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

Abstract

New Zealand (NZ) is a small country with an export-led economy with above 90% of primary production exported. 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. In 2014, the NZ Environmental Protection Authority ruled that plants produced via gene editing methods, where no foreign DNA remained in the edited plant, would not be regulated as GMOs. 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.

Regulation of Synthetic Biology: Developments Under the Convention on Biological Diversity and Its Protocols

“…The Cartagena Protocol applies to any living organism that possesses a novel combination of genetic material obtained using modern biotechnology (emphasis added) (Article 3; see Figure 2). In other words, regulation of the organism is triggered by the use of modern biotechnology, which amounts to processbased regulation (Atanassova and Keiper, 2018). At the time the Cartagena Protocol and national and regional frameworks were drafted, process-based triggers may have provided a clear distinction between organisms within or outside of the scope of regulatory oversight.…”

“…For example, if the Cartagena Protocol's definition of "modern biotechnology" was strictly applied to take into account the need for overcoming "natural physiological or reproductive or recombination barriers and that are not techniques used in traditional breeding and selection, " some recombinant DNA (e.g., cisgenesis) and "new" technologies (e.g., genome editing) may be excluded from its scope. Such definitions have given rise to debate in countries throughout the world on the regulatory status of "new techniques" such as genome editing, and this is one of the issues underlying the CBD discussions on synthetic biology (Atanassova and Keiper, 2018). In practice, Parties to the Cartagena Protocol differ in their interpretation and implementation of its definitions, with regulatory systems ranging from being largely process-based (e.g., European Union) to mostly product-based (e.g., Japan) (Nap et al, 2003).…”

CRISPR/Cas9 Gene Editing: An Unexplored Frontier for Forest Pathology

“…Disease resistance is one of the most promising avenues to combat forest pathogens, especially given the large geographical scales that these pathogens can affect. While there is recognition of the potential applications of CRISPR/Cas9 for forest ecosystems and a call for the use of this technology in these systems ( Tsai and Xue, 2015 ; Fernandez i Marti and Dodd, 2018 ; Fritsche et al., 2018 ), no applied studies in forest pathosystems have been performed.…”

Citrus Genetic Engineering for Disease Resistance: Past, Present and Future

“…However, confidence in applying genome-editing tools in agriculture remains limited. The biggest potential obstacles for the use of genome-editing technologies in agriculture are public acceptance and government regulation [185]. There is still no internationally accepted regulatory framework for gene-editing products, and different countries/agencies have different takes on the use of GMOs [185,186].…”

“…The biggest potential obstacles for the use of genome-editing technologies in agriculture are public acceptance and government regulation [185]. There is still no internationally accepted regulatory framework for gene-editing products, and different countries/agencies have different takes on the use of GMOs [185,186]. For instance, the European regulatory agencies emphasize how the plants were produced, and have recently ruled that gene-edited products/crops should be treated like traditional GMOs, which are under very strict regulation in the European Union [187,188].…”