New technologies, such as AI, nanotechnology and gene editing offer all kinds of opportunities for solving important societal issues. However, when there are suspicions that a new technology or substance could cause serious damage to health or the environment, precautions must be taken under European legislation. When there is no consensus or scientific certainty about the likelihood of these effects, the 'precautionary principle' serves as the basis for taking measures to ensure our safety and that of the environment. Think, for example, of restrictions on the authorisation of crop protection products. Different interests are at stake in putting the precautionary principle into practice. These have been mapped out by the Rathenau Instituut as part of the European RECIPES project.
When there is scientific uncertainty about the risks of a new development, the precautionary principle allows decision-makers to give the environment and public health priority over other (economic) interests.
When applying the precautionary principle, it is important to weigh up different interests, now and in the future.
In order to develop strategies that combine precaution with opportunities for innovation, insight into the stakes at play in applying the precautionary principle is important. This article is about these stakes.
The precautionary principle gives direction to what is right and fair in situations of scientific uncertainty, and how interests should be weighed up. However, the principle does not establish which measures are to be taken in which situations of scientific uncertainty.
This leads to different implementations of the principle in practice. For example, the safety of herbicide glyphosate will soon have to be reassessed by the European Commission, there is a European ban/moratorium on certain neonicotinoids used for insect control, and companies must be able to demonstrate scientifically that a GMO crop (genetically modified organism) is safe before they receive authorisation for it - and possibilities for authorisation also vary from country to country.
The question of how and when the principle should be implemented is a balancing act under uncertain circumstances. When putting the precautionary principle into practice, decision-makers make various considerations, such as: is the danger serious enough? Is there in fact scientific uncertainty? And which measures are proportionate to the prevention of potential damage? Decisions of this kind must be made carefully, because they can have far-reaching consequences for on the one hand the producers of the substance/technology, and on the other hand the potential victims of the associated risks, such as nature and European citizens.
Within this balancing exercise, we distinguish four stakeholder groups. Firstly, there are parties who formalize the precautionary principle in laws, rules and measures. Secondly, there are parties who implement the precautionary measures. Thirdly, there are parties who are directly affected by the way in which the precautionary principle is applied. Fourthly, there are parties indirectly affected. These four groups are explained below.
1. Stakeholders who formalize the precautionary principle in laws, regulations and measures
The precautionary principle is a leading principle for how all kinds of risks are handled in our society. Moreover, as an internationally recognized, general principle of law it has an enormous effect on how regulations, decisions, policies and guidelines are formulated on all kinds of levels: international, EU, national and even local.
As a legal principle, the precautionary principle has been applied in a variety of ways within local, national and global governance levels. Legal principles can be deployed as a ground for interpreting laws, the changing of laws, formulating specific exceptions to laws, making new rules and even as the sole ground for action (Raz, 1972). Sometimes the precautionary principle is explicitly formalized in different international and national laws, treaties and regulations. In the EU, the precautionary principle was included in the Maastricht Treaty in 1992. It is also formalized in EU Directives and Regulations, Regulatory Decisions and Court Judgments. In some applications, the principle is not mentioned as such, but a law seems to follow the main ideas behind it.
Many actors play a part in the creation, distribution and concretization of the principle for example in the jurisprudence in a country. These formalizations can be based on different interpretations of the principle, depending on answers given to questions like: does uncertainty justify action? Or is it enough to say that uncertainty does not justify inaction? How serious must a threat be to invoke the principle? Who has the burden of proof: does the developer need to prove its new product is safe or do those aiming for environmental protection need to prove it is not? Which measures are appropriate? In 2000, the European Commission released the Communication of the Precautionary Principle, a guide to applying the principle as interpreted by the EU. It prescribes moderate precaution: uncertainty justifies precautionary action, regulation should be ‘proportionate to the risk level’, and the banning of substances is only a last resort.
A number of European and global (advisory) organizations supporting policy and governance, like the World Health Organisation (WHO) and the European Environment Agency (EEA), have further developed policy recommendations based on the precautionary principle. Academic researchers in areas like Risk Research, Law, Ethics and Sustainability Studies can also provide expertise on the management and assessment of risk to government institutions. Finally, actor groups such as politicians, lobbyists and advocacy groups influence the debate on how to formalize the precautionary principle, for example, to the degree that it is enacted in laws through parliament.
2. Stakeholders involved in formal precautionary principle procedures
The second group of stakeholders is made up of actors involved in the procedures that implement the precautionary principle. In other words: those who decide when and how the principle is invoked, who are (generally) involved in legal, policy and risk assessment procedures - establishing the seriousness of a given threat, its plausibility, uncertainty and who can be held responsible. The European authorization procedure for a GM crop from the Netherlands, for example, includes stakeholders like the Dutch Bureau for Genetically Modified Organisms (Bureau GGO), the European Food Safety Authority (EFSA) and the European Commission.
While the precautionary principle's application has been elaborated by, for example, the European Commission and, furthermore, in EU case law, it serves as a general overarching principle for dealing with serious risks that are uncertain, complex and ambiguous, and the particularities of different cases that would not be served with a set procedure. Procedures can, therefore, differ between regions, governance levels and types of innovation.
Ultimately, political considerations determine whether and how the principle is implemented. As stated in the 2000 communication, “the appropriate response in a given situation is thus the result of a political decision, a function of the risk level that is ‘acceptable’ to the society on which the risk is imposed” (p. 16). To ‘apply’ the precautionary principle can, therefore, mean different things, like a (temporary) moratorium banning a specific type of substance or innovation, or a case by case assessment of risks. Considerations that are often taken into account in the determination of actions are the proportionality and reversibility of precautionary measures.
On the basis of existing evidence and sometimes additional research on a specific technology, countries often follow each other in drafting laws, regulation and directives. In the EU, the European Commission asks scientific committees or EU agencies to assess the potential risks, based on the available scientific evidence. Policy alternatives are weighed in consultation with interested parties and experts from Member States and the Commission trying to reach a unanimous decision. In some cases, there is a need to adopt new or revise existing EU legislation, which needs to be discussed and adopted by the EU legislators: the European Parliament and the Council of the EU.
When precaution has not sufficiently been taken, risks are frequently brought to the attention fairly early by individual researchers (in the sense of whistleblowers). The demand for action is then often voiced to policy makers by NGOs, advocacy groups, academics and journalists who have assembled evidence of the risks. Also in the formalization of procedures there is room for lobby groups, power play and public relations campaigning.
3. Stakeholders directly affected by its implementation
The third group of stakeholders consists of those that are directly affected by implementation of the precautionary principle: those involved in the introduction of new substances or products in the environment or the market. Actor groups that are forced to take risk reducing measures on the basis of the precautionary principle are: technology developers, actors from industry, and researchers that, for example, violated agreements of a moratorium.
Industrial or technological accidents seldom only haveone source of human failure; more typically they are the result of a chain of interrelated actions and systemic technological design.That means that when the precautionary principle is implemented, it can have a large impact on the entire supply chain of a product. For example, with regard to GM products, the legal framework put in place includes a high-level assessment of safety before any GMO is placed on the market, and ensures clear labelling and traceability of GMOs placed on the market . Of course, not all safety regulation is based on the precautionary principle.
Companies can be affected in different ways, also dependent on the regulations already in place. It is, for instance, possible that production is restricted, or that producers are required to inform consumers about possible health risks on their labels. Some companies might decide to no longer invest in the R&D of a certain technology. Others might become retroactively liable to lawsuits. In order to prevent taking drastic measures after products are market-ready, companies can also take a precautionary approach already in the development of their innovation. This way, the principle can stimulate innovators to invest in different innovation pathways or to develop innovations that are safe by design. Of course, in the complex daily reality of research and development, the precautionary principle is only one of many factors in decisions that innovators make.
4. Stakeholders indirectly affected by its implementation
The precautionary principle is a safety net for European citizens, who are represented by interest groups like patient organizations, consumer organizations, unions and activist groups. But the group of stakeholders indirectly affected by the implementation of the precautionary principle is much broader than the EU citizen. The principle is often applied in cases of technology that might be produced and distributed on a global scale with possible irreversible effects, and, therefore, stakeholders effectively include the whole world and even future generations. Especially in the case of chain reactions, as is the case with human induced climate change, a feedback loop can strengthen consequences for every generation that is to follow. The emergence of the precautionary principle has been inspired, amongst others, on the tenet that risk governance should account for both intra- and extragenerational equity: the needs of present generations should be met provided they do not impair the ability of future generations to meet their needs.
Moreover, deliberations based on the precautionary principle are sometimes informed on the idea that the negative impacts that human activities may have on nature should be considered, even if these impacts do not pose direct risks for humans. A technology that destabilizes an ecosystem can have ever wider consequences for all living things that are connected to it.
In light of the precautionary principle, the involvement of this fourth group of stakeholders in decisions under scientific uncertainty is very important. The ethical principle behind this idea is that decisions that affect parties other than the decision-maker should be consented to by these parties under conditions of transparent process and with freely accessible information.There are many NGOs committed to protecting the interests of the poor, minorities, animals and nature. However, in discussions involving uncertain risks, an adequate representation of stakeholders with less or even without voice or power, such as nature and future generations, is difficult.
What does this mean for the development of strategies for implementing the precautionary principle?
The precautionary principle is an important general principle that has amongst others been implemented as a general principle in EU law. Its application has an effect on the safeguarding of human health and the environment and innovation in a variety of ways. It aims to enable a response to uncertain serious risks that is appropriate and ‘acceptable’ to the society on which the risk is imposed. Our analysis demonstrates a complex array of forces and interests around the implementation of this principle. It is clear that it is not an easy task to take those into account who are affected by potential hazards in the long term, including those who cannot organize themselves into organizations or lobby groups that represent their interests.
Because RECIPES takes place in the middle of this dynamic and often political arena, co-creation and stakeholder involvement play an important and unique role within the project. The partners of the consortium come from different European countries and have different (academic) backgrounds. Different interest groups are represented in the advisory board of the project. Above all, we involve stakeholders in the different steps of our methodology.
For example, a dialogue with citizens was held on the subject, a media analysis of several European newspapers was carried out, and scenario workshops were held with a wide range of stakeholders. Ultimately, we are working towards discussions with policymakers on strategies that inherently link the precautionary principle to opportunities for responsible innovation.The Rathenau Instituut can draw on years of experience in facilitating dialogue on science and technology development, particularly on situations of scientific uncertainty. Examples of relevant Rathenau projects are the Nanodialoog (Nano dialogue), the Ammoniakdossier (Ammonia dossier) and our current project on radioactive waste.
The Precautionary Principle
The precautionary principle comes down to the following: where there are threats of serious or irreversible damage, such as with the introduction of new substances or technology that could have permanent systemic (side-)effects, scientific uncertainty should not be an excuse to not take precautionary measures. Or, in simple terms: better safe than sorry.
The principle has a long history and it has been given a place in our society in various ways. Since the 1970s the principle has increasingly acquired the status of an internationally recognized general principle of law. In every legal and regulatory domain where there is scientific uncertainty about serious risks - for example environmental law, legislation on chemical substances, or food law – the principle directs towards precautionary action. In this regard it has for example been included in the Lisbon Treaty of the Functioning of the EU and other important international treaties. More recently, it has also been formalized in, amongst others, practices in which risks are assessed, in company guidelines or instructions for policy makers.
But what exactly is a ‘principle’? Ronald Dworkin  describes principles in law as open-ended in character. They do not offer a predetermined solution. Rather, principles have a high moral content and aim to give decision makers direction, in particular with respect to justice and fairness. Principles, in contrast to policies or approaches, can be legally binding, and form the basis of specifically formulated rules . However, the interpretative flexibility in the formulation and application of these rules leaves room for judgement.
In order to strengthen the application of the precautionary principle, the Rathenau Instituut is participating in the European RECIPES project. This Horizon 2020 research initiative is designed to develop strategies and guidelines that combine the precautionary principle with innovation opportunities. This article is part of a series of articles on precaution and innovation that we write in the context of RECIPES.
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