A novel governance framework for
            <scp>GMO</scp>

Bratlie, Sigrid; Halvorsen, Kristin; Myskja, Bjørn K.; Mellegård, Hilde; Bjorvatn, Cathrine; Frost, Petter; Heiene, Gunnar; Hofmann, Bjørn; Holst‐Jensen, Arne; Holst-Larsen, Torolf; Malnes, Raino; Paus, Benedicte; Sandvig, Bente; Sjøli, Sonja Irene; Skarstein, Birgit; Thorseth, May; Vagstad, N.; Våge, Dag Inge; Borge, Ole Johan

doi:10.15252/embr.201947812

Cited by 43 publications

(31 citation statements)

References 2 publications

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“…In short, risk assessment can and should be tailored to the type of GMO in question and GEOs are definitely a special type of GMOs (cf. similar arguments by Bratlie et al, 2019 and Eriksson, 2018b).…”

Section: Roads Forwardsupporting

confidence: 78%

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

Wasmer

2019

Front. Bioeng. Biotechnol.

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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.

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Section: Roads Forwardsupporting

confidence: 78%

“…e.g., future medical applications that may require a permit for release. A new tiered approach has recently been proposed by the Norwegian Biotechnology Advisory Board (Bratlie et al, 2019).…”

Section: Roads Forwardmentioning

confidence: 99%

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

Wasmer

2019

Front. Bioeng. Biotechnol.

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“…This was driven by strong reactions and concerns created by the ruling, stating that recent technical developments have made the EU GMO Directive no longer fit for purpose (Jorasch, 2020;German National Academy of Sciences Leopoldina, 2019). In addition, a number of EU MS are calling on the EU to include adequacy of the European legislative framework on GMOs and to establish a dedicated international policy forum for further deliberations and collaboration in shaping a suitable governance framework (Bratlie et al, 2019). In particular, the former European Commissioner for Health and Food Safety declared that 'new plant breeding techniques need a new EU legislation that takes into account the latest advanced technologies'.…”

Section: Discussionmentioning

confidence: 99%

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

Ladu

2020

Journal of Environmental Policy & Planning

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Genome editing techniques (GETs) could support the transition towards a circular bio-based economy. This would require a regulatory framework that enables technical and scientific progress while ensuring safety for humans and environment. In this context, there is a debate among stakeholders in Europe whether products resulting from GETs should be subject to the GMO legislation. This paper analyses different stakeholder positions and underlying arguments on this question based on the Politically Inherent Dynamics Approach (PIDA). This takes into consideration the role of actor interests, the problem structure, institutions and alternative instruments. The analysis, based on a series of expert interviews and a Delphi survey, reveals that differing stakeholder positions are strongly shaped by differing beliefs and interests. This leads to a divergence in the definition of the problem structure, and the related solutions, in terms of the institutional setup and alternative instruments considered. It highlights the need to reach a shared vision among actors of the problems that need to be solved, in order to understand if GETs can be considered as one potential 'solution', embracing the precautionary and innovation principles. Alternative instruments are proposed, including a call for higher stakeholder engagement and diverse regulatory instruments.

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“…The respective references were also screened for the analysis of off-target effects CRISPR/Cas9, clustered regularly interspaced short palindromic repeats/CRISPR-associated 9; SDN-1, site-directed nuclease-1; TALENs, transcription activator-like effector nucleases; OTEs, off-target effects such as unintended integration of DNA caused by the genome editing process have only been observed relatively recently, and more types of unintended effects may be discovered as research progresses. A second argument considers whether the precision of genome editing renders it less prone to unexpected effects than conventional breeding or traditional mutagenesis [188][189][190]. However, we have shown here that genome editing can cause specific unintended effects and can be used to generate novel genetic combinations that cannot readily be achieved using conventional breeding or mutagenesis techniques.…”

Section: Table 3 Examples Of Genome Editing In Farm Animals For Incrementioning

confidence: 92%

Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture

Kawall¹,

Cotter²,

Then³

2020

Environ Sci Eur

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Genome editing techniques, especially the CRISPR/Cas technology, increase the possibilities and the speed of altering genetic material in organisms. So-called genome editing is increasingly being used to achieve agriculturally relevant novel traits and/or genetic combinations in both plants and animals, although predominantly as proof of concept studies, with commercial growing or rearing so far limited to the U.S. and Canada. However, there are numerous reports of unintended effects such as off-target effects, unintended on-target effects and other unintended consequences arising from genome editing, summarised under the term genomic irregularities. Despite this, the searching for genomic irregularities is far from routine in these studies and protocols vary widely, particularly for off-target effects, leading to differences in the efficacy of detection of off-target effects. Here, we describe the range of specific unintended effects associated with genome editing. We examine the considerable possibilities to change the genome of plants and animals with SDN-1 and SDN-2 genome editing (i.e. without the insertion of genes conferring the novel trait) and show that genome editing techniques are able to produce a broad spectrum of novel traits that, thus far, were not possible to be obtained using conventional breeding techniques. We consider that the current EU risk assessment guidance for GMOs requires revision and broadening to capture all potential genomic irregularities arising from genome editing and suggest additional tools to assist the risk assessment of genome-edited plants and animals for the environment and food/animal feed in the EU.

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A novel governance framework for GMO

Abstract: A proposal of a differentiated regulatory framework for genetically engineered organisms that can stimulate research and development while maintaining oversight and control.

Cited by 43 publications

References 2 publications

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

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

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

Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture

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