Risk Analysis of Nanomaterials: Exposing Nanotechnology's Naked Emperor

Abstract

Risk analysis (encompassing risk assessment, management, and communication) is touted internationally as the most appropriate approach for governing nanomaterials. In this article, we survey existing criticisms of risk assessment as a basis for regulatory decision making on emerging technologies, particularly highlighting its exclusion of key societal dimensions, its epistemological underdetermination, and its lack of democratic accountability. We then review the specific case of nanomaterials and identify six major barriers to the effective operation of both risk assessment and risk management. These include a lack of: nano-specific regulatory requirements, shared definitions, validated and accessible methods for safety testing, available scientific knowledge, reliable information on commercial use, and capacity for exposure mitigation. Finding the knowledge, standards, methods, tools, definitions, capacity, and political commitment all insufficient, we argue that risk analysis is a "naked emperor" for nanomaterial governance. We therefore suggest that additional concepts and approaches are essential for nanomaterials policy and regulation.

What can nanosafety learn from drug development? The feasibility of “safety by design”

“…SbD (US Congress, 1993;van Leeuwen, 2007). Even risk assessment, which has traditionally been understood as solely a scientific matter, is intertwined with societal concerns and values (National Research Council, 2009;Miller and Wickson 2015). For example, the very question of what data is required to suffice regulatory risk assessment and how such data should be generated is fundamentally a political decision (van Leeuwen, 2007).…”

“…Since establishing dedicated regulatory systems capable of adequately assessing the risks of ENMs 'downstream' from product development has proved problematic, considering safety as a characteristic that can be incorporated as a design parameter 'upstream' during product development is immediately appealing. Given that the regulatory situation for ENMs is still unclear and in development (Hansen and Baun, 2015), uncertainty concerning how to quantify and identify novel risks remains (Grieger, 2011, Johnston et al, 2013, Miller and Wickson, 2015, Saleh et al, 2015 and the pressing need for safety research to keep pace with innovation (Savolainen et al, 2013), the idea of safety by design seems to offer a particularly powerful approach to circumvent these obstacles.…”

Making Nanomaterials Safer by Design?

“…Moreover, scientisation disregards the fact that risk-related decisions are inherently political choices. Societal interests and values cannot be disentangled from risk assessment because it is always people who decide what counts as a risk and which and how many data are considered essential for performing the assessment [17]. A main deficit of existing SbD concepts is that they do not account for the fact that safety is always a matter of interpretation.…”

Expert stakeholders’ perception of nanotechnology: risk, benefit, knowledge, and regulation

“…Nanotechnology has great promise, but there are still concerns about the safety of engineered nanomaterials and nanotechnology applications, leading to several risk management and regulatory challenges. The toxicity of manufactured nanoparticles is not entirely predictable from the toxicity of the source materials in bulk or molecular form, and assessing the toxicity of nanomaterials is demanding due to systemic and structural complexities and physical-chemical-biological interactions at the nano level for any specific nanomaterial (Miller and Wickson 2015;Renn and Roco 2006). Although there is a growing body of research into the toxicity of various engineered nanoparticles, uncertainty remains about future use, exposures, and long-term effects regarding ecosystems and human health (Fadeel et al 2017).…”