Nanotechnologies and Novel Foods in European Law

Food is a big business in the EU and nanofood products are beginning to be placed on the market. It is still unclear whether the absence of minimum regulation at a global level promotes or prevents the growth of a market in nanofood. However, the development of an adequate risk management policy in relation to food safety is a key concern for consumers. Importantly, the European Parliament in its 2009 Resolution on “Legal aspects on nanomaterials” called for more in-depth scientific research on the toxicity of compounds in nanomaterials, and for the adoption of an EU definition of nanomaterials for regulatory purposes. Unfortunately, in 2011, nanotechnology led to inconclusive debates in the context of the revision of Novel Food Regulation. General Food Law applies to nanofood in terms of safety requirements, and specific rules also apply to food contact materials containing nanoparticles as well as to to additives, vitamins and minerals. The EU legislator also introduced mandatory labelling in respect of products derived from nanotechnologies. The legal framework is evolving according to the so-called “incremental approach”, a governance model that creates the risk of fragmentation. But the main problem is the inconsistent definition of the terms “nanotechnology” and “nanomaterials” when looking at the enforcement of regulations and the provision of a wide range of specific tools for different nanofoods: for example the use of positive lists of authorised substances applying only to food contact materials, additives and supplements. This contribution aims to review the regulations in force in respect to nanofood and novel foods and to highlight the problems that are still unresolved.     

Nanotechnology Bound: Evaluating the Case for More Regulation

In continuing news, there is a growing debate on whether current laws and regulations, both in the US and abroad, need to be strengthened as they relate to nanotechnology. On one side, experts argue that nanomaterials, which are making their way into the marketplace today, are possibly harmful to consumers and the environment, so stronger and new laws are needed to ensure they are safe. On the other side, different experts argue that more regulation will slow down the pace of business and innovation in nanotechnology, or that self-regulation is the answer, or other opposing positions. This paper will draw out the core issues behind the debate and explain that there is more at stake than merely environmental, health and safety (EHS) worries or business interests, as it first appears. We will also suggest an alternative solution to stricter laws, since stricter laws would face formidable practical challenges, even if they are warranted.     

Transnational Governance Arrangements: Legitimate Alternatives to Regulating Nanotechnologies?

In recent years, the development and the use of engineered nanomaterials have generated many debates on whether these materials should be part of the new or existing regulatory frameworks. The uncertainty, lack of scientific knowledge and rapid expansion of products containing nanomaterials have added even more to the regulatory dilemma with policy makers and public/private actors contenting periods of both under and over regulation. Responding to these regulatory challenges, as well as to the global reach of nanotechnology research and industrial needs, governance arrangements beyond the state have addressed the challenge head-on. This article focuses on the governance arrangements of the International Organization for Standardization (ISO), which has led to the development of numerous “horizontal anticipatory standards” with an important role in setting the foundation for science, technology and market development. During the course of its operation ISO has broadened its scope to address not only technical issues related to the concept and the size of nanomaterials but also broader aspects of the technology, including health, environment and safety issues. The increasing relevance of the ISO to regulate economic relations and achieve certain public policy goals has given rise to many concerns about its legitimacy. The important questions are whether these governance arrangements may be deemed as being legitimate and where this legitimacy is derived from? What are the main sources of legitimacy at the transnational level and how we can apply them to analyse nanotechnology standardization? This article provides concise answers to these questions. It focuses at the normative concepts of democratic and scientific legitimacy and explores the institutional structures and processes by which nanotechnology standards are established.     

Environmental Reform Organizations and Undone Science in the United States: Exploring the Environmental,Health, and Safety Implications of Nanotechnology

Environmental organizations have raised concerns about the environmental, health, and safety (EHS) implications of the hundreds of products containing nanomaterials that are now on the market. In the process they have drawn attention to the ‘undone science’ of EHS research and called for changes in both research and regulatory policy. Environmental and other advocacy organizations have been active in three policy fields in the United States: funding levels for EHS research, moratoria on the production of new nanomaterials largely based on the precautionary principle, and negotiations over definitions of safe or responsible nanotechnology with the private sector and the federal government. During the administration of President George W. Bush, calls for more research and industry guidelines met with greater success than those that called for moratoria and enhanced mandatory regulation. The more successful strategies tend to reproduce scientistic politics associated with risk assessment, whereas the less successful strategies would open up a broader public debate on the extent to which nanotechnology is needed or socially desirable.     

Failures in Clinical Trials in the European Union: Lessons from the Polish Experience

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed.     

Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK

ABSTRACT

Emerging flexibilities are apparent in gatekeeping regimes applicable to regenerative medicine products, raising issues about the extent to which and forms in which such flexibilities might promote emerging products as a sector warranting special treatment, in the context of recent policy developments in the UK and wider European Union. Concepts of ‘gatekeeping’, ‘gatekeeping regimes’ and ‘gateways’ can point to the ways in which regulatory institutions, health technology assessment organisations, and national planners and purchasers of health services together define and control entry to the medical product marketplace and the adoption of products into the public health-care system. Flexibilities in existing regimes and new gateways are a way of maintaining ‘connection’ between gatekeeping regimes and technoscientific innovation in order to steer innovation pathways. The gateways concept has affinity with that of Callon’s ‘obligatory passage points’. A wide set of recent policy documents show that the measures promoted exhibit a range of alternative gateways that are being constructed around central, legal, restrictive gatekeeping regimes. However, it would be easy to overestimate the significance of these developments as relaxations that would favour innovative producers and their products on a large scale with wide public health impacts. The concepts of gatekeeping regimes and gateways enable understanding of hybrid developments of exceptions and exemptions to dominant regimes which bridge across the arenas of market regulation, health technology assessment and health-care system planning. These arenas are being drawn closer together as a means of politically managing stakeholders’ aims in the UK, EU and other innovating biomedical health systems globally.     

Southern Roles in Global Nanotechnology Innovation: Perspectives from Thailand and Australia

The term ‘nano-divide’ has become a catch-phrase for describing various kinds of global nanotechnology inequities. However, there has been little in-depth exploration as to what the global nano-divide really means, and limited commentary on its early nature. Furthermore, the literature often presents countries from the Global South as ‘passive’ agents in global nanotechnology innovation—without the ability to develop endogenous nanotechnology capabilities. Yet others point to nanotechnology providing opportunities for the South to play new roles in the global research and development process. In this paper I report on the findings of a qualitative study that involved the perspectives of 31 Thai and Australian key informants, from a broad range of fields. The study was supplemented by a survey of approximately 10% of the Thai nanotechnology research community at the time. I first explore how the global nano-divide is understood and the implication of the divide’s constructs in terms of the roles to be played by various countries in global nanotechnology innovation. I then explore the potential nature of Southern passivity and barriers and challenges facing Southern endogenous innovation, as well as an in-depth consideration of the proposition that Southern countries could be ‘active’ agents in the nanotechnology process. I argue that it is the nano-divide relating to nanotechnology research and development capabilities that is considered fundamental to nanotechnology’s Southern outcomes. The research suggests that Southern countries will encounter many of the traditional barriers to engaging with emerging technology as well as some new barriers relating to the nature of nanotechnology itself. Finally, the research suggests that nanotechnology may offer new opportunities for Southern countries to enter the global research and development picture.     

Laboratory Safety and Nanotechnology Workers: an Analysis of Current Guidelines in the USA

Although some regulatory frameworks for the occupational health and safety of nanotechnology workers have been developed, worker safety and health issues in these laboratory environments have received less attention than many other areas of nanotechnology regulation. In addition, workers in nanotechnology labs are likely to face unknown risks and hazards because few of the guidelines and rules for worker safety are mandatory. In this article, we provide an overview of the current health and safety guidelines for nanotechnology laboratory workers by exploring guidelines from different organizations, including the Department of Energy Nanoscale Science Research Centers (DOE-NSRC), Massachusetts Institute of Technology (MIT), the National Institutes of Health (NIH), the National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA), Texas A&M University (TAMU), and University of Massachusetts-Lowell (UML). After discussing these current guidelines, we apply an ethical framework to each set of guidelines to explore any gaps that might exist in them. By conducting this gap analysis, we are able to highlight some of the weaknesses that might be important for future policy development in this area. We conclude by outlining how future guidelines might address some of these gaps, specifically the issue of workers’ participation in the process of establishing safety measures and the development and enforcement of more unified (and mandatory) guidelines.     

Standardisation in the Field of Nanotechnology: Some Issues of Legitimacy

Nanotechnology will allegedly have a revolutionary impact in a wide range of fields, but has also created novel concerns about health, safety and the environment (HSE). Nanotechnology regulation has nevertheless lagged behind nanotechnology development. In 2004 the International Organization for Standardization established a technical committee for producing nanotechnology standards for terminology, measurements, HSE issues and product specifications. These standards are meant to play a role in nanotechnology development, as well as in national and international nanotechnology regulation, and will therefore have consequences for consumers, workers and the environment. This paper gives an overview of the work in the technical committee on nanotechnology and discusses some challenges with regard to legitimacy in such work. The paper focuses particularly on stakeholder involvement and the potential problems of scientific robustness when standardising in such early stages of the scientific development. The intention of the paper is to raise some important issues rather than to draw strong conclusions. However, the paper will be concluded with some suggestions for improving legitimacy in the TC 229 and a call for increased public awareness about standardisation in the field of nanotechnology.     

Revisiting “Upstream Public Engagement”: from a Habermasian Perspective

The idea of conducting “upstream public engagement,” using nanotechnology as a test case, has been subject to criticism for its lack of any link to the political system. Drawing on the theoretical tools provided by Habermas, this article seeks to explore such a “link”, focusing specifically on the capacity of civil society organizations (CSOs) to distil, raise and transmit societal concerns in an amplified form to the public spheres at the European Union (EU) level. Based on content analysis and semi-structured interviews with relevant actors, this article examines the evolution of CSO approaches towards nanotechnology over the past decade and investigates whether and how upstream public engagement could contribute to more vibrant public spheres and facilitate the formation of communicative power. The answer to these questions is twofold: on the one hand, moving public engagement “upstream” enables CSOs to be better informed and to become part of the debates more quickly. A “green alliance” is taking shape, which calls for more stringent regulation on nanomaterials. On the other hand, upstream public engagement has turned out to be unsuccessful in generating substantial and sustained interest. A number of CSOs have quit this field in frustration at the tokenistic engagement and out of fatigue after the intense lobbying battle for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).     

Nanopatents and their impact on the medical environment

The nano-medical field is seen, by governments as well as the business sector as a very promising one. The process of converting basic research in nanomedecine into commercially viable products has already begun, even if it might be long and difficult. Part of the difficulties that could occur comes from regulatory and safety issues. Some of them are also coming from patent uncertainty in the global nanotechnology field. Indeed, the rush towards patents in the nanotechnology arena has already begun. Nanopatents are about to alter the legal landscape of the innovation economy, of research and development, and of industry--no doubt to an unprecedented extent because of the scope covered by these technologies. From a global point of view, the very delineation of the scope of nanotechnologies confronts patent law with complex problems of definition. The emergence and characteristics of this technology are also giving rise to a reassessment of the criteria for patentability that could be prejudicial to innovation. In the medical environment, this issue is even exacerbated in the real challenges which pharmaceutical companies are running up against.     

Patentable Novelty in Nanotechnology Inventions: a Legal Study in Iraq and Malaysia

Nanotechnology has been facing multiple obstacles related to the applicability of patentability criteria. In this article, the authors addressed the novelty requirement in nanotechnology inventions in Iraqi and Malaysian patent acts. First, novelty was discussed to determine its applicability in the field of nanotechnology. Then, problems on nanotechnology patent application were presented along with some suggested solutions. The problems encountered in the patentability of nanotechnology inventions were summarized in two categories. First, the multidisciplinary nature of nanotechnology casts its shadow on the examination process in patent offices. To overcome this problem, the United States Patent and Trademark Office and the European Patent Office created new divisions to examine nanotechnology inventions; thus, this step must be followed by developing countries. In addition, with the existence of larger scaled materials and devices in prior art, three potentials have been introduced to overcome this issue. First, novel properties in nanoinventions can be demonstrated to reach the point of novelty. Second, nanoinventions can be patentable if they are carried out despite scientific problems occurring when materials are shaped in nanoscale. Third, the process of creating nanomaterials can be patentable as the bottom-up approach, which is not used in larger scaled materials. Finally, pre-disclosure must be considered as an enabling disclosure, which enables a skilled man in the art to put the nanoinvention in practice.     

Health and life

This paper considers some of the potential implications for an interest in health of the basic fact that to live is to have been given something in advance. It is suggested that various thinkers such as Alfred Adler, Sartre, and Heidegger are unable to develop a positive attitude toward this fact and therefore are not logically in a position to be committed to health. An alternative to all of these is found in Hannah Arendt's notion that activity is an essential part of life. Following her lead, the paper moves on to a consideration of various forms of human activity, labor, work, and finally action both in terms of how they constitute an advance over the givens of life and how they contribute to health.     

Just a Cog in the Machine? The Individual Responsibility of Researchers in Nanotechnology is a Duty to Collectivize

Responsible Research and Innovation (RRI) provides a framework for judging the ethical qualities of innovation processes, however guidance for researchers on how to implement such practices is limited. Exploring RRI in the context of nanotechnology, this paper examines how the dispersed and interdisciplinary nature of the nanotechnology field somewhat hampers the abilities of individual researchers to control the innovation process. The ad-hoc nature of the field of nanotechnology, with its fluid boundaries and elusive membership, has thus far failed to establish a strong collective agent, such as a professional organization, through which researchers could collectively steer technological development in light of social and environmental needs. In this case, individual researchers cannot innovate responsibly purely by themselves, but there is also no structural framework to ensure that responsible development of nanotechnologies takes place. We argue that, in such a case, individual researchers have a duty to collectivize. In short, researchers in situations where it is challenging for individual agents to achieve the goals of RRI are compelled to develop organizations to facilitate RRI. In this paper we establish and discuss the criteria under which individual researchers have this duty to collectivize.     

The European and Member States’ Approaches to Regulating Nanomaterials: Two Levels of Governance

The nanotechnologies and nanomaterials sector is a huge and growing industry. The amount of legislation already in place and still to be produced in order to regulate it will be very substantial. What process is used to produce such regulation? The answer is that very diverse regulatory approaches are and will be used. The approach taken by the European Commission diverges from the one taken by the European Parliament. Moreover, at national level, Member States add their own contribution to the process. This article attempts to describe the landscape and various regulatory actions that have been undertaken by all these actors in the European Union. It first describes the role played by the European Commission and Parliament. It then looks at specific regulatory initiatives from a more sectoral perspective: Cosmetics, Food information, Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, Waste Electrical and Electronic Equipment and Biocides. The third part of the paper describes some major national initiatives, in particular those concerning the establishment of reporting systems for nanomaterials, mixtures, articles and consumer products containing them, as an example of how to improve the current governance in the EU and to prevent the risks to human health and the environment. The fourth part gives the perspective of the European Trade Union Confederation. Finally it presents some conclusions and policy recommendations, taking into consideration the diversity of regulatory approaches.     

Framing the Discussion: Nanotechnology and the Social Construction of Technology--What STS Scholars Are Saying

The emergence of nanotechnology, with all its promises of economic, social, and medical benefits, along with dire predictions of environmental, health, and safety threats, has occasioned an active debate in the Science and Technology Studies field, in which we have seen five distinct conversations that frame the discussion. The topical threads include ethics, regulation, opportunities and threats including utopian/dystopian visions of the future, public perception, public participation. These conversational distinctions are not absolutes with firm borders as they clearly overlap at many points. Nonetheless, common to all is a strong sense that control and consequence are significant problems that have yet to be addressed adequately by the promoters of nanotechnology. A final section addresses articles on nanotechnology that exemplify the social construction theory of technology. We include herein a selective summary of this recent body of science, technology, and society (STS) journal literature focused on the social and ethical interactions of nanotechnology (SEIN) that has emerged in the last few years. The intent is not to be encyclopedic in coverage, but rather to seek to understand, in a general way, the key issues and concepts STS scholars are discussing. It is clear that STS-oriented scholars are well poised to grapple explicitly with the cultural, socio-political, and ethical dimensions of nanotechnology. Drawing on understandings of earlier socio-technical areas of interest and concern??nuclear power, genetically modified organisms, the human genome??such scholars have moved well beyond the questions of whether and where nanotechnology intersects society. More important is their effort to seek an understanding in depth of exactly how they are socio-politically, culturally, and ethically interconnected. In doing so, SEIN studies have at the same time become increasingly diverse and more sophisticated and mature over the course of the past decade. Scholars have quite rightly recognized the inadequacies of blanket ideas of moratoria versus non-regulatory environments, utopian versus dystopian futures, and whether or not the public has a role to play in nanotechnology decision making. Rather, a more sophisticated, often case specific, flexible understanding of the societal context of a given issue or concern is called for.     

Bringing the European Union closer to its young citizens: Youth active citizenship in Europe and trust in EU institutions

Abstract

European Union countries are participatory and representative democracies. Therefore, active citizenship in the EU and trust in EU institutions are paramount for the continuation and the strengthening of the EU project. Young Europeans who hold the future in their hands need to be actively engaged not only in the social and political life within their national communities, but also in the wider European community. The papers in this special issue examine whether and how European youth identify with the EU, trust EU institutions and engage in EU issues, and which societal and proximal-level contexts and/or individual-level attributes promote or hinder young people’s active citizenship in European context. They are based on results from the Horizon 2020 CATCH-EyoU project, standing for Constructing AcTive CitizensHip with European Youth: Policies, Practices, Challenges and Solutions. Scientists represent different disciplines (Psychology, Political Science, Sociology, Media and Communications, Education) and from eight European countries (Sweden, Estonia, U.K., Germany, Czech Republic, Greece, Portugal, Italy). Together, the papers contribute to the development of a new, cutting-edge conceptualization of youth active citizenship in the EU, and to a better understanding of the factors promoting or inhibiting young EU citizens’ engagement, participation and active citizenship at the European level.     

Let’s Get Small: An Introduction to Transitional Issues in Nanotech and Intellectual Property

Much of the discussion regarding nanotechnology centers around perceived and prosphesied harms and risks. While there are real risks that could emerge from futuristic nanotechnology, there are other current risks involved with its development, not involving physical harms, that could prevent its full promise from being realized. Transitional forms of the technology, involving “microfab,” or localized, sometimes desk-top, manufacture, pose a good opportunity for case study. How can we develop legal and regulatory institutions, specifically centered around the problems of intellectual property, that both stimulate innovation, and make the best possible use of what will eventually be a market in “types” rather than “tokens”? This paper argues that this is the most critical, current issues facing nanotechnology, and suggests a manner to approach it.     

International stem cell tourism and the need for effective regulation. Part II: Developing sound oversight measures and effective patient support

Part I of this article, published in the March 2010 issue of the Kennedy Institute of Ethics Journal, traces and addresses the provision of unproven stem cell treatments in Russia and India, examines the concept of innovative treatment, and concludes that stronger regulations are needed to protect the health and informed choices of patients. The current paper, Part II, proposes that the regulatory frameworks for the development of safe and efficacious treatments in effect in the United States and the United Kingdom provide examples of strong oversight measures from which countries seeking to obtain international credibility for their biotechnological competence could draw when developing regulations for stem cell treatments. Major sources of information available to persons who consider receiving such unproven treatments are explored in order to understand and address their concerns. The paper concludes with proposed measures to inform those considering the pursuit of unproven stem cell treatments abroad more accurately about their efficacy and safety and provide them with improved medical and social support in their home countries.