Browsing by Author "Woutersen, M."
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- HBM4EU - Deliverable Report D 5.5: Human biomonitoring in risk assessment: 2nd set of examples on the use of HBM in risk assessments of HBM4EU priority chemicalsPublication . Santonen, Tiina; Mahiout, Selma; Bessems, J.; Buekers, J.; Baken, K.; Schoeters, G.; Woutersen, M.; Vermeire, T.; Bil, W.; Ougier, E.; Rousselle, C.; Šömen Joksić, A.; Kirinčič, S.; Louro, Henriqueta; Silva, Maria João; Assunção, Ricardo; Vinggaard, A. M.; Viegas, S.; Huuskonen, P.; Porras, S.; Kiilunen, M.; Uhl, M.; Hartmann, C.; Hauzenberger, I.; Losert, A.; Tratnik, J. Snoj; Horvat, M.; Schaddelee-Scholten, B.; Buist, H.; Westerhout, J.; Fletcher, T.; Rauscher-Gabernig, E.; Plichta, V.; Abraham, K.; Borges, T.; Kadikis, N.The aim of this work was to exemplify the inclusion of human biomonitoring (HBM) data in risk assessment (RA) and health impact assessment (HIA) strategies. RA was performed for six compound groups on HBM4EU’s first list of priority substances: anilines, cadmium/chromium, flame retardants, PAHs, PFAS and phthalates. In addition, burden of disease (BoD) calculations were made for cadmium. The general approach used included: 1) identification of an existing RA for the substance, 2) identification of possible existing biological limit or guidance values or biological equivalents (BEs), or if lacking, existing health based limit values for external exposure, 3) identification of relevant biomonitoring data to be used in the RA, 4) in case no existing biological limit or guidance values or BEs existed, identification of approaches for reverse/forward calculation, including the use of PBPK modelling or calculation of BE values based on one-compartment modelling, 5) RA or BoD calculation based on HBM data, 6) analysing the benefits and challenges of using HBM data in RA compared to the use of external exposure data. The overall result of the work was that HBM can be included in RA even when relatively few data are available, and its inclusion generally benefits the RA. Several methods exist, and a tiered approach is suggested, based on the amount and quality of data available. The recommended 1st tier method is a one-compartment modelling based derivation of BE values or reverse calculation of external exposure based on biomarker levels. This approach is simple and rough, and uses only very basic parameters. However, in many cases this approach can be considered sufficient, especially when conservative assumptions have been used for the FUE, and the calculated RCRs remain well below 1, indicating a low risk. Also, in cases in which risk assessment using this approach supports the RA made based on external exposure estimates, it is often a sufficient approach. Nevertheless, in some cases e.g. where the RCR is close to 1, a more detailed approach may be needed to refine the RA. For the 2nd tier, PBPK modelling is recommended. For the most robust, 3rd tier approach, measured data on correlations between external exposure and internal doses from well controlled studies would be needed. Certain cases were identified where inclusion of HBM would be particularly important for performing RA: for compounds, for which several exposure routes may contribute to the body burden and the health effects, as HBM reflects the total body burden, and cumulative compounds. For cumulative compounds, HBM could also be useful for hazard assessment in addition to exposure assessment. One of the major challenges for the inclusion of HBM into RA is the often limited data available on toxicokinetics. In addition, in some cases, there is an urgent need for more specific biomarkers or more sensitive analytic methods than currently available. It should be noted that these risk assessments were performed purely to determine how HBM data can contribute to the risk assessment of chemicals, and they have no regulatory implications. Overall for the substances on the HBM4EU’s first list of priority substances, more HBM data are needed. This work is ongoing in WP8, and the RAs presented here will be updated when new data become available.
- Human biomonitoring in risk assessment: analysis of the current practice and 1st examples HBM in risk assessments of HBM4EU priority chemicalsPublication . Santonen, T.; Heinälä, M.; Bessems, J.; Buekers, J.; Cornelis, C.; Vermeire, T.; Woutersen, M.; van Engelen, J.; Borges, T.; Rousselle, C.; Ougier, E.; Louro, Henriqueta; Alvito, Paula; Martins, Carla; Assunção, Ricardo; Silva, Maria João Silva; Krul, L.; Pronk, A.; Schaddelee-Scholten, B.; Gonzalez, M.C.; de Alba, M.; Díaz, G.; Castaño, A.; Viegas, S.; Humar-Juric, T.; Kononenko, L.; Abraham, K.; Vinggaard, A.M.In chemicals risk assessment frameworks, the default approach is to assess external intake from different sources of exposure and via different routes of exposure. They are often assessed separately. This approach includes various uncertainties and often overestimates the real uptake since default, conservative estimates are used e.g. for the absorption of the chemical. At the same time, actual (real life) exposure may be underestimated by not taking into account that exposure to a chemical substance may occur from different sources, which may fall under separate legislative frameworks. Examples are triclosan that is used in biocidal products as well as in consumer products and importantly, most if not all chemicals that are produced by workers where at the same time these workers may be exposed as part of the general population. In some cases, other tools to assess exposure via all possible routes may be insufficient; an example is occupational exposure via hand-to-mount exposure, which has been shown to occur for example in the case of many metals, like lead, through contaminated hands. Without biomonitoring, exposure in these cases could become severely underestimated. Human Biomonitoring (HBM) is an important tool to survey the real life body burden – or internal exposure – of humans resulting from ‘total’ exposure to chemicals via different routes (lung, skin, digestive tract) and ‘via’ different legislative frameworks on chemicals. By providing more accurate data on actual body burdens (internal exposure), inclusion of HBM data could improve human health risk assessment for both the general population (exposure via air, consumer products, drinking water and food) as well as for workers (exposure via inhalation and/or skin) separately or as part of the population.
- Improving risk assessment of chemicals by the use of human biomonitoring - HBM4EU project activitiesPublication . Santonen, T.; Alvito, Paula; Bessems, J.; Borges, T.; Brunet, D.; Buekers, J.; Cornelis, C.; van Engelen, J.; Gonzalez Caballero, M.C.; Humar-Juric, T.; Heinälä, M.; Klaus, A.; Kononenko, L.; Krul, L.; Lamkarkach, F.; Louro, Henriqueta; Pronk, A.; Ormsby, J-N.; Viegas, S.; Rousselle, C.; Schaddelee-Scholten, B.; Silva, Maria João; Stierum, R.; Vinggaard, S A.M.; Vermeire, T.; Woutersen, M.The default approach in the risk assessment (RA) of chemicals is to assess external exposure by combining different sources and routes of exposure. This kind of approach contains various uncertainties and may overestimate exposure, since conservative estimates are needed due to the limited data on, for example, the absorption of the chemical and interspecies and intraspecies differences. Human biomonitoring (HBM) can help improve RA by providing measured data on combined exposures. In some cases, biomonitoring data can even provide a direct link to health effects. In some cases, biomonitoring allows to link exposure to specific contexts such as occupational settings. Although recent years have seen good examples of the use of biomonitoring in the risk assessment of chemicals, much work is still needed to improve its use in regulatory RA and human impact assessment (HIA). The European Human Biomonitoring Initiative (HBM4EU) was recently launched for fulfilling the gap between the exposure to hazardous chemical agents and their impact on human health. One of the aims of the HBM4EU project is to enhance the use of HBM data in RA and HIA of chemicals in different regulatory contexts including legislations on chemicals, plant protection products and biocides, as well as legislation on cosmetics, food safety and occupational safety. RA models for mixtures are also considered. Firstly, current RA practices are evaluated: is the use of biomonitoring integrated in the available RA guidance, and do given RA schemes have good examples of the advanced use of biomonitoring? A survey is also conducted to gather information from national regulatory risk assessors (in the EU, but also in non-EU countries) on their risk assessment practices, the use of HBM, and the obstacles and challenges related to its use. The challenges of the use of HBM data in RA may include a lack of guidance in the use of biomonitoring, a lack of knowledge regarding the interpretation of biomonitoring results, or the inability to link biomonitoring data to different exposure sources. Using a selected group of priority chemicals as example, we can determine whether these challenges can be overcome by including the recent HBM data, collected during the HBM4EU project, in the existing RA schemes. Finally, proposals will be made for the better use of HBM in RA and HIA in different policy domains.