European HBM Platform

Survey design and fieldwork

This work package establishes the starting point for HBM4EU survey activities by gathering information on existing biobanked samples and finished, on-going or planned studies within the HBM4EU network. Available national and regional data from human biomonitoring surveys, as well as from health and occupational surveillance programmes, will be reviewed against quality criteria to establish whether existing data are comparable and whether they can be used to answer policy questions. On this basis, we will identify data gaps and determine whether new human biomonitoring data is needed or not. We will prepare technical guidelines and protocols to support the implementation of harmonized, high quality and cost effective surveys. Study protocols will be established for:

• the analysis of biobanked human samples;
• the use of samples from on-going studies; and
• the implementation of new harmonized surveys at EU level.

Additional tasks include the development of criteria and protocols to support the biobanking and exchange of samples, that take all relevant legal and ethics requirements into account. Communication materials aimed at engaging and informing survey participants will also be developed. A set of Standard Operating Procedures (SOPs) are under development to support fieldwork activities, including recruitment and sampling, as well as the conservation and transport of samples. Harmonized questionnaires are under preparation, to facilitate the systematic collection of information on individual characteristics, behaviours and environment.

For information on HBM4EU collaboration with the biobanking community, please see here.

Targeted field work surveys and alignment at EU level

Our work aims to align current human biomonitoring studies, where feasible, to produce a European dataset. The sampling frames of national programmes of HBM4EU partner countries will be aligned, as far as possible. Where population representative human biomonitoring studies are already planned in partner countries, we will explore the flexibility for adapting these activities to meet HBM4EU standards.We aim to substantially enhance the comparability of exposure data across Europe. Additional goals include:

• providing adequate representation of the environments and lifestyles of the EU population;
• ensuring comparability with international values; and
• including vulnerable and highly exposed subgroups.

There will also be focus on using biobanks to establish past exposures. A large number of EU cohorts and biobanks hold human samples, as well as associated information regarding exposure factors (including occupational exposure) health. The HBM4EU consortium will explore the opportunities to utilise several cohorts and biobanks for extended studies. We will also carry out targeted new fieldwork that can deliver new knowledge of added value at EU level.

Approximately 3000-4000 new samples will be collected in order to address current knowledge gaps. Furthermore, targeted occupational studies will also be carried out to bridge the gaps in our understanding of occupational exposure across different occupations, and to better compare occupational exposure with other sources. Our work will also focus on the logistics of fieldwork. A helpdesk will be established to support the countries where new data will be generated, with the aim of building capacities, as well as coordinating the surveys and promoting harmonisation.

Laboratory analysis and quality control

Partners in this work package coordinate the analytical phase and the design and implementation of our Quality Assessment/Quality Control Programme (QA/QC) via the Quality Assurance Unit (QAU).First steps involve producing an inventory of the analytical methods, biomarkers and matrices available, in order to select the most appropriate for use under the HBM4EU project. In order to maximise the participation of national laboratories without compromising the quality of the results, the selection of laboratories for inclusion in the HBM4EU network will be undertaken in step-wise process. This will allow us to establish a European database of candidate laboratories that can undertake analysis and develop of new methods. In order for a laboratory to be integrated into the HBM4EU network, the laboratory must successfully complete the QA/QC Programme, including inter-laboratory comparison. Our experts will provide support to the laboratories during the whole process through a dedicated helpdesk.

A list of candidate laboratories was identified after successful completion of an online questionnaire and applying the criteria approved by the Governing Board.

The purpose of this questionnaire was to identify the laboratories that were able to:

1. Perform the analysis of biomarkers present in the 1^st priority list of substances (phthalates, DINCH, bisphenols, per- and polyfluoroalkyl substances, flame retardants, aromatic amines, polycyclic aromatic hydrocarbons, cadmium and chromium VI)
2. Develop new analytical methods
3. Support in the organization of the Interlaboratory Comparison Investigations (ICI) and External Quality Assurance Scheme (EQUAS).

The questionnaire was completed by laboratories from 24 European countries, 83 in the section focus on performing the chemical analysis, 69 in the section to develop new analytical methods and 16 in the section about the support of QA/QC activities. The information was blindly evaluated against specific criteria in the three sections mentioned above by different institutions:

• Biomarkers analysis: University Institute for Biomedical and Health Research – ULPGC and the Biomarkers Unit – CNSA, ISCIII.
• New methods development: Laboratoire d’Etude des Résidus et Contaminants dans les Aliments – Oniris, INRA and the Chromatography Laboratory – CNSA, ISCIII.
• Support to the QA/QC program in WP9: Chemical Testing Department – NPHSL and the Quality Assurance Unit – CNSA, ISCIII.

List of candidate laboratories: Anilines – Bisphenols – Cadmium – Chromium VI – DINCH – Flame retardants – PAHs – Per and polyfluorinated alkylated substances – Phthalates

Data management and analysis

HBM4EU will collect and analyse individual and aggregated data and related information on the exposure of Europeans to toxic chemicals. Both existing and newly generated human biomonitoring data and accessory data will be processed, managed and quality controlled, while respecting European and national ethics and data protection requirements. Data collected at the national level will be harmonized and made available to the “Human Biomonitoring” module of the European Commission’s Information Platform for Chemical Monitoring (IPCHEM). The human biomonitoring module of IPCHEM will be further developed to serve as a sustainable data platform. Data will be analysed at the European level to understand variability in the exposure of the European population, to analyse spatial and time trends and to test exposure-related hypotheses. A helpdesk will be established to support data management in the HBM4EU National Hubs. The statistical analyses will be coordinated by a statistical working group.