Innovation is wanted to provide solutions to societal needs and the planet’s diminishing resources. Nano-enabled products are contributing to renewable energies, clean air and water, food production, cancer diagnosis and treatment and antibiotic resistance and represent major areas of investment and growth for the European economy. Engineered nanomaterials (ENMs) incorporated into these products may have enhanced properties because of their very large surface area per unit weight. They can be coated with various substances and can be incorporated into many different carriers, both liquid and solid dependent on the application.
Manufacturers are well aware of the importance of safe working practices that ensure minimal release of ENM both within and around production plants. Increasingly they must have foresight into the full life cycle of the product. Combined with the economic need where possible to reuse precious elements, this foresight calls for knowledge of where and in what quantity and form ENMs could enter the environment and how these might transform in different environmental compartments. All of this impacts on any environmental effect of ENM and hence on risk management and regulatory obligations. This is all part of an assessment of chemical hazard and exposure leading to determination of risk and underpins the motivation to provide industry with an environmental assessment framework with guidance to ensure its effective enaction.
In NanoFASE work has been carried out to guide industry in their response to future nanomaterial regulatory obligations. NanoFASE seeks to advance the understanding of environmental fate: where ENMs end up during their lifecycle and what changes they may have gone through. This information can be used to model the predicted environmental concentration (PEC) of nanomaterials to which organisms in the environment could be exposed. NanoFASE has focussed on the exposure side of the risk equation, delivering mathematical tools that allow detailed exposure assessments. Such exposure information can then be combined with other research knowledge about hazard to deliver statements about potential risk.
In NanoFASE we have shown that many ENMs can undergo rapid transformation to a less hazardous form in the environment. Examples are sulfidation in waste water treatment plants (WWTP) or hetero or homo aggregation in other media. The NanoFASE Water-Soil-Organism (WSO) model takes this into account for exposure assessment, and indicates the importance for risk assessment of using appropriate hazard tests and values (which must be drawn from other research projects and the large scientific literature focussed for its part on the hazard side of the equation).
In NanoFASE we are road-testing our exposure assessment framework where possible using industrial case studies. Bridging industry requirements with the environmental science community has been an aim of our project and we have attempted to bring some realism to production volume estimates and release estimates while being clear that there is more work to be done to avoid overestimations and uncertainties in these quantities.
|The NanoFASE case studies of nano-enabled products can serve industry stakeholders by systematically highlighting potential emission routes during the life cycle of a product all of which can be checked during industry safety assessments. Depending on the industrial methods and applications performed at each life cycle stage, release rates and pathways to different environmental reactors will differ. NanoFASE therefore collected information for a detailed release pathway analysis through direct surveys of industry actors as well as from the literature, especially regarding the transformations ENMs might undergo during use or end-of-life release from products. On the way NanoFASE developed the first inventory of ENM production, ENM use and ENM release modelled at European Member State level for TiO2, Ag, ZnO, carbon black and Cu-based nanomaterials.|
The NanoFASE Clickable Framework provides a host of resources to understand exposure assessment of ENMs in the environment:
- Key processes of transformation that nanomaterials may undergo before, during and after being emitted into the environment;
- Fate descriptors that can be used to quantify rates of nanomaterial transformation in the different compartments or ‘reactors’ of the environment (air, soil, water and biota) as well as waste management installations;
- The NanoFASE Model Catalogue including the NanoFASE water–soil–organism (WSO) model.
Visit the Site Map to get a full overview of the 160 pages available here. They have for the most part been written with a broad range of stakeholders in mind.
The knowledge assembled here for the models, and in the NanoFASE technical reports and scientific deliverables, may be most directly applicable by experienced consultants assisting industry in the case where REACH registration is required – that is, in the case where production volumes reach the threshold amount of more than one tonne of nanomaterial per year (a figure that is not to be confused with the very much larger volume of manufactured products in which the produced ENMs would in turn be employed).
|"As a small company designing, developing and manufacturing new nanoparticle dispersions, we prefer to get a competent expert in for such an important obligation as filling out a REACH dossier. First of all, we have to be sure that we get it right – and secondly, the amount of time needed to address the dossier without the relevant experience would far surpass the time spent by the expert consultant to complete the process." - Dr Selina Ambrose, Promethean Particles (NanoFASE partner and supplier).|
While the NanoFASE Clickable Framework is not a live decision-support tool (exposure assessment cannot be run online here) we have included a detailed example of workflow – explaining how our mathematical algorithms and models fit into a tiered assessment, moving from a first-tier ‘back of envelope’ estimate of predicted environmental concentration, through to third-tier precise numbers that can be provided by NanoFASE models regarding the spatiotemporal distribution of nanomaterials. Use of a higher-tier model is useful in the case that lower-tier findings when compared with risk management standards indicate that more detailed assessment is required. We have road-tested this approach and each tier of assessment by considering a hypothetical scenario based on one of our case studies involving the application of a catalytically active form of titanium dioxide to roads to reduce vehicular exhaust pollution.
The model furthermore could be used to predict the consequences of an incident (e.g. spill or leak) in which a one-time high concentration input of ‘as manufactured’ particles enters the environment at a single location.
NanoFASE Industry Insights
NanoFASE benefitted from the collaboration of a range of industry partners and advisors, who supplied particles for the empirical work, developed advanced techniques and instruments that going forward will serve Europe and other regions, pilot-tested nano-enabled applications in controlled experiments to help refine our models, and/or participated in road-testing the models.
Three short interviews highlight different facets of the NanoFASE experience for some of these valued partners.
Promethean Particles design, develop and manufacture bespoke inorganic nanoparticle dispersions: providing these in liquid phase obviates inhalation risk and controls aggregation. They supplied bare and PVP-capped particles (CeO2, Fe2O3 and Fe3O4, TiO2, and CuO) for NanoFASE experiments on fate and behaviour of nanomaterials in aquatic and soil compartments.
Promethean’s Dr. Selina Ambrose stated that ‘manufacturers of nanoparticles have a responsibility to understand how they are transformed in the course of their life cycle and how they may affect (if at all) the environment. The information gained from NanoFASE is useful in customer dialogue: "We are proactive – These are the steps we are taking to understand what actually happens with our particles in the environment, and hopefully you can pass that information on". It reflects well on our clients too – some of them big multinational companies. There is normal societal pressure on them to ensure nanosafety. If this awareness and responsibility feeds on further up the supply chain it can only be a benefit.’
Malvern Panalytical is a leading provider of scientific instrumentation for the measurement of elemental concentrations, crystallographic structure, molecular structure, remote sensing, rheology, particle size, particle shape, particle concentration and more.
Dr. Phil Vincent stated that within NanoFASE, the work of Malvern Panalytical has been focused on development of automated sample handling, specifically, the development of the NanoSight Sample Assistant (integration of the autosampler with flexible experimental design functions and data processing within the software). Technical decisions were guided through discussions and project goals of the NanoFASE consortium: ‘What samples are regularly used? what information is important about the sample? and how could we improve the process or address any pains?’ Consortium partners who could participate as beta testers for the Sample Assistant were not found and so more structured feedback through the development lifecycle was not obtained.
Dr. Vincent went on to say of his company’s participation in NanoFASE: ‘Interaction with consortium partners has informed our understanding of what’s important to the academic research community in sample measurement of nanomaterial. This is focused on not just solving a problem in standard sample measurements but also digging into the goal of the measurement and identifying how as a company we can provide insight (e.g. moving away from a single sample measurement at a set timepoint in deionised water to time-resolved measurements of sample behaviour across relevant periods in a range of environmentally relevant media - supporting these measurements requires additional techniques). We now see this capability as a significant advancement on the information we provide to the research community. We believe Malvern Panalytical can now give a fuller picture of the properties, fate & behaviour of nanomaterial.’
Professor Barry Park (GBP Consulting Ltd) is a Chartered Chemist with long experience in both public and private advisory service and in developing commercially viable nano-enabled products. He was Chief Operating Officer at Oxonica plc, overseeing quality, intellectual property and regulatory affairs while his product development programmes led to commercialisation of the widely used sunscreen component OptisolTM and EnviroxTM, a fuel borne nanocrystalline catalyst.
Visit the Regulator and Academic stakeholder welcome pages.
|With thanks to our interviewees:|
Visiting Professor, Cranfield University