Browsing by Author "Vermeire, Theo"
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- 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).