I. Questioning gene editing techniques

In the European (EU) “knowledge-based bio-economy”,Footnote ¹ where products are derived from biological sources,Footnote ² the concept of “innovation” in the agrifood sector is increasingly shaped by an intricate array of diverse yet intertwined methods and practices. Varied models of “scientificity”^{Footnote 3} interact, co-exist and combine with pioneering technologies^{Footnote 4} – from ICT to synthetic biology, from animal cloning to nanotechnologies – bringing to the attention of the EU legislator a varied set of ethical and legal issues that are difficult to resolve.

In such a composite, data-centric scenario, the use of so-called New Breeding Techniques^{Footnote 5} (NBTs) on both plants and non-human animals (hereafter animals) is increasingly surrounded by great promises and huge expectations, as it allows individual genetic modifications to be obtained more precisely and more quickly than with conventional breeding techniques.^{Footnote 6} At the same time, though, it has re-opened and sharpened the endless debate on which ethical-legal framework is appropriate to accommodate processes and products related to technoscience. Indeed, as an advanced molecular biology technique that can produce precisely targeted modifications in crops and animals,^{Footnote 7} gene editing displays distinguishable characteristics from genetic engineering. The EU legal classification of genetically modified organisms (GMOs) is based on whether the alteration has been made “in a way that does not occur naturally by mating and/or natural recombination”.^{Footnote 8} It is elaborated as “at least” requiring the use of a listed technique, which does not explicitly include gene editing techniques.^{Footnote 9} Therefore, although the European Food Safety Authority (EFSA) holds that products developed using SDN-3^{Footnote 10} techniques – which is one of the major categories of the NBTs – would be categorised as GMOs,^{Footnote 11} these new genomic tools call into question, first, the regulatory approach (process/product-based) to be used.Footnote ¹² Second, they ask for a critical reflection on the potential impact of products on both the industrial sector and citizens.Footnote ¹³ Concerns about the peril of objectifying and controlling humanness by altering and editing the genome are in fact deeply affecting public debate about science regulation.^{Footnote 14}

As a consequence, a possible reconfiguration of the EU discipline will have to grapple with not only agrifood market’s interests and needs, but mostly and primarily with growing demand for public and participatory discussion on the currently dominant vision of life sciences.Footnote ¹⁵ Indeed, not only do life sciences continue to be a crucial locus for both an epistemic^{Footnote 16} and ethical^{Footnote 17} reflection on scientific knowledge, but also they remain the emblem of a peculiar perspective where science, law and society legitimately evolve as places for co-production of knowledge and values.Footnote ¹⁸ Science cannot settle normative questions or determine policy judgements and decisions about regulating genetic engineering merely on its own assumptions, as both values and interests jointly contribute to framing social choices about the data to be acquired, analysed and interpreted. ^{Footnote 19}

In the light of this portrait, this contribution will proceed beyond the dilemma about the extent to which current EU regulations on GMOs should apply to genome edited organisms to be used in agriculture and the food industry. In a time in which GM legislation has come under criticism for being inconsistent, disproportionate, scientifically obsolete and vague in terms of its scope,Footnote ²⁰ the right question to be asked should focus on whether one technology is responsibly designed and assessed,^{Footnote 21} by questioning which rules should guide precautionary and responsible research and development of technoscience.

This is the crucial point which this paper is structured on and around. After a brief overview looking back at the ethical and legal framework that the EU established to cope with biotechnology, the third section will explore the dilemma on the legal status of the NBTs as it arose after the 2018 Court of Justice of the EU (CJEU) ruling^{Footnote 22} on the matter. This analysis will help to focus on current risk assessment procedures, for a reflection on the modalities needed to re-think of and re-frame them to establish peace with the risk management phase. Taking this broad approach will finally allow experts to advance plausible perspectives on law-science interactions when grappling with the advent of novel yet disruptive technologies, such as gene editing, within the agrifood marketplace. Our main conclusion posits that only through restoring visibility to the intertwining of knowledge production will it be possible to obtain EU governance of gene editing that is more authoritatively reliable from a scientific stance, as well as more transparently discussed and democratically shared at both legal and policy level.

II. Biosciences at issue: a look back at the past

Alluding to a set of novel techniques for manipulating the genome, the term “gene editing” is grounded on promises of innovating several fields (from biomedicineFootnote ²³ to agricultureFootnote ²⁴) through much greater precision than pre-existing forms of genetic engineering. Both precision and speed of using site-specific nucleases, such as CRISPR/Cas9,Footnote ²⁵ TALENFootnote ²⁶ or ZFNs,Footnote ²⁷ to insert, delete, or alter either one or more DNA nucleotides have been heralded as valuable and flexible tools through which to enable a wide spectrum of applications, while addressing industrial challenges. In the agrifood domain, applications unleash solutions spanning from yields similar to natural genetic variation, to increased crop diversity;Footnote ²⁸ from the development of perennial cereal crops,Footnote ²⁹ to more efficient variations in domestic breeds (for instance, hornless cattle and miniature pigs);Footnote ³⁰ from bacterial blight-resistant rice,Footnote ³¹ to nutritionally enhanced staple foods.Footnote ³²

As with the advent of any new technology, though, innovation brings risks and uncertainty that cannot be taken for granted.Footnote ³³ Research has shown that a DNA-cutting enzymes used for genetic modification can create large deletions and shuffle genes.Footnote ³⁴ Unintended changes to agricultural methods, problematic consequences on biodiversity, and effects on the management of pest resistance in crops are examples of some implications for the agrifood field.Footnote ³⁵ Ethical issues address the application of genomics to animal production in the human food chain,Footnote ³⁶ raising concerns on animal welfare and dignity.Footnote ³⁷ Further alarms deal with potential trade disruptions and public acceptance, as well as with changes in regulatory conditions between trading partners.Footnote ³⁸

From a normative stance, this picture of pros and cons incessantly swings between the opposing rhetorics of the “nothing new under the sun” and “the very unfamiliar”.^{Footnote 39} The National Academies of Sciences, Engineering, and Medicine, for instance, has argued that emerging processes – such as genome editing and synthetic biology – actually fail to fit current regulatory categories of genetic engineering. In sharp contrast to this opinion, the International Federation of Organic Agriculture Movements (IFOAM) has posited that all new genetic engineering techniques should be considered as techniques of genetic modification leading to GMOs, and as such, they fall within the scope of the existing GM legislation. From here, questions on what exactly to regulate and which kind of normative tools should be used in coping with technology continue to be a matter of heated debate.

As scholarly work has extensively explored,Footnote ⁴⁰ the early years of the development of biotechnology were accompanied by the EU Commission’s statement that the then existing legislation was suitable to achieve the objectives set for the new technology.^{Footnote 41} Before the issue of Regulation No 1829/2003,Footnote ⁴² in fact, GMOs fell under the normative framework of Novel Foods,^{Footnote 43} which provided for a simplified procedure for market authorisation based on the concept of substantial equivalence. Only later, after the spread of the bovine spongiform encephalopathy (BSE) crisis, did debates on the safety of biotechnology products lead to a set of binding legal instruments irrespective of the presence of traces of modified DNA in the final product. Those hard law tools – consisting of a set of directives^{Footnote 44} – were clearly inspired by a precautionary approach in order to anticipate possible harmful effects related to the scientific and technological impacts on both the environment and society. At the same time, the reductionist and objectivist vision of science pervaded EU policy- and law-making processes on biotechnological applications, exacerbating the “ideological separation” between “is” and “ought”, by relegating social values to technically manageable issues kept away from scientific facts. Several conceptual narratives enriched this panorama: the normalisation of risks through their “legal confinement” in controlled environments; the technical governability of risks through the mechanistic language of engineering; the rhetoric of using ethics as a soft and flexible “indicator of normativity” for the civic acceptability of biotech products.Footnote ⁴⁵

Ethical deliberation in particular – as acutely pinpointed by scholarsFootnote ⁴⁶ – was not “an exercise opening up diverse imaginations about issues at stake, but became a boundary-drawing move”, namely an abstract normative concept subordinated to narratives of market harmonisation, which closed the door to the creation of legitimate right and genuine public debate.Footnote ⁴⁷ Citizens’ role was relegated to that of mere recipients of EU ethics, “adequately informed”, albeit without any active involvement in the choice of the values at play. This was also because ethics and cultural values – according to the EU Commission^{Footnote 48} – are predominantly regulated at the national level and follow the principle of subsidiarity, whereby the Union does not take action (except in the areas which fall within its exclusive competence) unless it is more effective than action taken at national, regional or local level. Subsidiarity, therefore, deprived citizens of any possible voice in discussions regarding the principles of EU ethics, binding them, de facto, to the bureaucracy of national governments (the only interlocutors of the ethical discourse).Footnote ⁴⁹

Along this theoretical narrative “creating” EU consumers barely informed of biotech-related issues, a significant number of affluent consumers/citizens committed to such values as freshness and quality, the environment and small-scale farming, taste and food in season, considered genetic modification a long way away from their idea about naturalness of things. Against this backdrop, one relevant question arises: Is the process aimed at legitimising technocracy in the name of the integrity of scientific community newly under way with reference to gene editing techniques?

III. Science regulation in dispute

In 2015, the European Academies Science Advisory Council (EASAC) provided general principles on how best to capitalise on genomics research.Footnote ⁵⁰ It argued for evaluating new technologies according to the scientific evidence base, stressing the non-applicability of EU legislation on GMOs in the case of a product of genome editing not containing foreign DNA. More broadly, EASAC requested full transparency in disclosing the process used and a product-based regulation – for plants and animals – being irrespective of the breeding technique employed.Footnote ⁵¹ Later, in 2016, after continuous controversies and complex discussions on the regulatory status of gene-edited agricultural products between biotech companies, NGOs, and farmers,Footnote ⁵² the caseFootnote ⁵³ brought by the French Conseil d’Etat to the CJEU ended up representing a turning point for the issue in dispute. It was asked whether organisms obtained by mutagenesis constitute GMOs within the meaning of Article 2 of Directive 2001/18 (“GMO Directive”), although they are exempt under Article 3 of and Annex IB^{Footnote 54} to the directive from the obligations laid down for issuing and placing on the market of GMOs.

Put in other terms, the core question referred to the Court was whether the GMO definition covers the methods used, the result, or both. On 25 July 2018, the CJEU ruled on this request to provide legal certainty for the advancement of life sciences in Europe.^{Footnote 55} Its main conclusion was that “organisms obtained by means of techniques/methods of mutagenesis must be considered to be GMOs within the meaning of Article 2(2) of Directive 2001/18”.Footnote ⁵⁶ This statement was grounded on two major considerations. First, that the mutations brought about by techniques/methods of mutagenesis constitute alterations made to the genetic material of an organism.Footnote ⁵⁷ Second, that those techniques/methods alter the genetic material of an organism in a way that does not occur naturally, since they involve the use of chemical or physical mutageneous agents, or the use of genetic engineering.Footnote ⁵⁸ Only “organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record”Footnote ⁵⁹ are excluded from the scope of that directive. Moreover, the Court considered that the risks linked to the use of these new mutagenesis techniques might prove to be similar to those that result from the production and release of a GMO through transgenesis.

This is for two reasons. First, the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism (transgenesis). Second, those new techniques make it possible to produce GM varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis.

In sum, by bringing new mutagenesis techniques within the GMO Directive’s scope, the Court teleologically updated legislation that pre-dates technological developments, using the legal instrument of analogy as an ontological and epistemological tool to conceptualise gene editing. In so doing (unproductively, according to some scholars^{Footnote 60}), the ruling went for assuring legal convergence at supranational level, rather than permitting regulatory divergence, as Directive 2015/412/ECFootnote ⁶¹ did by assigning – as regards the cultivation of GMOs – regulatory responsibility to Member States,Footnote ⁶² in accordance with the precautionary principle.

This situation led the CJEU’s judgment to be labelled as “a double-edged sword”.Footnote ⁶³ On the one hand, the decision – it has been argued – is aimed at precautionarily protecting human health and the environment from potential biotech risks. On the other hand, though, it may hamper research activities due to the lengthy risk assessment and authorisation procedure prescribed for GMOs. Those considerations perfectly mirror the opposing opinions^{Footnote 64} that have emerged among stakeholders. The German chemical industry association VCI^{Footnote 65} and the biotech association EuropaBio^{Footnote 66} have severely criticised the Court’s judgment as “backward looking and hostile to progress”. The German Bioeconomy Council,Footnote ⁶⁷ moreover, has manifested its disappointment with the “complex, time-consuming and expensive approval procedure” that the future applications of gene editing will have to go through if the GMO Directive is applied. It has thus called for a prompt revision of GM legislation, in order to stipulate which applications of genome editing are essentially allowed (without special provisions relating to genetic engineering), which are prohibited, and which will only be allowed with a special permit. By contrast, the environmental group Friends of the Earth Europe^{Footnote 68} has applauded the Court’s attempt to grapple with the current deregulation of recently developed technology. Certainly, this backdrop will continue to trigger renewed quarrels on the role of both the precautionary principle and science regulation in the technology-based agrifood field,^{Footnote 69} all the more so since different yet equally valid ways of reasoning affect the democratic debate on the science-law relationship.

In the meantime, on 23 April 2019, 22 EU business organisations jointly called upon the EU Commission for the adoption of science-based, innovation-friendly rules for plant breeding.Footnote ⁷⁰ With the aim “to achieve important sustainable development goals”, while contributing to “a cleaner environment, healthy diets, and the protection of biodiversity”, the 22 signatories reiterated their concerns about both the costly and lengthy EU approval process for products resulting from targeted mutagenesis and the difficulty of implementing the CJEU’s judgment. This is because – they affirmed – “many gene-edited products may be indistinguishable from products changed by natural processes or with conventional breeding techniques”, as shown by a study conducted by the EU Commission’s Joint Research Centre.Footnote ⁷¹

Appealed on this intricate issue, in 2018 the Scientific Advice Mechanism (SAM) presented its explanatory noteFootnote ⁷² to the EU Commission. By stressing that “the safety of a product is determined by its characteristics and not by the way it was generated”, it called for an urgent revision of the existing GMO Directive. The novel legal rules – it affirmed – should be “proportionate and flexible” enough to “reflect current knowledge and scientific evidence on gene editing and established techniques of genetic modification”, as well as facing future advances in science and technology in the domain.

Both the 22 organisations’ and SAM’s requests agree, therefore, on a product-based approach to the NBTs that moves away from the process-based argumentation Europe has developed to address GMOs. Indeed, as only rational legal reasoning and evidence-based policy are considered transparent, legitimate and accountable processes through which to regulate intricate social problems, science-based legislations appear reliable tools to make normative statements more objective.

Interestingly, however, in the same proposal for a clear, evidence-based and implementable “legal environment”, SAM also focused on the need “to promote a broad dialogue with relevant stakeholders, and the public at large”, with the aim of clearly and transparently considering the ethical, legal, social and economic considerations that usually inform decision-making processes. Such a problem strictly correlates to the broader debate on the complex mechanisms underpinning risk assessment procedures and their correlation with risk management and communication phases. The actual conundrum, in this respect, not only refers to the process of assessing and communicating science, but mostly regards how to promote more meaningful interactions between policy-decision makers, scientists, producers and the public, so that connections with citizens no longer be viewed as exercises in better communications from a privileged elite.Footnote ⁷³ “The starting point” – as has been observed – “is that scientists and the public can learn from each other, that both have access to knowledge as well as having political and normative values that are relevant for scientific choices”.Footnote ⁷⁴ The next two sections are devoted to scrutinising these issues. They will be focused, first, on the ongoing EU debate on the need to reframe the role of risk assessment within the wider process of risk analysis; second, on the plausible perspectives the citizens’ right to democratically and reflexively participate in the governance of biosciences may elicit for gene editing in the future of EU food and farming.

IV. On re-framing risk assessment

In the EU’s employment of a process-based risk assessment framework, EFSA provided two guidance documents for evaluating the impact of GM plantsFootnote ⁷⁵ and plant-derived food and feed.Footnote ⁷⁶ In questioning whether those methodologies are adequate to analyse organisms arising from gene editing techniques, though, scholarly workFootnote ⁷⁷ has identified several knowledge gaps that pertain, specifically, to appropriate focus, selection of test organisms, and the use of comparators. Technical discussions on these gaps are beyond this contribution. Here it is worth noticing the modalities through which those hurdles and challenges could be correctly overcome when addressing the value-laden issues associated with gene-edited plants and animals.

In recent years, in the light of the EU Commission’s acknowledgement that “risk assessments make little sense unless they are informing risk management”,^{Footnote 78} EFSA carried out relevant initiatives to foster communication between risk assessors and risk managers, such as its 2016 guidanceFootnote ⁷⁹ on specific protection goals for environmental risk assessment. Indeed, it is now commonly accepted that issues concerning the identification of significant risks, or the parameters for measuring them, or even the criteria for comparing the implications on the social groups involved, represent implicit assumptions that precede risk assessment procedure. Hence, in spite of the clear distinction between the two phases, “assessment is informed but not influenced by management, at least in terms of how the assessments are carried out and what conclusions are drawn from them”.Footnote ⁸⁰ This implies that risk assessment should take into account both social-behavioural factors to better define problems at the formulation stage, and the type of information risk the assessor has to provide to better inform risk managers in addressing different societal needs. If risks related to gene editing constitute “warning signs” requiring prudence, a precautionary decision is expected to pay scientifically rigorous attention to all situations of uncertainty, through a procedure that considers all divergent scientific opinions, including the interests (political, social and institutional) of the stakeholders involved.Footnote ⁸¹

At a time of structural challenges to the integrity, validity and reliability of scientific data,Footnote ⁸² making the interpretative aspects of risk assessment policy (namely how are data interpreted?) explicit, and comparing them with each other in open and accountable ways, might give policy-making regimes their scientific and democratic legitimacy. Remarkably, EU public bodies gradually started taking steps in this direction: first, with the “Open EFSA” initiative;Footnote ⁸³ second, with the decision to increase the transparency and sustainability of the EU risk assessment model in the food chain, particularly in response to the “EU Citizen Initiative to ban glyphosate”.^{Footnote 84}

As for EFSA’s activities for wider scrutiny and participation, the plethora of actions aimed at producing more robust, transparent, and open scientific assessments culminated in a Data Warehouse (DWH), which publishes and distributes EFSA’s collected data to both improve the overall quality of the data used and comply with normative and societal expectations of openness.Footnote ⁸⁵ In 2018, moreover, practical guidance was released for EFSA communicators on the best way to communicate different expressions of uncertainty in scientific assessments.Footnote ⁸⁶

As for the EU Commission’s action addressing risk assessment, a Regulation for a rethinking of risk assessment in the food chain was released in September 2019.Footnote ⁸⁷ The novel rules, which find their legal basis in Articles 43, 114 and 168(4) lett. b) of TFEU, provide EFSA with a toolkit of transparency rules regarding several areas – like GMOs, additives and plant protection products. Their major focus spans from the appointment of the members of the Management Board of EFSA, to consultation of third parties to identify the availability of other relevant scientific data or studies. Further novelties range from compliance of studies submitted by business operators with applicable standards to public access – as early as possible in the risk assessment process – to all scientific data and information supporting requests for authorisations. The proposed rules, however, are not free from concerns,^{Footnote 88} especially as regards the exception to public access to a general horizontal list of confidential items, such as, with respect to GMOs, “DNA sequence information (except for sequences used for the purpose of detection, identification and quantification of the transformation event) and breeding patterns and strategies” (Article 25(2)). Such a kind of information is considered central to providing the breeding sector with sufficient information, for example to identify varieties covered by patents.^{Footnote 89} Further initiatives are therefore expected to solve these limits. Meanwhile, implementing the EFSA’s and the EU Commission’s commitments would support revolutionary rethinking of decision-making practices in a participatory sense, democratising the cognitive structure within which public policies are formed, and including lay people in the notion of expert and expertise. In this way, the widest range of relevant knowledge dispersed in society may reach the table of political decision-makers, for the achievement of a more democratic vision of the EU society under uncertainties.

V. Democratic tools for the future of EU food and farming

In which “terrain” is the EU agrifood domain predisposed to accommodate gene editing processes and products? One of the main lessons from the GM experience is that science-based forms of appraisal need to be embedded within a much broader reflection on public values, especially in the entrenched technoscientific fields where scientific uncertainty is steadily in the driver’s seat. The inability of mathematical language to correctly translate across the borders of converging technologies requires that the actors involved in decision-making be expanded to include new decision-makers for pluralistic reflections and opinions.

Over the years, the EU institutions seem to have learned from GMO events. While EFSA is gradually changing its approach towards the handling of scientific uncertainty, by opening up its working activities, the traditional risk regulation process is moving towards a more open dialogue among stakeholders and a diversified collection of scientific expertise within the ongoing and still unfinished process of rethinking science governance.Footnote ⁹⁰ However, many obstacles tend to slow this democratic impetus. Contextualising science governance in a broader context of new “social geographies” requires to reshape the boundaries between policy institutions and society and rethink the role of EU citizens in the deliberative process.

Over the years, the EU “Smart or Better Regulation programme”Footnote ⁹¹ has continued to promote a still mechanistic vision of reason. The EU legislator is expected to act as a sort of “body-machine”: the smarter it is, the more capable it is of rationally predicting citizens’ choices and behaviours; the more efficient it is the more capable it is of leveraging on the “scientifisation” of regulatory procedures to legitimise them.Footnote ⁹²

It is true, however, that against the regulatory responses of “command and control” in GM food,Footnote ⁹³ the CJEU’s ruling left room for future interpretations and reasoned argumentations on the systemic interactions between science and society. In this regard, the scholar Sheila Jasanoff has drawn attention to the unavoidable need to make use of “technologies of humility”Footnote ⁹⁴ to lead the public debate on the role of science in society towards new democratic horizons. This fascinating expression alludes to the desire to institutionalise those habits of thought that are fragmented in society to create more than mere formal mechanisms of engagement. Those new social technologies – which focus on public assessments of framing, vulnerability, distribution, and learning – would permit experts to recognise uncertainty, as well as multiplying knowledge production and making the normative dimension of science explicit.

Although these exploratory forms of sharing ideas, values and knowledge are to be further explored and discussed, they could represent valid and influential tools for spreading transparency and dialogue between heterogeneous knowledge sources. To this end, two proposals appear worthy of being highlighted for the subject we are discussing.

The first one suggests inclusion and application of the so-called “Open Access Paradigm”Footnote ⁹⁵ as a guiding principle for research and development in the biotech field. Given the inadequacy of current treaties, such as the Nagoya Protocol, to deal with the digitalisation and privatisation of genetic resources, such an approach could push for the structuring and standardisation of information, together with reframing molecular genetics as a participatory and democratising toolbox. Going beyond those metaphors and analogies that courts used in the coproduction of biotech intellectual property,Footnote ⁹⁶ the free transfer, use, and reuse of knowledge may facilitate the promotion and spread of creative common licensing and plant breeders’ rights under the umbrella of genetic resources and digitalisation. This sharing of knowledge would also contribute to guaranteeing the emerging citizens’ rights to access to open and raw food-related data,^{Footnote 97} for more active and trustworthy interactions with authorities.

This vision is perfectly in line with the recent (2019) CJEU decisionFootnote ⁹⁸ that requests EFSA to disclose details of studies on toxicity and carcinogenic properties of glyphosate. Interestingly, this judgment is grounded on interpreting “the concept of information which ‘relates to emissions into the environment’ […] as covering not only information on emission as such […], but also data concerning the medium to long-term consequences of those emissions on the environment”. In so ruling, the Court has de facto re-affirmed the importance and necessity of increasing public transparency in food and health safety.

In parallel with these quests for public access to scientific data, an international network of scholars and organisations has advocated a wide consortium on the norms that should guide research.^{Footnote 99} It aims to determine how the potential of gene editing can be better steered by the values and priorities of society, promoting information exchange across cultural divides.Footnote ¹⁰⁰

With gene editing technology potentially altering plant and animal farming practices, government support and impetus from interlinked networks – such as farmers’ unions and activist organisations, agricultural companies and institutions focused on development – are considered powerful instruments in this respect. They would allow for connecting people to debates on the social, political, moral and economic implications of gene editing,Footnote ¹⁰¹ bringing different sets of evidence and entirely different values to democratic discussion.Footnote ¹⁰² Such a creative and intellectual environment would also permit individuals to question those “master narratives” – from the myth of progress to the identification of modern rational science as a valuable and privileged type of knowledge – that in policy practices continue to shape the collective imagination, outlining the possible and acceptable actions on the basis of factual data.Footnote ¹⁰³ Certainly, framing science governance in these terms would not diminish the value of scientific knowledge. Rather, the redistribution of decision-making powers within the innumerable sites of knowledge production would give concrete form to a renewed EU citizenship, while favouring the multi-functionality of EU agricultural and food systems in the near future.^{Footnote 104}

VI. Final remarks

Since the political debut of biotechnology in the 1970s, food law has approached scientific reality by displaying control and flexibility in balancing the strength of rules with the endemic uncertainty of science. Yet history shows how the complexity of emerging technologies, and the levels and contours of uncertainty running with them, are such that, when addressing the “seemingly unfamiliar”, acceptance and tolerability of risks depend on the convergence of factors inextricably merged with each other. Consequently, the dichotomy of “regulation versus deregulation” recursively re-emerges to trigger adaptive capacity in dealing with the technology at issue.

Exploring the moral questions raised by the use of genome editing in food production, the Nuffield Council on Bioethics has supported the vision of enlarging critical reflection and discussion on new techniques. It has suggested challenging the debates’ parameters (introducing new future visions) and the assumptions (such as the significance of the GMO/non-GMO disjunction) underpinning them, together with addressing normative and ethical questions from the standpoint of the societal challenges that run with genomic tools.Footnote ¹⁰⁵ These considerations clearly fit into the open and democratic infrastructure which scholars are promoting for accountable and transparent research on gene editing techniques. Meanwhile, Europe is strongly committed to supporting knowledge, innovation and technology for a smarter and more resilient agriculture of tomorrow, by providing farmers, through the Common Agricultural Policy (CAP), with a diverse set of tools to prevent and manage risks in food production chains.Footnote ¹⁰⁶ With such a landscape in mind, the growing and essential need to preserve the “human dimensions” of biosciences^{Footnote 107} is hoped to guide the future regulation and governance of EU agricultural biotechnology.