In: Journal of risk research: the official journal of the Society for Risk Analysis Europe and the Society for Risk Analysis Japan, Band 20, Heft 2, S. 277-298
All new technologies have an inherent risk, which is typically assessed alongside the development of applications of the technology. This is also the case for nanotechnology: a key concern in the case of engineered nanomaterials (ENMs) is that due to their very small size, NMs can reach areas such as the cell that are inaccessible to other materials, such as implants and drugs. As a result of their large surface area, NMs may be more reactive than other larger materials. The large physical and chemical variability of NMs, and the fact that small changes can have large consequences, mean that there is insufficient data on which to make safety or risk assessments at present. Thus, a widely supported scientific basis and sufficient high quality data upon which to base regulatory decisions are required urgently. NanoImpactNet (NIN) can support the development and dissemination of such data. This report presents the outcome of the discussions of 60 experts in the field of safety assessment of manufactured NMs from academia, industry, government and non-profit organizations on some of the critical issues pertaining to the development of standard protocols and reference materials for assessment of the potential hazards associated with ENMs. It should be noted here that there was a separate NIN workshop on determining the best metrics for assessing NP safety, and that this workshop was directed specifically to how best to standardise testing protocols and develop reference materials for human health assessment.
AbstractSocieties worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration of the complex issues that occur in this rapidly evolving research and development area. Here, we propose three sets of essential elements required to generate an effective risk governance framework for nanomaterials. (1) Advanced tools to facilitate risk‐based decision making, including an assessment of the needs of users regarding risk assessment, mitigation, and transfer. (2) An integrated model of predicted human behavior and decision making concerning nanomaterial risks. (3) Legal and other (nano‐specific and general) regulatory requirements to ensure compliance and to stimulate proactive approaches to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology.