The challenges of regulatory science: the case of chemicals

By Susana Fonseca

In the last decades, there have been regular alerts on the risks that different chemical substances found in day-to-day life products – textiles, toys, cosmetics, food, electronic equipment, inks, etc. – pose for human health, particularly when vulnerable groups – among them children and women in childbearing age – are considered.

The research community has been a central intervenient in this debate. In fact, at the scientific level, research conducted on the interaction between some chemical substances and human health started, in a more systematic way, more than a century ago, even if regulatory effects resulting from that work can only be identified in more recent decades. But this is an area of strong controversy, where the strength of evidence necessary to act by anticipation by applying the precautionary principle has been everything but consensual.

The progressive development of what some authors call regulatory science, resulting from the interconnection between scientific expertise and regulatory policy in particularly controversial areas, is also of great relevance for the analysis of political decisions regarding the interface between chemical substances, human health and the environment. In fact, “throughout the twentieth century, scientific knowledge and expertise were constantly mobilized to develop public policies designed to prevent and manage the effects of toxic substances on health and the environment” (Boudia & Jas, 2014: 1). However, and despite the unfulfilled promise to guarantee the safety for human health, scientific knowledge has retained a key position in the regulatory process, for it is still essential in the identification and characterization of toxic chemical substances and in constructing a narrative to legitimize the policies enacted.

Regulatory science used to have (and to some extent still has), as one of its structural elements, the idea that “the dose makes the poison”, what leads to the possibility of establishing thresholds. This means that for every potentially dangerous chemical put on the market there is the theoretical perspective that is it possible to define a limit below which no relevant negative impacts will happen.

The emergence of the area of research connected with chemical substances with the potential to interfere with our hormones (usually called endocrine disrupting chemicals – EDCs), introduced in the regulatory science debate the perspective that there might be some chemical substances whose impacts can be far greater at low than at high doses, or whose impact may depend more on the timing of exposure that on the quantity. This new evidence became a major disruptor of the underlying assumption of regulatory systems: that a threshold can always be established. Also perspectives regarding the cocktail effect, namely the diversity of chemical substances that our bodies get in contact with every day, are far from being addressed by the regulatory system. The possibility that even if they are present in small doses they can add up (increasing the concentration inside our bodies) or react with one another, resulting in effects no substance was tested to before entering the market (there is no obligation for testing substances on their synergistic effects nor is it possible to consider all possible combinations, since each of us is the recipient of a unique chemical cocktail) is a challenge that is far from being addressed both by science and policy.

The interconnections between different forms of scientific expertise and how health and environmental threats (or perceived threats) are regulated are not recent and tend to show, not only the way different scientific knowledges are valued (medical community, chemists, toxicologists, etc.), but also how the idea of progress, the prevailing research  paradigms, the faith in technology and the interdependencies between scientific expertise and economic interests evolved throughout history  (for example see Le Roux, 2016 for an illustration of situations in the 17th and 18th centuries, or more recently, the European Environment Agency publications, 2001 and 2013).

Photo 1 (Susana Fonseca) post 4 Abril 2018
Regulatory Science is a negotiation process between different stakeholders (Creative Commons, Source:

The end of the 19th century and the beginning of the 20th century were key moments for the institutionalization of regulatory systems in areas such as medicines, food, industrial pollution and chemical substances, establishing science as a building block of systems regulating dangerous activities.

The limits that such regulatory systems present were revealed by several episodes throughout history, particularly after the Second World War, when a clear increase in industrial activities (including petrochemical, chemical) introduced many new substances into the market and to everyday lives, with the promise of development and wellbeing. This context eventually led to an increase in the scientific scrutiny of potential impacts and to the emergence of the “diversification of the sources and places of production of knowledge on toxicants” (Boudia and Jas, 2014: pp.6 -10).

A scrutiny of how scientific knowledge is constructed also allowed for the portraying of uncertainties in regulation not just as technical uncertainties, which can be reduced by further investigation and rational discussion, but also as the result of deeper underlying structural indeterminacies and conflicts in the policy-process, resulting from the differing perspectives, interests and rationalities of different groups involved in regulation.

Photo 2 (Susana Fonseca) post 4 Abril 2018
Chemicals are omnipresent in our lives (Creative Commons, Source:
Photo 3 (Susana Fonseca) post 4 Abril 2018
Creative Commons. Source:

All these challenges, and the discussion surrounding them, led to a new conceptualization of what regulatory science main objective was. It was no longer seen as a process that would guarantee absolute safety, but a process through which a socially acceptable risk was established. A difference was accepted between risk assessment and risk management, allowing for the social definition of what degree of risk is acceptable in a given society at a given moment in time and for specific groups. In essence, as Soraya Boudia and Nathalie Jas say, “regulatory systems recognize that standards of exposure, and more generally, the regulation of toxicants, result from scientific as well as economic and political processes. Yet at the same time, expertise and scientific knowledge are still publicly referred to in order to legitimate decisions on toxicants and their effects” (2014: 11).

In essence, regulatory science represents a combination of different factors, some scientific, other social, economic, cultural or political and yet, despite this fact and the challenges resulting from the emergence of new scientific paradigms that create strong debates between different scientific knowledges and cultures (for example, between toxicologists and endocrinologists), continues to be presented publicly as an almost purely scientific process.

A stronger public debate on this is urgent, particularly in Portugal where the regulation of chemical substances is usually low in the political agenda.

Susana Fonseca is a postdoc researcher at the Institute of Social Sciences of the University of Lisbon (ICS-ULisboa), where she works on the integration of the precautionary principle in family and health practices . She is a founding member and one of the directors of the environment NGO ZERO, as well as of Coopérnico – Cooperative for Sustainable Development.


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