A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward

Abstract

Summary A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing. In 2015, Argentina launched a regulatory framework, followed by Chile in 2017 and recently Brazil and Colombia. In March 2018, the USDA announced that it will not regulate genome‐edited plants differently if they could have also been developed through traditional breeding. Canada has an altogether different approach with their Plants with Novel Traits regulations. Australia is currently reviewing its Gene Technology Act. This article illustrates the deviation of the European Union's (EU's) approach from the one of most of the other countries studied here. Whereas the EU does not implement a case‐by‐case approach, this approach is taken by several other jurisdictions. Also, the EU court ruling adheres to a process‐based approach while most other countries have a stronger emphasis on the regulation of the resulting product. It is concluded that, unless a functioning identity preservation system for products of directed mutagenesis can be established, the deviation results in a risk of asynchronous approvals and disruptions in international trade.

The Economics of Regulating New Plant Breeding Technologies - Implications for the Bioeconomy Illustrated by a Survey Among Dutch Plant Breeders

“…In the EU, food products will still be regulated under the EU food law (Purnhagen, 2019). The same can be observed for other countries (Eriksson et al, 2019). If NPBTs do not fall under the GMO regulation, labeling for food products will be simplified and it reduces costs.…”

“…In 2017, only 131,535 (James, 2017) of the 11.9 million total hectares for permanent crops (Eurostat, 2018) were planted with the one genetically modified crop approved for cultivation, an insect-resistant maize. It was expected that the introduction of new more precise and nature-like plant breeding techniques, especially CRISPR-Cas, would overcome the resistance to the application of modern biotechnology in plant breeding and unleash the potential of improved plant varieties (Eriksson, 2019). The recent ruling by the EU's highest court that requires plants developed by these mutagenesis-based modification methods to follow the approval process for GMOs, therefore came as a blow (Purnhagen et al, 2019).…”

“…The design of a regulatory regime for new plant breeding technologies (NPBTs) is under discussion in the European Union (EU), the United States (US), Canada, and many other parts of the world. In particular, it is being discussed whether or not they should be regulated similarly to genetically modified organisms (GMOS) or non-GMOs, or whether they need special regulations (Eriksson et al, 2019). In the case of the EU, since NPBTs include a wide range of methods, some applications will result in crops to be considered a GMO under the EU regulatory system, and others not (see Sprink et al, 2016 for an overview).…”

Gene Editing Regulation and Innovation Economics

“…Technical details pertaining to scientific and legal regulatory criteria applied in this regulation can be found elsewhere, both in our recent publications (Lema, 2019;Whelan and Lema, 2019) and the updated regulatory texts (Infoleg, 2019a,b). There is also literature available that contextualizes this regulatory approach at the international level (Duensing et al, 2018;Eriksson et al, 2019;Metje-Sprink et al, 2020).…”

Getting an Imported GM Crop Approved in China

“…In this article we describe the approval process for GM crops in China, and compare the approval dates and length with those in the USA, Canada, and the EU. The length of the approval process and related differences have implications for food security in China, in particular because this may also affect the approval of food products derived from new plant breeding techniques [3].…”