This article aims to address challenges of translating emerging scientific technologies into legal terms and incorporate them into the existing North American regulatory regimes. A lack of full scientific knowledge about nanomedicine technologies results in the lack of development in legal discourse to describe products and to clearly set legal standards on their safety and efficacy. The increasing complexity and hybrid nature of technologies negatively impact the functionality of “law in action” leading to a legal uncertainty and ultimately to a (...) public distrust. Nanomedicine is an illustrative example of how law lags behind increasingly fast-paced scientific technologies making it difficult to find a balance between innovation and safety. This article argues that the boundary crossing nature of nanomedicine through different domains of science triggers a methodological and epistemological debate within science and law, suggesting that a critical revision is required in our traditional methods to learn, create, and categorize knowledge from breakthrough scientific advances. The highly disruptive nature of nanomedicine places stress on traditional conceptual frameworks, classifications of knowledge, and existing regulations. The legal challenge to identify definitions or to classify nanoapplications brings to light a conceptual vacuum surrounding nanomedicine. Moving away from confusing policies and obsolete classificatory models, this article suggests to undertake changes that are only the first steps of a more in-depth “epistemological transformation” that addresses knowledge as the process of not only gathering data, but also, as the process of elaborating new conceptual bases to better fulfill the legal language and facilitate the legal task of finding definitions and formulating criteria more adherent with scientific advances. This should compel regulators to explore new paradigms and develop new methodologies to evaluate data on nanomedicine applications in order to provide sustainable bases for a responsible development of nanomedicine. (shrink)

This paper reflects on the change of relations among participants in nanotechnology governance through their participation in governance processes such as stakeholder dialogues. I show that policymaking in practice—that is, the practice of coming and working together in such stakeholder dialogues—has the potential for two-fold performative effects: it can contribute to the development of trust and mutual responsibility on the part of the involved actors, and it may bring about effects on the formation of boundaries of what is sayable and (...) thinkable in nanotechnology governance. Three vignettes about the work of the German NanoKommission indicate the development of new relations of trust, recognition and mutual responsibility among actors. It is concluded that governance in practice can assemble new collectives in which relations of trust are the glue holding the complex structure together. While such a consensus-based progress may be favourable for smooth technology development, it can be considered problematic if evaluated against the ideals of deliberative democracy, which often form the premises on which public engagement is based. Stakeholder forums were set in place with the intention of including various actors, but this is Janus-faced: if a dialogue becomes encapsulated in new governance networks, new exclusions can arise. For example, a policing of which information is released to a wider audience can occur. (shrink)

There have been several conscious efforts made by different stakeholders in the area of nanoscience and nanotechnology to increase the awareness of social and ethical issues (SEI) among its practitioners. But so far, little has been done at the laboratory level to integrate a SEI component into the laboratory orientation schedule of practitioners. Since the laboratory serves as the locus of activities of the scientific community, it is important to introduce SEI there to stimulate thinking and discussion of SEI among (...) practitioners, which would eventually contribute toward the responsible development of this technology. In this article, through an example (at the Cornell NanoScale Science and Technology Facility (CNF), practitioners of which represent a section of the nano researchers’ community in the USA), it is shown how a SEI component can be incorporated into the laboratory orientation schedule of the practitioners from diverse disciplinary and institutional backgrounds. Results show that, at CNF, the practitioners enjoyed the discussion since most of them learned about SEI for the first time in their professional career. At the same time, some of them were also knowledgeable about SEI and contributed to the debates. Moreover, the SEI orientation had significant positive impact on the scientific community enabling them to self-reflect upon their own research and its implications for the wider society. This article also describes the efforts that were undertaken to disseminate this form of SEI orientation to other 13 USA universities within the National Nanotechnology Infrastructure Network (NNIN, one of the biggest networks funded from National Science Foundation for Nanotechnology research, of which CNF is a part). As a result of this effort, most of the NNIN sites have already started or were in the process of integrating a SEI component into their nanofabrication laboratories to make their users aware of SEI, ensuring eventual robust socio-technical integration in the NNIN laboratories. In the future, this form of SEI orientation can also be disseminated to other nanofabrication laboratories in the USA. (shrink)

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA policy, we argue, does (...) not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

La búsqueda institucional de una innovación responsable se ha centrado en gran parte en el control de los impactos negativos del progreso científico-tecnológico. Así, las propias dinámicas de la ciencia y la tecnología han tendido a abordarse como un fenómeno autónomo, impermeable al escrutinio crítico. Sin embargo, iniciativas más recientes de las políticas científicas de la UE, tales como Responsible Research and Innovation u Open Science, dicen abogar por que los propios procesos de ciencia e innovación sean objeto de debate (...) inclusivo. Aparentemente representativas de un avance sustancial respecto al modelo de control de riesgos, su capacidad para transformar las prácticas científico-tecnológicas es, sin embargo, también limitada, al verse constreñidas igualmente por un horizonte normativo caracterizado por la asunción de que el progreso tecno-industrial es por principio armonizable con todo tipo de hitos sociales, ecológicos y sanitarios. (shrink)

The European Union is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance to develop special (...) regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as “Responsible Research and Innovation”, widely claim that a diversity of considerations and issues are integrated into R&D processes. Even so, the possibility of more radically alternative constitutions of socio-technical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy. (shrink)

The genetically manipulated organism crisis demonstrated that technological development based solely on the law of the marketplace and State protection against serious risks to health and safety is no longer a warrant of ethical acceptability. In the first part of our paper, we critique the implicitly individualist social-acceptance model for State regulation of technology and recommend an interdisciplinary approach for comprehensive analysis of the impacts and ethical acceptability of technologies. In the second part, we present a framework for the analysis (...) of impacts and acceptability, devised—with the goal of supporting the development of specific nanotechnological applications—by a team of researchers from various disciplines. At the conceptual level, this analytic framework is intended to make explicit those various operations required in preparing a judgement about the acceptability of technologies that have been implicit in the classical analysis of toxicological risk. On a practical level, we present a reflective tool that makes it possible to take into account all the dimensions involved and understand the reasons invoked in determining impacts, assessing them, and arriving at a judgement about acceptability. (shrink)

What is the significance of the wicked problems framework for environmental philosophy? In response to wicked problems, environmental scientists are starting to welcome the participation of social scientists, humanists, and the creative arts. We argue that the need for interdisciplinary approaches to wicked problems opens up a number of tasks that environmental philosophers have every right to undertake. The first task is for philosophers to explore new and promising ways of initiating philosophical research through conducting collaborative learning processes on environmental (...) issues. The second task is for philosophers to recognize the value of philosophical skills in their engagements with members of other disciplines and walks of life in addressing wicked problems. The wicked problems framework should be seen as an important guide for facilitating philosophical research that is of relevance to problems like climate change and sustainable agriculture. Content Type Journal Article Category Articles Pages 1-14 DOI 10.1007/s10806-011-9344-0 Authors Paul B. Thompson, Department of Philosophy, Michigan State University, 503 S. Kedzie Hall, East Lansing, MI 48824, USA Kyle Powys Whyte, Department of Philosophy, Michigan State University, 503 S. Kedzie Hall, East Lansing, MI 48824, USA Journal Journal of Agricultural and Environmental Ethics Online ISSN 1573-322X Print ISSN 1187-7863. (shrink)