I. Introduction

In the current climate of rising food insecurity, new technologies such as modern agricultural biotechnologies, i.e. the genetic modification of plants and animals, and the cloning of animals, are identified as one of the main solutions to achieve sustainable intensification.Footnote ¹ The development of modern agricultural biotechnologies and their derived products has been controversial. Biotech foods are allegedly underpinned by scientific uncertainty. To regulate such technologies and to ensure information and safety, the European Union has adopted a precautionary approach relying on premarket authorisation and mandatory labelling. Despite these provisions, biotech foods continue to attract close scrutiny, in particular from the EU public. Against this background, this opinion explains why I came to research biotech foods, how these foods are currently regulated in the EU and why the existing regimes could be improved to allow for the consideration of consumer preferences and more generally non-scientific factors.

II. Why biotech foods?

Coming from a family of dairy farmers and horticulturists, I have particular attachments to biodiversity, food, and the social relationships that can be created through such mediums. Further, I have always been interested in science and technological innovations. I have translated this passion into my research since finishing my undergraduate Law degree. Through the combination of my personal background and education, I decided to focus my PhD research on the transatlantic policy and regulation of products resulting from modern agricultural biotechnology. As a PhD student undertaking this type of research I stumbled across the fact that biotech foods were received very differently in the EU and the US: the EU restricts their use and requires premarket authorisation and labelling, while the US allows their development and expansion by adopting a more laissez-faire approach. The risk assessments of these modern agricultural biotechnologies rely on similar scientific data and came to similar conclusions: such technologies are safe. Therefore, why are the US and EU approaches so different?

Multiple aspects can be mentioned when explaining these regulatory differences but two are of particular interest when writing about risk regulation and biotech foods: the roles of scientific uncertainty, especially the precautionary principle, and non-scientific factors.Footnote ²

III. The precautionary principle as the basis to EU regulation of biotech foods

Risk plays a crucial role in the regulation of biotech foods and is particularly significant since scientific evidence is inconclusive. To handle the risks and scientific uncertainty underpinning biotech foods, the EU has created distinctive and separate frameworks for biotech foods. The regulatory intervention of the European legislature in the domain of GMOs and their derived foods is “not founded on scientific certainty, but is on the contrary motivated by the uncertainty of the existence and scope of the potential risk of these organisms”.Footnote ³ The EU adopts a “better safe than sorry” or precautionary approach to manage the uncertainty created by biotech foods. GM foods from plants and animals are regulated under the Food and Feed Regulation and Regulation 1830/2003 whilst cloned foods presently fall under the scope of the 1997 Novel Foods Regulation and from 1 January 2018, the 2015 Novel Foods Regulation.Footnote ⁴ As noted, these regulations require the premarket authorisation and labelling of such products. The established mechanisms create a safe and precautionary commercialisation of such foods following thorough risk assessment and risk management decisions.Footnote ⁵

To minimise risks, precaution is the linchpin of the regulation of EU biotech foods. Under EU law, the 2002 General Food Law Regulation (GFL)Footnote ⁶ enshrines the precautionary principleFootnote ⁷ as a fundamental element of the EU food safety system and establishes the first legally binding definition of the principle within EU law.Footnote ⁸ The precautionary principle is central, applicable in all food safety legislation. Commonly, the precautionary principle provides that regulatory action is not precluded and should not be postponed in the face of scientific uncertainty. For de Sadeleer, the precautionary principle is significant within the “broader context of risk analysis, which comprises a two-step process: risk assessment and risk management”.Footnote ⁹ As it is an encompassing principle within a risk analysis, the precautionary principle can further advance relationships between science (risk assessment) and politics (risk management) and the various actors involved.Footnote ¹⁰ Both phases are strongly intertwined.

The role of the precautionary principle in the risk regulation of biotech foods is interestingly restricted to the risk management stage in the GFL.Footnote ¹¹ This limitation emanates from the 2000 Commission’s Communication on the Precautionary Principle.Footnote ¹² The precautionary principle offers risk managers some leeway where they can weigh policy alternatives, consult with all interested parties and consider risk assessment and other relevant non-scientific factors, such as the ethics and morals of consumers. Nevertheless, the existing dichotomy between the risk assessment and risk management phases prevents non-scientific factors from playing a role in the risk assessment phase for biotech foods and favours the scientific advice received. Decision-makers cannot be precautionary in the risk assessment stage. Bergkamp argues that by restricting the precautionary principle to risk management, the Commission “denies the precautionary principle special status as an overarching concept”.Footnote ¹³ This argument is reinforced by the fact that other legitimate factors, which could include non-scientific factors, are only taken into account in the risk management phase and not during risk assessment under the GFL, the Food and Feed Regulation and the 2015 Novel Foods Regulation.Footnote ¹⁴

The precautionary principle, and its various interpretations, challenges the prevalence of this dominant position of scientific evidence within the decision-making process and privileges a populist model towards biotech foods. For populists, feelings and concerns have normative force and ought to be taken into account. The principle broadens the scope of approaches that can be considered. However, the strict divide between risk assessment and risk management in the regulation of foods, including biotech foods, makes it difficult to take into account the general context and perceptions of such foods and prevents decision-makers from adopting a comprehensive view of the risks and perception of risks at stake. This divide promotes the existence of a technocratic model for biotech foods and favours scientific evidence.Footnote ¹⁵ It reflects how risk and risk regulation can be utilised as legitimating devices.Footnote ¹⁶ Risk assessment methods undertaken by experts take little or no account of the social and ethical ramifications of technologies. This is supposedly left to decision-makers under the risk management phase. But, as observed, they are heavily influenced by scientific evidence.

IV. Towards a risk assessment encompassing non-scientific factors

Regulating technological innovation is critical to reduce and mitigate risks but is also problematic for states, particularly “when different stakeholders have differing views over the existence of risks and how they should be regulated, as well as which factors should be relevant to regulation-making”.Footnote ¹⁷ The EU public has had mixed approaches concerning modern agricultural biotechnology and is concerned by such technology. This is due to the scientific uncertainty raised by the technology, in particular about the environment and public health, and due to the animal health and welfare concerns relating to the cloning and genetic modification of animals.Footnote ¹⁸ Gaining consumer confidence and acceptance of these foods has proved problematic, as EU citizens feel that the regulatory frameworks do not reflect their preferences for mandatory labelling and potential bans.

Public perception of risk is multi-faceted, embedded in values, morals and ethics, and depends on social influences. Two schools oppose each other when scrutinising the “risk regulation and public” relationship. For Sunstein, risk regulation ought to be kept away from the irrational public.Footnote ¹⁹ Public concerns are a “source of risk, and so risk management is partly an exercise in governing ‘unruly perceptions’”.Footnote ²⁰ In contrast, Jasanoff argues for the consideration of other factors in risk assessment rather than a blindness to the disruption technology posed to patterns of living.Footnote ²¹ Ordinary people are not mistaken and their perceptions about risks involve evaluative judgments that are worthy of respect.Footnote ²² The development of technological innovations “no longer rests with governments alone but must be shared with increasingly knowledgeable publics”.Footnote ²³

In the EU, the scientific approach to assessing risk results in a fragmented and compartmentalised approach towards measures relating to biotech foods to the detriment of other factors and values which dominate the decision-making process. A characteristic of new challenges, such as modern biotechnology, is that “paradigms such as safe science or rigid distinctions between risk assessment and risk management are highly traditionalist, and are unable to accommodate the full texture and range of either the politics of risk or the politics of anxiety”.Footnote ²⁴ Risk is not just a matter for the experts: various factors, such as the institutional, social, and economic contexts, play an important role in the determination of the threshold above which the risk is judged unacceptable.Footnote ²⁵ Risk is more than a calculation of probabilities by experts and generally goes beyond conventional tools of prediction, such as cost-benefit analysis.Footnote ²⁶ The divide should be removed to enable non-scientific factors to play a role. This means that the European way to perceive and assess risk relating to (biotech) foods must be adapted as society evolves.

The contentiousness of these issues is reflected in the tensions between actors involved in the EU decision-making process. A rising number of Member States wish to listen to their citizens and want EU rules to be modified to reflect citizens’ concerns towards such foods. Asymmetric relationships between competing European and national policies have led EU Member States to challenge the existing regulatory frameworks. Recent proposals aim to tackle these limitations within the decision-making process for biotech foods. In 2015, the Commission prepared a proposal including an “opt-out” clause that would have allowed Member States to limit trade in GM foods while other Member States could have profited from such trade.Footnote ²⁷ Restrictions on the import of GM foods were limited to specific grounds, such as ethics and moral. Unfortunately, at the end of 2015 the European Parliament rejected the proposal preventing non-scientific factors from playing a role in the decision-making process. The justification for the vote was based on MEPs not being willing to see trade barriers rebuilt within the single market by allowing opt-outs from the Europe-wide approval system.Footnote ²⁸

This proposal would have paralleled and supplemented the rights given to Member States to restrict or prohibit the cultivation of GMOs under Directive (EU) 2015/412.Footnote ²⁹ This directive creates an “opt-out” clause which modifies the approval system for GM crop cultivation. It establishes a balance between an authorization procedure at EU level based on risk assessments and the option for Member States to express the concerns of their citizens without having to rely on scientific evidence or to take into account other Member States. The directive reinforces the democratic process for GMO approvals by allowing Member States to consider non-scientific factors.Footnote ³⁰ There is no reason why this new type of EU approach could not be utilised more generally for food products. The existing competition between national values and policy preferences is not sustainable.

To conclude, the accommodation of non-scientific factors in the authorisation procedure of biotech foods would reinforce the regulatory system. As new modern agricultural biotechnologies develop in changing societies, so should their associated regulatory frameworks.

This opinion would not be complete without mentioning the “B” word. Brexit and its consequences could be detrimental to the existence of strong regulatory regimes for biotech foods and modern agricultural biotechnology in the UK. The UK Conservative-led Government that began in 2010 has consistently favoured GM and animal cloning.Footnote ³¹ The consequences of this pro-biotech stance on farming and the food supply chain could be damaging if accompanied by deregulation leading to a spiral to the bottom. Further, the issues of coexistence and trade within the UK as a whole could be affected and negatively impacted as Wales, Scotland and Northern Ireland are against GM and have established moratoria against their cultivation but England appears to be pro-GM.