Technical- and risk- and regulatory assessment of NPBTs
In CHIC project, NPBTs are applied to improve industrial chicory for better inulin and production of health-related terpenes. As part of CHIC, different NPBT approaches to edit chicory genomes were employed. We will technically evaluate these approaches and assess, whether chicory plants generated by the different techniques pose differences on a technical level such as off-target rate, efficiency, or fall under different regulations. Currently, CHIC partners generate chicory plants with different approaches. To ensure comparability between the different approaches, all partners work on the same target genes.
These approaches are compared in terms of efficiency, time-frame needed, and costs. Furthermore, different approaches may show differences in potential off-target activity. We identified potential off-target sites in the genome of the chicory, which could be edited by the used NPBTs. In a first approach, we tested whether identified potential off-target sites were cleaved in vitro. The first results let assume is a high specificity of the tested NPBT, as none of the identified off-target sequences was cleaved so far.
Furthermore, it has been screened the current literature systematically together with the ELSA-Gea project (www.dialog-gea.de) and identified thousands of studies wherein NPBTs was successfully applied in a diverse set of more than 40 plant species all over the world. Many studies let us assume, that the first products are soon touching the commercial market. In many countries, the regulation lags behind this success of NPBTs. Currently, the regulation of NPBT differs from country to country. In Member states of the European Union, due to a decision by the European Court of Justice in 2018, plants mutagenized using NPBTs are seen as genetically modified organisms (GMOs). NPBTs are not exempted from the strict European GMO regulation. However, there is an open-ended debate; whether this strict regulation is justified also for NPBTs. Outside Europe other regulations are represented: for several years now, the USA, Canada, Argentina, Israel, and Chile have a liberal position towards the use of NPBTs. Since the CHIC project began in 2018, five more countries clarified the legal position of NPBTs. Among these countries are Brazil, Paraguay, Colombia, Japan, and Australia. A number of other countries, e.g. Russia and China, are expected to join soon. Different to Europe, in these countries usually assesses NPBTs derived plants in a case-by-case dependent manner. Mostly they fall out of the scope of regulation, when certain prerequisites were met, e.g. when no foreign DNA was integrated into the edited genome. We are constantly monitoring changes in legislation and follow closely the debate in European Union and its neighbours.
About CHIC Project
CHIC is the Chicory Innovation Consortium. Its objective is to implement New Plant Breeding Techniques (NPBTs) in chicory in order to establish it as a multipurpose crop for the production of health-related products with clear benefits for consumers and to develop co-innovation pathways with stakeholders for game-changing technologies, such as NPBTs. CHIC will develop four different NPBTs. They will be used to steer bioprocesses in chicory and mobilize its under-explored potential to produce immunomodulatory prebiotics and medicinal terpenes. The conceptually different NPBTs will be assessed with respect to technological potential, risks, regulatory framework, and their socio-economic impacts. This will be done in close consultation with a Stakeholder Advisory Group (SAG) composed of relevant stakeholders in industry and society. For more information, visit our website at chicproject.eu/