Risking Regulation,Regulating Risk: Lessons from the Transatlantic Biotech Dispute

Debates over the future of new technologies frequently implicate governmental policies and regulation, the purpose of which has traditionally been to mitigate the dangers of new technologies through promotion of conditions of safe use. It is increasingly recognized, however, that regulation is predicated on a particular conception of the nature of risk which may or may not correspond to the views and beliefs held by society. Here I explore three broadly related questions in the context of the debates around agricultural biotechnology. First, what are the implications of varying conceptions of risk for regulatory policy in the United States and in the European Union? Second, what are the implications of differing conceptions of risk and resulting regulatory policy for agricultural trade relations between the two giants of international trade? And finally, what lessons might we draw from contemporary disputes over agricultural biotechnology?     

Unpackaging synthetic biology: Identification of oversight policy problems and options

The emerging field of synthetic biology (SB) is just entering policy debates. Reports from non-governmental organizations, such as the ETC Group and the International Risk Governance Council, have recently been issued, but there have been few systematic analyses of the policy problems that we will likely face as this area develops. Biosecurity issues are the most defined; other societal oversight issues and implications have not been well explored. Although SB could assist in addressing pressing global challenges, such as sustainable and renewable energy, there are considerable societal concerns that accompany its development and applications. This article is designed to anticipate and prepare for these concerns by identifying policy problems associated with SB oversight, upstream of its development. Projected applications of SB are reviewed and a typology of them is developed. Key oversight policy problems are then identified based on historical experiences with other emerging technologies, such as nanotechnology and biotechnology. Problems associated with biosecurity, biosafety, intellectual property, and ethics are discussed in relation to the typology of SB applications to identify applications of the highest potential concern. Finally, policy options for SB oversight are considered, preventative to promotional. We propose that different categories of SB application may warrant different oversight regimes: there might not be an appropriate “one size fits all” approach. We stop short of making specific recommendations, but suggest that the typology, problems, and oversight options identified in this article be used as a starting point for deliberative, democratic decisionmaking processes that take into account a wide range of perspectives about risk, economic impact, scientific progress, and moral reasoning in the design of oversight systems.     

The Multiple Streams Framework and the problem broker

John Kingdon's Multiple Streams Framework (MSF) constitutes a powerful tool for understanding the policy process, and more specifically, agenda‐setting, through three separate streams: problems, policies and politics. This article argues that the MSF would benefit from further development of the problem stream. It introduces a clearer conception of agency into the problem stream by suggesting the inclusion of the problem broker. The problem broker is a role in which actors frame conditions as public problems and work to make policy makers accept these frames. The problem broker makes use of knowledge, values and emotions in the framing of problems. The use of these three elements is seen as a prerequisite for successful problem brokering – that is, for establishing a frame in the policy sphere. Other important factors are: persistence, access to policy makers, credibility and willingness. Problem brokers also need to know who to talk to, how and when in order to make an impact. The context, in terms of, for example, audience and national mood, is also crucial. The inclusion of the problem broker into the MSF strengthens the analytical separation between streams. According to Kingdon, policies can be developed independently from problems. The MSF, therefore, enables a study of policy generation. The inclusion of the problem broker, in the same sense, makes it possible to investigate problem framing as a separate process and enables a study of actors that frame problems without making policy suggestions. The MSF is, in its current form, not able to capture what these actors do. The main argument of this article is that it is crucial to study these actors as problem framing affects the work of policy entrepreneurs and, thereby, agenda‐setting and decision making.     

Competing Policy Windows in Biotechnology: The FDA,the 21st Century Cures Act,and Laboratory‐Developed Tests

In 2014, the U.S. Food and Drug Administration (FDA) proposed taking a more active role in the regulation of laboratory‐developed tests (LDTs). Meanwhile, the U.S. House of Representatives embarked upon the 21st Century Cures initiative to develop legislation to expedite the development of new biotechnology innovations. During that initiative and in the public comments responding to the draft guidance, there was significant disagreement as to whether the increased FDA regulation of LDTs was beneficial or detrimental to biotechnology. Both the FDA guidance document and the 21st Century Cures Act came about due to the opening of a window of opportunity created by the convergence of circumstances. The question is whether the windows of opportunity are competing and how to resolve this competition. This study will investigate these questions through a qualitative case study. It will also provide recommendations for resolving policy disputes involving wicked problems like biotechnology policy.     

From Reagan to Trump: The Origins of US Neoliberal Protectionism

Donald Trump is often seen as a radical departure from the neoliberalism that has shaped recent American history and, at first glance, nowhere does this seem truer than on trade. Trump’s support for protectionism certainly seems to depart from neoliberalism, which we are used to thinking of as involving unqualified support for free trade. But should this really be seen as a departure? This paper argues that, instead, Trump’s trade policy should be seen a kind of ‘neoliberal protectionism’, which seeks to use the coercive power of the state to force other nations to conform to a market‐based economic logic. The origins of this neoliberal protectionism can be traced back to the 1980s when debates about foreign industrial policies first caused the United States to adopt a more aggressive approach to trade. From this perspective, Trump’s trade policy represents not a rejection of neoliberalism but an extreme articulation of it.     

When doctors shape policy: The impact of self‐regulation on governing human biotechnology

This paper investigates the development and adoption of governance modes in the field of human biotechnology. As the field of human biotechnology is relatively new, voluntary professional self‐regulation constituted the initial governing mode. In the meantime, with the exception of Ireland, all Western European countries have moved toward greater state intervention. Nevertheless, they have done so in contrasting ways and the resulting governance modes for assisted reproductive technology and embryonic stem‐cell research vary greatly. Instead of imposing their steering capacity in a “top‐down” fashion, governments have taken pre‐existing self‐regulatory arrangements in the field into account and built up governance mechanisms in conjunction with private actors and pre‐existing modes of private governance. Our analysis demonstrates that the form and content of the initial self‐regulation explain why the self‐steering capacity of the medical profession was largely or at least partially preserved through hybrid governance systems in Britain and Germany, while in France the self‐regulation was entirely replaced by governmental intervention.     

Lessons from the past? Cultural memory in Dutch integration policy

This article explores the contribution that cultural memory studies can make to the debate about the role of ideas and the dynamics of ideational change in policy making. Cultural memory studies engage with the cultural dimensions of remembering, and analyse how shared images of the past are mediated and transferred across distance and time. Such research shows how the past may continue to influence the present by informing the frameworks through which groups and individuals interpret and give meaning to events and phenomena. Since policy makers operate within a cultural context, shared memories are likely also to affect the way they think about the nature and roots of policy issues and the appropriateness and feasibility of policy options. In this article, policy memory (the memory shared by policy makers about earlier policies) is identified as a subcategory of cultural memory. The role of cultural memory among policy makers is studied with reference to Dutch integration policies in two periods: the mid‐1990s and the early 2000s. On the basis of an in‐depth analysis of policy reports and parliamentary debates, references to the past and the role they play in the policy debate are identified. Different modes of dealing with the past are found in the two periods studied, reflecting the different political contexts in which the debates took place. In the 1990s, the memory of earlier policy was invoked in the mode of continuity – that is, policy change was legitimised (conceived) as part of a positive tradition. In the 2000s, memory was invoked in the mode of discontinuity. The same policies were reinterpreted in more negative terms and policy change legitimised by the perceived need to break with the past. Arguably, this reinterpretation of the past was a precondition for the shift in policy beliefs that took place around that time.     

The Inclusion of Nonsafety Criteria within the Regulatory Framework of Agricultural Biotechnology: Exploring Factors that Are Likely to Influence Policy Transfer

Policy makers of various countries are exposed to critiques that call for the consideration of issues that transcend human, animal, and environmental safety concerns when assessing agricultural biotechnology products. While some jurisdictions have decided to broaden the scope of their approval process for genetically modified (GM) foods, this paper analyzes legal, political, and economic factors that can influence the transfer of these initiatives. Drawing on mechanisms presented in the policy transfer literature, this article examines their mixed effects pertaining to the regulation of biotechnology. Although the mechanisms of competition and coercion do not preclude such a possibility, one must admit that they do not create any incentives for policy makers to include nonsafety criteria within biotechnology regulations. By contrast, to varying degrees, the mechanisms of mimicry and learning can foster the transfer of such a broadened scope that allows a better assessment of GM foods' social acceptability.     

The Limits to Evidence‐Based Policy: Evidence,Emotion and Criminal Justice1

While ‘evidence‐based’ or ‘rationalist’ approaches to criminal policy may appeal to technocrats, bureaucrats and a number of academics, they often fail to compete successfully with the affective approaches to law and order policies which resonate with the public and which appear to meet deep‐seated psychological needs. They also often fail to recognise that ‘policy’ and ‘politics’ are related concepts and that debates about criminal justice are played out in broader arenas than the academy, the bureau or the agency. To be successful, penal reform must take account of the emotions people feel in the face of wrongdoing. Further, successful reform must take into account changes in public ‘mood’ or emotions over time and be sensitive to different political and social cultures. This article argues that criminal justice policies are more likely to be adopted if, in addition to the gathering and presentation of evidence, they recognise and deal with the roles of emotions, symbols, faith, belief and religion in the criminal justice system. It also recognises that evidence alone is unlikely to be the major determinant of policy outcomes and that the creation and successful implementation of policy also requires extensive engagement and evidence‐based dialogue with interested and affected parties. This necessitates a different kind of modelling for evidence‐based policy processes.     

A Capacity for Central Coordination: The Case of the Department of the Prime Minister and Cabinet

For the Department of the Prime Minister and Cabinet (PM&C) the year 1987 can now be seen as pivotal in marking a clear end to a period of transition in coordinating structures in the Australian Public Service (APS) that had lasted roughly 20 years. The abolition in 1987 of the Public Service Board, formerly a powerful coordinating agency, is the most obvious marker of the change. The PSB's departure left the Secretary of PM&C with a role that is now often described as ‘head of the public service’. More broadly, the 1987 changes to the machinery of government both formalised and enabled a sea‐change in PM&C's role. Before 1987 a large policy initiation and development project would usually have been considered as beyond PM&C's scope. Since then, extensive and direct policy development work by PM&C has become common. The continuing debates have been over whether PM&C actually delivers in these roles (an empirical question) and how far it should play them (a normative issue). In this article we itemise the capacity, both continuing and developing, which PM&C has to support policy development. Traditional coordination mechanisms are an important part of this armoury and PM&C has long experience of most of them. However policy initiation and development calls for other tools which PM&C has had to develop over the past few decades. There is scope for conflict between the coordination and initiation/development roles. Understanding how a central agency like PM&C carries out each of them and balances the two can potentially contribute to debates on organisational design. We also address the normative issue: whether the growth of prime ministerial impact is a result of an increase in public service support or a cause of its increase ( Walter and Strangio 2007 ) and whether it should be restrained. We accept that the new developments give prime ministers the capacity to oversee policy arenas where once they could not, but regard this as a consequence as much of demand from above as of ambition within the department.     

Globalization,International Organizations,and Telecommunications

Since the 1990s over 158 countries established pro‐market reforms in telecommunications—a fast pace for such a drastic change. For example, Sweden and Botswana, two nations vastly different across multiple dimensions, both liberalized their telecom sectors. Why did so many countries adopt liberal reforms in such a short period of time? Conventional wisdom highlights the role of global markets and technology, powerful states, global diffusion, and domestic politics. I argue that contrary to these claims, diffusion through key international organizations is the critical and overlooked factor in explaining rapid global convergence of pro‐market telecom reforms. Using an original dataset for 189 countries between 1970 and 2003 and event history analysis, I demonstrate that membership in key liberal trading organizations, especially the WTO and the OECD, increases the likelihood that countries will adopt liberal pro‐market reforms in telecommunications. These results speak directly to current public policy debates about the reregulation of global markets and bridges the literatures of policy diffusion, institutional design, and regulatory regimes.     

Public Perceptions of Benefits from and Worries over Plant‐Made Industrial Products and Plant‐Made Pharmaceuticals: The Influence of Institutional Trust

Although agricultural biotechnology has been a seminal reference point in risk perception studies, public awareness of their exposure to risk deriving from this new technology has been minimal at best. However, recent events indicate there may be growing public concern as new variations of this technology appear. Understanding what drives perceptions of benefits from the third generation of the agricultural biotechnology and what determines public worries are keys for the future of this technology. To this end, this study analyzes survey data from the midsouth region of the United States to construct four separate regression models of perceived benefits from and worries over plant‐made industrial products and plant‐made pharmaceuticals. Findings suggest that while prior experience with and knowledge about agricultural biotechnology has an impact on perceptions of benefits and worries, trust in farmers plays a highly important role in determining perceptions.     

The Polarization of American Environmental Policy: A Regression Discontinuity Analysis of Senate and House Votes, 1971–2013

The partisan polarization of environmental policy is an important development in American politics, but it remains unclear how much such polarization reflects voter preferences, as opposed to disagreements between partisan elites. We conduct a regression discontinuity analysis of all major environmental and energy votes in the Senate and the House, 1971–2013. In total, we have 368,974 individual roll call votes by senators and House Representatives. The causal effect of electing a Democrat instead of a Republican in close elections on pro‐environmental voting is large: when a Democrat wins, pro‐environmental voting increases by over 40 percentage points. Because of the quasi‐experimental research design, this difference cannot be attributed to the median voter's preferences. Next, we test hypotheses concerning possible explanations for the elite partisan conflict. The Democrat–Republican gap is the widest when fossil fuel interests make contributions exclusively to Republicans and when state‐level public opinion is polarized.     

Determinants of Firm‐Level Lobbying and Government Responsiveness in Agricultural Biotechnology in China

Understanding what stimulates agribusiness firms to lobby the government and what makes the government responsive to lobbying are the two issues that have been discussed extensively in the debates concerning determinants of biotechnology policy. This paper examines the factors influencing agribusiness firms' lobbying and government response using econometric modeling on a new data set of 160 leading agribusiness firms in the food, feed, chemical, and seed industries in China. The results show that approximately 10% of agribusiness firms lobbied the government about biotechnology policy and regulations and over half of those that lobbied received a verbal or written acknowledgment from government agencies. Seed and feed companies are more likely to engage in lobbying than chemical companies. Owning GM patents not only has a positive impact on firms' lobbying activities, but firms with these patents are more likely to receive a government response to their lobbying efforts. The experience of selling GM products does not significantly influence lobbying activities or response from the government.     

Co‐enforcing Labor standards: the unique contributions of state and worker organizations in Argentina and the United States

Labor inspection is a central response to the tremendous gap between formal regulations and outcomes for workers throughout the world. Scholarly and policy debates on labor regulation have focused on improving the targeting of enforcement, changing strategies of street‐level agents, and creating private alternatives to state regulation. This paper argues that these proposals, while important, fail to systematically incorporate the potential contributions of worker organizations and, as a result, overlook opportunities for co‐enforcing labor standards, a key element of labor inspection. By contrast, we develop a framework to analyze the relationships between worker organizations and state regulators that underpin co‐enforcement. We ground this framework empirically in comparative cases, set in Argentina and the United States, presenting two cases of co‐enforcement in highly different institutional contexts. In so doing, we seek to illuminate key attributes of labor inspection and guide attempts to enhance enforcement by forging partnerships between regulators and worker organizations.     

Science and Politics in the Regulation of Genetically Modified Organisms in Brazil

This paper analyzes the regulation of genetically modified organisms (GMOs) in Brazil, focusing on the debates that preceded the enactment in 2005 of the current Biosafety Law and the factors (both domestic and international) that influenced the policy‐making process. More specifically, it identifies the social and governmental actors that influenced the congressional debates, showing how their interests and agenda were translated into two different institutional frameworks. Here, the policy outcome was what we call a “hybrid” and “conciliatory” regulatory model, which formally acknowledges the importance of both technical/scientific and social/political considerations in the evaluation of GMO biosafety and engages most of the stakeholders in the regulatory process. The new policy regime also establishes a middle ground between the conflicting demands of promoting agricultural development and protecting the country's biodiversity.     

The Moderating Effect of Debates on Political Attitudes

In theory, candidate debates can influence voters by providing information about candidates' quality and policy positions. However, there is limited evidence about whether and why debates influence voters in new democracies. We use a field experiment on parliamentary debates during Ghana's 2016 elections to show that debates improve voters' evaluations of candidates. Debates have the strongest effect on partisan voters, who become more favorable toward and more likely to vote for opponent-party candidates and less likely to vote for co-partisans. Experimental and unique observational data capturing participants' second-by-second reactions to the debates show that policy information was the most important causal mechanism driving partisan moderation, especially among strong partisans. A follow-up survey shows that these effects persist in electorally competitive communities, whereas they dissipate in party strongholds. Policy-centered debates have the potential to reduce partisan polarization in new democracies, but the local political context conditions the persistence of these effects.     

Domestic actors and agendas in Chinese aid policy

Abstract

As China's aid has increased, so has scrutiny by the international development and foreign policy community. Despite recognition that foreign aid policy is a result of domestic political contests, the existing literature tends to overlook Chinese debates about the purpose of aid, and how that purpose should be achieved. This paper argues that examining these debates shows that Chinese aid is not a well-considered element of an overarching strategy. Rather, where foreign aid is considered relevant vis-à-vis China's goals, its use is hotly contested. Competing actors' varying agendas, rather than any coherent strategy, underpin inchoate aid projects.     

Connecting social and environmental policy in Australia: Collateral gains or collateral damage?

Climate change research relating to “co‐benefits” suggests that the facilitation of social‐welfare outcomes through environmental policy offers a powerful means of incentivising climate change action. Concerns about social‐welfare, however, are often used to undermine climate change policies, typically through political claims that low‐to‐middle‐income households should not shoulder the costs of greater policy alignment between social and environmental objectives. Integrating the social into the environmental can therefore, on the one hand, lead to “co‐benefits” as each agenda promotes the other in political discourse, or alternatively to collateral damage if the policy objectives are framed as incompatible. This article explores both scenarios through two case studies of energy policy in Australia. The findings show that social‐welfare concerns can be a powerful discursive tool with the potential to facilitate political consensus, but also that this potential is not being fully realised, primarily because environmental concerns suffer when attempts are made to integrate the two areas discursively.