Frameworks and tools for risk assessment of manufactured nanomaterials

Abstract

Commercialization of nanotechnologies entails a regulatory requirement for understanding their environmental, health and safety (EHS) risks. Today we face challenges to assess these risks, which emerge from uncertainties around the interactions of manufactured nanomaterials (MNs) with humans and the environment. In order to reduce these uncertainties, it is necessary to generate sound scientific data on hazard and exposure by means of relevant frameworks and tools. The development of such approaches to facilitate the risk assessment (RA) of MNs has become a dynamic area of research. The aim of this paper was to review and critically analyse these approaches against a set of relevant criteria. The analysis concluded that none of the reviewed frameworks were able to fulfill all evaluation criteria. Many of the existing modelling tools are designed to provide screeninglevel assessments rather than to support regulatory RA and risk management. Nevertheless, there is a tendency towards developing more quantitative, higher-tier models, capable of incorporating uncertainty into their analyses. There is also a trend towards developing validated experimental protocols for material identification and hazard testing, reproducible across laboratories. These tools could enable a shift from a costly case-by-case RA of MNs towards a targeted, flexible and efficient process, based on grouping and read-across strategies and compliant with the 3R (Replacement, Reduction, Refinement) principles. In order to facilitate this process, it is important to transform the current efforts on developing databases and computational models into creating an integrated data and tools infrastructure to support the risk assessment and management of MNs.

Environmental risk assessment of engineered nano‐SiO2, nano iron oxides, nano‐CeO2, nano‐Al2O3, and quantum dots

“…The results from the present study can provide regulators a scientific foundation for a risk-based environmental policy regarding ENMs in the future. The present work will complement the growing number of risk-assessment frameworks that are proposed or under development to deal with the specific challenges existing in the risk-assessment process for ENMs (Hristozov et al 2016;Steinh€ auser and Sayre 2017).…”

The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies

“…This work has resulted in an array of nano‐specific or nano‐relevant experimental and modeling tools suited to address the complexity associated with the identity, biological, and environmental interactions of NMs in order to reduce the uncertainty in their risk assessment. These tools were comprehensively reviewed by Hristozov et al …”

“…This work has resulted in an array of nano-specific or nano-relevant experimental and modeling tools suited to address the complexity associated with the identity, biological, and environmental interactions of NMs in order to reduce the uncertainty in their risk assessment. These tools were comprehensively reviewed by Hristozov et al (32) These tools have been applied to generate extensive physicochemical, hazard, and exposure data sets. However, although a significant body of data exists for some NMs, for many (including next-generation) NMs, risk assessment is likely to be based on incomplete data sets.…”

Value of information analysis for assessing risks and benefits of nanotechnology innovation

“…Technology innovation is often stalled due to an inability to quantify benefits, costs and risks associated with new materials and products [1,2]. Nanotechnology is one example where benefits may be considerable but both uncertain product risk during the research and development phases as well as consumer and environmental risks during the use phase can be potentially large and very uncertain.…”