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As a result of ESBIO WP 3 a "Multi-step Approach" was developed that outlines which steps need to be undertaken to translate HBM data into policy action, trying as much as possible to prioritise among different pollutants measured and different Member States.
The Multi-step approach will eventually lead to:
1. Aggregation of individual data based on geographical entities;
2. Determine whether there is a deviation (increase/decrease) at the aggregated level in one or more biomarkers measured;
3. Determine the seriousness of the deviation, based on a variety of expert opinions;
4. Set priorities in order to deal with these deviations;
5. Track the causes of these deviations, retrace pollutant loads to potential local, external sources, and identify the different actors that may contribute to the pollutant body burden;
6. To suggest appropriate risk reduction strategies, taking into account the relevant knowledge, actors and opinions;
7. To communicate with the general public and policy makers in a transparent and objective way, proposing and motivating different policy options.
Conducting a human bio-monitoring study is a challenging. Guidelines for all critical steps might be helpful for the successful implementation of a human bio-monitoring approach. Beside clarification on the study design emphasis must be laid on a harmonised way of collecting, of analysing the samples and on data management.
In this guideline three steps (sampling, analysing and data management) have been clustered. The guideline might be used by institutions or organisations conducting human bio-monitoring studies to develop Standard Operating Procedures (SOPs) for each step described.
Workpackage 4 concentrated on ethical issues related to present and future bio-monitoring programs in EU countries by describing rules and practices in a number of countries and by organising a workshop. Special supplementary issue of the web based journal Environmental Health reporting from the workshop on ethical issues and communication within bio-monitoring in Copenhagen March 2007 will be issued and a number of reports are available on the ESBIO web site and in open literature.
The recommendations are:
A protocol must be developed at an early stage describing rationale, justification of study, calculation of minimum number of study persons needed for sufficient power of study, recruitment of study persons, informed consent and information of ethics committees and before initiation of studies
Bio-banking issues needs to be solved prior to study initiation to ensure legal uses of data and samples
Incentives for participation must be considered to avoid economic pressure for participants and special concerns have to be made regarding children
Information to study persons about study results must be described and ensure respect of the right not to know
Harmonised approaches to steps of recruitment, information, consent, data protection, bio-banking, dissemination and data/sample transfer between countries and institutions should be considered e.g. in future directives/guidelines for human environmental bio-monitoring in Europe (and worldwide).
The first part contains data on the existing human biomonitoring (HBM) systems and reference values as well as information on the interlaboratory quality assurance systems and reference materials for internal daily quality control programs.
The second part includes background information on the biomarkers of exposure to substances considered priority for HBM system in Europe (cadmium, lead, mercury, cotinine), other biomarkers used on routine basis to evaluate magnitude of exposure against the reference values or to compare the levels and trends of exposure in different regions or countries (PAHs, phthalates, volatile organic compounds, pesticides, arsenic, PCDD/PCDF, PCB¿s), and biomarkers used at present for research purposes.
According to the recently published data, in spite of the downward trend in emission to the environment, the substances considered the priority (cadmium, lead, methylmercury and nicotine) can still be regarded as the possible cause of early health effects in fetuses and children. Therefore, the implementation of biomonitoring of exposure to these substances seems to be fully justified.
For all the substances discussed in the present report, validated analytical methods, external quality assurance systems and reference materials are available.
Conducting a human bio-monitoring study is a challenging task. Guidelines for all critical steps might be helpful for the successful implementation of a human bio-monitoring approach.
Beside clarification on the study design emphasis must be laid on a harmonised way of collecting, of analysing the samples and on data management. A guideline for laboratory selection (invitation to tender and evaluation of proposals) for human bio-monitoring studies has been evaluated. The guideline might be helpful for institutions or organisations conducting human bio-monitoring studies.
Socio economic optimisation and concept for coordination for an harmonised approach to HBM in Europe
In order to perform a socio economic optimisation for a future EU HBM pilot project first of all tasks necessary for a HBM pilot project have been identified. Subsequently an EXCEL tool has been developed in which different parameters are variable to be filled in by the user and which calculates with the inserted figures the total necessary budget for several different study approaches.
In order to achieve the optimal approach several contradictions had to overcome, this means to maximise the number of participating Member States, the biomarkers to be measured, the number of samples, the synergies effects and to maximise the scientific progress while keeping costs as low as possible.
In addition a coordination concept has been elaborated proposing different work levels, i.e. performance of the pilot study should be done in each country by a national team; the harmonisation, support and evaluation of the study and its results should be done on EU level by multinational teams. In order to take into account the different levels of existing experiences a research-component should be established. The results have been discussed with all Member States and can be used for a future HBM pilot project.
The result is an online inventory of European human research and non-research bio-monitoring actions, either ongoing or having been carried out in the last ten years. The online structure and the procedure for self-registration of activities provide the optimum strategy for maintaining the available information both accurate and up-to-date. Additional functionalities such as user-defined searches of the activities and the message-board are also favoured by the web environment, and move the inventory closer to the concept developed for a platform for exchange of expertise and experience between human bio-monitoring (HBM) stakeholders.
The inventory holds potential for impacting all research, industry or policy sectors in any way related to HBM, in that it provides information on what is being done in the field, who is carrying out the actions, what methodologies are being applied and which laboratories have analytical experience in the area. Developments planned for the platform, such as discussion forums and web-pages dedicated to specific issues within HBM, including the organization of events, will expand this potential further through greater user involvement and a larger target public, ensuring the platform self-fulfils its potential, as a larger amount of information is registered and its usefulness consequently increases.
In order to accompany a European human bio-monitoring pilot project a communication strategy has to follow four main principles:
- There should be no double work between the involved actors
- There should be a close coordination with other EU activities in the field of E&H
- The red thread and the core statements have to match in all communication activities
- The campaign should be flexible and adaptable according to different needs
In order to meet these principles BiPRO has developed a modular concept which provides a tool to establish an effective and efficient communication. Starting point are the five modules target groups, aims, content to be communicated, actors to realise and tools to be used, which are elaborated in terms of their use for a HBM project supporting communication.
To establish a communication strategy the individual modules are linked appropriately in a way to follow the causal chain "to whom - why - what - how - who?". The concept provides a common ground for communication activities within one project even if they differ greatly from each other e.g. due to different needs and expectations. The concept is ready to be used in a future HBM pilot project by the responsible communication unit.
Conducting a human biomonitoring study it is essential to gather additional information on potential exposure pathways, behaviour and socio-demography. In the framework of ESBIO a suitable questionnaire was developed and reached a ready to use status. The questionnaire was divided into four sections.
1. The In-/Exclusion Section is aiming at the (pre-selected) mothers and addresses eligibility criteria and willingness to participate.
2. The Socio-Demography Section shall be filled by participants only and addresses socio-economic determinants of exposure.
3. The Environment and Food Frequency Section shall be filled by the participating mothers and is supposed to facilitate the individual and overall exposure assessments by elucidating the parents and children¿s participants' association with known (or suspected) exposure sources of various domains (indoor/ambient, food, lifestyle habits).
4. The Admission and Sampling Section addresses very basic health-related matters and the guided documentation of specimen collection. This section shall be managed by health officials only.
The questionnaire is available to the public via the ESBIO internet page. It might be used by other scientific groups or a guideline and serve as a standard, respectively.
In the framework of this proposal the current knowledge regarding biomarkers of exposure proposed for an EU Human Bio-monitoring Project are presented. They are arranged in two groups, representing two scenarios of basic/obligate and extended/facultative biomarkers. Beside health related aspects of the individual pollutant, a brief rationale for the selected type of specimen and proposed biomarkers is provided.
The pollutants are: lead, cadmium, mercury, cotinine, perfluorinated chemicals, polybrominated flame retardants and metabolites of phthalates, polycyclic aromatic hydrocarbons, organophosphate insecticides and pyrethroids.
A number of key aspects and recent policy developments were brought together which the future European Network on Human Biomonitoring needs to take into account:
- HBM and REACH: it was briefly outlined how HBM data may assist in the REACH assessment scheme, and also how HBM will benefit from REACH, mainly due to the generation of more and better toxicity data;
- HBM and health examination surveys: In many countries, large-scale HBM survey projects are linked to health examination surveys. Also for the European Pilot Project on Human Biomonitoring such a liaison would be possible in terms of the FEHES project, which studies the feasibility of a pan-European Health Examination Survey;
- HBM and INSPIRE: Geographical information systems may offer an excellent opportunity to combine environment, HBM and health data under one currency, being the spatial location of the data. In order to optimally integrate HBM data with other sources of information, a geographically representative sampling scheme for the European Pilot Project on Human Biomonitoring is advisable, although it remains until now uncertain what this sampling scheme could look like.
This result provides an overview of:
- The available data on pollutant concentrations in air, water, food (quality and quantity) and other relevant environmental compartment as sources of exposure;
- The past and current projects dealing with health data for the 4 key health issues within the European Environment and Health Action Plan
- Possible ways to link human biomonitoring data with both environmental and health data through either physiologically based pharmacokinetic (PBPK) modelling or spatial epidemiological statistics methods (e.g. Geographic information systems (GIS) and Bayesian Statistics)
The document identified available data, but also highlighted where no immediate information was available. In the overall assessment, 5 criteria (availability, harmonisation, geographical context, quality control and policy developments) were taken into account to identify data availability and quality on different sources of information on environmental exposure and health responses.
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