Review of National Gene Technology Scheme - Online Submissions

Nexgen Plants Pty Ltd believes there is a need to address the regulatory status surrounding the use of new plant breeding technologies. New plant breeding technologies include the use of gene editing, oligo-directed mutagenesis, cisgenic, and intragenic approaches to develop beneficial traits. Gene editing and oligo-directed mutagenesis can result in events that mimic natural mutations, while cisgenics and the Nexgen Plants intragenics (including the Nexgen Plants developed intragenic approaches) can result in events that mimic naturally occurring duplication and recombination events. Each approach can be utilized without the introduction of foreign DNA.
Such manipulations may be considered unethical in animal systems, or perhaps microbial systems. However, there are no such ethical concerns for applying such techniques in plants. We suggest plant systems should NOT be subject to the same regulatory framework as other systems.

Response
Very little concern when applied to plant systems. Evolution through mutation happens constantly in plants. Genetic duplication and recombination events happen constantly in nature and in conventional plant breeding programs.
Any potential impact of such manipulations in other systems should not hinder the ability to use such techniques in plant systems.

Response
With respect to plant systems, we do not believe it is appropriate to regulate gene editing or intragenic approaches that result in events that are theoretically possible or indistinguishable from those events that occur through conventional methods.

With respect to plant systems, the regulatory trigger should be the presence of foreign DNA in the resulting plant event, and/or an event that results in the presence of a potential allergen or toxic substance. A precedent has been set in the US, where the introduction of foreign DNA or potential allergens triggers regulation.

With respect to plant systems, we favor updating to a product-based regulatory scheme. As stated in the consultation paper, it should not matter how the event was generated, if the event mimics what happens naturally. This would apply to gene-editing based techniques that mimic natural mutations, or Nexgen Plants intragenic techniques that mimic natural duplication and recombination events in plants.

Certainly treating plant based applications separately from other systems could allow fast-tracking the processing of submissions that use safe new breeding technologies.

As previously discussed, ethical concerns surrounding animal and microbe systems should not apply to plant systems. It would be sensible to treat plants as a separate class of lower risk.

With respect to plant systems, it should be easy to reassure the public that there is no need to regulate events that mimic what happens naturally.
Any other event that requires introducing foreign DNA, or results in a new protein, or some other material difference can be assessed on a case by case basis.

With respect to plants, events that mimic naturally occurring mutations or genetic recombination and duplication should be exempt or assessed via a fast-track process.
Events that result in a new protein should be assessed on a case-by-case basis.
Events that introduce foreign DNA or a potential allergen should be subject to a higher level of scrutiny, and decisions made on a case-by-case basis.

No. The processed based regulatory mechanism hinders benefit to Australians and Australian companies seeking to utilize and develop emerging technologies. With regards to plant based systems, if the outcome event is indistinguishable from those events occurring naturally, then it seems unreasonable to prevent their application because of the process used to generate the event.

With regard to plant systems, a clear policy of product based decision making, rather than process based decision making , would be of great benefit. Such a clear policy might state that as long as no foreign DNA and no potential allergen has been introduced, and the event mimics naturally occurring processes such as a mutation or recombination and duplication event, then the event could be deemed exempt from regulation or enter a fast-track approval system.
A clear policy position of allowing up to X nucleotides (e.g. up to 3 nucleotides) of substitution/deletion or insertion could provide clarity as to the definition of an event that mimics a natural mutation event in plants. Similarly a clear policy position that specifies stretches of at least X nucleotides (e.g. at least 20 nucleotides) of host plant derived sequence can be recombined and duplicated to mimic naturally occurring duplication and recombination events.
Where a new protein results from such an event, the event could be scrutinised on a case-by-case basis.

In the case of plant based systems, it should be relatively easy for the community to understand the benefits of utilizing new breeding technologies that produce events indistinguishable from naturally occurring events, only much faster and more affordably. The risks are essentially the same as conventional breeding.

With respect to plant based systems, the only real lack of confidence stems from talk of genetic modification to introduce foreign DNA. Any change in the gene technology regulatory scheme can still reflect the public concern over introduction of foreign DNA.

Reassurance that new breeding technologies, such as gene editing or Nexgen Plants intragenics, produce plant events that are indistinguishable from what can occur during conventional breeding and in nature.