Standardising through concepts: scientific experts and the international development of the HACCP Food Safety Standard

This paper deals with international standard-setting. Using the HACCP food safety standard as the basis of discussion, this paper considers the influence of scientific experts on the regulatory process. What is usually referred to as the diffusion or dissemination of soft or voluntary standards is here explained in terms of transferability of a regulatory concept. It is the ability of scientific experts to transform practices into a universal concept and, conversely, to develop technologies for users which translate the concept into practice, that explains why this reference has travelled so well across countries, industry sectors and historical periods. Scientific experts played a translating role between standard-setters and groups of practical users. This highlights the counter-intuitive distribution of power in standard-setting: while experts dominate the development of generic rules, official rule-makers (such as governments) assert their authority by developing alternative technologies for the appropriation of the standard by users and, sometimes, allow the latter to deviate from experts' universal concepts where these are shown to be problematic

Institutional polymorphism: the designing of the European Food Safety Authority with regard to the European Medicines Agency

This paper looks at the formation and designing of the European Food Safety Authority (EFSA). It seeks to assess the reality of institutional isomorphism in the European Union. It does so by analysing why references were made during the formation of the EFSA to the European Medicines Agency (EMEA), and the active differentiation of its design by actors involved in the process. The paper argues that institutional design is the encounter between a political decision to create an agency and the norms and practices that constitute sector-specific regulatory regimes. Institutional design across sectors derives from the same institutional principles, but detailed rules and structures eventually differ because they reflect the prevailing conception of the job of the future agency, such as assessing risks or approving products, which substantiate and legitimize the decision to establish it

Isabelle Bruno and Emmanuel Didier, Benchmarking: l’Etat sous pression statistique, Paris, la découverte, 2013

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Modèles d’effets, effets des modèles

Le calcul prédictif des risques est suspecté d’être une discipline favorable aux intérêts industriels. Prédire les risques, c’est définir précisément les dangers auxquels les populations font face et pousser à ajuster la décision publique à ces niveaux de danger, ou à la repousser dans l’attente de plus de certitudes. Cet article propose une histoire de l’utilisation de modèles prédictifs dans l’évaluation des produits chimiques et questionne ses effets sur la gouvernance environnementale. Il montre que les effets des modèles dits de Physiologically-Based PharmacoKinetics (PBPK) sur la décision publique sont en réalité souvent limités. Loin d’imposer un calcul de risque aux décideurs, ils ouvrent des espaces de débat sur la qualité des données et leurs incertitudes. Les effets du calcul peuvent être appréciés, de ce fait, à l’aune des configurations sociales dans lesquelles leur interprétation et leur évaluation sont conduites, et des réseaux qui dominent ces configurations. De ce point de vue et dans ce cas, le pouvoir de l’industrie gagné à travers cette technique a décliné au cours du temps.The prediction of health risks is underpinned by the ambition to measure the hazards facing human populations, when it is impossible to experiment these hazards. It is sometimes suspected that model-based predictions of risk are inherently favourable to the interests of regulated industries: by staging the possibility to measure future risks with precision, modelling harms the credibility of the other kinds of evidence that are used by regulatory agencies to establish risks, such as animal experiments or human studies. In effect, the invokation of models would delay or even block the estimation of risks by agencies, and eventually halt their decision-making. This article provides a history of the development and use of a modelling technique, known as Physiologically-Based Pharmaco-Kinetics (PBPK), to verify whether it has such an effect on the governance of chemicals. It shows that the effects of models on regulatory decision-making are often limited, for one main reason: models, their theoretical construction, their parameters or outputs, are routinely evaluated by the modellers who work for regulatory agencies. Models, therefore, do not set the risk, but open a space of interpretation of the value of different forms of knowledge to know those risks. The political effects of modelling, and the extent to which they strengthen the power of one or the other actor in the governance of chemicals, depends on the position of this very actor in configurations of uncertainty, or the set of networks that control the evaluation of knowledge and of their uncertainties. From this perspective, the power of the industry is far from being absolute.Se sospecha que el cálculo del riesgo predictivo es una disciplina favorable a los intereses industriales. Predecir los riesgos es definir con precisión los peligros que enfrentan las personas y presionar para ajustar la decisión pública a estos niveles de peligro, o posponerla esperando más certeza. Este artículo propone una historia del uso de modelos predictivos en la evaluación de productos químicos, y sus efectos sobre la gobernanza ambiental. Muestra que los efectos de los modelos de “Physiologically-Based PharmacoKinetics” (PBPK) sobre las decisiones públicas son realmente limitados. Lejos de imponer un cálculo de riesgo a los tomadores de decisiones, abren espacios para el debate sobre la calidad de los datos y sus incertidumbres. Los efectos del cálculo pueden apreciarse, por lo tanto, mediante el criterio de las configuraciones sociales en la interpretación y evaluación, y las redes que dominan estas configuraciones. Desde este punto de vista y en este caso, el poder de la industria ganado a través de esta técnica, disminuyó con el tiempo

The work of making risk frameworks

(...) This chapter analyses the origins of the risk assessment-risk management framework, which is commonly traced to a specific report: risk assessment in the federal government: managing the process (RAFG) produced by th USA national Research Council (NRC) (NRC, 1983). The chapter has on key question in mind: what kind of work underpins the construction and institutionalization of a framework? This question is motivated by the particular properties of a management framework.(...

Une société (de l’analyse) du risque ?

L’apparition des risques comme expérience collective et problèmes publics dans les sociétés contemporaines est inséparable de l’ambition de calculer et d’analyser ces risques. Ces deux phénomènes contemporains n’ont pourtant que rarement été rapportés l’un à l’autre. L’ouvrage inaugural de Beck sur la société du risque insiste sur la perte de crédibilité et d’autorité de la science dans l’énonciation de ce que seraient les risques, mais n’évoque pas l’émergence, pourtant contemporaine, d’une discipline dite de l’analyse des risques et la formalisation et l’universalisation de ses méthodes de calcul et d’aide à la décision. Allant au-delà de l’incohérence apparente de ces deux images de la société contemporaine − une société du risque et une société de l’analyse des risques –, l’article montre que la capacité à répondre aux controverses typiques de la première est précisément une des caractéristiques des savoirs de gouvernement typiques de la seconde

Les jeux politiques du calcul

Une diversité de contextes et de modes de quantification dans les sociétés contemporaines ont aujourd’hui été explorés, grâce aux œuvres majeures, notamment, d’Alain Desrosières. Cette introduction au numéro spécial de la Revue d’anthropologie des connaissances sur les jeux politiques du calcul note l’écart qui subsiste entre différentes littératures de sociologie politique de la quantification – celle qui insiste sur la gouvernementalité qu’elle incarne et la discipline qu’elle instaure, l’autre qui prête attention aux capacités de mobilisation collective qu’elle offre. L’action publique est proposée comme terrain d’étude pour comprendre comment s’articulent ces deux régimes politiques de quantification et évaluer dans quelle mesure des acteurs externes aux réseaux qui contrôlent les politiques publiques peuvent influencer ces dernières en recalculant tant les problèmes pris en charge que les effets des programmes d’action publique. Croisant sociologie des sciences et des techniques et sociologie politique, ces pages font l’hypothèse que le calcul est une des modalités de construction de coalitions dans l’action publique, et un des objets de ce qui se débat dans ses arènes. De ce fait aussi, l’action publique est un des contextes dans lesquels se forgent les formes contemporaines du calcul et s’inventent ses algorithmes.A diversity of modes of quantification in contemporary societies have now been explored, following the path of scholars who inspired this field, such as Alain Desrosières. This introduction to the special issue of the Revue d'Anthropologie des Connaissances on the politics of calculation argues that there remains a gap between different strains of the sociology of quantification - one that emphasizes the governmentality it embodies and the discipline it establishes, the other that pays attention to the collective mobilization capacities it offers. It is suggested that public policy and governance is a good field of investigation, to understand how these two “regimes of quantification” are articulated together, and evaluate the extent to which actors external to the networks that control public policies can influence them by recalculating both the problems addressed and the effects of policy programs. Combining the sociology of science and technology and political sociology, this special issue thus hypothesizes that calculation is one of the ways of building coalitions in governance, and one of the objects of what is being debated in its arenas; and, conversely, that governance is one of the contexts in which contemporary forms of calculation are forged and algorithms invented.La diversidad de modos de cuantificación en las sociedades contemporáneas ha sido explorada gracias a las grandes obras, en particular de Alain Desrosières. Esta introducción al número especial de la Revue d'Anthropologie des Connaissances sobre los juegos políticos de cálculo señala la brecha que sigue existiendo entre las diferentes literaturas de la sociología política de la cuantificación, una que enfatiza el carácter gubernamental que encarna y la disciplina que establece, la otra que presta atención a las capacidades de movilización colectiva que ofrece. La acción pública se propone como un campo de estudio para entender cómo se articulan estos dos regímenes políticos de cuantificación, y para evaluar en qué medida los actores externos a las redes que controlan las políticas públicas pueden influir en ellas, recalculando tanto los problemas abordados como los efectos de los programas de acción pública. Combinando la sociología de la ciencia y la tecnología y la sociología política, plantea la hipótesis de que el cálculo es una de las formas de construir coaliciones en la acción pública, y uno de los objetos debatidos en sus escenarios. Como resultado, la acción pública es uno de los contextos en los que se forjan las formas contemporáneas de cálculo y se inventan los algoritmos

The Science of Bureaucracy

How the US Environmental Protection Agency designed the governance of risk and forged its legitimacy over the course of four decades. The US Environmental Protection Agency was established in 1970 to protect the public health and environment, administering and enforcing a range of statutes and programs. Over four decades, the EPA has been a risk bureaucracy, formalizing many of the methods of the scientific governance of risk, from quantitative risk assessment to risk ranking. Demortain traces the creation of these methods for the governance of risk, the controversies to which they responded, and the controversies that they aroused in turn. He discusses the professional networks in which they were conceived; how they were used; and how they served to legitimize the EPA. Demortain argues that the EPA is structurally embedded in controversy, resulting in constant reevaluation of its credibility and fueling the evolution of the knowledge and technologies it uses to produce decisions and to create a legitimate image of how and why it acts on the environment. He describes the emergence and institutionalization of the risk assessment–risk management framework codified in the National Research Council's Red Book, and its subsequent unraveling as the agency's mission evolved toward environmental justice, ecological restoration, and sustainability, and as controversies over determining risk gained vigor in the 1990s. Through its rise and fall at the EPA, risk decision-making enshrines the science of a bureaucracy that learns how to make credible decisions and to reform itself, amid constant conflicts about the environment, risk, and its own legitimacy