White Paper on the Regulation of Genome Editing in Agriculture
This report is the work of the Task Force on Sustainable Agriculture and Innovation which was established by Re-Imagine Europa (RIE) as part of its programme on Narratives, Climate and the Future. The Task Force consists of more than 70 experts from a wide range of backgrounds and disciplines covering NGOs, academia, CSOs and industry. This report has been prepared in the context of the current discussions on the legislation on genetically modified organisms (GMOs), which should be more resilient, future-proof and uniformly applied. On the 29th of April, the European Commission published a study on new genomic techniques where the Commission indicated that it will initiate a policy action on plants derived from new genomic techniques (NGTs). Here we present five policy options to be considered in the upcoming debate between the Council, the European Parliament and relevant stakeholders. In an era of climate change and biodiversity loss, the need for innovation in human activity has never been more pressing. The focus of this report is the topic of genome editing as the first innovation, amongst a number, to be considered. The reason for this initial focus is the major developments in the technology over recent years and the legislative ramifications that these developments entail.
There has been much discussion in the European Union in recent years concerning the regulatory status of organisms obtained by novel genomic techniques (NGTs) following a judgment of the Court of Justice of the European Union (CJEU), which “clarified that organisms from new mutagenesis techniques [by implication including those from genome editing] fall within the scope of the EU legislation”. The most significant reaction to the judgment of the CJEU came from the Council of Ministers. The Council requested the Commission to submit, by 30 April 2021, “a study in light of the
Court of Justice’s judgment in Case C-528/16 regarding the status of novel genomic techniques under Union law. To better address current needs of an ideal legislation and to develop possible policy options, RIE organized a high-level meeting with the Expert Committee, which has been timed to follow on from the study of the Commission as a contribution to the subsequent debate. It focuses on plant breeding and crops and does not address farm animals or other aspects of genome editing.
Amongst the attributes discussed, it was agreed that an ideal regulatory system should be clear in its scope and implementation, adaptable to advances in scientific understanding, proportional to risks, and it would be enforceable, harmonised as broadly as possible and would be non-discriminatory towards stakeholders. Clarity implies that all active participants in the regulatory system are aware of their rights and obligations. Adaptability implies that a system should be sufficiently capable of remaining compatible with rapid developments in genetics and genome editing. Proportionality implies that a system should not impose measures that are not commensurate with the risks under consideration. Enforceability is self-evident; if legislation is not
enforceable, then it is liable to fall into abuse and disrepute. Harmonisation implies that a regulatory system is compatible with equivalent neighbouring
systems. Finally, non-discrimination is the notion that legislation should not favour one group of stakeholders over others. It should favour choice and diversity. In terms of policy outcomes, there was a sense within the Task Force that these should be compatible with wider EU policy objectives including the European Green Deal, the Farm to Fork Strategy, the Biodiversity Policy and Sustainable Food Systems. There was a view that genome editing, as one of many innovations in agriculture, could make a positive contribution to these wider aims. The second element of the report considers policy options which could be pursued in relation to existing Union law on GMOs to address products of genome editing amongst novel genomic techniques. Most of
these options focus on Directive 2001/18/EC as has most of the debate following the judgment of the CJEU. These options include the consequences of taking no action; making use of article 7 of Directive 2001/18/EC8, allowing, potentially, for simplified procedures for specific types of GMOs; limited changes to Directive 2001/18/EC such as the amendment of the GMO definition and/ or an expansion of the list of techniques that do not lead to genetic
modification; a more thorough revision of the EU GMO legislation; or new legislation which would specifically address genome edited products. It is also clear that there is further discussion to be had on what can be achieved in the short-term as opposed to longer-term solutions. It is also worth noting that there is a view amongst some stakeholders, that there is nothing flawed with current Union GMO law per se. It is the differences of opinion amongst member states as expressed in the Council, for example, that makes any agreement difficult. The discussions that informed this report anticipated
many of the issues highlighted in the recently published European Commission study and its conclusions are intended as a point of reference in the continued debate.
Source: Re-Imagine Europa (2021) lead authors: Kearns, P.; Dima, O.; Nowak, A.; Napiórkowski, M.; Magan, J; Nicolosi, M. and Widegren, E. White Paper on the Regulation of Genome Editing in Agriculture. Task Force for Sustainable Agriculture and Innovation. Brussels.