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- A Tiered Approach for Assessing Individual and Combined Risk of Pyrethroids Using Human Biomonitoring DataPublication . Tarazona, Jose; Cattaneo, Irene; Niemann, Lars; Pedraza-Diaz, Susana; González-Caballero, MCarmen; Alba-Gonzalez, Mercedes de; Cañas, Ana; Domínguez-Morueco, Noelia; Esteban, Marta; Castano, Argelia; Borges, Teresa; Katsonouri, Andromachi; Makris, Konstantinos C.; Ottenbros, Ilse; Mol, Hans; De Decker, Annelies; Morrens, Bert; Berman, Tamar; Barnett-Itzhaki, Zohar; Probst-Hensch, Nicole; Fuhrimann, Samuel; Snoj Tratnik, Janja; Horvat, Milena; RAMBAUD, Loic; RIOU, Margaux; Schoeters, Greta; Govarts, Eva; Kolossa-Gehring, Marike; Weber, Till; Apel, Petra; Namorado, Sónia; Santonen, TiinaPyrethroids are a major insecticide class, suitable for biomonitoring in humans. Due to similarities in structure and metabolic pathways, urinary metabolites are common to various active substances. A tiered approach is proposed for risk assessment. Tier I was a conservative screening for overall pyrethroid exposure, based on phenoxybenzoic acid metabolites. Subsequently, probabilistic approaches and more specific metabolites were used for refining the risk estimates. Exposure was based on 95th percentiles from HBM4EU aligned studies (2014–2021) covering children in Belgium, Cyprus, France, Israel, Slovenia, and The Netherlands and adults in France, Germany, Israel, and Switzerland. In all children populations, the 95th percentiles for 3-phenoxybenzoic acid (3-PBA) exceeded the screening value. The probabilistic refinement quantified the risk level of the most exposed population (Belgium) at 2% or between 1–0.1% depending on the assumptions. In the substance specific assessments, the 95th percentiles of urinary concentrations in the aligned studies were well below the respective human biomonitoring guidance values (HBM-GVs). Both information sets were combined for refining the combined risk. Overall, the HBM data suggest a low health concern, at population level, related to pyrethroid exposure for the populations covered by the studies, even though a potential risk for highly exposed children cannot be completely excluded. The proposed tiered approach, including a screening step and several refinement options, seems to be a promising tool of scientific and regulatory value in future.
- HBM4EU-MOM: Prenatal methylmercury-exposure control in five countries through suitable dietary advice for pregnancy – Study design and characteristics of participantsPublication . Katsonouri, Andromachi; Gabriel, Catherine; Esteban López, Marta; Namorado, Sónia; Halldorsson, Thorhallur; Snoj Tratnik, Janja; Rodriguez Martin, Laura; Karakoltzidis, Achilleas; Chatzimpaloglou, Anthoula; Giannadaki, Despina; Anastasi, Elena; Thoma, Anthi; Domínguez-Morueco, Noelia; Cañas, Ana; Jacobsen, Eva; Assunção, Ricardo; Peres, Maria; Santiago, Susana; Nunes, Carla; Pedraza-Diaz, Susana; Iavicoli, Ivo; Leso, Veruscka; Lacasaña, Marina; González-Alzaga, Beatriz; Horvat, Milena; Sepai, Ovnair; Castano, Argelia; Kolossa-Gehring, Marike; Karakitsios, Spyros; Sarigiannis, DimosthenisBackground: Seafood is a major source of vital nutrients for optimal fetal growth, but at the same time is the main source of exposure to methylmercury (MeHg), an established neurodevelopmental toxicant. Pregnant women must be provided with dietary advice so as to include safely fish in their diet for nutrition and mercury control. The aim of this work is to present the design of a multicentre randomized control trial (RCT), which combines human biomonitoring (HBM) with dietary interventions using seafood consumption advice to pregnant women for MeHg control, and to collect information about other possible sources of exposure to mercury. It also presents the materials developed for the implementation of the study and the characteristics of the study participants, which were self-reported in the first trimester of pregnancy. Methods: The "HBM4EU-MOM" RCT was performed in the frame of the European Human Biomonitoring Initiative (HBM4EU) in five coastal, high fish-consuming European countries (Cyprus, Greece, Spain, Portugal and Iceland). According to the study design, pregnant women (≥120/country, ≤20 weeks gestational age) provided a hair sample for total mercury assessment (THg) and personal information relevant to the study (e.g., lifestyle, pregnancy status, diet before and during the pregnancy, information on seafood and factors related to possible non-dietary exposures to mercury) during the first trimester of pregnancy. After sampling, participants were randomly assigned to "control" (habitual practices) or "intervention" (received the harmonized HBM4EU-MOM dietary advice for fish consumption during the pregnancy and were encouraged to follow it). Around child delivery, participants provided a second hair sample and completed another tailored questionnaire. Results: A total of 654 women aged 18-45 years were recruited in 2021 in the five countries, primarily through their health-care providers. The pre-pregnancy BMI of the participants ranged from underweight to obese, but was on average within the healthy range. For 73% of the women, the pregnancy was planned. 26% of the women were active smokers before the pregnancy and 8% continued to smoke during the pregnancy, while 33% were passive smokers before pregnancy and 23% remained passively exposed during the pregnancy. 53% of the women self-reported making dietary changes for their pregnancy, with 74% of these women reporting making the changes upon learning of their pregnancy. Of the 43% who did not change their diet for the pregnancy, 74% reported that their diet was already balanced, 6% found it difficult to make changes and 2% were unsure of what changes to make. Seafood consumption did not change significantly before and during the first trimester of pregnancy (overall average ∼8 times per month), with the highest frequency reported in Portugal (≥15 times per month), followed by Spain (≥7 times per month). During the first-trimester of pregnancy, 89% of the Portuguese women, 85% of the Spanish women and <50% of Greek, Cypriot and Icelandic women reported that they had consumed big oily fish. Relevant to non-dietary exposure sources, most participants (>90%) were unaware of safe procedures for handling spillage from broken thermometers and energy-saving lamps, though >22% experienced such an incident (>1 year ago). 26% of the women had dental amalgams. ∼1% had amalgams placed and ∼2% had amalgams removed during peri-pregnancy. 28% had their hair dyed in the past 3 months and 40% had body tattoos. 8% engaged with gardening involving fertilizers/pesticides and 19% with hobbies involving paints/pigments/dyes. Conclusions: The study design materials were fit for the purposes of harmonization and quality-assurance. The harmonized information collected from pregnant women suggests that it is important to raise the awareness of women of reproductive age and pregnant women about how to safely include fish in their diet and to empower them to make proper decisions for nutrition and control of MeHg, as well as other chemical exposures.
- Harmonization of Human Biomonitoring Studies in Europe: Characteristics of the HBM4EU-Aligned Studies ParticipantsPublication . Gilles, Liese; Govarts, Eva; Rodriguez Martin, Laura; Andersson, Anna-Maria; Appenzeller, Brice M.R.; Barbone, Fabio; Castano, Argelia; Coertjens, Dries; Den Hond, Elly; Dzhedzheia, Vazha; Eržen, Ivan; Esteban, Marta; Fábelová, Lucia; Fillol, Clémence; Franken, Carmen; Frederiksen, Hanne; Gabriel, Catherine; Haug, Line Småstuen; Horvat, Milena; Halldórsson, Thórhallur Ingi; Janasik, Beata; Holcer, Nataša Janev; Kakucs, Réka; Karakitsios, Spyros; Katsonouri, Andromachi; Klánová, Jana; Kold-Jensen, Tina; Kolossa-Gehring, Marike; Konstantinou, Corina; Koponen, Jani; Lignell, Sanna; Lindroos, Anna Karin; Makris, Konstantinos C.; Mazej, Darja; Morrens, Bert; Murínová, Ľubica Palkovičová; Namorado, Sónia; Pedraza-Diaz, Susana; Peisker, Jasmin; Probst-Hensch, Nicole; Rambaud, Loïc; Rosolen, Valentina; Rucic, Enrico; Rüther, Maria; Sarigiannis, Dimosthenis; Tratnik, Janja Snoj; Standaert, Arnout; Stewart, Lorraine; Szigeti, Tamás; Thomsen, Cathrine; Tolonen, Hanna; Eiríksdóttir, Ása; Van Nieuwenhuyse, An; Verheyen, Veerle J.; Vlaanderen, Jelle; Vogel, Nina; Wasowicz, Wojciech; Weber, Till; Zock, Jan-Paul; Sepai, Ovnair; Schoeters, GreetHuman biomonitoring has become a pivotal tool for supporting chemicals’ policies. It provides information on real-life human exposures and is increasingly used to prioritize chemicals of health concern and to evaluate the success of chemical policies. Europe has launched the ambitious REACH program in 2007 to improve the protection of human health and the environment. In October 2020 the EU commission published its new chemicals strategy for sustainability towards a toxic-free environment. The European Parliament called upon the commission to collect human biomonitoring data to support chemical’s risk assessment and risk management. This manuscript describes the organization of the first HBM4EU-aligned studies that obtain comparable human biomonitoring (HBM) data of European citizens to monitor their internal exposure to environmental chemicals. The HBM4EU-aligned studies build on existing HBM capacity in Europe by aligning national or regional HBM studies. The HBM4EU-aligned studies focus on three age groups: children, teenagers, and adults. The participants are recruited between 2014 and 2021 in 11 to 12 primary sampling units that are geographically distributed across Europe. Urine samples are collected in all age groups, and blood samples are collected in children and teenagers. Auxiliary information on sociodemographics, lifestyle, health status, environment, and diet is collected using questionnaires. In total, biological samples from 3137 children aged 6–12 years are collected for the analysis of biomarkers for phthalates, HEXAMOLL® DINCH, and flame retardants. Samples from 2950 teenagers aged 12–18 years are collected for the analysis of biomarkers for phthalates, Hexamoll® DINCH, and per and polyfluoroalkyl substances (PFASs), and samples from 3522 adults aged 20–39 years are collected for the analysis of cadmium, bisphenols, and metabolites of polyaromatic hydrocarbons (PAHs). The children’s group consists of 50.4% boys and 49.5% girls, of which 44.1% live in cities, 29.0% live in towns/suburbs, and 26.8% live in rural areas. The teenagers’ group includes 50.6% girls and 49.4% boys, with 37.7% of residents in cities, 31.2% in towns/suburbs, and 30.2% in rural areas. The adult group consists of 52.6% women and 47.4% men, 71.9% live in cities, 14.2% in towns/suburbs, and only 13.4% live in rural areas. The study population approaches the characteristics of the general European population based on age-matched EUROSTAT EU-28, 2017 data; however, individuals who obtained no to lower educational level (ISCED 0–2) are under represented. The data on internal human exposure to priority chemicals from this unique cohort will provide a baseline for Europe’s strategy towards a non-toxic environment and challenges and recommendations to improve the sampling frame for future EU-wide HBM surveys are discussed.
- Harmonized human biomonitoring in European children, teenagers and adults: EU-wide exposure data of 11 chemical substance groups from the HBM4EU Aligned Studies (2014-2021)Publication . Govarts, Eva; Gilles, Liese; Rodriguez Martin, Laura; Santonen, Tiina; Apel, Petra; Alvito, Paula; Anastasi, Elena; Andersen, Helle Raun; Andersson, Anna-Maria; Andryskova, Lenka; ANTIGNAC, Jean-Philippe; Rüther, Maria; Sarigiannis, Denis; Silva, Maria João; Šlejkovec, Zdenka; Snoj Tratnik, Janja; Stajnko, Anja; Szigeti, Tamas; Tarazona, Jose; Thomsen, Cathrine; Tkalec, Žiga; Trnovec, Tomas; Tolonen, Hanna; Uhl, Maria; Van Nieuwenhuyse, An; Vasco, Elsa; Verheyen, Veerle J.; Viegas, Susana; Vinggaard, Anne Marie; Vogel, Nina; Vorkamp, Katrin; Wasowicz, Wojciech; Wimmerova, Sona; Weber, Till; Woutersen, Marjolijn; Zimmermann, Philipp; Zvonar, Martin; Koch, Holger; Kolossa-Gehring, Marike; Esteban López, Marta; Castano, Argelia; Stewart, Lorraine; Sepai, Ovnair; Appenzeller, Brice; Schoeters, Greta; Barbone, Fabio; Barnett-Itzhaki, Zohar; Barouki, Robert; Berman, Tamar; Bil, Wieneke; Borges, Teresa; Buekers, Jurgen; Cañas-Portilla, Ana; Covaci, Adrian; Csako, Zsofia; Den Hond, Elly; Dvorakova, Darina; Fabelova, Lucia; Fletcher, Tony; Frederiksen, Hanne; Gabriel, Catherine; Ganzleben, Catherine; Göen, Thomas; Halldorsson, Thorhallur; Haug, Line Småstuen; Horvat, Milena; Huuskonen, Pasi; Imboden, Medea; Jagodic Hudobivnik, Marta; Janasik, Beata; Janev Holcer, Natasa; Karakitsios, Spyros; Katsonouri, Andromachi; Klanova, Jana; Kokaraki, Venetia; Kold Jensen, Tina; Koponen, Jani; Laeremans, Michelle; Laguzzi, Federica; Lange, Rosa; Lemke, Nora; Lignell, Sanna; Lindroos, Anna Karin; Lobo Vicente, Joana; Luijten, Mirjam; Makris, Konstantinos C.; Mazej, Darja; Melymuk, Lisa; Meslin, Matthieu; Mol, Hans; Montazeri, Parisa; Murawski, Aline; Namorado, Sónia; Niemann, Lars; Nübler, Stefanie; Nunes, Baltazar; Olafsdottir, Kristin; Palkovicova Murinova, Lubica; Papaioannou, Nafsika; Pedraza-Diaz, Susana; Piler, Pavel; Plichta, Veronika; Poteser, Michael; Probst-Hensch, Nicole; Rambaud, Loic; Rauscher-Gabernig, Elke; Rausova, Katarina; Remy, Sylvie; Riou, Margaux; Rosolen, Valentina; Rousselle, ChristopheAbstract: As one of the core elements of the European Human Biomonitoring Initiative (HBM4EU) a human biomonitoring (HBM) survey was conducted in 23 countries to generate EU-wide comparable HBM data. This survey has built on existing HBM capacity in Europe by aligning national or regional HBM studies, referred to as the HBM4EU Aligned Studies. The HBM4EU Aligned Studies included a total of 10,795 participants of three age groups: (i) 3,576 children aged 6–12 years, (ii) 3,117 teenagers aged 12–18 years and (iii) 4,102 young adults aged 20–39 years. The participants were recruited between 2014 and 2021 in 11–12 countries per age group, geographically distributed across Europe. Depending on the age group, internal exposure to phthalates and the substitute DINCH, halogenated and organophosphorus flame retardants, per- and polyfluoroalkyl substances (PFASs), cadmium, bisphenols, polycyclic aromatic hydrocarbons (PAHs), arsenic species, acrylamide, mycotoxins (deoxynivalenol (total DON)), benzophenones and selected pesticides was assessed by measuring substance specific biomarkers subjected to stringent quality control programs for chemical analysis. For substance groups analyzed in different age groups higher average exposure levels were observed in the youngest age group, i.e., phthalates/DINCH in children versus teenagers, acrylamide and pesticides in children versus adults, benzophenones in teenagers versus adults. Many biomarkers in teenagers and adults varied significantly according to educational attainment, with higher exposure levels of bisphenols, phthalates, benzophenones, PAHs and acrylamide in participants (from households) with lower educational attainment, while teenagers from households with higher educational attainment have higher exposure levels for PFASs and arsenic. In children, a social gradient was only observed for the non-specific pyrethroid metabolite 3-PBA and di-isodecyl phthalate (DiDP), with higher levels in children from households with higher educational attainment. Geographical variations were seen for all exposure biomarkers. For 15 biomarkers, the available health-based HBM guidance values were exceeded with highest exceedance rates for toxicologically relevant arsenic in teenagers (40%), 3-PBA in children (36%), and between 11 and 14% for total DON, Σ (PFOA + PFNA + PFHxS + PFOS), bisphenol S and cadmium. The infrastructure and harmonized approach succeeded in obtaining comparable European wide internal exposure data for a prioritized set of 11 chemical groups. These data serve as a reference for comparison at the global level, provide a baseline to compare the efficacy of the European Commission's chemical strategy for sustainability and will give leverage to national policy makers for the implementation of targeted measures.