## Abstract

Nanotechnology has been celebrated as driving a new global industrial revolution that has the potential to harness economic growth and remediate the environment, yet could pose risks to health and the environment. Two of the largest economic actors, the EU and the US, have made very different regulatory decisions toward nanotechnology. The EU introduced an official definition of nanotechnology and created several new nano-specific regulations in recent years, whereas the United States has followed more of a “wait and see” policy. I argue that politics, not technology, best explains the divergence between the US and the EU in creating nano-specific regulations, and I introduce a regulatory regime framework to show why, how, and where politics affect divergent environmental politics. To support this argument, I employ comparative case analysis of the EU and US from 2000 to 2015.

Nanotechnology has been celebrated as driving a new, global industrial revolution (Drexler 2013). Nanotechnologies have enabled scientists to deliver cancer-curing treatments through personalized medicines (Gottardi and Douradinha 2013), they have contributed to clean water through the use of nanofiltration straws (OECD 2011), and they have added new commercial products and processes that promise increased economic growth through research and innovation (OECD/NNI 2013). However, nanotechnologies also pose potential risks to human health and the environment (Renn and Roco 2013), with high uncertainty about their life cycle effects (Dahlben et al. 2013), the impacts on workers and consumers of nanotechnology products (NSET/NEHI 2011), and effects on national security (Clunan and Rodine-Hardy 2014; Kosal 2009). The European Union and the United States, two of the largest economic actors, have made very different decisions regarding how to assess risk, as well as when and how to enact regulation, if at all. The EU, for example, introduced an official definition for nanomaterials, which is incorporated within several EU-wide regulations. The US, on the other hand, has not created federal nano-specific legislation. Why has the EU created nano-specific legislation, whereas the US has not?

Conventional wisdom suggests three arguments, rooted in the technological uniqueness of nanotechnology, deep-rooted cultural differences between the EU and the US, and the varying power of global markets and interest groups that exert different pressures on EU and US decision-makers. I argue that the differences in the creation of nano-specific legislation have less to do with science than with politics.

In the first section of this article, I present the dependent variable: the creation of nano-specific legislation. Second, I discuss the conventional wisdom of three sets of explanations—technological uniqueness, deep cultural differences, and varying global market power—and show gaps in these explanations. Third, I introduce my regulatory regime framework, which shows how the EU and the US differ in their regulatory regime orientations (ideas and norms) as well as their regulatory regime organizations (institutions, policy entrepreneurs). Next, I present a comparative case study that illustrates how the EU and US have differed in terms of nanotechnology regulation and governance, particularly after 2009. Finally, I present a discussion of specific examples of nanotechnology in cosmetics, food, and chemicals as well as avenues for further research. This article shows how globalization affects environmental politics and how policies regarding emerging technologies affect politics, the environment, and global markets. The article contributes to the literatures on comparative environmental politics and risk regulation, comparative political economy, and global governance of environmental politics.

## Dependent Variable: Creating Nano-Specific Regulations in EU and US

Until the mid-2000s, both the EU and the US relied on existing regulatory statutes and legislation (European Commission 2008, 366), but in 2009 the EU introduced nano-specific requirements in the context of its new Cosmetics Regulation, the first of its kind (European Parliament and Council of the European Union 2009). Having an official definition and codifying this language into regulations that apply equally across the entire EU, including all twenty-eight member states, constitutes an important policy innovation and shift in direction toward more nano-specific legislation in the EU.

The United States, however, does not have an official definition of nanotechnology, especially one that is codified in a federal statute. The United States has opted to rely on existing regulatory statutes for chemicals, pesticides, food, pharmaceuticals, and cosmetics, most of which were introduced in the 1970s. The US has introduced nanotechnology regulations at the agency level, through the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), although these typically take the form of industry guidance and information and recordkeeping requirements for nanomaterials.

## Conventional Wisdom

Much of the literature on regulatory cooperation and conflict builds upon models of powerful states competing over standards in pursuit of power and gains (Drezner 2007; Krasner 1976). This power is extended as firms in large markets exert their own preferences over national policies, and thus create a national interest rooted in the power of domestic interests (Moravscik 1993). We would expect to find large firms and large states exerting their own preferences upon EU and US policy. However, this does not really reflect the process of creating and spreading new policies for nanotechnology regulation.

I argue that nanotechnology regulation can be understood as nested within an overall regulatory regime for the environment, health, and safety. Several important scholars have already treated the question of transatlantic divergence in the areas of overall environmental, health, and safety regulation. David Vogel, in The Politics of Precaution, argues that three factors best explain the EU-US divergence: public pressure for more stringent or protective regulations, the policy preferences of influential government officials, and risk criteria (D. Vogel 2012). I build upon his framework, by including nano-specific provisions and targeting some of the hypotheses to the creation of nano-specific legislation in the EU and not in the US.

Jonathan Wiener has argued that the differences between the EU and the US in terms of risk regulation are dependent on the specific risk being addressed, rather than on broad national differences in regulation (cf. Kelemen and Vogel 2010). For example, the EU can be more precautionary on paper but less precautionary in practice, in the case of chemicals regulations and persistent organic pollutants (Wiener 2012). I agree, and address variation between the EU and the US across sectors. My argument aligns with Justo-Hanani’s focus (Justo-Hanani and Dayan 2013, 2015, 2016) on state determinants of regulatory reform, although my regulatory regime framework takes a more expansive view of state involvement and interaction with domestic politics.

## Argument: Regulatory Regime Framework

My regulatory regime framework (Rodine-Hardy forthcoming) complements and extends the paradigm of a new school of scholars who have applied insights from comparative political economy to transnational issue areas, including financial regulation, privacy regulation, global markets, insider trading regulation, stock markets, and private governance (Bach and Newman 2010b; Büthe and Mattli 2011; Farrell and Newman 2015; Newman 2008; Posner 2009). I employ a similar approach in my regulatory regime framework to explain the divergence between the EU and the US.

My regulatory regime framework builds upon a rich comparative political economy of regulation (S. K. Vogel 1996) and includes the dimensions regime orientation (precautionary vs. market-based) and regime organization (multilevel, permeable to innovation vs. high capacity to block, status quo). A summary of the framework can be seen in Table 1.

Table 1

The Argument in Diagram Form—Nano Regulatory Regime Divergence

United StatesEuropean Union
Nano-specific legislation? No Yes
Key legislation Toxic Substance Control Act (TSCA) Regulations, General: General product safety directive, Product liability, Occupational health and safety
Federal Insecticide and Rodenticide Act (FIFRA) Horizontal Chemical Regulations: REACH, Classification labeling and packaging (CLP)
Federal Food Drug and Cosmetic Act Vertical Specific Regulations: Biocidal products, Cosmetics, Food, Food contact materials, Medical devices, Plant protection, Pharmaceuticals
Regime orientation Market-based, wait-and-see Precautionary principle, Polluter pays, Pay to play, Affected by BSE crisis and GMOs
Regime organization 1970s-era 2000s-era, Growing in capacity
Federal system Multilevel system of supranational body and member states
Institutionally dense Institutionally diverse (EU Parliament, European Commission, Council of Europe, European Court of Justice)
Older statutes (1970s-era) Modern statutes (REACH 2006)
Status quo bias Divergent preferences of member states combat status quo
High ability to block regulatory innovation Variety of political parties leads to policy innovation and ease of pushing for change (parliamentary systems, prominent Green parties)
United StatesEuropean Union
Nano-specific legislation? No Yes
Key legislation Toxic Substance Control Act (TSCA) Regulations, General: General product safety directive, Product liability, Occupational health and safety
Federal Insecticide and Rodenticide Act (FIFRA) Horizontal Chemical Regulations: REACH, Classification labeling and packaging (CLP)
Federal Food Drug and Cosmetic Act Vertical Specific Regulations: Biocidal products, Cosmetics, Food, Food contact materials, Medical devices, Plant protection, Pharmaceuticals
Regime orientation Market-based, wait-and-see Precautionary principle, Polluter pays, Pay to play, Affected by BSE crisis and GMOs
Regime organization 1970s-era 2000s-era, Growing in capacity
Federal system Multilevel system of supranational body and member states
Institutionally dense Institutionally diverse (EU Parliament, European Commission, Council of Europe, European Court of Justice)
Older statutes (1970s-era) Modern statutes (REACH 2006)
Status quo bias Divergent preferences of member states combat status quo
High ability to block regulatory innovation Variety of political parties leads to policy innovation and ease of pushing for change (parliamentary systems, prominent Green parties)

A country’s regulatory regime orientation affects how government actors interpret common forces for change, as well as the kinds of measures that are considered appropriate. Regime organization affects who can control the reform process—for instance, whether or not government officials can resist political party initiatives or civil society pressures, as well as how government officials try to shape regulatory reform. Institutions therefore can shape state and industry preferences (Steinmo et al. 1992).

## Data and Methods

I created a nested multilevel research design that provides a quantitative description of growing nanotechnology markets and production based on market research and publicly available data. I also used a recent survey conducted by the OECD on regulatory developments in nanotechnology (OECD 2014), and examined how the US and EU regulatory regimes operated from 2000 to 2014. The EU and the US are two of the largest and most important actors politically and economically, and competition between regulatory systems affects global markets. Understanding the divergence between these two big cases illuminates patterns in how rules are created, adopted, and spread across the world stage. This work complements the legal and regulatory analysis conducted at the macro level by Reut Snir (Snir 2014; Snir and Ravid 2015).

## Findings and Discussion

For the most part, nanotechnology is not regulated, contrary to many predictions in the early, heady years of “nano-hype” (Berube 2006). That said, the EU and US approaches diverge considerably in terms of developing legislation and regulatory frameworks specifically relating to nanotechnology and of framing the perception of risk. As will be developed in this section, the EU has a precautionary regulatory regime orientation and a multilevel, fragmented regime organization, which has increased the propensity to create nano-specific legislation in the form of definitions, regulations, and guidance. The US, on the other hand, has a market-oriented regulatory regime orientation and a fragmented regime organization with a high capacity to block, which has decreased the likelihood of creating nano-specific legislation.

### EU Nanotechnology: Politics of Precaution Extended

In the EU, nanomaterials are increasingly regulated specifically. Regulations for nanomaterials are vertical and apply to specific products (e.g., chemicals, cosmetics), as opposed to horizontal regulation that applies to a particular class of substances. The EU first added nanotechnology-specific legislation in the Cosmetics Regulation (Brosset 2013; Ngarize et al. 2013). The EU adopted an official definition of nanotechnology in 2011 (European Commission 2011), and has attached nano-specific provisions to regulations on plastic material and articles that come into contact with food. For overarching regulations, the EU introduced nano-specific provisions to the Classification, Labelling, and Packaging (CLP) Regulation on dangerous substances and mixtures, as well as in the Biocidal Products Regulation. The EU is currently discussing incorporating nano-specific language in the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) annexes, as well as in the area of novel foods. All EU definitions of the term “nanomaterial” intended for regulatory purposes use size as the main identifier (European Commission 2011). To explain this shift toward more nano-specific legislation, it is necessary to examine more closely both the precautionary regime orientation and the multilevel, open regime organization within the EU.

### EU Regulatory Regime Orientation: Spirit of Precaution

The precautionary principle is a true force in Europe, and it fuels political entrepreneurs at multiple levels across the EU, including both industry and civil society. The precautionary principle is an enabling principle that allows and justifies a regulatory action even in the absence of conclusive scientific evidence of harm with regard to a specific risk. The precautionary principle, found in the European Treaty, animates discussions and political choices across Europe (Selin and VanDeveer 2015). To what extent does this apply in the case of nanotechnology regulation?

In Europe, the nanotechnology regulatory regime falls within the legacy of regulatory developments in other key sectors that have also included a precautionary mandate. The REACH program tightened the regulation and testing of chemicals. REACH puts the onus on a chemical manufacturer to demonstrate the safety of a chemical product before it can be put on the market, and is evinced by the slogan “no data, no market” (Breggin et al. 2009). Nanomaterials would be a “material,” although REACH itself does not have nano-specific provisions. Nanomaterials also are regulated under the CLP Regulation 2008 on dangerous substances and mixtures.

The regulatory regime orientation of precaution in the EU has been influenced by the trigger events of public outcry in the cases of bovine spongiform encephalopathy (BSE –“mad cow disease”) and genetically modified organisms (GMOs). In fact, many fear that nanotechnology could become the next GMO (Borrás 2006; Carlarne 2007; Sylvester et al. 2009), in this instance a promising technology derailed by (possibly unwarranted) public fears about its potential ill effects. Many players have advocated that governments must act now to pave the way for nanotechnology regulation, in efforts to shape public opinion and provide regulation (Bowman and Hodge 2007).

### EU Regulatory Regime Organization: Open and Dense

In the EU, the regime organization shifted over time from more of a closed system to an open system, as the EU itself began to build regulatory capacity for environmental, health, and safety regulations in general (Héritier et al. 2004; D. Vogel 2003). The multilevel nature of the EU political structure opened the opportunity space for new actors and political entrepreneurs to push through a vision of the precautionary principle, and to mobilize support at multiple levels (Selin and VanDeveer 2009). In addition, the proportional-representation electoral system allowed space for the mobilization of smaller parties, such as Green parties, which gave voice to environmental concerns (Kelemen 2002). In the EU, the newly invigorated European Parliament after the Lisbon Treaty in 2009 has provided an opportunity structure for environmental activists and civil society to influence the development of new legislation and regulation. For example, within the European Parliament, individual members have been able to act through committees to put forth serious challenges and changes in environmental legislation and regulations. This is true in general, and for nanotechnology in particular.

European regulatory capacity for environmental, health, and safety regulations increased dramatically during the 1990s, which had a great effect on the subsequent regulatory capacity for nanotechnology (Breggin et al. 2009; D. Vogel 2003). Following the regulatory failure in the 1960s of thalidomide, which caused significant birth defects, the EU developed a stronger regime for regulating pharmaceuticals as well as other health and safety products, emulating the US regulatory regime (D. Vogel 2012). By the 1990s, as Newman and Bach describe in great detail, the structure of European pharmaceutical regulations had transformed in two key ways: a shift from informal, industry-led governance to more formal regulatory institutions at the national level within member states, as well as the coordination and centralization of these regulatory institutions at the European level (Bach and Newman 2010a). This process of increasing regulatory capacity created opportunities for the regulation of nanotechnology, as well.

The EU has introduced nano-specific language in the form of its definition of a nanomaterial, and reviewed this consideration as part of its Second Regulatory Review in 2012 (European Commission 2012). This study provided an overview of the nanomaterials on the market and the available information on hazard properties, background information on the definition, an assessment of regulatory options through REACH and potential amendments to the REACH annexes, and overview of other product-specific legislation.

The EU has many regulatory gaps in terms of specific environmental, health, and safety regulations among the EU-wide directives and regulations. In addition, the single-market policies of harmonization as well as the principle of subsidiarity rely heavily on the leadership and institutions of the twenty-eight member states, which vary significantly in their attention to nanomaterials and capacity for implementing regulations. For example, the United Kingdom has played a leadership role in developing precedents and principles for regulating nanotechnology (Walter 2009). France introduced separate legislation on nanotechnology, including a mandatory registry for engineered nanomaterials (Kaddour 2013), and Sweden has developed an action plan for nanotechnology (Lemańczyk 2013). In addition, some member states have taken the initiative to introduce either voluntary or mandatory registries of nanomaterials, led by France, Belgium, Denmark, and Sweden (OECD 2014). Thus, the overall regulatory regime organization has multiple levels, with gaps across sectors and between the EU as a whole and the member states.

Time and again, the EU has reiterated its commitment to precaution in regulating nanotechnology in chemicals, food, and cosmetics, yet this precautionary approach has failed to cross the Atlantic. The US is similarly a prominent figure in the nanotechnology market; yet, as the following section will detail, it has assumed a vastly different regulatory approach, based not on precaution but on the market.

### United States and Nano: A Market-Oriented “Flexible” Approach

Protecting public health, safety and our environment while promoting economic growth, innovation, competitiveness, and job creation

President Barack Obama, Executive Order 13563, January 18, 2011
The US regulatory regime can be characterized as market-oriented, with government playing a role as the coordinator and organizer of regulation for nanotechnology. The US relies less on nano-specific legislation and more on a rich basis of federal and state statutes. Congress has not acted to update or review the National Nanotechnology Initiative (NNI) or nano-specific legislation. Thus, more regulatory action has taken place through agencies, on both the federal and subnational levels.

The US created the first coordinated nanotechnology effort through the NNI in 2001, for which the President’s fiscal 2015 budget provides over $1.5 billion and cumulatively totaling nearly$21 billion since 2001 (US-PCAST 2014). Despite its image of coordination, the NNI remains an umbrella entity without its own budget or policy-making capacity. Furthermore, the research and development funding for nano reveals much higher levels of funding from the private sector. A recent study by the OECD on the economic impact of nanotechnology reveals that the private sector accounts for the majority of research and development in nanotechnology in the US (OECD/NNI 2013). This private-sector focus is confirmed by market research on new technology development (Battelle 2013) and global markets for emerging technology (Lux Research 2014). This is also true in Europe, but most private-sector spending focuses on applied research and development, while “basic” research is still dependent on government support.

In the US, the language in the policy principles for regulating emerging technologies in general, and nanotechnology in particular, stresses that regulatory decisions should be based on the “best reasonably obtainable scientific, technical, economic … information” and that “where possible, regulatory approaches should promote innovation while also advancing regulatory objectives, such as protection of health, the environment, and safety” (US OMB 2011a, 2011b).

In Europe the regulatory regime orientation is “no data, no market” and “pay to play,” in that entities putting chemical substances on the market must provide registration data and pay fees. In the US, however, the regulator assumes the burden of asking for information from the producer, and new regulation requires evidence of harm or need for oversight. Both the EU and US approaches rely on science and cooperation, yet they make fundamentally different assumptions about who is required to produce information, and when, regarding emerging technologies.

### US Regime Organization: Dense Legal Frameworks, Fragmented, Status Quo Bias

In contrast to the image of a coordinated nanotechnology research agenda, the actual regulation and governance of nanomaterials and nanotechnology-based products in the US is fragmented, multilevel, and weak, with little coordination between the various levels of regulation (Breggin et al. 2009). Regulatory authority for nanomaterials and nanotechnology-based products is divided among several federal agencies, and much of the regulatory legal framework dates back to the “golden age” of innovation in environmental, health, and safety regulation in the 1970s. The Environmental Protection Agency (EPA) regulates any chemical substances or pesticides that are, or contain, nanomaterials, and depends heavily on the Toxic Substances Control Act (TSCA), enacted in 1976, for its regulatory authority. The FDA considers the risks of nanomaterials used in drugs, medical devices, food, food additives, and cosmetics. The Occupational Health and Safety Administration deals with workplace safety dimensions, while the Consumer Product Safety Commission is concerned with protection against risks from consumer products.

Section 5 of the TSCA gives EPA the power to screen and track new chemical products before they come to market. Manufacturers are required to give EPA notice prior to producing a new chemical substance, defined as a substance not already on EPA’s list of existing chemicals. TSCA also requires manufacturers to give EPA information that it has or might “reasonably ascertain” relating to the potential health or environmental impacts of the new chemical substance. EPA then reviews the notification and determines whether it “presents or will present an unreasonable risk.” If an existing chemical has a significant new use, EPA may also issue restrictions through a “significant new use rule.” (SNUR)

In 2008, the EPA decided that carbon nanotubes should be treated as a new rather than an existing chemical under TSCA, with the consequence that stricter regulatory requirements apply, including premanufacture notice (US EPA 2008). To close potential knowledge gaps, the EPA had previously introduced a voluntary reporting initiative, the Nanoscale Materials Stewardship Program, launched in 2007, which invited the producers of nanomaterials to report to the agency safety-relevant information. However, the low response rates of voluntary participation in the framework reveal some of the weaknesses of “soft-law” approaches to regulating new technologies (Fiorino 2012). The EPA faces challenges in regulating risk due to a need for more data, better technologies for assessing risk, and the mandate to gather information on emerging technologies (US GAO 2010). For example, the provisions on confidential business information preclude sharing information about the specific functionalities of nanomaterials, a classic case of information asymmetry.

Under TSCA, since 2005 the EPA has received more than 160 premanufacture notices for nanoscale materials.1 Some of these include carbon nanotubes (CNT) and nano fibers, as well as fullerenes, quantum dots, nano polymers, silica derivatives, and titanium derivatives. The EPA has allowed most of these 160+ new nanoscale materials to “enter into commerce,” the technical term for entering the market. The EPA, however, has included some requirements in its consent to manufacture for these nanomaterials. These include requirements to prevent human and environmental exposure and to develop data. In addition, in 2015 the EPA proposed a rule under TSCA Section 8(a) to require reporting and recordkeeping information on certain chemical substances when they are manufactured or processed at the nanoscale (US EPA 2015).

Demonstrating the importance of a “science” focus in regulation of new technologies, FDA Commissioner Margaret A. Hamburg, M.D., recently stated that “our goal is to regulate these products using the best possible science.… Understanding nanotechnology remains a top priority within the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and the FDA into a new, more innovative era” (Hamburg 2012; US FDA 2012). The FDA regulates nanotechnology products under existing statutory authorities, and it does not make broad, general assumptions about the safety of nanotechnology products (Brown 2013; Brown and Kuzma 2013; US FDA 2014a; US FDA 2014b; Yang et al. 2014). Substances used as food and color additives are subject to premarket authorization by the FDA, while other food substances, including food ingredients that are “generally recognized as safe,” (GRAS) do not require premarket authorization by the FDA. The FDA recently released guidance on the use of nanomaterials in cosmetics and its approach toward regulation (US FDA 2014c). The guidance states that “companies and individuals who market cosmetics are legally responsible for the safety of their products,” which conforms with well-established principles of liability and reflects the focus on the private sector for assuming risks in cosmetics.

Within the US, there is continued divergence across states, with many gaps between federal statutes and state regulations in nanotechnology as well as other areas of environmental politics. California has been very active with respect to nanotechnology-related information disclosure through utilizing the state’s Department of Toxic Substances Control and the Safer Consumer Products Regulation to obtain information about nanomaterials from manufacturers. However, limited information has been obtained regarding the production volume of these nanomaterials (Malloy 2012).

## Key Similarities and Differences in the EU and US

Both the EU and the US have made serious efforts to gather and share information about the scientific uncertainty, risks, and hazards of nanomaterials in the context of rapidly globalizing marketplaces. Both the EU and the US consult regularly with scientists, international networks (e.g., the OECD and the International Standards Organization), and private-sector groups in crafting policies and regulations for products containing nanomaterials. However, despite the common interests in using the best scientific evidence available, the EU and the US have taken different approaches to regulating these risks. My regulatory regime framework helps explain these key differences, as well as some areas of cooperation.

### Voluntary and Private-Sector-Led Initiatives

Both the EU and the US have introduced voluntary efforts to report information about nanomaterials on the market, yet both have been regarded as failures due to low participation and low amounts of information gathered about risk, uncertainty, hazard, and exposure.

### Registry of Products Containing Nanomaterials

In the EU, some stakeholders have called for the creation of an EU-wide registry of nanomaterials to address some of the information asymmetry and uncertainty inherent in new technologies and products. The European Commission thus far has suggested that revising the REACH annexes to require manufacturers to provide nano-specific data would be more useful and would better address any risks posed by nanomaterials (European Commission 2012). Several member states within the EU attempted to address some of these governance gaps in nanomaterials by creating voluntary registries of nanomaterials, including France, Belgium, and Denmark (OECD 2014). In recent years, several member states have started to introduce mandatory nanomaterial registries, including France, Denmark, Belgium, Sweden, and Italy.

In the US, on the other hand, there has been some effort to collect information on nanomaterials in consumer products through the Project on Emerging Nanotechnology, but there is no movement to create a government-initiated product inventory of nanomaterials. Stakeholders have asserted the need to protect confidential business information and the proprietary aspects of nanomaterials that need premanufacture notice. In both the EU and the US, there is considerable debate among stakeholders about how and to what extent to introduce reporting requirements on a voluntary or mandatory basis for nanomaterials (Auplat 2012; Auplat 2013).

### Labeling of Products Containing Nanomaterials

In the EU, hazard labeling is required according to the CLP directive. In addition, ingredient labeling can be found in product-specific legislation where ingredient lists exist, including food information for consumers, cosmetics, and biocides. In these instances, labeling needs to be “risk-independent” and done by mention of the term “nano” in brackets after the ingredient in question. However, there is no indication whether nanomaterials pose high levels of hazard or exposure, thus raising the question of whether labeling helps or hinders understanding risk.

## Conclusions

The regulatory regime framework shows that the US and the EU could never “trade places” in terms of precautionary versus market-oriented approaches, or in terms of regulatory structures. While some scholars may argue in favor of large-scale convergence of regulatory and policy outcomes, a regulatory regime framework argues against this type of convergence. That said, the US and the EU share many common interests and motivations in some areas that may lead to greater cooperation and exchange, particularly along the lines of information exchange, commitments to develop common standards for scientists, issuing recommendations, and improved scientific understanding of risk, uncertainty, hazard, and exposure from nanomaterials.

Many analysts support bypassing government regulation in favor of “soft-law” opportunities for regulatory reform through insurance providers and liability claims (Marchant et al. 2012), as well as voluntary product certification schemes (Marchant et al. 2010). Insurance policies may contribute incentives and constraints for hybrid governance through the emergence of “private regulation” (Büthe and Mattli 2012). However, voluntary schemes also suffer problems of information asymmetry and low participation, thus challenging the effectiveness of business self-regulation in environmental protection (Bowman and Hodge 2009; Coglianese and Nash 2014). “Soft-law” approaches such as codes, standards, and agreements may provide more flexibility and room to move, yet there is substantial variation in how much they can affect the actual regulation and governance of nanotechnology, particularly as they interact with existing “hard-law” frameworks (Marchant et al. 2010). These governance proposals suffer some of the same analytical blind spots as many of the other legal-institutional tools: the roles of power, politics, and ideas in the design and implementation of the institutions and in the policies themselves (Abbott et al. 2012).

Environmental, health, and safety concerns continue to grow as technologies grow, and people insist that technological innovations provide credibility of attractive economic undertakings. A transparent and fair regulatory process could ensure the predictability of regulatory oversight and provide assurances for investors and for the public. There are market-driven arguments in favor of smarter regulation. Sometimes, in other words, freer markets require more rules.

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## Author notes

*

I gratefully acknowledge support by the National Science Foundation: “Nanotechnology in the Public Interest: Regulatory Challenges, Capacity, and Policy Recommendations” (SES #0609078). I am grateful to many for help, particularly Christopher Bosso, Anne Clunan, Denise Garcia, Roselyn Hsueh, Margaret Kosal, Susan Sell, and JP Singh. I thank Corinne Austin, Pavitra Chari, Fernando Loya, Chelsea Mattioda, and Margaret Osthues for research assistance, as well as three anonymous reviewers for valuable comments and suggestions. All mistakes remain my own.