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NanoSafetyCluster - Compendium 2012 2 Background Strong proponents of nanotechnology, such as Lux Research, anticipate that “nanotechnology applications will affect nearly every type of manufactured good over the next ten years.” Nevertheless the promise by nanotechnology of a significant contribution in boosting the economy, living standards and improving the quality of life may be outweighed by the perceived occupational, environmental health and safety risks that it poses. Due to the lack of quantitative risk assessment, underwriting such risk is particularly difficult and may compel the underwriter community to refuse to insure nanotechnology industry in the fear of potential bankruptcy. Small and Medium Enterprises (SMEs), which are in the driving seat of nanotechnology innovation, are particularly vulnerable to such conditions as they lack resources to put expensive preventive measures in place to safeguard their workers’ health and safety. Owing to increasing knowledge in the nanotechnological development and Occupational Health and Safety issues, there is a new awareness that safety options should also include “smart” nanoparticle (NP) design (i.e. safe by design) to ensure effectiveness of preventive measure. Given the limited amount of information about the health risks associated with occupational exposure to NMs, the precautionary principle has suggested to take measures to minimize worker exposures. Research Institutions and Governmental Agencies have addressed specific efforts to clarify the nature and the extent of potential hazard raised by handling NMs and to provide a solid platform for nanotechnology occupational safety and health. Thus, a hierarchy of control measures as applied to inhalation and dermal risks, including elimination, substitution, process enclosure, engineering controls, procedural control, personal protective equipment (PPE) has been identified. All these measures have been implemented on a voluntary basis by some industries worldwide, but the majority of companies does not foresee unintentional release of NMs throughout the life cycle. Only recently, “Prevention through Design” (PtD) has been envisaged as a proactive tool to prevent possible exposure and risk. PtD is an approach (and in the U.S., a national initiative) to design out hazards rather than address them when there are exposures. Such an approach is particularly applicable to NMs at the molecular and process scales. At the molecular scale, there is potential for modification of molecules to retain commercial and scientific functionality while reducing toxicity. At the process scale, companies can look to the pharmaceutical industry for engineering controls that could be adopted for potentially hazardous NMs. 3 What is Sanowork The SANOWORK project is built around the promotion, development and implementation of “Elimination/Substitution” control strategies and proposes to fill the gaps that already delay their diffusion. In order to address nanomanufacturing industries needs, SANOWORK project propose sustainable Risk Remediation Strategies with a balanced approach between design for manufacturing and design for safety. The evaluation of proposed Risk Remediation Strategies will pass through a globally harmonized analysis and reporting of process/NMs performances, hazard data, emission/exposure collection, in relation to operational conditions and NMs physicochemical properties. The process/NMs performances and risk specific evaluation will be performed off line (NMs as delivered, provided by companies or surface engineered during the project, exposure scenarios at lab scale level) and on-site (NMs collected on-site, exposure scenarios at pilot scale level). The process and NMs performances, as well as exposure and hazard profiles, will be assessed BEFORE and AFTER the introduction of risk control extrasteps. We will develop and integrate NMs design options strategies within target processing lines as extra-steps for improving the efficiency of the process while preserving and/or increasing NMs performances. Health risk depending on the intrinsic hazard and exposure frequency/concentration level, will be evaluated according to NMs physico-chemical properties. Five strategies will be proposed based on NMs surface engineering so that exposure can be reduced but if exposure has accidentally occurred the health hazard would still be decreased. Based on the knowledge of NMs dispersion behaviour, a combination of selfassembled monolayer coating and tailored aggregation processes will be developed in order to decrease the hazard and/or emission potential of target NMs (strategies: I, II, III, V). The described strategies will be accompanied by a process of immobilization of NMs with an expected exposure potential (strategies: IV). The SANOWORK proposed strategies are industry-driven and will therefore comply with the following criteria: • satisfying the production requirements; • cost-effectiveness and suitability for large-scale production; • easy processing-line implementation for manufacturing nano-structured components; • decreasing exposure potential and/or health impacts, while preserving nano-scale properties. Manufacturing processes, relevant for different industrial sectors, were identified and the proposed ‘primary prevention’ of risk will be integrated within six processing lines and implemented at pilot scale level by companies involved in SANOWORK. The final goal is to develop and demonstrate the efficacy of “design options” based Risk Remediation Strategies, providing practical tools for: developing potentially useful safe design features; preventing NMs related worker injuries; reducing the need of expensive risk management measures; implement safe manufacturing processes. 3.1 Summary of SANOWORK’s key strengths KEY CONCEPT • Industrial driven strategies applied on-site to target processing lines. • Product design options for safer nanotechnology. • Decreased emission potential and/or human hazard, preserving the nano-scale properties. 256 Compendium of Projects in the European NanoSafety Cluster
• Practical risk assessment of NMs with a reasonable balance between health hazards and exposure data. KEY BENEFITS • Cost-effective tools for safer manufacturing processes. • Primary prevention of potential risks that can occur during worker manufacturing or customer use. 4 Organisation of SANOWORK The overall work plan is designed for 42 operational months and comprises 7 Work Packages (WPs). A schematic representation of the work plan is reported in Figure 1. Figure 1: Sanowork WPs description (Pert chart). An exposure scenario as requested by REACH deals with the collection of substance/product properties, operational conditions, risk management measures to take the exposure of workers to NMs under hazardous level. The SANOWORK S/T methodology is driven by the REACH definition of exposure scenario and establishes a synergy between WPs 2-6, in order to take as much indications as possible for the development of a safe worker exposure scenario. WP1 and WP8 are the Administrative and Scientific management workpackages, respectively. In this WP, we will implement a rigorous administrative management process to ensure the timely achievement of the project deliverables and the scientific excellence of each workpackage task. Table 1 Workpackages (WP) of SANOWORK WP Title Topic 1 Administrative Management This workpackage is aimed to: NanoSafetyCluster - Compendium 2012 WP2 is related to the assessment and analysis of the risks caused by the occupational exposure to SANOWORK target NMs, in different stages of their manufacturing life cycle. LEITAT will develop databases which will be versatile to include new data from other sources. The essential information on NMs characteristics, exposure potential and toxicity to be used for the risk assessment will be included from literature sources as well as from data generated in the project by WP3 and WP5 worker exposure and toxicological hazard characterization, respectively. The risk analysis will provide the inputs to: 1) evaluate the effectiveness of existing or proposed risk remediation strategies; 2) assist UL in transferring information to insurance companies. An occupational exposure assessment strategy (WP3), will be developed by INERIS. INERIS will collect exposure data 1) off-line, by semi-quantitative approach on as-delivered NMs and on chronic or accidental scenarios, at the lab scale (data useful for the so called RISK 1 assessment); 2) on-site, by a quantitative approach on processing lines (data useful for the so called RISK 2 assessment). It will also apply a control banding approach to risk assessment and management, providing data useful for a comparison between existing and proposed risk remediation strategies. The toxicological hazards (WP5) will be assessed by IOM, UNIPR and UNIPI. ISTEC will develop “Design Options” based Risk Remediation Strategies and evaluate NMs functional properties and their performances in relation to specific steps of the process. UL will assist ISTEC, INERIS, UNIPR, UNIPI and IOM providing a physicochemical characterization of NMs. PCHEM, NIRO, ELM, COL and LEITAT will develop industrial demonstration platforms to prove the integration of proposed risk control extra steps in different pilot lines (WP6), and make the industrial scenarios available for exposure assessment on-site. ISTEC will supervise the implementation of target processing lines and will assist UL for COST/BENEFIT evaluation. The results of the risk analysis (WP2) merged with COST/BENEFIT evaluation (WP6) of the proposed strategies will represent the basis for the definition of the safe worker exposure scenarios, tailored for each of the target processing line. In WP7 the results and other outputs of the project will be disseminated internally and externally, after appropriate intellectual property protections, as and when needed. The results of risk analysis and COST/BENEFIT evaluation will be disseminated and used to inform the industrial partners about the strategies to implement in their processes, in order to create a safer workplace environment. Sanowork is structured and organized around 4 technical Work Packages (WP2-6), beside project management and dissemination/exploitation of results (WP1, WP8 and WP7) - coordinate and manage the administrative, financial and legal-contractual activities of the project - ensure an accurate and on-time communication flow with the European Commission (EC) and the Compendium of Projects in the European NanoSafety Cluster 257
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Compendium of Projects in the Europ
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EDITED BY Michael Riediker, PD Dr.s
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CONTENTS NanoSafetyCluster - Compen
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Project Acronym ENNSATOX ENPRA EURO
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Foreword NanoSafetyCluster - Compen
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ENNSATOX ENgineered Nanoparticle Im
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The biological membrane and its dep
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distinguishes between the interacti
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Figure 10. Schematic representation
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WP5: • Permeability of NPs in hyd
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NanoSafetyCluster - Compendium 2012
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ENPRA RISK ASSESSMENT OF ENGINEERED
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vitro findings with in vivo models;
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protocols with real biological samp
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and it was organised in the frame o
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First Name Last Name Affiliation Ad
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EURO-NanoTox European Center for Na
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silver nanoparticles, iron nanopart
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The core functions of the Center, h
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8 Directory Table 1 Directory of pe
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HINAMOX Health Impact of Engineered
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High Resolution Electron Microscopy
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integrated risk assessment. Integra
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powders: What is the difference in
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InLiveTox Intestinal, Liver and End
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- to develop and validate a novel m
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environments, IEEE Industrial Elect
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INSTANT Innovative Sensor for the f
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complementary research which will l
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7 Copyright NanoSafetyCluster - Com
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ITS-NANO Intelligent testing strate
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approach to conveying the appropria
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in the discussion. The integration
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MARINA MANAGING RISKS of NANOMATERI
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for risk analysis, these tools need
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environmental ENM toxicity, but tox
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propose it as a Method Validation F
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and SiO2-NM200 and NM203, and a SiO
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ModNanoTox Modelling nanoparticle t
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3) To model environmental exposure
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Nanodetector European Network on th
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measurement interval. Measurements
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5 Directory Table 1 Directory of pe
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NANODEVICE Novel Concepts, Methods,
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ENP in order to be sure of their sa
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4.3 Exploring the association betwe
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NanoFATE Nanoparticle Fate Assessme
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or proteins associated with particu
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sludge. Information on rates of slu
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The exposures to be conducted will
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NanoFATE progression beyond the “
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Timing, hosts and locations of (grouped) events of NanoImpactNet

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