Niveau juridique : Union européenne
Le Panel STOA (Panel fot the Future of Science and Technology), comité de députés du Parlement européen qui analyse des problématiques liées aux sciences et au technologies, a publié une note intitulée « What if CRISPR became a standard breeding technique? » (Et si CRISPR devenait une technique de sélection standard ?), dans laquelle la technique est présentée de façon très élogieuse comme un moyen « d’accélérer drastiquement les processus traditionnels de sélection ». Encensant les variétés GM comme le riz d’or, les blés rendus résistants à l’odium, les tomates dont on a inhibé la maturation des fruits, le panel sont persuadés que les cultures provenant de variétés éditées par CRIPR seront un instrument pour « une transition vers une forme plus durable d’agriculture » (« will be part of a transition to a more sustainable form of agriculture. »).
Le panel reprends à son compte l’argumentaire selon lequel les produits issus de ces techniques ne seraient pas des OGM car ils ne contiennent pas de gènes extérieur, et que les changements introduits auraient pu intervenir par mutations aléatoires ou mutagénèse classique. S’ils reconnaissent que les effets hors-cibles sont fréquents (« CRISPR-Cas does have the tendency to produce off-target effects »), cela ne constitue pas pour eux un problème car des mutations arrivent aussi naturellement, sans que cela ne produise aucun effet. Sur la question de la réglementation de ces pratiques, bien qu’elle ne soit pas explicitement exprimée, la position des auteurs de la note semble claire… (voir extraits ci-dessous)
Extraits : (passages en gras soulignés par nos soins) :
« These engineered plants and animals are only edited, in other words they contain no transgenes, i.e. genes from other species (even though this is possible using CR ISPR-Cas). This means that all changes introduced could have occurred by random mutation or classical mutagenesis in conventional breeding. CRISPR-Cas does have the tendency to produce off-target effects, which means edits occasionally occur in ot her parts of the genome that were not targeted. This is not really a problem, as mutations also occur naturally in organisms, often without effect. Moreover, the edit itself and potential off-targets can be checked by DNA sequencing, allowing the selection of organisms with only the desired edits. Scientis ts ar e also work ing hard to improve the CRISPR-Cas system to reduce off-target effects and make it specific to the targeted sequence.
Policy can determine whether the technology contributes to more sustainable food production or, on the contrary, leads to an unfair distribution of the surplus value resulting from innovative gene editing.
Anticipatory policy-making
Given the rapid pace of scientific developments in the field of gene editing, its regulatory oversight seems more necessary than ever. In February 2017, the European Group on Ethics in Science and New Technologies (EGE) noted that the debate about genome editing should address not only safety, but also broader societal questions, such as justice, equality, proportionality and autonomy. In July 2018, the European Court of Justice (ECJ) ruled that genome-edited organisms qualify as products of genetic engineering and hence fall under the scope of the Deliberate Release Directive 2001/18/EC. According to the ruling, as genome-editing techniques have not yet demonstrated a long safety record in the open field or in a number of applications they cannot be exempted from the rules applying to GMOs.
The Commission is now working with EU Member States and stakeholders to implement the Court’s ruling. In October 2018, the Commission asked the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), together with the European Network of GMO Laboratories (ENGL), to draw up a report on the detection of food and feed plant products obtained by new mutagenesis techniques. The report was published in March 2019. It highlights challenges and limitations relating to detection and identification, concluding that products of genome editing can only be readily detected in commodity products if prior knowledge of the altered genome sequence is available. During the 2014-2019 term, the European Parliament objected to every proposed authorisation of genetically modified food and feed, demanding the suspension of all GMO approvals.
In November 2019, the Council asked the European Commission to prepare a study on the status of new genomic techniques under EU law, by 30 April 2021, so as to minimise legal uncertainties in this area. The Commission is currently carrying out targeted consultations with Member States and EU-level stakeholders to gather information for this study. The main question that needs to be addressed is whether products developed using gene editing should be regulated on the basis of the process or the final product’s characteristics, or whether a hybrid approach should be taken.
As food safety is a sensitive matter of primary concern to all Union citizens, any policy initiative in this field should not only be informed by the findings of the Commission study and the respective public consultations, but also be grounded in the principles introduced by Regulation 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain and the need to accommodate conflicting value frames by broadening the scope of the risk assessment framework and/or by transforming ethical or socio-economic considerations into substantive regulatory standards. »
Lien vers la page de la publication sur le site du Parlement européen 641535) ICI ou directement le texte 641535_EN.pdf ) ICI
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