It is argued that neoliberal political ideology has redefined the regulatory state to have greater convergence of interests and goals with the pharmaceutical industry than previously, particularly regarding acceleration and cost reduction of drug development and regulatory review. Consequently, the pharmaceutical industry has been permitted to set the agenda about how shorter term and cheaper alternative carcinogenicity testing systems are investigated for validity. The authors contend that, with the tacit approval of the neoliberal regulatory state, the commercial interests of the (...) pharmaceutical industry framed the process and interpretation of validating these new test systems, thereby influencing what counts as knowledge about the carcinogenic status of new pharmaceuticals. While such alternative tests were occasioned by “molecularization,” the framing of their validation was not determined by technoscientific logic or a lack of standards of validation, but by the sociopolitical goals of the controlling institutions. Indeed, a different validation process could have been conducted had the priority been to develop carcinogenicity testing in the interests of public-health protection. While the resulting validation indicated that the short-term alternative tests posed small risks to the commercial interests of pharmaceutical firms, they provided little reassurance that patients would not be exposed to greater risks than before from undetected carcinogens. (shrink)

While the demands for greater engagement in science in general and regulatory science in particular have been steadily increasing, we still face limited understanding of the empirical resonance of these demands. Against this context, this paper presents findings from a recent study of a potential participatory opening of the German Federal Institute for Risk Assessment, a prominent regulatory scientific organization in the field of risk governance. Drawing upon quantitative surveys of the public and selected professional experts as well as in-depth (...) qualitative expert interviews, we identify a general support for greater engagement in science-based risk assessment. However, we also find significant contestation concerning its potential enactment and its normative and strategic merit. Underlying these contestations, we identify the persistence of a normal view of science and decisionist understanding of risk assessment, which create conflicting legitimacy demands for BfR and other regulatory scientific organizations. Together with concerns about imbalances in the power to participate, especially in highly specialized engagement processes, these pose significant challenges for the institutionalization of more participatory practices. (shrink)

In recent decades, the Organisation for Economic Co-operation and Development has become a powerful forum for trade liberalization and regulatory harmonization. OECD members have worked to reconcile divergent national regulatory approaches, applying a single framework across sovereign states, in effect determining whose knowledge-making practices would guide regulatory action throughout the industrialized world. Focusing on US regulators, industry associations, and environmental groups, this article explores the participatory politics of OECD chemical regulation harmonization in the late 1970s to early 1980s. These efforts (...) were conditioned by differential institutional access and resources among stakeholders who sought to shape regulatory knowledge rules. Facing competing European and US approaches to chemical data—a minimum “base set” of test data versus case-by-case determinations—OECD members chose the European approach in 1980. However, US regulatory politics shifted with the election of President Reagan, prompting industry associations to lobby the US government to block the agreement. Examining the micropolitics of these standards in the making, I demonstrate that while long-term structures advantaged industrial actors, ideological alignment with the US government precipitated their decisive influence. The case illustrates the importance of attending to the distinctive politics of international harmonization and the effects on transnational knowledge-making and regulatory intervention. (shrink)

How do “international” epistemic communities shape regulatory contests between transnational firms and civil society organizations in the Global South? With the establishment of the World Trade Organization, member states committed to basing trade-restrictive national regulations on science-based “international” standards set by “international” standard-setting bodies. Yet we know little about how the WTO regime has shaped the operation of epistemic communities within standard-setting bodies and, in turn, how standard-setting bodies articulate with national policy-making processes in the Global South. Building on work (...) in the new political sociology of science, I argue that neoliberal globalization and the establishment of the WTO have created incentives for Western epistemic communities to at once cast themselves as “international” under the WTO regime and orient their scientific agendas toward the priorities of transnational firms. Moreover, this transformation of epistemic communities has created opportunities for transnational firms facing contentious policy environments in the Global South to effectively outsource regulatory decision-making to “international” epistemic communities that can claim legal status under the WTO regime. Empirically, I focus on the case of one Western epistemic community—the Association of Analytical Communities International—and its claim to epistemic jurisdiction over pesticide residue standards for soft drinks in India. (shrink)

Nongovernmental organizations (NGOs) and scientific controversies are often the common denominators in most of the cases that have significantly shaped science and society relationships in the Global South during the past two decades. National and international NGOs and their network have often facilitated the “opening up” of regulatory governance in multiple sectors. This article draws from three cases—the bottled water controversy, the agribiotechnology debates, and the nanotechnology initiatives—and charts out the role of the NGOs and controversies in (re)defining the science-society (...) relationship in India. The three cases illustrate how NGOs and controversies by their presence or absence at various stages of technology development shape the regulation-making exercise and the overall regulatory governance of science and technology. (shrink)

Based on the French notion of terroir or ‘the taste of place,’ a certified geographical indication (GI) identifies an agro-food product as originating in a particular territory and suggests that its quality, reputation, or other characteristics are essentially or exclusively attributable to its geographical origin. Previous scholarship exploring the social construction of terroir has focused on how disparities in political, economic, and cultural power shape GI regulations, certification procedures, and territorial boundaries. While these works have considered knowledge as a resource (...) deployed through relations of authority, studies of GI implementation have not adequately considered an important aspect of power in contemporary politics: the epistemic authority to assert the legitimacy of knowledge and its relevance to policymaking. In contrast, in this article, I take the accomplishment of epistemic authority – to determine the ‘essential’ and ‘exclusive’ physical and/or cultural attributes of place that shape product character – as key to the social construction of terroir and the institutionalization of GI regulations. This process is explored through a case study of Ecuador’s 2013-2019 implementation of a GI for Galápagos Islands coffee. I draw on analysis of relevant policy and regulatory documents and semi-structured interviews with 21 key stakeholders to argue that analytical attention to the legitimacy and relevance of terroir knowledge explains how coffee producers were able to deploy authoritative knowledge to disrupt and reinforce relations of authority and challenge the terms and mechanisms of GI qualification. (shrink)

The political ideology of neoliberalism is widely recognized as having influenced the organization of national and global economies and public policies since the 1970s. In this article, we examine the relationship between the neoliberal variant of globalization and science. To do so, we develop a framework for sociology of science that emphasizes closer ties among political sociology, the sociology of social movements, and economic and organizational sociology and that draws attention to patterns of increasing and uneven industrial influence amid several (...) countervailing processes. Specifically, we explore three fundamental changes since the 1970s: the advent of the knowledge economy and the increasing interchange between academic and industrial research and development signified by academic capitalism and asymmetric convergence; the increasing prominence of science-based regulation of technology in global trade liberalization, marked by the heightened role of international organizations and the convergence of scientism and neoliberalism; and the epistemic modernization of the relationship between scientists and publics, represented by the proliferation of new institutions of deliberation, participation, activism, enterprise, and social movement mobilization. (shrink)