Percorrer por autor "Bessems, Jos"
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- Developing human biomonitoring as a 21st century toolbox within the European exposure science strategy 2020-2030Publication . Zare Jeddi, Maryam; Hopf, Nancy B.; Louro, Henriqueta; Viegas, Susana; Galea, Karen S.; Pasanen-Kase, Robert; Santonen, Tiina; Mustieles, Vicente; Fernandez, Mariana F.; Verhagen, Hans; Bopp, Stephanie K.; Antignac, Jean Philippe; David, Arthur; Mol, Hans; Barouki, Robert; Audouze, Karine; Duca, Radu-Corneliu; Fantke, Peter; Scheepers, Paul; Ghosh, Manosij; Van Nieuwenhuyse, An; Lobo Vicente, Joana; Trier, Xenia; Rambaud, Loïc; Fillol, Clémence; Denys, Sebastien; Conrad, André; Kolossa-Gehring, Marike; Paini, Alicia; Arnot, Jon; Schulze, Florian; Jones, Kate; Sepai, Ovnair; Ali, Imran; Brennan, Lorraine; Benfenati, Emilio; Cubadda, Francesco; Mantovani, Alberto; Bartonova, Alena; Connolly, Alison; Slobodnik, Jaroslav; Bruinen de Bruin, Yuri; van Klaveren, Jacob; Palmen, Nicole; Dirven, Hubert; Husøy, Trine; Thomsen, Cathrine; Virgolino, Ana; Röösli, Martin; Gant, Tim; von Goetz, Natalie; Bessems, JosHuman biomonitoring (HBM) is a crucial approach for exposure assessment, as emphasised in the European Commission’s Chemicals Strategy for Sustainability (CSS). HBM can help to improve chemical policies in five major key areas: (1) assessing internal and aggregate exposure in different target populations; 2) assessing exposure to chemicals across life stages; (3) assessing combined exposure to multiple chemicals (mixtures); (4) bridging regulatory silos on aggregate exposure; and (5) enhancing the effectiveness of risk management measures. In this strategy paper we propose a vision and a strategy for the use of HBM in chemical regulations and public health policy in Europe and beyond. We outline six strategic objectives and a roadmap to further strengthen HBM approaches and increase their implementation in the regulatory risk assessment of chemicals to enhance our understanding of exposure and health impacts, enabling timely and targeted policy interventions and risk management. These strategic objectives are: 1) further development of sampling strategies and sample preparation; 2) further development of chemical-analytical HBM methods; 3) improving harmonisation throughout the HBM research life cycle; 4) further development of quality control / quality assurance throughout the HBM research life cycle; 5) obtain sustained funding and reinforcement by legislation; and 6) extend target-specific communication with scientists, policymakers, citizens and other stakeholders. HBM approaches are essential in risk assessment to address scientific, regulatory and societal challenges. HBM requires full and strong support from the scientific and regulatory domain to reach its full potential in public and occupational health assessment and in regulatory decision-making.
- FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovationPublication . Zare Jeddi, Maryam; Galea, Karen S.; Viegas, Susana; Fantke, Peter; Louro, Henriqueta; Theunis, Jan; Govarts, Eva; Denys, Sébastien; Fillol, Clémence; Rambaud, Loïc; Kolossa-Gehring, Marike; Santonen, Tiina; van der Voet, Hilko; Ghosh, Manosij; Costa, Carla; Teixeira, João Paulo; Verhagen, Hans; Duca, Radu-Corneliu; Van Nieuwenhuyse, An; Jones, Kate; Sams, Craig; Sepai, Ovnair; Tranfo, Giovanna; Bakker, Martine; Palmen, Nicole; van Klaveren, Jacob; Scheepers, Paul T. J.; Paini, Alicia; Canova, Cristina; von Goetz, Natalie; Katsonouri, Andromachi; Karakitsios, Spyros; Sarigiannis, Dimosthenis A.; Bessems, Jos; Machera, Kyriaki; Harrad, Stuart; Hopf, Nancy B.The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning the identification of appropriate data and metadata to be gathered, along with established procedures for their collection, documentation, and management. Furthermore, suitable approaches must be implemented to evaluate and ensure the quality of the data. Therefore, the 'Europe Regional Chapter of the International Society of Exposure Science' (ISES Europe) human biomonitoring working group (ISES Europe HBM WG) proposes the development of a FAIR Environment and health registry (FAIREHR) (hereafter FAIREHR). FAIR Environment and health registry offers preregistration of studies on exposure sciences and environmental epidemiology using HBM (as a starting point) across all areas of environmental and occupational health globally. The registry is proposed to receive a dedicated web-based interface, to be electronically searchable and to be available to all relevant data providers, users and stakeholders. Planned Human biomonitoring studies would ideally be registered before formal recruitment of study participants. The resulting FAIREHR would contain public records of metadata such as study design, data management, an audit trail of major changes to planned methods, details of when the study will be completed, and links to resulting publications and data repositories when provided by the authors. The FAIREHR would function as an integrated platform designed to cater to the needs of scientists, companies, publishers, and policymakers by providing user-friendly features. The implementation of FAIREHR is expected to yield significant benefits in terms of enabling more effective utilization of human biomonitoring (HBM) data.
- FAIREHR: a novel online research registry platform to advance global environmental and occupational health researchPublication . Galea, Karen S.; Brooker, Finlay; Rashid, Shahzad; Bader, Michael; Ait Bamai, Yu; Bessems, Jos; Beyene, Embialle Mengistie; Connolly, Alison; Costa, Carla; Deligannu, Pravina; Duca, Radu-Corneliu; Chbihi, Kaoutar; Eba, Kasahun; Ghosh, Manosij; Gonzales, Melissa; Harrad, Stuart; Haynes, Erin N.; Hopf, Nancy B.; Huang, Po-Chin; Jones, Kate; Kasiotis, Konstantinos M.; Chung, Ming Kei; Kil, Jihyon; Koch, Holger; Kwon, Jung-Hwan; Lin, Elizabeth Ziying; Louro, Henriqueta; Machera, Kyriaki; Magagna, Barbara; Menouni, Aziza; Mizuno, Yuki; Van Nieuwenhuyse, An; Nakayama, Shoji F.; Robert Pasanen-Kase; Pollock, Tyler; Quirós-Alcalá, Lesliam; Santonen, Tiina; Scheepers, Paul J.; Sepai, Ovnair; Bird, Emily; Serrano Ramòn, Blanca; Silva, Maria Joao; Souza, Gustavo; Stingone, Jeanette A.; Teitelbaum, L. Susan; Teixeira, João Paulo; Tranfo, Giovanna; Vekic, Ana Maria; Viegas, Susana; Xia, Yankai; Yunesian, Masud; Zare Jeddi, MaryamThe FAIREHR (Findable, Accessible, Interoperable, Reusable Environmental and Health Registry) platform is a state-of-the-art online registry for prospective harmonization of human biomonitoring (HBM). It was developed by the HBM working group of the Europe Regional Chapter of the International Society of Exposure Science (ISES Europe) and is supported by the HBM Global Network. FAIREHR is designed to harmonize HBM metadata and support the implementation of the FAIR (Findable, Accessible, Interoperable and Reusable) Guiding Principles throughout HBM studies or programs. The registry enables preregistration of HBM by capturing key metadata on study design, metadata management, and planned methods before participant recruitment. This process enhances transparency and reproducibility in environmental and occupational health research. FAIREHR includes both study-level and program-level metadata. Its harmonized metadata template facilitates the storage of results (measurement data) in repositories such as IPCHEM and PEH. Here we outline the unique features of the FAIREHR platform, emphasizing its role in increasing research visibility, improving metadata comparability and harmonization, and strengthening the exchange of information. By supporting the effective use of HBM data, FAIREHR is expected to yield significant benefits for researchers, policymakers, and the broader fields of environmental and occupational health.
- Guidance on minimum information requirements (MIR) from designing to reporting human biomonitoring (HBM)Publication . Jeddi, Maryam Zare; Galea, Karen S.; Ashley-Martin, Jillian; Nassif, Julianne; Pollock, Tyler; Poddalgoda, Devika; Kasiotis, Konstantinos M.; Esteban-López, Marta; Chung, Ming Kei; Kil, Jihyon; Jones, Kate; Covaci, Adrian; Ait Bamai, Yu; Fernandez, Mariana F.; Pasanen Kase, Robert; Louro, Henriqueta; Silva, Maria J.; Santonen, Tiina; Katsonouri, Andromachi; Castaño, Argelia; Quirós-Alcalá, Lesliam; Argelia Castaño; Lesliam Quirós-Alcalá; Lin, Elizabeth Ziying; Pollitt, Krystal; Ana Virgolino; Virgolino, Ana; Scheepers, Paul T.J; Mustieles, Vicente; Cañas-Portilla, Ana Isabel; Viegas, Susana; von Goetz, Natalie; Sepai, Ovnair; Bird, Emily; Gӧen, Thomas; Fustinoni, Silvia; Ghosh, Manosij; Dirven, Hubert; Kwon, Jung-Hwan; Carignan, Courtney; Mizuno, Yuki; Ito, Yuki; Xia, Yankai; Shoji F. Nakayama; Nakayama, Shoji F.; Makris, Konstantinos C.; Parsons, Patrick J.; Gonzales, Melissa; Bader, Michael; Dusinska, Maria; Menouni, Aziza; Duca, Radu Corneliu; Chbihi, Kaoutar; El Jaafari, Samir; Godderis, Lode; van Nieuwenhuyse, An; Qureshi, Asif; Ali, Imran; Costa Trindade, Carla; Teixeira, Joao Paulo; Bartonova, Alena; Tranfo, Giovanna; Audouze, Karine; Verpaele, Steven; LaKind, Judy; Mol, Hans; Bessems, Jos; Magagna, Barbara; Nasution Waras, Maisarah; Connolly, Alison; Nascarella, Marc; Yang, Wonho; Huang, Po-Chin; Heussen, Henri; Goksel, Ozlem; Yunesian, Masud; Yeung, Leo W.Y.; Souza, Gustavo; Vekic, Ana Maria; Haynes, Erin N.; Hopf, Nancy B.Human biomonitoring (HBM) provides an integrated chemical exposures assessment considering all routes and sources of exposure. The accurate interpretation and comparability of biomarkers of exposure and effect depend on harmonized, quality-assured sampling, processing, and analysis. Currently, the lack of broadly accepted guidance on minimum information required for collecting and reporting HBM data, hinders comparability between studies. Furthermore, it prevents HBM from reaching its full potential as a reliable approach for assessing and managing the risks of human exposure to chemicals. The European Chapter of the International Society of Exposure Science HBM Working Group (ISES Europe HBM working group) has established a global human biomonitoring community network (HBM Global Network) to develop a guidance to define the minimum information to be collected and reported in HBM, called the “Minimum Information Requirements for Human Biomonitoring (MIR-HBM)”. This work builds on previous efforts to harmonize HBM worldwide. The MIR-HBM guidance covers all phases of HBM from the design phase to the effective communication of results. By carefully defining MIR for all phases, researchers and health professionals can make their HBM studies and programs are robust, reproducible, and meaningful. Acceptance and implementation of MIR-HBM Guidelines in both the general population and occupational fields would improve the interpretability and regulatory utility of HBM data. While implementation challenges remain—such as varying local capacities, and ethical and legal differences at the national levels, this initiative represents an important step toward harmonizing HBM practice and supports an ongoing dialogue among policymakers, legal experts, and scientists to effectively address these challenges. Leveraging the data and insights from HBM, policymakers can develop more effective strategies to protect public health and ensure safer working environments.
- HBM4EU - Deliverable Report D 6.2. Revised set of key indicatorsPublication . Reynders, Hans; Van Campenhout, Karen; Mampaey, Maja; Gilles, Liese; Colles, Ann; Baken, Kirsten; Bessems, Jos; Schoeters, Greet; Ay, Derya; Lobo Vicente, Joana; Ganzleben, Catherine; Isidro, Glória; Louro, Henriqueta; Silva, Maria João; Uhl, Maria; Ubong, Dorothy; Sepai, Ovnair; Tarroja, Elena; Persoz, Charles; Barouki, Robert; Kobosil, Nicole; David, Madlen; Appel, Petra; Kolossa, Marike; Coertjens, Dries; Crabbé, Ann; Loots, Ilse; Covaci, Adrian; Antignac, Jean-Philippe; Debrauwer, Laurent; Fernandez, Mariana; Berglund, Marika; Blaha, Ludek; Esteban López, Marta; Scheepers, Paul; Tolonen, Hanna; Nørager., SofieThe current deliverable describes the process of revision of the first list of indicators (published in June 2017 as D6.1.) and presents the indicator leaflets ((see attachment 1) that link key results of HBM4EU to the objectives of the project as laid down in the description of action. These indicator leaflets already contain a lot of results on the revised list of indicators, and give very valuable information on the progress of HBM4EU in relation to the specific goals of the project. Combining the information from these leaflets in the frame of expected impacts will allow us to put forward conclusions towards impact and sustainability of HBM4EU. As such, this restructured list answers to the main comments on the first list of indicators from the task 6.5 partners, the Management Board, the Governing Board and the EU Policy Board, in concretu to: • Drastically reduce the number of indicators from 48 indicators (including 9 internal indicators) on the first list to 28 indicators on the revised list without losing essential information. Moreover by bundling related indicators we now have 22 indicator leaflets (and 1 overview leaflet); • Make the relationship between the indicators and the goals of HBM4EU more clear by structuring the list of indicators according to the overarching objectives and specific goals; • Use the indicators to say something about the impact of the HBM4EU project: the indicator leaflets were used to give input for the impact section of the periodic technical reporting 2018 to describe the progress made for the 5 expected impacts of HBM4EU. This exercise will be continued and ameliorated in the 2019 periodic technical reporting as more indicator leaflets will be available compared to 2018; • Link the indicators with the work on sustainability of HBM in Europe: the indicators were presented at the sustainability workshop in Paris. Participants indicated that they think the leaflets will be useful for institutional discussions, national hub meetings, meetings with policy makers and other meetings and that they would like to use them as soon as they are available. The added value of having indicators of success, is to monitor the implementation and achieved impact of HBM4EU. This will allow for a more efficient tracking of achieved goals. This deliverable will help to further optimize and revise the first set of indicators to monitor the implementation of the HBM4EU and the achieved impact. The indicators of success are written in a clear language, they are concise and capture the main achievements in the list of indicators that has been agreed amongst the partners. Therefore, they can be easily used by all partners across the consortium, the EU Policy Board and our HBM4EU ambassador Thomas Jackl.
- How to use human biomonitoring in chemical risk assessment: Methodological aspects, recommendations, and lessons learned from HBM4EUPublication . Santonen, Tiina; Mahiout, Selma; Alvito, Paula; Apel, Petra; Bessems, Jos; Bil, Wieneke; Borges, Teresa; Bose-O'Reilly, Stephan; Buekers, Jurgen; Cañas Portilla, Ana Isabel; Calvo, Argelia Castaño; de Alba González, Mercedes; Domínguez-Morueco, Noelia; López, Marta Esteban; Falnoga, Ingrid; Gerofke, Antje; Caballero, María del Carmen González; Horvat, Milena; Huuskonen, Pasi; Kadikis, Normunds; Kolossa-Gehring, Marike; Lange, Rosa; Louro, Henriqueta; Martins, Carla; Meslin, Matthieu; Niemann, Lars; Díaz, Susana Pedraza; Plichta, Veronika; Porras, Simo P.; Rousselle, Christophe; Scholten, Bernice; Silva, Maria João; Šlejkovec, Zdenka; Tratnik, Janja Snoj; Joksić, Agnes Šömen; Tarazona, Jose V.; Uhl, Maria; Van Nieuwenhuyse, An; Viegas, Susana; Vinggaard, Anne Marie; Woutersen, Marjolijn; Schoeters, GreetThe need for such information is pressing, as previous research has indicated that regulatory risk assessors generally lack knowledge and experience of the use of HBM data in RA. By recognising this gap in expertise, as well as the added value of incorporating HBM data into RA, this paper aims to support the integration of HBM into regulatory RA. Based on the work of the HBM4EU, we provide examples of different approaches to including HBM in RA and in estimations of the environmental burden of disease (EBoD), the benefits and pitfalls involved, information on the important methodological aspects to consider, and recommendations on how to overcome obstacles. The examples are derived from RAs or EBoD estimations made under the HBM4EU for the following HBM4EU priority substances: acrylamide, o-toluidine of the aniline family, aprotic solvents, arsenic, bisphenols, cadmium, diisocyanates, flame retardants, hexavalent chromium [Cr(VI)], lead, mercury, mixture of per-/polyfluorinated compounds, mixture of pesticides, mixture of phthalates, mycotoxins, polycyclic aromatic hydrocarbons (PAHs), and the UV-filter benzophenone-3. Although the RA and EBoD work presented here is not intended to have direct regulatory implications, the results can be useful for raising awareness of possibly needed policy actions, as newly generated HBM data from HBM4EU on the current exposure of the EU population has been used in many RAs and EBoD estimations.
- A human biomonitoring (HBM) Global Registry Framework: Further advancement of HBM research following the FAIR principlesPublication . Zare Jeddi, Maryam; Virgolino, Ana; Fantke, Peter; Hopf, Nancy B.; Galea, Karen S.; Remy, Sylvie; Viegas, Susana; Mustieles, Vicente; Fernandez, Mariana F.; von Goetz, Natalie; Vicente, Joana Lobo; Slobodnik, Jaroslav; Rambaud, Loïc; Denys, Sébastien; St-Amand, Annie; Nakayama, Shoji F.; Santonen, Tiina; Barouki, Robert; Pasanen-Kase, Robert; Mol, Hans G.J.; Vermeire, Theo; Jones, Kate; Silva, Maria João; Louro, Henriqueta; van der Voet, Hilko; Duca, Radu-Corneliu; Verhagen, Hans; Canova, Cristina; van Klaveren, Jacob; Kolossa-Gehring, Marike; Bessems, JosData generated by the rapidly evolving human biomonitoring (HBM) programmes are providing invaluable opportunities to support and advance regulatory risk assessment and management of chemicals in occupational and environmental health domains. However, heterogeneity across studies, in terms of design, terminology, biomarker nomenclature, and data formats, limits our capacity to compare and integrate data sets retrospectively (reuse). Registration of HBM studies is common for clinical trials; however, the study designs and resulting data collections cannot be traced easily. We argue that an HBM Global Registry Framework (HBM GRF) could be the solution to several of challenges hampering the (re)use of HBM (meta)data. The aim is to develop a global, host-independent HBM registry framework based on the use of harmonised open-access protocol templates from designing, undertaking of an HBM study to the use and possible reuse of the resulting HBM (meta)data. This framework should apply FAIR (Findable, Accessible, Interoperable and Reusable) principles as a core data management strategy to enable the (re)use of HBM (meta)data to its full potential through the data value chain. Moreover, we believe that implementation of FAIR principles is a fundamental enabler for digital transformation within environmental health. The HBM GRF would encompass internationally harmonised and agreed open access templates for HBM study protocols, structured web-based functionalities to deposit, find, and access harmonised protocols of HBM studies. Registration of HBM studies using the HBM GRF is anticipated to increase FAIRness of the resulting (meta)data. It is also considered that harmonisation of existing data sets could be performed retrospectively. As a consequence, data wrangling activities to make data ready for analysis will be minimised. In addition, this framework would enable the HBM (inter)national community to trace new HBM studies already in the planning phase and their results once finalised. The HBM GRF could also serve as a platform enhancing communication between scientists, risk assessors, and risk managers/policy makers. The planned European Partnership for the Assessment of Risk from Chemicals (PARC) work along these lines, based on the experience obtained in previous joint European initiatives. Therefore, PARC could very well bring a first demonstration of first essential functionalities within the development of the HBM GRF.
- Human biomonitoring in health risk assessment in Europe: current practices and recommendations for the futurePublication . Louro, Henriqueta; Heinälä, Milla; Bessems, Jos; Buekers, Jurgen; Vermeire, Theo; Woutersen, Marjolijn; van Engelen, Jacqueline; Borges, Teresa; Rousselle, Christophe; Ougier, Eva; Alvito, Paula; Martins, Carla; Assunção, Ricardo; Silva, Maria João; Pronk, Anjoeka; Schaddelee-Scholten, Bernice; Del Carmen Gonzalez, Maria; de Alba, Mercedes; Castaño, Argelia; Viegas, Susana; Humar-Juric, Tatjana; Kononenko, Lijana; Lampen, Alfonso; Vinggaard, Anne Marie; Schoeters, Greet; Kolossa-Gehring, Marike; Santonen, TiinaHuman biomonitoring (HBM) is an important tool to survey the internal exposure of humans which represents the real life chemical body burden to chemicals and/or their metabolites. It results from total exposure to chemical substances from different sources and via different routes. These substances may be regulated under different legislative frameworks on chemicals (e.g., environmental, occupational, food safety etc). In occupational health, HBM has long traditions to control the exposures at workplaces. By providing accurate data on internal exposure, HBM data can improve human health risk assessment (RA) for both the general population and workers. Although the past few years have shown good examples on the use of HBM in the RA of chemicals, there is still quite some work to be done to improve its use in a regulatory RA. Under the scope of the European Human Biomonitoring Initiative (project HBM4EU, 2017-2021), the current study reviews the state-of-the-art of HBM use in chemicals RA with a special focus in Europe, and attempts to identify hurdles and challenges faced by regulators. To gather information on the use of HBM, including the availability of guidance on how to use it in RA, the RA schemes applied by different European or international organizations were analysed. Examples of such use were identified for a few selected groups of chemicals of concern for human health. In addition, we present the results of a survey, aimed at collecting information from national regulatory risk assessors on their day-to-day RA practices, the use of HBM data, and the obstacles and challenges related to their use. The results evidenced and explained some of the current obstacles of using HBM data in RA. These included the lack of HBM guidance values or biomonitoring equivalents (BEs), limited toxicokinetic information to support the interpretation of HBM data and, in the occupational health and safety (OSH) field, the lack of legal enforcement. Therefore, to support the integration of HBM in regulatory RA, we recommend, on one hand, the elaboration of a EU level guidance on the use of HBM in RA and, on the other hand, the continuation of research efforts to integrate HBM with new RA approaches using in vitro/in silico data and Adverse Outcome Pathways (AOPs).
- Interpreting biomonitoring data: Introducing the international human biomonitoring (i-HBM) working group's health-based guidance value (HB2GV) dashboardPublication . Nakayama, Shoji F.; St-Amand, Annie; Pollock, Tyler; Apel, Petra; Bamai, Yu Ait; Barr, Dana Boyd; Bessems, Jos; Calafat, Antonia M.; Castaño, Argelia; Covaci, Adrian; Duca, Radu Corneliu; Faure, Sarah; Galea, Karen S.; Hays, Sean; Hopf, Nancy B.; Ito, Yuki; Jeddi, Maryam Zare; Kolossa-Gehring, Marike; Kumar, Eva; LaKind, Judy S.; López, Marta Esteban; Louro, Henriqueta; Macey, Kristin; Makris, Konstantinos C.; Melnyk, Lisa; Murawski, Aline; Naiman, Josh; Nassif, Julianne; Noisel, Nolwenn; Poddalgoda, Devika; Quirós-Alcalá, Lesliam; Rafiee, Ata; Rambaud, Loïc; Silva, Maria João; Ueyama, Jun; Verner, Marc-Andre; Waras, Maisarah Nasution; Werry, KateHuman biomonitoring (HBM) data measured in specific contexts or populations provide information for comparing population exposures. There are numerous health-based biomonitoring guidance values, but to locate these values, interested parties need to seek them out individually from publications, governmental reports, websites and other sources. Until now, there has been no central, international repository for this information. Thus, a tool is needed to help researchers, public health professionals, risk assessors, and regulatory decision makers to quickly locate relevant values on numerous environmental chemicals. A free, on-line repository for international health-based guidance values to facilitate the interpretation of HBM data is now available. The repository is referred to as the "Human Biomonitoring Health-Based Guidance Value (HB2GV) Dashboard". The Dashboard represents the efforts of the International Human Biomonitoring Working Group (i-HBM), affiliated with the International Society of Exposure Science. The i-HBM's mission is to promote the use of population-level HBM data to inform public health decision-making by developing harmonized resources to facilitate the interpretation of HBM data in a health-based context. This paper describes the methods used to compile the human biomonitoring health-based guidance values, how the values can be accessed and used, and caveats with using the Dashboard for interpreting HBM data. To our knowledge, the HB2GV Dashboard is the first open-access, curated database of HBM guidance values developed for use in interpreting HBM data. This new resource can assist global HBM data users such as risk assessors, risk managers and biomonitoring programs with a readily available compilation of guidance values.
- Towards a systematic use of effect biomarkers in population and occupational biomonitoringPublication . Zare Jeddi, Maryam; Hopf, Nancy B.; Viegas, Susana; Price, Anna Bal; Paini, Alicia; van Thriel, Christoph; Benfenati, Emilio; Ndaw, Sophie; Bessems, Jos; Behnisch, Peter A.; Leng, Gabriele; Duca, Radu-Corneliu; Verhagen, Hans; Cubadda, Francesco; Brennan, Lorraine; Ali, Imran; David, Arthur; Mustieles, Vicente; Fernandez, Mariana F.; Louro, Henriqueta; Pasanen-Kase, RobertEffect biomarkers can be used to elucidate relationships between exposure to environmental chemicals and their mixtures with associated health outcomes, but they are often underused, as underlying biological mechanisms are not understood. We aim to provide an overview of available effect biomarkers for monitoring chemical exposures in the general and occupational populations, and highlight their potential in monitoring humans exposed to chemical mixtures. We also discuss the role of the adverse outcome pathway (AOP) framework and physiologically based kinetic and dynamic (PBK/D) modelling to strengthen the understanding of the biological mechanism of effect biomarkers, and in particular for use in regulatory risk assessments. An interdisciplinary network of experts from the European chapter of the International Society for Exposure Science (ISES Europe) and the Organization for Economic Co-operation and Development (OECD) Occupational Biomonitoring activity of Working Parties of Hazard and Exposure Assessment group worked together to map the conventional framework of biomarkers and provided recommendations for their systematic use. We summarized the key aspects of this work here, and discussed these in three parts. Part I, we inventory available effect biomarkers and promising new biomarkers for the general population based on the H2020 Human Biomonitoring for Europe (HBM4EU) initiative. Part II, we provide an overview AOP and PBK/D modelling use that improved the selection and interpretation of effect biomarkers. Part III, we describe the collected expertise from the OECD Occupational Biomonitoring subtask effect biomarkers in prioritizing relevant mode of actions (MoAs) and suitable effect biomarkers. Furthermore, we propose a tiered risk assessment approach for occupational biomonitoring. Several effect biomarkers, especially for use in occupational settings, are validated. They offer a direct assessment of the overall health risks associated with exposure to chemicals, chemical mixtures and their transformation products. Promising novel effect biomarkers are emerging for biomonitoring of the general population. Efforts are being dedicated to prioritizing molecular and biochemical effect biomarkers that can provide a causal link in exposure-health outcome associations. This mechanistic approach has great potential in improving human health risk assessment. New techniques such as in silico methods (e.g. QSAR, PBK/D modelling) as well as 'omics data will aid this process. Our multidisciplinary review represents a starting point for enhancing the identification of effect biomarkers and their mechanistic pathways following the AOP framework. This may help in prioritizing the effect biomarker implementation as well as defining threshold limits for chemical mixtures in a more structured way. Several ex vivo biomarkers have been proposed to evaluate combined effects including genotoxicity and xeno-estrogenicity. There is a regulatory need to derive effect-based trigger values using the increasing mechanistic knowledge coming from the AOP framework to address adverse health effects due to exposure to chemical mixtures. Such a mechanistic strategy would reduce the fragmentation observed in different regulations. It could also stimulate a harmonized use of effect biomarkers in a more comparable way, in particular for risk assessments to chemical mixtures.