Regulatory science can be defined as the scientific foundation of public policy decisions, whether regulatory, legislative, or judicial (FDA 2013). As a practice, it includes, among other things, technical reasoning such as risk analysis and modeling; the operation of expertise in policy; and procedures for validating knowledge in courts and other governing institutions. The politics and operation of these forms of technical reason within public process has been the subject of STS scholarship for some time (e.g. Nelkin 1984). This work has helped uncover, in nuanced ways, the politics of who makes authoritative knowledge, using whose methods, for whom, and subject to what political consequences (e.g. Jasanoff 1987; Gieryn 1999; Sarewitz 2004). As STS scholars have shown, regulatory science does not represent knowledge free of value. Often sitting in a context of uncertainty and contestation, it combines scientific reasoning with social and political judgment (Jasanoff 1990: 229).
Scholars turning their attention to regulatory science at the global and international levels have largely focused on its operation, broadly speaking, within single institutions. A central finding has been that these institutions can act as hegemonic centers of calculation and assessment, specialized knowledge, and embodied expertise. This work has analyzed, among other things, the use of science for environmental impact assessments at the World Bank (Goldman 2005); the use of self-governance and peer review at the IPCC (Edwards and Schneider 2001); and power dynamics in the Millennium Ecosystem Assessment (Miller 2007). Such work has also exam- ined how expert communities function and acquire power at the global scale (Oreskes and Conway 2010; Haas 1992).
Much less has been said about how science operates through governance systems that traverse levels, scales, and sectors to address collective problems (Ostrom 2009; Biermann and Pattberg 2008). It is well understood that regulatory approaches to global issues, from climate change to food safety, are increasingly moving away from globalizing systems and instead operating through pluralistic, overlapping, and fragmented regimes (Boyd 2010). These forms of “polycentric” or “complex” governance are hailed by some
scholars and policy-makers (e.g. Ostrom 2009; Rabe 2004). But they can result in jurisdictional overlap and competition. Regulatory science is often a focal point of conflict (e.g. Peel 2010).
The jurisdictional politics of ethanol regulation is a good illustration. In the absence of strong Federal leadership, U.S. cities, states, and regions are enacting efficiency incentives and purchasing mandates to mitigate their carbon footprints. California recently enacted a “low-carbon fuel standard” which was cited as a model by the European Union in its passage of the 2009 Renewable Energy Directive. However, in a lawsuit currently being heard in an appellate court in California, private actors have sued California on the grounds that national standards pre-empt California’s technical standards on federalist grounds. Meanwhile, at the global level, Brazil and the U.S. are beginning to challenge the EU Directive at the World Trade Organization (“WTO”) on the grounds that its sustainability standards constitute an unfair technical barrier to trade. In this process, technical indicators of sustainabil- ity themselves will likely go on trial.
How is regulatory science operating in the jurisdictional politics of complex regulatory regimes, and what are the implications for democratic legitimacy? A number of cases of cross-level legal friction and multi-level formation help me explore these questions. First, I attempt to theorize the role of regulatory science within multi-level governance through the STS framework of coproduction, drawing attention to what I call “epistemic jurisdiction.” Second, I analyze legal encounters with regulatory science in three case studies, including food safety adjudication at the WTO, the Clean Air Act at the U.S. Supreme Court, and California Global Warming Solutions Act. Through these cases, I argue that the creation of epistemic jurisdictions and the authorization of particular forms of regulatory science are performing critical political work in shaping multi-level regimes.
Coproduction, multi-level governance, and the law
Important strands of work on regulatory science focus on the decision- making processes within expert communities, the contingency of knowledge, and political influences on knowledge production (e.g. Edwards and Schneider 2001; Oreskes 2010). In this chapter, I wish to examine not only how regulatory science is shaped in contexts of multi-level conflict, but also how it is productive of new jurisdictional arrangements.
Work in the STS framework of coproduction (Jasanoff 2004) is useful here because it understands science and technology on the one hand, politics and law on the other, as co-constitutional. STS scholars have explored the co- emergence of political and epistemic order in a wide array of contexts, including climate change (Miller 2005), the protection of endangered species (Thompson 2004), patenting in the life sciences (Parthasarathy 2007), and racial categorization in drug development (Kahn 2012). As a
theory, coproduction draws on Michel Foucault’s insight that knowledge is not just a factor in governance but a constitutive element (e.g. Foucault 1971 [1966]).
The coproductionist framework encourages us to view the development of regulatory science and the formation of jurisdictional architecture in the same breath. This architecture is in a period of rapid change and so deserves analysis and scrutiny. In the U.S., it is an era of devolution. Power is actively shifting, broadly speaking, from the center back toward the States and towards even lower levels in arenas like environmental policy. In the European Union, the process of integrating economic and regulatory func- tions has birthed a politics of “subsidiarity” (Nicolaidis and Howse 2001: 1). There is, in general, a move to complex regulatory architectures that depart from the clearly demarcated levels of regulatory jurisdiction found in pure federalism (Hooghe and Marks 2001). For this reason, many legal scholars have given new power sharing agreements across levels the name of “dynamic federalism” (Ruhl and Salzman 2010: 66) or prefer to speak of “complex governance.” Multiple levels of government are interacting in regulatory processes (Engel 2006), and these interactions require more attention within the field of STS.
Coproduction points to how processes both of political centralization and decentralization may depend upon, more than has been acknowledged, the production of new forms of science and expert authority. In particular, evolv- ing multi-level governance raises questions about the allocation and reallocation of “epistemic jurisdiction”: the power to produce, interpret or warrant technical knowledge for a given political community, topical arena, or geographical territory.
The production of new epistemic jurisdiction can support political central- ization. For instance, the mandate to liberalize trade has called into being new global standard setting bodies that have a taken a share of regulatory authority from sovereign states. Through appeals to a universalist expertise and regulatory science, these bodies can operate as depoliticized vectors of globalization (Moore et al. 2011). But epistemic jurisdiction can also be invoked to oppose political centralization. For instance, within the arena of climate change, sub-national actors have resisted international regimes, and the policies of their own states, through appeals to “local knowledge” (Long- Martello and Jasanoff 2004). In other words, the appeal to local expertise can underwrite claims of localized political autonomy.
Understanding the ways in which centralization and decentralization depend on regulatory science and the configuration of epistemic authority requires more systematic investigation at different sites of practice. Legislative history, rule making, and adjudication are promising sites for they stage the interaction of legal and epistemic forms of authority, and are productive of new regulatory architectures. Legal process within the regula- tory arenas of food safety and climate change will be the focus here. These
cases show the different ways in which new jurisdictions—both epistemic and political—are built through legal entanglements with regulatory science. International food safety regime
The Sanitary and Phytosanitary (SPS) Agreement, one of the suite of agree- ments adopted under the WTO in 1994, is the dominant source of food safety governance at the global level. The agreement grew out of widespread concerns that food safety regulations were being used to protect domestic production against foreign competition. The aim of the SPS Agreement is actually more ambitious than that of the core Global Agreement on Tariffs and Trade (GATT), for it moves beyond the principle of non-discrimination to one of regulatory harmonization (Charnovitz 2000). Harmonization is not homogenization, and the agreement recognizes the need to preserve a degree of regulatory autonomy for member states (SPS Prologue). Even so, harmonization does imply the operation of a common rationality that can serve to promote convergence and cooperation.
The negotiation history, text, and legal contestations of the SPS Agreement suggest how regulatory science has been a constitutive element of the food safety regime. Harmonization as embodied in the agreement was only achieved via a technocratic ideology, a scientistic epistemology, and the delegation of epistemic jurisdiction to a global agency. Further, as adjudica- tion under the SPS shows, the system of power sharing within the global regime has co-emerged with interpretations of what counts as valid science.
The ascent of risk assessment and a global regulator y jurisdiction
While regulatory harmonization was a goal of the Uruguay round of trade negotiations, it was not easy to achieve (Winickoff and Bushey 2010). Food, after all, is a highly regulated area sitting squarely within the traditional police powers of the sovereign state. Safety standards of all kinds, let alone ones in the arena of food, are value-laden and indicative of ethical choices (Busch 2012; Timmermans and Epstein 2010). To develop global standards, then, is to enact a form of global political and cultural order (Nils Brunsson and Bengt Jabobsson 2000).
The negotiating history of the SPS Agreement shows how science became the primary ideological resource for producing agreement (Winickoff and Bushey 2010). As the lone superpower in the mid-1990s, the U.S. pushed a universalist notion of “scientific justification” as the primary tool to combat bans on beef hormones in European states and other non-tariff barriers to the food trade. Negotiators from Canada, Australia, New Zealand, and the U.S. identified formal risk assessment as the earmark of scientific justification, even though it was not yet well established in food safety regulation world- wide. Concurrently, the European Commission—Europe’s trade
representative at the WTO—was engaged in its own project of harmonizing “social regulation” across EU member states (Joerges 1997), and was ulti- mately willing to embrace risk analysis as a harmonizing force within the SPS Agreement. Given the alignment of interests across the U.S. and the EC to harmonize food safety regulation, scientific evidence was a plausible enough idea around which to forge agreement.
The focus on science is evident in the text of the agreement. The SPS’s core disciplines require that WTO members ensure that any food safety measure “is based on scientific principles and is not maintained without suffi- cient scientific evidence” (SPS 2.2). Final regulatory judgments of states are given safe harbor, so long as they are “rationally based” on technical risk assessments. Scientific validity, as established through a particular type of regulatory science, is thus necessary to establish legal validity.
Harmonizing regulatory logic does not address the substance of standards themselves, so SPS negotiators looked for existing international food stan- dards as a possible resource for substantive harmonization.1They found the
Codex Alimentarius Commission, a little-known bureau of the FAO and WHO that had been producing voluntary food safety standards on residues, pesticide use, etc., since the 1960s. Accordingly, within the SPS Agreement, the Codex was designated one of three “relevant international organiza- tions” around whose standards the signatories would attempt to harmonize (SPS 3.4).2 The guidelines and recommendations of Codex, if adopted by
nations, would be considered to satisfy the obligations under the agreement (SPS 3.2). Ironically, it was only the prospect of designation as a “scientific” agency of the WTO that the Codex began to formalize its own risk assess- ment protocols (Winickoff and Bushey 2010). Far from drawing upon a well-established set of epistemic authorities, the WTO regime was a midwife to them.
The negotiation and text of the SPS Agreement reveal how within multi- level governance systems, authorizing regulatory science and new epistemic jurisdictions can underwrite projects of centralization. Within this regime, derogation from known international standards requires special scientific justification. Epistemic jurisdiction has evolved from an exclusively national one to a multi-level one in which state agencies are held accountable to certain methodological universals.
Adjudicating GMOs at the World Trade Organization
The fact that the SPS Agreement did not settle questions of power sharing is evidenced by the litigation that has steadily gone on since its execution. It is
1 Interview with members of the SPS Secretariat, Geneva Switzerland, 2006–2007. 2 The others are enumerated as the International Office of Epizootics and the Secretariat of
unsurprising that these legal disputes have tested the requirements of “scien- tific justification,” given its pivotal role in the regime. Cases involving hormones in beef, imported salmon, apples, and genetically modified crops show how the patterns of regulatory power sharing within the global regime are co-evolving with interpretations of validity in regulatory science.
In particular, the GMO dispute under the SPS Agreement illustrates this process. The context of the dispute is well known. In the 1980s, the U.S. developed a “products approach” for regulating agricultural biotechnology. This approach assumes that transgenesis entails no additional risk to consumers or agriculture and requires no additional scientific evidence of safety so long as the new product is deemed “substantially equivalent” to its conventional counterparts. All new GMO crops in the 1980s and 1990s met this standard. In the EC and European states, regulators have taken a more precautionary “process approach.” This approach assumes that transgenesis may entail novel and unique risks to human health or the environment and puts an extra scientific burden on producers to demonstrate safety (Jasanoff 1995).
In 2003, the WTO Dispute Settlement Body had to address the growing trade conflict on GMOs, and adjudicate these distinct approaches to eviden- tiary burden and scientific justification. Europe had begun importing Round-up Ready soy and other GMOs in the mid-1990s. In the face of rising consumer concerns in the late 1990s, European states had delayed the approval process for new GMO applications, ostensibly waiting until the EU could pass new legislation on traceability and labeling (Winickoff et al. 2005). The United States, Canada, and Argentina initiated dispute settle- ment procedures at the WTO against the EC for delaying approvals of GM crops.
This dispute became the so-called Biotech Products case,3and it involved
the interpretation provisions of the SPS Agreement concerning “scientific justification” and “risk assessment.” In Biotech Products, the U.S. challenged the scientific basis of various European actions preventing the importation of GM crops and food products. In particular, the U.S. alleged that reversals of GM regulatory policy within the EU illustrate the EU’s departure from a fixed body of sound science and constituted “unreasonable” or “undue delay” under Annex C(1)(a) of the agreement. In response, the EC focused its argument on the safe harbor provision of SPS Article 5.7—which permits members to impose provisional or precautionary measures “in cases where relevant scientific evidence is insufficient”—arguing that GM presented novel scientific and social questions and therefore, at the time, required a more developed scientific record of safety.
3 Formally called, European Communities—Measures Affecting the Approval and Marketing
In the process of the adjudication, the WTO took up a detailed review of the risk assessment processes of European states, putting it in the position of certification or rejection of competing models of technical reason (Winickoff et al. 2005). The Dispute Settlement Body (DSB) found against individual EU member states and the European Commission for procedural irregulari- ties in their risk assessment processes (Bonneuil and Levidow 2012). The DSB held that a number of European countries had conducted risk assess- ments, and the conclusions of these assessments did not support a “precautionary” moratorium on crop approvals. Rather, their procedure entailed an “undue delay” and therefore a violation of the agreement. Further, the DSB disagreed that “relevant scientific evidence was insuffi- cient” for a valid risk assessment, an interpretation that seems to narrow the availability of defenses based on the precautionary principle.
The Biotech Products case achieved an important result in the food safety regime, effectively strengthening the SPS Agreement as a sword against nationally-enacted food safety regulations. The international level of gover- nance was strengthened within the multi-level regime at the same time as risk assessment was reinforced as the master regulatory science.
Perhaps less predictably, the ruling produced new regulatory order at lower levels. A follow-on result was that Biotech Products helped the European Commission consolidate its epistemic jurisdiction over food safety across Europe. The EC had recommenced GM approvals before the resolu- tion of Biotech Products, and had adopted the sharpened risk-based approach emerging out of Codex and WTO case law. As the opinion found non- compliance of individual member states, there has been a shift in epistemic jurisdiction from the national to the European level. Since Biotech Products, there has been an ongoing struggle between the European Food Safety Authority (EFSA), which nominally holds the authority to conduct the science-based risk assessment, and national authorities. Although the ability of member states to make a political judgment concerning the acceptability of a given set of risks (as outlined by EFSA) has not been questioned, the idea that the EC would take from member states the power to assess, i.e., conduct the technical analysis itself, has led commentators and activists to label this as an unwarranted grab at state sovereignty.
Political legitimacy has been a key concern of EFSA’s power to assess. This assignment of epistemic authority over food safety is perceived to be part of a larger pattern whereby Europe attempts “to integrate new geographic spaces and populations not by overt coercion, but by instituting a host of harmonized regulations, codes, and standards” (e.g. Dunn 2005). For some, centralization of these “powers to know” are a back channel for constituting Europe as a unified political community without the proper political debate and without democratic accountability (Wickson and Wynne 2012).
Climate federalism in the United States
The food safety case evinces a redistribution of power operating through particular scientific logics and the redistribution of epistemic authority. It has been a top-down process, although lower levels are pushing back in Europe through the “safeguard clause” of the European GMO directive (Dir. 2001/18/EC). In the arena of climate change, regime formation is not occurring from the top down, but from the bottom up, creating innovative approaches to carbon mitigation, but also introducing conflicts between lower and higher regulatory authorities. Here, too, science and epistemic jurisdiction are important terrain for negotiating multi-level power sharing.
Climate change is currently a crucial site in the construction of a more complex global order (Boyd 2010). Networks of cooperation are moving vertically and horizontally across cities,4 states, regions, and nations world-
wide. In the U.S.—where national policy has moved at snail’s pace—regions, states, counties, and cities are taking matters into their own hands, produc- ing what legal scholars have called “climate federalism” (Farber 2008). Advocates of this de facto decentralized approach argue that it can foster a laboratory of democratic experimentation and render governance more accountable (Rabe 2004; Chimerinski et al. 2008). Critics see a multi-level approach as potentially causing unnecessary patchworks of regulation (Farber 2008).
Regardless of the relative merits of climate federalism in the U.S., it has