Media reports of the health hazards posed by nano-sized particles have turned a white hot spotlight on the risks of nanotechnology. Worried about the risks posed to workers producing nano-materials, the Washington Post has labeled nanotechnology a “seat-of-the-pants occupational health experiment.” This article examines our emerging knowledge base about the hazards of two types of exposure: inhalation of NSPs and topical application of products containing NSPs. It argues that a clear-eyed evaluation of the benefits and risks of nanotechnology is made (...) extremely difficult by the marriage of a complex science with a venture capitalist-like hype. It then suggests that, absent additional statutory authority, governmental regulators cannot readily address the risks posed by these products. This regulatory inaction leaves a significant role for the private insurance market, a role that regulators should support in tangible ways outlined in the article. (shrink)

Nanotechnology is a subject about which we know less than we should, but probably more than we think we do at first glance. Like Defense Secretary Donald Rumsfeld's “known unknowns,” we have learned enough to know what we should be concerned with. Glimmers of risk cropped up recently when German authorities recalled a bathroom cleansing product, “MagicNano,” that purported to contain nanosized particles and was on the market for only three days. More than one hundred people suffered severe respiratory problems (...) – six of whom were hospitalized with pulmonary edema. Although a subsequent analysis of MagicNano found that the nanoliquid ingredient morphed in the production into “supersized” particles, the recall nonetheless turned a white hot spotlight on the risk of NSPs. Latching onto the risks posed to workers producing materials using nanotechnology, the Washington Post has labeled nanotechnology a “seat-of-thepants occupational health experiment.”. (shrink)

Nanotechnology presents significant challenges in terms of developing a regulatory framework. This is due to a lack of scientific knowledge about the behaviour of the technology in its interactions with biological and ecological processes, the environment and other technologies. Crucially, there is a great deal of uncertainty surrounding the potential environmental and human health and safety impacts of NT. Consequently, the development of NT is a potential test case for framing new models of ‘soft law’ voluntary governance as a substitute (...) for traditional command and control type regulation. Driven by ‘new science governance,’ an approach based on a combination of ideas in anticipatory ethics, future-oriented responsibility, upstream public engagement and deliberation and theories of justice may offer a solution. The uniqueness of the approach can be found in the incorporation of anticipatory approaches via public participation and deliberation as the input into procedural justice approaches with distributional justice as the output. The overarching objective of this work is to contribute to the discussion in relation to the internalisation of responsibility and the building of intellectual and societal capacity to anticipate negative consequences before they arise in the hope that such an approach could be the antithesis of the retrospective imposition of responsibility and liability after the harm is done, which is the outcome of traditional regulatory and ethical approaches. Ultimately, the purpose is to contribute to the long-term sustainability of NT. (shrink)

As policy makers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are the following: public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; regulation should avoid discriminating against particular technologies unless there is a scientifically based rationale for the disparate treatment; regulatory systems need to be flexible (...) and adaptive to rapidly changing technologies; ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and international harmonization of regulation may be beneficial in a rapidly globalizing world. (shrink)

Nanotechnology is the latest in a growing list of emerging technologies that includes nuclear technologies, genetics, reproductive biology, biotechnology, information technology, robotics, communication technologies, surveillance technologies, synthetic biology, and neuroscience. As was the case for many of the technologies that came before, a key question facing nanotechnology is what type of regulatory oversight is appropriate for this emerging technology. As two of us wrote several years ago, the question facing nanotechnology is not whether it will be regulated, but when and (...) how.Yet, appropriate regulation of nanotechnology will be challenging. The term “nanotechnology” incorporates a broad, diverse range of materials, technologies, and products, with an even greater spectrum of potential risks and benefits. This technology slashes across the jurisdiction of many existing regulatory statutes and regulatory agencies, and does so across the globe. Nanotechnology is developing at an enormously rapid rate, perhaps surpassing the capability of any potential regulatory framework to keep pace. Finally, the risks of nanotechnology remain largely unknown, both because of the multitude of variations in the technology and because of the limited applicability of traditional toxicological approaches such as structure-activity relationship to nanotechnology products. (shrink)

Risk management of nanotechnology is challenged by the enormous uncertainties about the risks, benefits, properties, and future direction of nanotechnology applications. Because of these uncertainties, traditional risk management principles such as acceptable risk, cost–benefit analysis, and feasibility are unworkable, as is the newest risk management principle, the precautionary principle. Yet, simply waiting for these uncertainties to be resolved before undertaking risk management efforts would not be prudent, in part because of the growing public concerns about nanotechnology driven by risk perception (...) heuristics such as affect and availability. A more reflexive, incremental, and cooperative risk management approach is required, which not only will help manage emerging risks from nanotechnology applications, but will also create a new risk management model for managing future emerging technologies. (shrink)

Nanotechnology shows great promise in a variety of applications with attractive economic and societal benefits. However, societal issues associated with nanotechnology are still a concern to the general public. While numerous technological advancements in nanotechnology have been achieved over the past decade, research into the broader societal issues of nanotechnology is still in its early phases. Based on the data from the Web of Science database, we applied the main path analysis, cluster analysis and text mining tools to explore the (...) main research fronts and hierarchical structure of these societal issues. We found that the research studies fell into four categories: "General Toxicity and EHS (Environment, Health and Safety)," "Medicine and Cytotoxicity," "Assessment and Regulation," and "Environment and Ecotoxicity." These research studies have disclosed much information about the potential effect of nanotechnology on public health and the environment. Relatively speaking, the studies on the assessment, regulation, preventive solutions, and environmental protection are just emerging. This finding indicates that an abundance of effort should be conducted on these emerging themes to maximize the benefits of nanotechnology while minimizing its potential harm. The implications for various parties in this domain are also presented. (shrink)

Despite their growing usage in commercial and industrial applications, nanomaterials have yet to be been thoroughly researched as to their potential health, safety, and environmental risk to human life after incorporation into new product improvement, development, design, and manufacturing processes. Identifying the appropriate governance framework for effective risk assessment analysis of toxicological risk to human beings—specifically manufacturing employees and consumers—and other living organisms, resulting from the development and application of these nanotechnology-based products, has yet to be scientifically determined. With major (...) regulatory gaps in the public regulation framework at national and international levels of governance, a proposed private governance framework is needed to assist the existing public regulatory framework with the proliferation of products and manufacturing processes utilizing nanomaterials. There are three distinct (yet complimentary) approaches available to develop a private governance framework to complement existing national public regulatory frameworks: responsible innovation, risk management, and voluntary guidelines/industry standards. The case for supporting a hybrid governance framework, combining public and private governance mechanisms, for nanotechnology is reflective of the current public policy environment that has emerged to best address health, safety, and environmental risk assessment issues concerning nanotechnology and nanomaterials. (shrink)

Does national success with an emerging technology require ethical sacrifices? This question is considered through the simultaneous consideration of ethics, investment, and outcomes in the nine jurisdictions that are making the largest investments in nanotechnologies—an important emerging technology. It is found that while ethical environment has no notable effect on pure and applied research, a more positive ethical environment is associated with measures associated with invention and commercialization. In summary, a race-to-the-top supports invention and commercialization of emerging technologies. A critical (...) finding as it suggests that issues such as corruption and regulation could be critical in limiting the extraction of social and economic benefit from emerging technologies (like nanotechnologies). (shrink)

The ‘Precautionary Principle’ provides a somewhat ill-defined guide, often of uncertain normative status, for those exercising administrative decision-making power in circumstances where that may create potential risks to human health or the environment. This paper seeks to explore to what extent the precautionary principle should have been and was in fact utilised by the Australian Therapeutic Goods Administration (TGA) in its decision to approve the marketing of sunscreens containing titanium dioxide (TiO2) and zinc oxide (ZnO) in nanoparticulate form. In particular, (...) this article assesses to what extent better application of that principle might have altered the TGA’s decision that TiO2 and ZnO ENPs in sunscreens do not require new safety testing, because they are considered to be functionally equivalent to their bulk counterparts. (shrink)

This paper, guided by the UNESCO Universal Declaration on Bioethics and Human Rights, assumes that regulators should aim to support the development of nanomedicine while, at the same time, putting in place whatever limits or safeguards are indicated by ethical considerations. Relative to this regulatory objective, it is argued that, notwithstanding the importance of precaution (characteristically, concerning health, safety, and the environment), ethical reflection needs to go both broader and deeper. It is suggested that, by attending to the basic matrix (...) of ethical debate and the “bioethical triangle” through which the matrix is currently articulated, the breadth, depth, and conflictual plurality of ethical concerns about nanomedicine will be clarified. In this light, the conventional thinking about precaution is revisited and concerns about human dignity and informed consent (under conditions of extreme uncertainty) are analysed. The paper concludes that, once the range of ethical pluralism is grasped, the extent of the challenge facing regulators will be more clearly appreciated. (shrink)