGTs is unlimited – new flavours, better yields, diseases resistance, anti-browning, and so on. As they become affordable, the time they save compared with conventional breeding means their potential is great.

Opportunities and barriers

Not surprisingly then, NGTs are fast becoming the new frontier of plant breeding. Traditional techniques will always have their place, but breeders can now achieve outcomes in the laboratory which otherwise take years in the field.

In practical terms, this creates significant opportunity to address social issues to do with food supply affected by climate change and increasing populations.

But, as is often the case, acceptance and uptake depends on regulators and lawmakers. It was the same with medicinal cannabis – a lack of scientific understanding among politicians and unnecessarily complex legal frameworks could hold back the benefits NGTs offer.

The authorities need to learn quickly how NGTs differ from traditional breeding techniques, and really that means understanding how the DNA itself influences and decides what a product is like.

Standard difference

For breeders, especially those with international commercial marketing programmes, the challenge is that different jurisdictions currently address NGTs differently.

In the EU, current practice distinguishes between random genetic changes that do indeed occur naturally, and so-called targeted mutagenesis – as happens with varieties bred using an NGT like Crispr.

For the latter to be eligible for plant breeders’ rights (PBR) protection in the EU, there needs to be a “long history of safe use” of the breeding process used. For obvious reasons this is currently unlikely to be the case with most NGTs.

In 2023, a draft EU regulation effectively split NGT-bred plants into two categories. The first, which includes any that could occur naturally or through conventional breeding, would be exempt from current GMO regulations. The second, which applies to all others, would require risk assessment and authorisation under those same GMO rules.

That means Category 1 varieties would likely be eligible for PBR protection in the same way it is given to new varieties bred using conventional methods. A decision on the draft Regulation is currently expected mid-2026.

No such distinction applies right now in Australia when protecting the breeder’s rights to a new variety. There, the core criteria for eligibility remain novelty, distinctness, uniformity, and stability. Simply put, Australia is ‘technology neutral’ in terms of the breeding process used.

However, whether you can sell an NGT variety in Australia does depends on the legal definition of ‘genetically modified’. If the variety was not bred using what the law regards as ‘gene technology’, then it is not considered to be genetically modified, and no regulatory approval is needed.

If a genome is edited or modified by a process classified as SDN-1 – such as Crispr/Cas9 where no foreign DNA is introduced – it is not considered a GMO.

But if it is determined to be GMO under current Australian law, any commercial sale must be approved after a comprehensive risk and safety assessment.

Rethink required

If the lawful protection and commercial exploitation of a new variety bred using an NGT in one jurisdiction leads to the loss of ‘novelty’ of that variety in another, I would suggest there is clearly a problem with what purports to be an international system for the protection of new plant varieties.

It goes without saying that regulatory shortcuts should never be taken when it comes to new technology and where safety issues exist. At the same time, however, it is critically important that due and proper consideration be given to new methods like NGTs that might offer real and significant benefits to breeders, farmers, and consumers.

It cannot be a political issue. Instead, it must involve properly qualified individuals who understand the technology well enough to comment either in favour or against it.

How NGTs are perceived, and the extent to which they are adopted by plant breeders, will be affected by the laws that govern them, in particular IP law, as much as by the results their use will achieve.

A lot has been written about this, and there is certainly more to come. What can be said however, is that the breeding technique involved should be no fundamental obstacle to a new variety’s protection. And as much as any conventional process, NGTs present as a sound and legitimate basis for plant breeding.

To consider NGTs properly though, and to embrace them alongside traditional methods, we need to accept that changes to the way plant breeding is regulated and protected will probably be required – potentially even to the main international rules that govern breeders’ rights, established under the UPOV Convention.

For example, if ‘tests’ can determine the results of breeding undertaken using an NGT, then the means of establishing the existence of a ‘new’ variety will no longer only be achieved by repeated growing trials (for uniformity and stability) or by reference to listed phenotypic characteristics (for distinctness).

When it comes to plant breeding, we live in interesting times.