Browsing by Author "Galea, Karen S."
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- Biomonitoring as an underused exposure assessment tool in occupational safety and health context: challenges and way forwardPublication . Viegas, Susana; Jeddi, Maryam Zare; Hopf, Nancy B.; Bessems, Jos; Palmen, Nicole; Galea, Karen S.; Jones, Kate; Kujath, Peter; Duca, Radu-Corneliu; Verhagen, Hans; Santonen, Tiina; Pasanen-Kase, RobertRecent advances in analytical chemistry have allowed a greater possibility of using quantitative approaches for measuring human exposure to chemicals. One of these approaches is biomonitoring (BM), which provides unequivocal evidence that both exposure and uptake of a chemical have taken place. BM has been a longstanding practice in occupational health for several reasons. BM integrates exposure from all routes. It can help identify unintentional and unexpected exposures and assess the effectiveness of existing risk-management measures. BM also provides relevant information to support policy development by delivering better evidence of workers' exposure to chemical substances, even within the framework of the present regulations. Thus, BM can allow for both the evaluation of the impact of regulation and the identification of further needs for new or improved regulation. However, despite all these well-recognized advantages, BM is currently an underused exposure assessment tool. This paper provides an overview of the key aspects to be considered when using BM in the context of occupational health interventions. Additionally, this paper describes the potential of BM as an exposure assessment tool, distinguishing the role of BM in exposure assessment and health surveillance and clarifies ethical and communication aspects to guarantee that general data protection regulations are followed. In addition, actions and research needs are identified (particularly with reference to the European situation), which aim to encourage the increased use of BM as an exposure assessment tool.
- Developing human biomonitoring as a 21st century toolbox within the European Exposure Science Strategy 2022-2030Publication . Jeddi, Maryam Zare; 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.; Philippe Antignac, Jean; David, Arthur; Mol, Hans; Barouki, Robert; Audouze, Karine; Duca, Radu-Corneliu; Fantke, Peter; Scheepers, Paul; Ghosh, Manosij; Van Nieuwenhuyse, An; Vicente, Joana Lobo; 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; de Bruin, Yuri Bruinen; 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.
- HBM4EU chromates study: determinants of exposure to hexavalent chromium in plating, welding and other occupational settingsPublication . Viegas, Susana; Martins, Carla; Bocca, Beatrice; Bousoumah, Radia; Duca, Radu Corneliu; Galea, Karen S.; Godderis, Lode; Iavicoli, Ivo; Janasik, Beata; Jones, Kate; Leese, Elizabeth; Leso, Veruscka; Ndaw, Sophie; van Nieuwenhuyse, An; Poels, Katrien; Porras, Simo P.; Ruggieri, Flavia; Silva, Maria João; Verdonck, Jelle; Wasowicz, Wojciech; Scheepers, Paul T. J.; Santonen, Tiina; Ladeira, Carina; Ribeiro, EdnaWork-related exposures in industrial processing of chromate (chrome plating, surface treatment, and welding) raise concerns regarding the health risk of hexavalent chromium (Cr(VI)). In this study, performed under the HBM4EU project, we focused on better understanding the determinants of exposure and recognising how risk management measures (RMMs) contribute to a reduction in exposure. HBM and occupational hygiene data were collected from 399 workers and 203 controls recruited in nine European countries. Urinary total chromium (U-Cr), personal inhalable and respirable dust of Cr and Cr(VI), and Cr from hand wipes were collected. Data on the RMMs were collected by questionnaires. We studied the association between different exposure parameters and the use of RMMs. The relationship between exposure by inhalation and U-Cr in different worker groups was analysed using regression analysis and found a strong association. Automatisation of Cr electroplating dipping explained lower exposure levels in platers. The use of personal protective equipment resulted in lower U-Cr levels in welding, bath plating, and painting. An effect of wearing gloves was observed in machining. An effect of local exhaust ventilation and training was observed in welding. Regression analyses showed that in platers, exposure to an air level of 5 µg/m3 corresponds to a U-Cr level of 7 µg/g of creatinine. In welders, the same inhalation exposure resulted in lower U-Cr levels reflecting toxicokinetic differences of different chromium species.
- HBM4EU chromates study: overall results and recommendations for the biomonitoring of occupational exposure to hexavalent chromiumPublication . Santonen, Tiina; Porras, Simo P.; Bocca, Beatrice; Bousoumah, Radia; Duca, Radu Corneliu; Galea, Karen S.; Godderis, Lode; Göen, Thomas; Hardy, Emilie; Iavicoli, Ivo; Janasik, Beata; Jones, Kate; Leese, Elizabeth; Leso, Veruscka; Louro, Henriqueta; Majery, Nicole; Ndaw, Sophie; Pinhal, Hermínia; Ruggieri, Flavia; Silva, Maria J.; van Nieuwenhuyse, An; Verdonck, Jelle; Viegas, Susana; Wasowicz, Wojciech; Sepai, Ovnair; Scheepers, Paul T.J.; Aimonen, Kukka; Antoine, Guillaume; Anzion, Rob; Burgart, Manuella; Castaño, Argelia; Cattaneo, Andrea; Cavallo, Domenico Maria; De Palma, Giuseppe; Denis, Flavien; Gambelunghe, Angela; Gomes, Bruno; Hanser, Ogier; Helenius, Riikka; Ladeira, Carina; López, Marta Esteban; Lovreglio, Piero; Marsan, Philippe; Melczer, Mathieu; Nogueira, Ana; Pletea, Elisabeta; Poels, Katrien; Remes, Jouko; Ribeiro, Edna; Santos, Sílvia Reis; Schaefers, Françoise; Spankie, Sally; Spoek, Robert; Rizki, Mohamed; Rousset, Davy; van Dael, Maurice; Veijalainen, HennaExposure to hexavalent chromium [Cr(VI)] may occur in several occupational activities, e.g., welding, Cr(VI) electroplating, and other surface treatment processes. The aim of this study was to provide EU-relevant data on occupational Cr(VI) exposure to support the regulatory risk assessment and decision-making. In addition, the capability and validity of different biomarkers for the assessment of Cr(VI) exposure were evaluated. The study involved nine European countries and involved 399 workers in different industry sectors with exposures to Cr(VI) such as welding, bath plating, applying or removing paint, and other tasks. We also studied 203 controls to establish a background in workers with no direct exposure to Cr(VI). We applied a cross-sectional study design and used chromium in urine as the primary biomonitoring method for Cr(VI) exposure. Additionally, we studied the use of red blood cells (RBC) and exhaled breath condensate (EBC) for biomonitoring of exposure to Cr(VI). Personal measurements were used to study exposure to inhalable and respirable Cr(VI) by personal air sampling. Dermal exposure was studied by taking hand wipe samples. The highest internal exposures were observed in the use of Cr(VI) in electrolytic bath plating. In stainless steel welding, the internal Cr exposure was clearly lower when compared to plating activities. We observed a high correlation between chromium urinary levels and air Cr(VI) or dermal total Cr exposure. Urinary chromium showed its value as a first approach for the assessment of total, internal exposure. Correlations between urinary chromium and Cr(VI) in EBC and Cr in RBC were low, probably due to differences in kinetics and indicating that these biomonitoring approaches may not be interchangeable but rather complementary. This study showed that occupational biomonitoring studies can be conducted successfully by multi-national collaboration and provide relevant information to support policy actions aiming to reduce occupational exposure to chemicals.
- HBM4EU chromates study: reflection and lessons learnt from designing and undertaking a collaborative European biomonitoring study on occupational exposure to hexavalent chromiumPublication . Galea, Karen S.; Porras, Simo P.; Viegas, Susana; Bocca, Beatrice; Bousoumah, Radia; Duca, Radu Corneliu; Godderis, Lode; Iavicoli, Ivo; Janasik, Beata; Jones, Kate; Knudsen, Lisbeth E.; Leese, Elizabeth; Leso, Veruscka; Louro, Henriqueta; Ndaw, Sophie; Ruggieri, Flavia; Sepai, Ovnair; Scheepers, Paul T. J.; Silva, Maria J.; Wasowicz, Wojciech; Santonen, TiinaThe EU human biomonitoring initiative, HBM4EU, aims to co-ordinate and advance human biomonitoring (HBM) across Europe. As part of HBM4EU, we presented a protocol for a multicentre study to characterize occupational exposure to hexavalent chromium (Cr(VI)) in nine European countries (HBM4EU chromates study). This study intended to collect data on current occupational exposure and to test new indicators for chromium (Cr) biomonitoring (Cr(VI) in exhaled breath condensate and Cr in red blood cells), in addition to traditional urinary total Cr analyses. Also, data from occupational hygiene samples and biomarkers of early biological effects, including genetic and epigenetic effects, was obtained, complementing the biomonitoring information. Data collection and analysis was completed, with the project findings being made separately available. As HBM4EU prepares to embark on further European wide biomonitoring studies, we considered it important to reflect on the experiences gained through our harmonised approach. Several practical aspects are highlighted for improvement in future studies, e.g., more thorough/earlier training on the implementation of standard operating procedures for field researchers, training on the use of the data entry template, as well as improved company communications. The HBM4EU chromates study team considered that the study had successfully demonstrated the feasibility of conducting a harmonised multicentre investigation able to achieve the research aims and objectives. This was largely attributable to the engaged multidisciplinary network, committed to deliver clearly understood goals. Such networks take time and investment to develop, but are priceless in terms of their ability to deliver and facilitate knowledge sharing and collaboration.
- 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) programs 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 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 harmonized open-access protocol templates from designing, undertaking 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 the implementation of FAIR principles is a fundamental enabler for digital transformation within environmental health. The HBM GRF would encompass internationally harmonized and agreed open access templates for HBM study protocols, structured web-based functionalities to deposit, find, and access harmonized protocols of HBM studies. Registration of HBM studies using the HBM GRF is anticipated to increase the FAIRness of the resulting (meta)data. It is also considered that the harmonization of existing data sets could be performed retrospectively. As a consequence, data wrangling activities to make data ready for analysis will be minimized. 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 finalized. The HBM GRF could also serve as a platform enhancing communication between scientists, risk assessors, and risk managers/policymakers. The planned European Partnership for the Assessment of Risk from Chemicals (PARC) works along these lines, based on the experience obtained in previous joint European initiatives. Therefore, PARC could very well bring the first demonstration of the first essential functionalities within the development of the HBM GRF.
- Setting up a collaborative European human biological monitoring study on occupational exposure to hexavalent chromiumPublication . Santonen, Tiina; Alimonti, Alessandro; Bocca, Beatrice; Duca, Radu Corneliu; Galea, Karen S.; Godderis, Lode; Göen, Thomas; Gomes, Bruno; Hanser, Ogier; Iavicoli, Ivo; Janasik, Beata; Jones, Kate; Kiilunen, Mirja; Koch, Holger M.; Leese, Elizabeth; Leso, Veruscka; Louro, Henriqueta; Ndaw, Sophie; Porras, Simo P.; Robert, Alain; Ruggieri, Flavia; Scheepers, Paul T. J.; Silva, Maria J.; Viegas, Susana; Wasowicz, Wojciech; Castano, Argelia; Sepai, OvnairThe EU human biomonitoring initiative, HBM4EU, aims to coordinate and advance human biomonitoring (HBM) across Europe. Within its remit, the project is gathering new, policy-relevant, EU-wide data on occupational exposure to relevant priority chemicals and developing new approaches for occupational biomonitoring. In this manuscript, the hexavalent chromium (Cr(VI)) study design is presented as the first example of this HBM4EU approach. This study involves eight European countries and plans to recruit 400 workers performing Cr(VI) surface treatment e.g. electroplating or stainless steel welding activities. The aim is to collect new data on current occupational exposure to Cr(VI) in Europe and to test new methods for Cr biomonitoring, specifically the analysis of Cr(VI) in exhaled breath condensate (EBC) and Cr in red blood cells (RBC) in addition to traditional urinary total Cr analyses. Furthermore, exposure data will be complemented with early biological effects data, including genetic and epigenetic effects. Personal air samples and wipe samples are collected in parallel to help to inform the biomonitoring results. We present standard operational procedures (SOPs) to support the harmonized methodologies for the collection of occupational hygiene and HBM samples in different countries.