Final Report Summary - 4FUN (The FUture of FUlly integrated human exposure assessment of chemicals: Ensuring the long-term viability and technology transfer of the EU-FUNded 2-FUN tools as standardised solution) Executive Summary:Current exposure assessment is recognised by many as a weak point in ecological and human health risk assessment due to a lack of integrated approaches for combined stressors, widespread use of over-conservative ‘worst-case’ scenarios, estimation of only external and not internal exposures and a lack of uncertainty and sensitivity analysis for the identification of key exposure drivers. To overcome these drawbacks, the FP6 project 2-FUN produced a prototype software containing a library of models for exposure assessment, coupling environmental multimedia and pharmacokinetic models. The main objectives of the 4FUN project were to further improve and standardise the 2-FUN tool and guarantee its long-term technical and economic viability. Therefore, stakeholder requirements were identified and an analysis of the strengths, weaknesses, opportunities and threats (SWOT) of existing exposure assessment tools was conducted. The 2-FUN tool was subject to rigorous standardisation, which includes verification, benchmarking, documentation and demonstration. To demonstrate the reliability of modelling estimations and the feasibility of building complex realistic scenarios, three case studies based on actual datasets were performed. The improved and standardised 2-FUN software, named MERLIN-Expo, was delivered, together with supporting documentation and training courses. The training events were organised in such a way as to reach out to as many people as possible in different locations across the EU and promote the tool. The aim was also to raise the skill level of regulators and enable a community of users to develop.MERLIN-Expo answer the present conundrum of coupling environmental multimedia and pharmacokinetic models. It is equipped with a flexible modular format, pharmacokinetic considerations, and uncertainty and sensitivity analysis functionality. MERLIN-Expo can enable robust, regulatory-relevant environmental and exposure assessments with ease and transparency. At a time when chemical risk assessment to human health is a major concern for policy and industry regulators alike, the need of such a tool has never been more evident. Project Context and Objectives:The main objectives of the 4FUN project were to further improve and standardise the 2-FUN tool and guarantee its long-term technical and economic viability. In order to achieve these aims the work plan for 4FUN was broken down into 7 work packages dedicated to consortium management (WP1), research (WP2-4) and demonstration (WP5) related activities, as well as dissemination and exploitation activities (WP6-7).In particular the main objective of WP2 ‘SWOT analysis of exposure assessment tools’ was to identify strengths and weaknesses of the 2-FUN tool. Therefore a list of existing exposure tools was done, and the criteria to be included in the an analysis of the strengths, weaknesses, opportunities and threats (SWOT) were developed. The SWOT analysis was done for the selected exposure tools, including 2-FUN, to identify gaps between current and desired conditions. Key stakeholders and regulatory frameworks for exposure assessment were identified. An analysis of the market environment was performed. Furthermore, projects related to software initially developed in the frame of European/national research projects and widely disseminated among the scientific/regulatory/consultant world were analysed in order to learn from previous experiences. Results from other work packages were used in WP3 (‘Updating the 2-FUN tool to meet stakeholders requirements’) as an input for upgrading the 2-FUN tool to satisfy stakeholder requirements. In particular WP3 took into account technical recommendations for improvement resulted from WP2, specifications resulting from case studies, specifications for market dissemination developed in WP7. An important decision from the SWOT analysis and case study specifications was to extend the applicability domain of the tool, to be able to contribute to Human Exposure Assessment but also to Ecological Exposure Assessment. The new upgraded 2-FUN tool was named MERLIN-Expo. The main objective of WP4 (‘Documentation, verification and benchmarking processes of the 2-FUN tool’) was to produce standardised documentation to build confidence in the tool through verification and benchmarking and to facilitate assimilation by end-users. Standardisation framework for large exposure models was set. In addition, a CEN (European Committee for Standardization) Workshop Agreement (CWA n. 16938) was done in order to establish terms and definitions for exposure models and their elements, specifies minimum requirements for the amount and type of information to be documented on exposure models, and proposes a structure for communicating the documentation to different users. A verification process was performed together with benchmarking. All the models included in the MERLIN-Expo library are documented according the CEN standard previously indicated. WP5 (‘Demonstration of the 2-FUN tool via the creation of a case studies library’) focused to increase the confidence in the applicability of the MERLIN-Expo through targeted demonstration activities based on complex realistic case studies. In particular, WP5 aimed at demonstrating: the reliability of the modelling predictions through a comparison with actual measurements; the feasibility of building complex realistic exposure scenarios satisfying the needs of stakeholders; and how uncertainty margins can improve risk governance. The objectives of WP6 (‘Dissemination and training for technology transfer towards end-users, especially SMEs’) were: to disseminate MERLIN-Expo; to coordinate the activities to ensure that the tool is suitable for regulatory use in the EU, within the context of the relevant regulatory frameworks; to develop user-friendly guidance suitable for consideration by the relevant end-users. The main goal of WP7 (‘Long-term viability’) was to ensure that the MERLIN-Expo tool will be recognised in the long term as a standard, widely used tool, that further improvements/extensions will be guaranteed and that the financing of these activities will be supported by a sustainable business model.Above all these WPs, WP1 (‘Coordination and management’) aimed at ensuring the scientific, technical and administrative management of the consortium for the achievement of the project objectives. WP1 took care of the successful implementation of the project, applying administrative management and cooperating closely with partners, stakeholders and the European Commission.Project Results:Major achievements for each work package are reported here.WP2: SWOT analysis of exposure assessment tools• Overview of currently available exposure models and identification of 60 multimedia models;• Relevant aspects, features, functionalities related to exposure models were identified and translated into a set of evaluation criteria, which were written as questions to be submitted to experts;• A comprehensive list of criteria was set up to perform the SWOT analysis of MERLIN-Expo model and currently existing exposure models;• Application of multi-criteria decision analysis to 14 models;• The SWOT analysis allowed evaluating strengths, weaknesses, opportunities, and threats of MERLIN-Expo model;• A stakeholder consultation with 51 stakeholders from 7 countries was carried out to identify the needs of exposure model users;• Six groups of potential customers were identified.WP3: Updating the 2-FUN tool to meet stakeholder requirements• Based on the SWOT analysis, the applicability domain of the tool was extended to contribute to human exposure assessment and to ecological exposure assessment;• Definition of a list of priority substances;• Parameterisation of all models included in the tool;• Improvement of soil model to better represent degradation and exchange with atmosphere;• Improvement of river model for aquatic biota and PBPK model;• Migration of 2-FUN models to Ecolego 6;• River, soil, fish, phytoplankton, fruit tree, leaf, root, tuber, and human (PBPK) models available in the library of the MERLIN-Expo tool;• The user interface was completely overhauled to allow users to easier navigate between different screens;• The library functionality was updated to allow several models to share parameter data• Models in MERLIN-Expo put much higher stress on the simulation engine.WP4: Documentation, verification and benchmarking of the 2-FUN tool• Literature review of documentation frameworks (e.g. US-EPA guidance on model development, OECD framework for QSARs, etc.);• Development of Standard Documentation Protocol (SDP) to satisfy pre-defined specifications (comprehensive information, 4-level hierarchical structured documentation for different end-users);• A standard documentation of chemical exposure models proposed in a new CEN (European Committee for Standardization) workshop agreement (CWA 16938), which is available on the market and can be purchased on-line on National Standardization Bodies websites;• All MERLIN-Expo models were documented according to standard (CWA 16938) and are available at http://merlin-expo.eu/learn/documentation/model-documentation/; • The models of MERLIN-Expo library were verified by assessing implementation against the standard documentation. The verification procedure included the inspection of the definition and the equations or the values of each model component; • A sanity check was carried out to assure that the models run with default values and simple inputs;• Benchmarking of the multimedia models was completed by comparing the results obtained for specified reference scenarios using MERLIN-Expo and EUSES;• For the PBPK model, the benchmarking was carried out by simulating the scenarios from studies published in scientific literature and comparing the model predictions to actual experimental data.WP5: Demonstration of the 2-FUN tool via the creation of a case studies library• MERLIN-Expo was tested on three case studies exhibiting different characteristics in order to cover a wide range of substances, contamination sources, environmental policy endpoints, spatial/temporal scales;• Default values are now provided in MERLIN-Expo and guidance on how to obtain additional, more specific data is given in the documentation of each model;• The availability of different options for uncertainty and sensitivity analysis in MERLIN-Expo is targeted to a wide range of end-users and should facilitate the incorporation of such issues in future decision making. These analyses provide valuable information for both risk assessors and decision-makers by supporting decisions to conduct additional analyses or prioritise resource allocations for additional research and/or data collection efforts;• The reliability of the predictions obtained by MERLIN-Expo was assessed; in most cases, a factor less than 3 was observed between the model predictions and the actual experimental data;• The flexibility in building realistic site-specific scenarios in an intuitive fashion was demonstrated. The case studies offered the opportunity to explore the applicability of the tool at several levels of complexity, ranging from very simple to rather complex scenarios;• Incorporating uncertainty and sensitivity analyses in risk assessment. This is in line with the recommendations of international agencies and makes MERLIN-Expo an appealing tool for advanced exposure assessment;• Participating to the evolution of MERLIN-Expo by developing new modules or features that could further facilitate scenario building and/or the interpretation of the results.WP6: Dissemination and training for technology transfer towards end-users, especially SMEs• Definition of name and logo for the tool;• Setup of internal partner collaboration site, web-platform to access the tool and website with additional information;• Internal training course held in Paris 2013 with preparation of initial training materials;• Creation and implementation of 4FUN European observatory;• Dissemination of results at several scientific conferences – SETAC, SRA-E, ICESEC, etc…;• Partners submitted a book project to SPRINGER and a special issue for publication in STOTEN;• Six trainings events were successfully performed at several locations;• Around one hundred persons participated to the trainings;• An on-line training programme was developed;• Full package of dissemination materials used for the trainings was developed;• On-line tutorials were created;• The summer school in Cremona was supported by SETAC and included in the CRA program of SETAC;• MERLIN-Expo was disseminated to people belonging to different institutions in Europe (e.g.: JRC, ANSES, EFSA, ECHA).WP7: Long-term viability• Detailed analysis of the market environment • Definition of business model, business plan and sales/marketing plans as well as governance model • Revision of the models after the review feedback and based on additional information gathered throughout the projectPotential Impact:The 4FUN consortium produced the MERLIN-Expo tool that combines external/internal exposure, emerging chemicals and uncertainty/sensitivity analyses, it is considered to prepare the future in exposure regulation. Moreover the tool can be easily used by end-users, because of its flexibility, its standardised documentation and the training material available (on-line training included). The software is an advanced tool for higher tiers in exposure assessment; it includes dynamic modelling, a wide range of chemicals, uncertainty and sensitivity analysis, probabilistic simulations and a combination of health exposure assessment and environmental exposure assessment. Equipped with a flexible modular format, pharmacokinetic considerations, and uncertainty and sensitivity analysis functionality, MERLIN-Expo can enable robust, regulatory-relevant environmental and exposure assessments with ease and transparency. At a time when chemical risk assessment to human health is a major concern for policy and industry regulators alike, the need of such a tool has never been more evident.During the 4FUN project a standard documentation of chemical exposure models has been proposed in a new CEN workshop agreement (CWA 16938). CEN, the European Committee for Standardization, is an association that brings together the National Standardization Bodies of 33 European countries. The CWA was developed together with other stakeholders and establishes terms and definitions for exposure models and their elements, proposes guidelines for a tiered presentation of the information and proposes a structure for communicating the documentation to different users. The aim of this CWA was to make model description more transparent, comprehensive and unambiguous. This document is applicable to the documentation of a wide range of exposure models (quantitative and non- quantitative), including environmental models describing the chemical fate in different media, environmental models describing the chain of chemicals from the environment to humans, and human exposure models.The main dissemination activities performed in the project were: - The project website (http://4funproject.eu/ ) was set up to inform the public, the stakeholders and the scientific community about the 4FUN project itself and its status and results. The is updated on a regular basis. - From the web-based platform (merlin-expo.eu) the users can download the latest version of the MERLIN-Expo and all the accompanying documentation. Furthermore, video tutorials, training materials, documentation developed in WP6 can be freely downloaded. The platform facilitates and encourages collaboration and the exchange of knowledge and experience in exposure and risk assessments using the tool. - Three flyers were made: a brochure with general information about the project; a flyer was made to largely promote all the upcoming training events; a specific flyer aimed at promoting the Cremona summer school. - a project poster showed the general outline of the project and the expected results.- The online professional network LinkedIN and also Facebook were used to spread information in a cost- and time-efficient manner to an appropriate audience. - Several video tutorials describing the functioning and the processes behind the different part of the MERLIN-Expo tool were made; the first internal training was recorded and uploaded on the web-based platform; a short video about the MERLIN-Expo tool is being finalized and will be published on the project website; the last workshop held in September 2015 in Brussels was recorded and is available in the project platform. - A special issue was planned and will be published in the journal “Science of the Total Environment” in 2016. - Six training courses were organised and training material was prepared. - A training course was made on-line on the OpenTEA platform (http://opentea.eu/). - CORDIS wire, the European Commission's Research and Development Information Service, was used to publish a number of press releases. CORDIS Wire offers visibility to externally generated information on research and innovation. The following press releases were published: a general press release about the project; a press release about the CEN Workshop for the standardisation procedure; a press release promoting and informing about the 4FUN Observatory; a press release about the Regulators’ Workshop held in Paris (which was the first training event); a press release to promote the stakeholder workshop organised in Brussels, on 17th September; a press release to inform about the CEN Workshop Agreement about the standardisation process of the model documentation; a press release about the CEN Workshop Agreement for Standard documentation of chemical exposure models. - Two newsletters were sent to all the contacts of the 4FUN stakeholder database, in order to disseminate the project and the main events organised by the consortium. Furthermore, news on the project were reported in Newsletter produced by some partners of the consortium. - A QR code was made for the 4FUN project to give to interested persons the possibility to gather quickly information on the project from the internet. - A project roll-up was made to briefly describe the objectives of the MERLIN-Expo tool and to disseminate the online training course. - For the trainings give-away materials (such as USB, bag, notes and pens) were made and distributed to the participants. - A first webinar ‘The MERLIN-Expo tool - General introduction’ was held by Philippe Ciffroy on the online training platform (http://www.opentea.eu/en/e-learning/courses-The-Future-of-Environmental-and-Human-Health-Exposure-Modelling-of-Chemicals.10/#webinars) A list of national and international conferences where the 4FUN partners presented the project results is reported below: - SETAC Europe Annual Meetings (2013, 2014, 2015) - SRA-E Conference (The Society for Risk Analysis – Europe) (2013) - ICESEC 2013 - First International Conference on Environmental Safety and Ecological Criteria (co-organized by SETAC Asia-Pacific) - Conference of the International Society of Environmental Epidemiology (ISEE), the International Society of Exposure Science (ISES), and the International Society of Indoor Air Quality and Climate (ISIAQ) (2013) - “GLOCOM” seminars held in Beijing (China) (2014, 2015) - York Conference: Pesticide Behaviour in Soils, Water and Air (2013) - International Symposium on Environment and Health (co-organized by SETAC Asia-Pacific and Society of Environmental Geochemistry and Health) (2014) - 13th International Congress on Pesticide Chemistry (IUPAC) (2014) - CABERNET 2014: Tailored & Sustainable Redevelopment towards Zero Brownfield. 4th International Conference on Managing Urban Land. - XV Congress of the Division of Environmental Chemistry and Cultural Heritage of the Italian Society of Chemistry (2015) - ICCE2015 - 15th EuCheMS International Conference on Chemistry and the Environment (2015) - Symposium in Pesticide Chemistry (2015) The consortium has got high motivation to maintain and further develop MERLIN-Expo. In particular, three different needs were identify for the future: 1. Maintenance: the basic maintenance includes the website, a FAQ page, basic support to end-users, and an electronic forum. The website will be active for another 12 months and afterwards the 4FUN Observatory page will be moved to the MERLIN-Expo site. 2. Development: new features/models/chemicals could be added to the tool, depending on resources and requests; another possible development could be the extension of the applicability domain. The development of new models will be possible in the frame of other projects or in internal activities (by internal partners) or by external parties. The development of models should follow standard documentation and verification procedures. 3. Dissemination: on-site training sessions, on-line training, webinars could be organized in the future to disseminate the tool. As far as the trainings are concerned, the consortium agreed that future training events need to be charged. Webinars are considered a good vehicle with defined topics. A number of 4FUN partners are available as contributors. List of Websites:More information available on the 4FUN website: http://4funproject.eu/ and on the web-based platform: http://merlin-expo.eu/ final1-logo-4fun-def.jpg final1-logo-merlin-expo-colours.jpg Related documents final1-4fun_poster-01-2014-12-22_final.pdf final1-merlin-expo_flyer_final.pdf final1-4fun_flyer_final.pdf
