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  • Periodic Report Summary 2 - GUIDENANO (Assessment and mitigation of nano-enabled product risks on human and environmental health: Development of new strategies and creation of a digital guidance tool for nanotech industries)
FP7

GUIDENANO Report Summary

Project ID: 604387
Funded under: FP7-NMP
Country: Spain

Periodic Report Summary 2 - GUIDENANO (Assessment and mitigation of nano-enabled product risks on human and environmental health: Development of new strategies and creation of a digital guidance tool for nanotech industries)

Project Context and Objectives:
Current uncertainties on the safety of nano-enabled products need to be urgently and carefully addressed. Otherwise, public fears could end up blocking the benefits of nanotechnology. Sound scientific information must be generated to identify potential risks of nano-enabled products on human and ecosystems health and, when considered unacceptable, efficiently mitigate such risks. This has to be done in a holistic manner, taking into consideration all stages of the life cycle of these products as the materials are prepared along the project when requested by WP3, WP5 and WP6.
Numerous guidance resources have been generated on isolated parts of the risk assessment process. However, most of these consist on extensive papers documents of difficult use by industry. Some web-based control banding tools are also available, but these mainly focus on the worksite and are mainly intended at the identification of hotspots rather than a complete risk assessment.
The main objective of GUIDEnano is to develop innovative methodologies to evaluate and manage human and environmental health risks of nano-enabled products, considering the whole product life cycle: synthesis of NM, manufacturing of NM-enabled products, use, and end-of-life phase. These developments are incorporated into an interactive web-based Guidance Tool, which guide the NM-enabled product developers (mainly industry) into the design and application of the most appropriate risk assessment & mitigation strategy for a specific product. The correct implementation of this guidance ensures that the risks associated with a NM-enabled product, throughout its whole life cycle/ value chain, have been appropriately evaluated and mitigated to an acceptable level, according to the most recent knowledge at the time of implementation. The evaluation of a NM-enabled product using this Tool is also useful for risk communication to regulators, insurance companies, and society.
In order to achieve the web-based Guidance Tool, a series of goals are addressed along the project:
1. To develop methodologies to evaluate the risks of a wide diversity of nano-enabled products on human and environmental health, throughout their life cycle. This means to develop methodologies to determine NM release along the whole life cycle; NM occupational, consumer and environmental exposures; NM environmental fate and transformations; and NM toxicity and ecotoxicity for hazard assessment. Moreover, a risk evaluation strategy and decision flow needs to be developed, as a sensitivity/uncertainty analysis.
2. To develop innovative solutions to reduce the identified risks. A wide range of risk mitigation strategies and guidance on the selection of the most appropriate measures for each scenario associated to an unacceptable risk are provided. This includes exposure control measures to reduce exposure, nano-specific waste management treatments (including recycling) to reduce NM release to the environment and safer-by-design measures to reduce (eco)toxicity, release and/or environmental persistency.
3. To integrate the risk evaluation and mitigation strategies into the GUIDEnano Tool and to carry out an iterative process of performance testing, feedback and improvement steps to validate its suitability and applicability to real-case NM-enabled products, including a detailed plan for the hosting and maintenance of the GUIDEnano Tool after the life time of the project.
4. To efficiently communicate to consumers, regulators and insurance communities that, by following the GUIDEnano Tool, risks associated with an NM-enabled product have been adequately identified, evaluated and mitigated across the whole of their life cycle. Thus, ensuring that workers, consumers and environmental health have been appropriately protected, and facilitating social acceptance, regulatory control, and insurance activities related to nanotechnologies.

Project Results:
In the period from 18-36 months of the project the main objective was to deliver the second version of GUIDEnano Tool. To reach this specific goal all the technical WPs (WP3-8) work further on the refinement as well as on developing further methodologies/ strategies on their specific areas to be integrated within the risk assessment approach of GUIDEnano (WP7), working in close collaboration with WP9 (tool developers). This theoretical work focused on improving the conceptual knowledge in the different modules (frameworks) already implemented in the first version of the Tool and on the generation and implementation of new knowledge in some of the less developed modules (frameworks). Furthermore, experimental work was designed and performed in order to cover gaps that are then contributing to the refinement of roles or creating new ones, to be included in the conceptual knowledge of the GUIDEnano Tool. Finally, dissemination material was prepared to publically present the GUIDEnano Tool to stakeholders and other potential users. The complexity and consequent potential of the Tool was presented in a dedicated workshop organized in the context of NanoSafe conference in Grenoble (November the 10th)
More specifically, technical WPs have developed/ provided the following outcomes:
WP3 (release), in collaboration with WP4 (human exposure), has created an activity card library in which the release values (and forms) for each type of process involved in the different life-cycle stages of the nano-enabled products are defined. This activity card library is being implemented in the current version of the GUIDEnano Tool. Regarding the experimental work, different release assessments on GUIDEnano case studies have been performed in order to evaluate the release ratio and form. Furthermore, released materials were produced or collected for their toxicological evaluation. Different safer by design strategies have been implemented in different GUIDEnano case studies mainly focused on reducing the release of nanomaterials from products during their different life cycle stages. A scheme for the determination of exposure was developed to be implemented in the GUIDEnano Tool. There are two generic ways to determine the exposure in the Tool: via release data converted into exposure data by using a dispersion model or via input of exposure data/ from existing exposure models. For the exposure modeling, the exposure scenario library (ESL) developed within the MARINA project was linked to the GUIDEnano Tool (44 additional scenarios are included based on measured in exposure chamber and at the workplace). For cases in which the user has no activity card and therefore no release/exposure data available for the Assessment Scenario (AS) guidance is given to determine the similarity, relevance & quality of a data source of comparable scenarios found in literature.
The conceptual fate model framework (WP5), focused on the NM fate and behavior in the considered compartments, was developed and implemented in the GUIDEnano Tool. The experimental validation of the assumptions made during the establishment of the fate model, and also the experimental work performed to fulfill data gaps, lead to a continuously update of the fate world model, including the development of new analytical equations to describe specific NP fate processes. The experimental work was design to: i) determine the validity of the transfer factor as the key parameter in the WWTP fate model, ii) determine the relationships between NM, soil properties and fate descriptors (ka, kd, kt), iii) quantify the migration parameters of different nZVI in the subsurface, and iv) quantify kinetic rates for dissolution, aggregation and sedimentation in freshwater, and determination of the main components present in the environmental compartment dictating these kinetic rates. Moreover, experimental work was performed with the safer-by-design NMs to determine their fate and bioavailability to the organisms.
A wide range of (eco)toxicity studies (WP6) have been performed to further understand how some physicochemical properties of NMs determine toxicity. Results were used to determine whether rules can be derived for assessing the hazard of coated nanomaterials. The physicochemical properties that are considered critical in assessing similarity between NMs in different toxicity evaluation contexts (administration route or toxicity endpoint) have been identified. Algorithms to systematically score the similarity between two NMs for each of the properties selected have been defined.
The risk assessment strategy (WP7) was updated, which is a continuous ongoing process, based on new insights and discussions with various project partners from different WPs, including the tool developers. The currently chosen (deterministic) strategy for RA is to derive one final value as an outcome for the hazard assessment, the safety limit value, instead of a distribution of values. The safety limit value will be compared to the exposure value (either one value or a distribution) in order to derive a risk characterization ratio (RCR). Within the developed RA strategy, three different types of factors are distinguished: Uncertainty, variability and modification factors. The prediction models, default values, assumptions and performance of the GUIDEnano Tool v2 were evaluated by the use of case studies either reported in the literature or hypothetical, depending on the availability of data from literature and regulatory sources. Different modules and versions of the Tool have been checked, although a final conclusion has been provided for the last version available.
Different types of NMs were synthesized (WP8), characterized and provided to the relevant WPs to be tested under different perspectives. A set of NMs were synthesized to test "general" SbD strategies (i.e.: increase the size of Ag NMs to reduce dissolution phenomena), or strategies "contextualized" in the case studies (i.e.: for ITEX case study: improve the NM compatibilization within the matrix, to reduce NM releases and therefore lowering exposure towards humans and the environment). PPEs commonly used by the industrial partners in the projects were evaluated. The experimental work included the selection and validation of the adequate experimental testing protocols and devices to measure the efficiency of the different RMMs. The data generated experimentally and data collected from literature contributed to the development of a database of Exposure Controls Measures and related efficiencies to include into the GUIDEnano Tool. The efficiency of some waste water treatment strategies was determined experimentally, treating samples from waste water fraction generated in the case studies. The data obtained provided information on the type of waste, their attributes, the treatment processes and related NM removal efficiency, to be further incorporated into the GUIDEnano Tool. SbD strategies were designed and developed focussing the efforts on reducing release of NM to the environmental compartments and provision of released NM to the relevant WPs.
Significant results for this period are v2 and v2.5 of the GUIDEnano Tool (WP9). V2.5 is the first version really showing the full potential of the GUIDEnano Tool. V2.5 is proving that an iterative and object oriented modelling approach is a successful and flexible way of dealing and integrating complex knowledge domains leading to concrete, maintainable and operational results.
Industrial partners were working together with Tool Developers and WP leaders (experts in each of the Tool modules Knowledge frameworks) in the implementation of the different case studies in the Tool v2 (WP10). They tested all the functionalities of the Tool to guide the user to the risk assessment running their own case study, with the data they did have available as well as data generated in the project in different WPs. The feedback from this first iteration in the implementation process has been reported back to the Tool developers for their consideration towards the GUIDEnano Tool v3.

Potential Impact:
At the end of the project, GUIDEnano project will release a tool that will determine the Risks of a NM or a nano-enabled product along its life-cycle (NM synthesis, product manufacturing, use and end-of-life) and will provide the Tool user a list of Risk Mitigation Measures that make the whole process safe. GUIDEnano Tool is being built upon the state-of-the-art on NM risk assessment, which has not yet been translated into regulatory guidance, and, so, the project will provide a Tool to be used by industry with the aim to complement existing regulations in different frameworks. By using this Tool, industry will be able to evaluate and efficiently mitigate possible health risks for workers, consumers and the environment associated to the use of nanotechnologies.
The risk assessment report generated by the GUIDEnano Tool will be designed to facilitate communication and acceptance by regulatory agencies, occupational safety and health agents, insurance companies, and consumer protection associations. Transparency in the risk assessment process, i.e. specific methodology and assumptions used, is crucial in such a new and scientifically-challenging framework that is constantly evolving and that does not yet benefit from internationally accepted risk assessment standards.
Economically, the impact the Tool will have on the nano-enabled materials industry will be significant, and fully dependent on the RMM proposed reduce the risks associated with the production of such materials. The impact of the Tool is already being evaluated for the 8 industrial sectors that have been selected as GUIDEnano case studies. Moreover the Tool and 2 of the case studies were presented to potential stakeholders and future adopters at a workshop in NanoSAFE 2016 Conference. The feedback in general was positive and the future benefits of the Tool were evident. The GUIDEnano Risk Assessment framework under development is very broad and therefore can be applied to other related substance even outside the nano knowledge domain. Products from sectors such as cosmetics and food, currently outside the scope of the Tool, will benefit from this approach. The time to market for new nano-enabled products and materials will shorten because industry is guided in a uniform, reproducible and testable way through all relevant steps of the risk assessment. Future dialogue with stakeholders and with the insurance sector will guarantee their confidence to implement the Tool as a risk assessment measure.
GUIDEnano will help implement the EC communication Regulatory Aspect of Nanomaterials (COM (2008)36629 and COM (2012)57230), which calls for improvement in the knowledge of characterization, hazards, exposure, risk assessment and risk management of NM. To maximize the impact of GUIDEnano, all the members of the consortium has been (and will be) actively participating/ organizing different type of events (conferences, workshops, trainings); cooperating with other projects, participating in discussion working groups at the national, European and international levels (CoRs, Nanosafety Cluster, OECD, ECHA...).
More specifically, for the generation the web-based Tool, GUIDEnano project was working on the technical part on: a) a methodology and a database to determine NM release/ exposure during the whole value chain of a product; b) a NM fate model that makes possible to determine the environmental zones where the NMs will end up, target ecosystem communities, exposure scenarios and the NM relevnt-aforms that the general population is exposed to; c) a methodology for hazard evaluation of NM, even when no specific data is provided/ available (read-across); d) nano-specific innovative solutions for risk management in industrial settings, including the efficiency of exposure control measures specific for NM This will positively impact on the different nanotechnologies as it will allow them to trustworthy work under safe conditions.

List of Websites:
www.guidenano.eu

Contact

Amro Satti, (Project Manager)
Tel.: +34 937882300
Fax: +34 937891906
E-mail
Record Number: 195928 / Last updated on: 2017-03-14
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