9. GMO risk assessment in the EU: interplay between science, policy and politics

2018

Theor Appl Genet

Plant breeding has always relied on progress in various scientific disciplines to generate and enable access to genetic variation. Until the 1970s, available techniques generated mostly random genetic alterations that were subject to a selection procedure in the plant material. Recombinant nucleic acid technology, however, started a new era of targeted genetic alterations, or precision breeding, enabling a much more targeted approach to trait management. More recently, developments in genome editing are now providing yet more control by enabling alterations at exact locations in the genome. The potential of recombinant nucleic acid technology fueled discussions about potentially new associated risks and, starting in the late 1980s, biosafety legislation for genetically modified organisms (GMOs) has developed in the European Union. However, the last decade has witnessed a lot of discussions as to whether or not genome editing and other precision breeding techniques should be encompassed by the EU GMO legislation. A recent ruling from the Court of Justice of the European Union indicated that directed mutagenesis techniques should be subject to the provisions of the GMO Directive, essentially putting many precision breeding techniques in the same regulatory basket. This review outlines the evolving EU regulatory framework for GMOs and discusses some potential routes that the EU may take for the regulation of precision breeding.

Section: Eu Gmo Legislation 20: Centralization and Amplificationmentioning

confidence: 99%

The evolving EU regulatory framework for precision breeding

2018

Theor Appl Genet

“…An additional compromising factor for plant biotechnology is that isolated publications implying risks associated with GMOs often receive disproportionate attention and consequently have a large influence on public attitudes and political decision-making. 20 This is normally not how science works. The principle of science is that evidence and knowledge accumulate through a cautious and iterative challenging of consensus, and single, spectacular studies are ideally weighed against the entire body of accumulated research within a specific area.…”

Section: Reasons For the Stakeholder Imbalancementioning

confidence: 99%

“…The decision-making process for GMOs was to some extent decentralized starting with the first GMO Directive in 1990, 24 whereas the oversight during the period 1998–2003 established a more centralized process. 20 Directive 2015/412 was a step towards re-nationalization of the decision-making process. Though it regrettably goes against the idea of a common market in the EU, the suggested “opt-in” mechanism would contribute to a better balance accounting for the opinions of all stakeholders at a national level.…”

Section: Establishing a Better Stakeholder Balancementioning

confidence: 99%

Responsible decision-making for plant research and breeding innovations in the European Union

Chatzopoulou

2017

GM Crops & Food

Plant research and breeding has made substantial technical progress over the past few decades, indicating a potential for tremendous societal impact. Due to this potential, the development of policies and legislation on plant breeding and the technical progress should preferably involve all relevant stakeholders. However, we argue here that there is a substantial imbalance in the European Union (EU) regarding the influence of the various stakeholder groups on policy makers. We use evidence from three examples in order to show that the role of science is overlooked: 1) important delays in the decision process concerning the authorization of genetically modified (GM) maize events, 2) the significance attributed to non-scientific reasons in new legislation concerning the prohibition of GM events in EU member states, and 3) failure of the European Commission to deliver legal guidance to new plant breeding techniques despite sufficient scientific evidence and advisory reports. We attribute this imbalance to misinformation and misinterpretation of public perceptions and a disproportionate attention to single outlier reports, and we present ideas on how to establish a better stakeholder balance within this field.

“…Labelling and traceability requirements were also established through Regulation 1830/2003 (Official Journal of the European Union ). There is considerable inherent tension in the GMO governance framework though, and Casacuberta et al () have listed a number of contentious issues between actors and values in the GMO risk assessment and management, including (1) the balance between the EU centralised power and Member States, (2) the balance between consistency and the case‐by‐case approach and (3) the difficulty of dealing with uncertainty in the risk assessment, which is carried out by scientific experts, while at the same time deliver a clear message on the risk to risk managers.…”

Section: Introductionmentioning

confidence: 99%

Scandinavian perspectives on plant gene technology: applications, policies and progress

Brinch-Pedersen

Chawade

et al. 2017

Physiologia Plantarum

Plant research and breeding has a long and successful history in the Scandinavian countries, Denmark, Finland, Norway and Sweden. Researchers in the region have been early in adopting plant gene technologies as they developed. This review gives a background, as well as discuss the current and future progress of plant gene technology in these four countries. Country-specific details of the regulation of genetically modified plants are described, as well as similarities and differences in the approach to regulation of novel genome-editing techniques. Also, the development of a sustainable bioeconomy may encompass the application of plant gene technology and we discuss whether or not this is reflected in current associated national strategies. In addition, country-specific information about the opinion of the public and other stakeholders on plant gene technology is presented, together with a country-wise political comparison and a discussion of the potential reciprocal influence between public opinion and the political process of policy development. The Scandinavian region is unique in several aspects, such as climate and certain agriculturally related regulations, and at the same time the region is vulnerable to changes in plant breeding investments due to the relatively small market sizes. It is therefore important to discuss the role and regulation of innovative solutions in Scandinavian plant research and breeding.