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  • A New Zealand Perspective on the Application and Regulation of Gene Editing
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A New Zealand Perspective on the Application and Regulation of Gene Editing

Plant-based primary commodities derived from the pastoral, horticultural and forestry sectors account for around half of the export earnings. Productivity is characterized by a history of innovation and the early adoption of advanced technologies.

Gene editing has the potential to revolutionize breeding programmes, particularly in NZ. Here, perennials such as tree crops and forestry species are key components of the primary production value chain but are challenging for conventional breeding and only recently domesticated.

Uncertainty over the global regulatory status of gene editing products is a barrier to invest in and apply editing techniques in plant breeding. NZs major trading partners including Europe, Asia and Australia are currently evaluating the regulatory status of these technologies and have not made definitive decisions.

NZ is one of the few countries where the regulatory status of gene editing has been clarified. However, following a challenge in the High Court, this decision was overturned such that NZ currently controls all products of gene editing as GMOs. Here, we illustrate the potential benefits of integrating gene editing into plant breeding programmes using targets and traits with application in NZ.

The regulatory process which led to gene editing's current GMO classification in NZ is described and the importance of globally harmonized regulations, particularly to small export-driven nations is discussed. Primary exports are critical to New Zealand's NZ's economy providing both employment and export revenue.

New Zealand's pasture-based dairy industry is the world's largest dairy exporter and accounts for a third of the world's dairy trade Chobtang et al. Sheep and beef make up the majority of animal-based exports but venison and wool are significant contributors. Forestry, based around exotic plantation forests primarily radiata pine and Douglas-fir , covers 1. Nations with small domestic markets like NZ face pressure to continuously adjust and innovate in order to maintain global competitiveness Vitalis,To support this, NZ has a long history of implementation of agritech innovation Easton, ; Vitalis, ; Hedley, including the use of genetic technologies Harris et al.

In order to maintain NZ's position whilst providing sustainable solutions to the challenges of global food security and climate change a step change in productivity beyond that which has been possible through conventional breeding will be required Williams et al.

Solutions are also urgently required for the increased threat from pests and diseases. In the last decade the kiwifruit and forestry industry have suffered considerable losses from emerging diseases Vanneste, ; Scott and Williams,Myrtle rust, which has caused worldwide damage to both agricultural and native ecosystems, arrived in NZ in Office of the Minister of Conservation,Biotechnology-based improvements have the potential to be an important tool in delivering this.

The unprecedented uptake of genetically modified GM crops over the last 20 years, such thatCurrently no GM crops are grown in NZ. The globally traded cash crops corn, soybean, canola and cotton that make up the majority of current GM plantings are not widely grown and do not provide a compelling value proposition for NZ. In contrast, NZ aims to supply high value innovative products that are not cultivated on a global large scale e.

The time and cost of developing and gaining regulatory approval for GM versions of these for the NZ market is prohibitive. The lack of relevant GM crops has meant that there has not been recent nationwide debate on the merits of these technologies in NZ Bryan and Roberts,Over the last decade genome editing methods based on Zinc finger nucleases Urnov et al.

The wide-ranging applications of this technology have been extensively reviewed elsewhere Voytas, ; Carroll, ; Wang et al. In this review, we will focus on the use of gene editing to carry out targeted mutagenesis on plant species where no DNA template is used. We believe this technology has the ability to encourage a paradigm shift in the incorporation of biotechnology into NZ plant breeding programmes. Particularly if, as seems likely, it is ultimately regulated in a less burdensome way than GM technology.

Here, we give examples of the traits that could be modified to give NZ relevant outcomes, describe the current regulatory landscape, and discuss the implications of this on the future innovation in NZ plant-based primary industries. Gene editing offers the potential to produce a step change in NZ primary industry productivity, biosecurity and speed of innovation. This is particularly the case for perennial crops with slow or complex breeding cycles that are a feature of NZ's plant-based exports.

Although gene editing has already been demonstrated for a number of NZ relevant crops Table 1 , it is still to be implemented for a number of important species particularly conifer forestry species. This review focuses on plant-based applications, however, uses in animal breeding Wei et al. Below, as examples, we describe possible scenarios where plant-based gene editing could have an impact on primary production and innovation.

Table 1. Examples of species relevant to New Zealand's plant-based primary industries that have been modified using genome editing technologies. The social and economic costs of these escapes is challenging the ability of forest owners to carry out new plantings with commercially advantageous, but potentially invasive species such as Douglas-fir. The capability to generate trees that are unable to reproduce would allow control programs to focus on the existing populations and give freedom to operate for new plantings.

Prevention of cone development is also predicted to increase growth and wood development by the redirection of energy and nutrients toward vegetative growth Santos-del-Blanco and Climent,Gene editing provides an attractive approach to prevent the generation of new escapees via targeted mutagenesis of genes essential for normal sexual reproduction. Genes involved in the transition from the juvenile to reproductive growth phase, cone initiation or development, and pollen formation and development are potential targets Strauss et al.

If transgene-free edited trees are required, DNA-free delivery methods would be necessary because the long breeding cycles of conifers would prevent timely segregation of transgenes from edited genes. Breeding of new apple varieties is a slow process limited by a long-lasting juvenile stage taking more than two decades to bring a new variety into the market Flachowsky et al.

Shortening the juvenile stage has been the subject of intensive research and is a major objective in breeding Meilan,A similar result has been obtained using antisense-based silencing of MdTFL1 expression Kotoda et al. Gene editing could be used to knock out the expression of MdTFL1 to reproduce this early flowering phenotype.

This would allow rapid breeding of new cultivars through several cycles after which the edited gene could be crossed out to restore the non-engineered flowering phenotype without any trace of the modification.

The dairy, meat and wool industries in NZ draw a significant market advantage from the predominantly pasture-based feed.

Limiting environmental impacts whilst meeting the increase in global demand for dairy products requires improvements in pasture productivity Chobtang et al. Forage pastures generally consist of ryegrass, alfalfa and clover.

Of these, annual and perennial ryegrass are most common. Gene editing provides tools to improve productivity and reduce disease either through the direct manipulation of forage crops or via manipulation of endophytes.

The incorporation of herbicide tolerance Butler et al. These are likely to offer routes to both increased productivity and a reduced environmental footprint. Forage grasses like ryegrass are usually infected with symbiotic fungal endophytes Latch et al. These benefits can be compromised by the production of high levels of indole-diterpenes and alkaloids that have negative impacts on livestock e. To minimize the toxicity of these symbionts, strains of endophytes were selected that produced low levels of these alkaloids and indole-diterpenes Davies et al.

Molecular analysis revealed these lower levels were due to deletions within the coding sequence of genes in the biosynthetic pathway Young et al. Gene editing will allow the modification of biosynthetic pathways to decrease or eliminate toxins and increase the production of desirable metabolites without the need to screen for extremely rare natural variants. The global social and regulatory landscape surrounding GM crops remains complex with many different regulatory systems in place Wolt et al.

The primary difference being whether a process or product driven framework is used Ishii and Araki,As yet there is not a global consensus on the regulation of gene editing which was developed after current regulatory frameworks were put in place.

Several nations, including the USA, Canada and Argentina, have decided that gene editing technologies where the final plant does not contain introduced DNA will not be regulated Whelan and Lema, ; Ishii and Araki, ; Waltz,In contrast the European Union recently decided that all gene editing technologies will be regulated in the same way as conventional GM organisms Callaway, ; Kupferschmidt,Others, including the two main destinations for NZ's primary exports, China and Australia, are yet to decide on their regulatory approach.

The Act defines a GMO very broadly as any organism where the genes or genetic material have been modified by in vitro techniques Table 2a. A number of technologies that were in use at the time the Act was passed are captured by this broad definition e. In , Scion, a forestry-focused Crown Research Institute, used this procedure to seek a determination on how gene edited organisms would be regulated.

Scion's application argued that gene editing technologies that did not include the insertion of a transgene into host genome were similar in process and outcome to chemical mutagenesis. Scion noted that the list of techniques that were excluded from regulation was preceded by the word included underlined for emphasis in Table 2b suggesting that these were example techniques and not a closed list.

In their decision of April , the EPA concluded that the non-transgenic gene editing approach proposed by Scion had similarities to both chemical mutagenesis and genetic manipulation. However, because the changes involved the use of a chemical agent in this case, a protein without the introduction of foreign DNA it is more similar to chemical mutagenesis Environmental Protection Authority,The EPA further stated that the Regulations Table 2b exclude products of chemical mutagenesis from being regulated as GMOs under the Act and that the proposed modifications were sufficiently similar to those listed in the Regulations and should also be excluded, and organisms arising from them should not be considered GMOs.

The Court concluded that the list of techniques listed in the HSNO Organisms Not Genetically Modified Regulations Table 2b are a closed list and that adding to the exceptions list is a political decision and not an administrative decision Kershen,In the court ruling the judge pointed out that the regulations are not well drafted, brackets are in the wrong place and the grammar poor.

Some long-standing in vitro chemical treatments do not have these effects, but are caught by this definition. Thus, techniques such as EMS mutagenesis that cause point mutations rather than changes in chromosome number or chromosome rearrangements are regarded technically as GMOs. In response to these inconsistencies the government held a review of the not genetically modified regulations. The review, which included a public consultation process, resulted in changes intended to maintain the intent of the regulations and address the drafting errors present in the original regulations.

The wording was changed such that mutagenesis techniques that were in use before were not regulated whilst those developed later are regulated as GMOs. Mutagenesis techniques developed later, including gene editing, however similar they are to the original excluded techniques are regulated as GMOs. Gene editing continues to rapidly evolve with developments such as new enzyme capabilities Yin et al.

Recent decisions in USA Waltz, and the UK Rogowsky and Wilhelm, indicate that crops produced using gene editing-based targeted mutagenesis will be able to go to market without going through a time-consuming and burdensome regulatory process required for GMO crops. This regulatory approach will drastically reduce the time to market and compliance costs for gene edited crops. In contrast, NZ has adopted a wait-and-see-approach with regard to the regulation of gene editing.

The government indicating that a cautious approach is appropriate because as an exporter of billions of dollars of food products we need to be mindful of market perceptions as well as the science The New Zealand Government, b. The current NZ approach prevents rapid implementation of non-transgenic gene editing and also places the extremely high regulatory compliance costs associated with GM research on developers of such technology. For NZ to maintain its current global competiveness it is essential that industry is able to continue to implement innovative solutions.

For this to happen with gene editing, it will be necessary for the government to be proactive in ensuring NZ is in step with global competitors and that innovation is not stifled by the current outdated regulations. Despite the opinion released in January, by the advocate-general of the European Court of Justice, that gene edited crops that did not contain foreign DNA could be exempted from the GMO regulations, the EU has recently decided to adopt a similar regulatory approach to that of NZ.

All gene edited crops will be subject to the same stringent regulations as conventional genetically engineered organisms Callaway,This makes a global consensus on regulation of gene editing impossible in the immediate future.

Although it is too early to judge the long-term impacts of this decision on the global uptake of gene editing or the regulatory approach that will be taken by currently undecided nations, the existence of different regulatory systems will undoubtedly create many challenges, particularly for those nations with strong trading links with the EU.

All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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