Roads Forward for European GMO Policy—Uncertainties in Wake of ECJ Judgment Have to be Mitigated by Regulatory Reform

Abstract

This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms. Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation. In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law. However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.

Familiarity in the Context of Risk Assessment of Transgenic Crops: Focus on Some Countries in the Americas

“…Familiarity, on the other hand, refers to the body of knowledge (evidence/data) and experience (of use, but also with risk assessment) with technologies and products that have undergone a risk assessment process or for which substantial data are available (Figure 1). Ambiguous language can create confusion and ultimately leads to discretionary interpretations and less predictable risk assessment processes (Wasmer, 2019). To exemplify the relevance of clear definitions, in the specific case of transgenic comparators for field studies, using HOSU as an acceptance criterion would be discretional.…”

The governance of genome editing techniques for the European bio-based industry

“…Post-market monitoring, traceability and labelling: Traceability of GEOs imported into the EU market faces challenges linked to the lack of adequate detection methods to identify with which technology the changes in the genome have been made (Wasmer, 2019). Although research on detection methods is increasing, it is still unclear how techniques that allow for unequivocal identification of SDN-1, SDN-2, and ODM events could be designed.…”

“…The list is not exhaustive, in the sense that it only presents results originated by consulted experts, without including additional instruments suggested by other scholars in existing literature (e.g. Wasmer, 2019). Some instruments represent suggestions related to non-regulatory aspects, while others aim to suggest updates to the existing regulatory framework (German National Academy of Sciences Leopoldina, 2019) or call for a new regulatory framework (suggested by 77% of the respondents of the Delphi).…”

“…Some experts propose that a faster solution to change the current situation could be to ask ECJ to interpret another unsolved case at a national level. However, there would be challenges related to costs and time in doing this (Wasmer, 2019).…”

“…An alternative regulatory instrument that is debated in the political process is a new regulation on genome editing. Bio-based industrial actors, plants breeders, scientists call for such a new regulation (Purnhagen et al, 2018b;Wasmer, 2019). Figure 4 summarises and ranks potential futures that, in the view of the experts consulted in the Delphi survey, the supporting European regulations on genome editing should include.…”