Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms , challenges current practices of governance and science. Employing environmental risk assessment for governance and oversight assumes we have a reasonable ability to understand consequences and predict adverse effects. However, traditional ERA has come under considerable criticism for its many shortcomings and current governance institutions have demonstrated limitations in transparency, public input, and capacity. Problem Formulation and Options Assessment is a methodology founded on three key concepts in risk assessment (...) and three in governance . Developed through a series of international workshops, the PFOA process emphasizes engagement with stakeholders in iterative stages, from identification of the problem through comparison of multiple technology solutions that could be used in the future with their relative benefits, harms, and risk. It provides “upstream public engagement” in a deliberation informed by science that identifies values for improved decision making. (shrink)

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms, challenges current practices of governance and science. When a governing body is confronted by a technology whose use has potential environmental risks, some form of risk analysis is typically conducted to help decision makers consider the range of possible benefits and harms posed by the technology. Environmental risk assessment is a critical component in the governance of nanotechnology and genetically engineered organisms because the uncertainties and complexities surrounding these technologies (...) pose such risk potential. However, GEOs are unique technologies, and there is widespread, international recognition that many traditional forms of ERA are not well-suited for evaluating them. Nanotechnology products are also likely to need different models of risk assessment, as there is very little information on their fate, transport, and impacts in the environment. (shrink)

There is a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at least three (...) ethical and policy challenges that have to do with public trust and fair representation. First, the presence of former key industry personnel on review boards could adversely impact the public’s confidence in regulatory decisions about new technology products, including agrifood biotechnologies. Second, the ‘‘revolving door’’ may result in policy decisions about technologies that are biased in favor of industry interests. And third, the ‘‘revolving door’’ virtually guarantees industry a voice in the policy-making process, even though other stakeholders have no assurance that their concerns will be addressed by regulatory agencies. We believe these three problems indicate a failure of regulatory review for new technologies. The review process lacks credibility because, at the very least, it is procedurally biased in favor of industry interests. We argue that prohibiting the flow of personnel between regulatory agencies and industry would not be a satisfactory solution to the three problems of public trust and just representation. To address them, regulatory entities must reject the traditional notion of objectivity. Instead they should adopt the conception of objectivity developed by Sandra Harding and re-configure their regulatory review on the basis of it. That will ensure that a heterogeneous group of stakeholders is at the decision-making table. The fair representation of interests of different constituencies in the review process could do much to inspire warranted public confidence in regulatory protocols and decisions. (shrink)

Novel targeted genetic modification (TagMo) techniques for plants have the potential to increase the speed and ease of genetic modification and fall outside existing regulatory authority. We conducted 31 interviews with expert-stakeholders to explore the differing visions they have for the future of plant TagMo environmental regulation. To guide our analysis we review the tenets of anticipatory governance in light of future studies literature on emerging technology, focusing on how to contribute to reflexivity by making explicit the assumptions within envisioned (...) futures. Our findings reveal that the environmental regulation futures articulated by expert-stakeholders could be classified into three categories—optimistic, pragmatic, and critical—based on their differing underlying assumptions concerning what constitutes environmental risk and the adequacy of existing U.S. genetically modified plant regulations. By gathering these diverse perspectives on the future and studying how they differ, we hope to further the anticipatory governance-informed engagement with regulation and foster a more productive discussion of plant TagMo regulation. (shrink)

Growing public concern and uncertainties surrounding emerging technologies suggest the need for socially-responsible behavior of companies in the development and implementation of oversight systems for them. In this paper, we argue that corporate social responsibility (CSR) is an important aspect of nanotechnology oversight given the role of trust in shaping public attitudes about nanotechnology and the lack of data about the health and environmental risks of nanoproducts. We argue that CSR is strengthened by the adoption of stakeholder-driven models and attention (...) to moral principles in policies and programs. In this context, we examine drivers of CSR, contextual and leadership factors that influence CSR, and strategies for CSR. To illustrate these concepts, we discuss existing cases of CSR-like behavior in nanotechnology companies, and then provide examples of how companies producing nanomedicines can exhibit morally-driven CSR behavior. (shrink)

This paper reviews the paper by Kuzma, Najmaie, and Larson that looks at what can be learned from the experience with genetically engineered organisms for oversight of emerging technologies more generally. That paper identifies key attributes of a good oversight system: promoting innovation, ensuring safety, identifying benefits, assessing costs, and doing so all while building public confidence. In commenting on that analysis, this paper suggests that looking at “oversight” in three phases — research and development, regulatory review, and market acceptance (...) — can help to determine when certain of these attributes should take precedence over others and how to structure remedies when an error occurs. The result is an approach that is precautionary with respect to research and development, prudent and open to public input in the regulatory review stage, and purposefully persuasive once market acceptability is at stake, with remedies that are risk-containing in the first phase, risk-managing in the second, and risk-assuaging in the third. Combining the key attributes with the idea of three phases can help attune oversight to society's needs. (shrink)

Commentators continue to weigh in on whether there are ethical, social, and policy issues unique to nanotechnology, whether new regulatory schemes should be devised, and if so, how. Many of these commentaries fail to take into account the historical and political environment for nanotechnologies. That context affects regulatory and oversight systems as much as any new metrics to measure the effects of nanoscale materials, or organizational changes put in place to facilitate data analysis. What comes to count as a technical (...) or social “problem” says much about the sociotechnical and political-historical networks in which technologies exist. This symposium's case studies provide insight into procedural successes and failures in the regulation of novel products, and ethical or social analyses that have attended to implications of novel, disruptive technologies. Yet what may be needed is a more fundamental consideration of forms of governance that may not just handle individual products or product types more effectively, but may also be flexible enough to respond to radically new technological systems. Nanotechnology presents an opportunity to think in transdisciplinary terms about both scientific and social concerns, rethink “knowns” about risk and how best to ameliorate or manage it, and consider how to incorporate ethical, social, and legal analyses in the conceptualization, planning, and execution of innovations. (shrink)

That cacophony you hear is coming from the growing number of commentators addressing ethical, social, and policy issues raised by nanotechnology. Like many novel technologies that disturb the status quo, nanotechnologies raise questions about the adequacy of oversight systems; the extent to which the technologies push legal, moral, and political boundaries; and ultimately, the implications for human health and well-being. Because nanoscale techniques and products challenge our ways of thinking about biology, physics, and chemistry, nanotechnology forces us to reconsider accepted (...) wisdom on toxicity, mutagenicity, contamination, biocompatibility, and other interactions among humans, the environment, and technologies. The sheer scale and reach of nanotechnologies demands institutions, collaborations, and conventions that can cross-link knowledge across organizations, disciplines, and locales. If ever there was an occasion to rethink the limits of disciplinary-specific knowledge, norms about regulatory processes, and societal implications of new technologies, nanotechnologies provide the opportunity. (shrink)