« HUMAN BIOMONITORING » Consultative Forum on Environment & Health 19th October 2005 in Luxembourg Update on developments

The EU Pilot Project on HBM... is a « learning by doing » tool to (1) test methodological issues in the development of a coordinated EU approach to HBM, (2) to facilitate the establishment of collaboration networks and sharing of methodologies, (3) to give a first indication of comparability of HBM data in EU for specific pollutants. The IG stressed that a close link with research is needed to allow: (i) defining harmonised procedures; (ii) defining best ways of providing information to and obtaining consent from study persons; (iii) the interpretation of measurements with biomarkers; (iv) the integration with other data (environmental and health); (v) the translation into policy.

ROADMAP EU PILOT PROJECT : 1.Technical preparation 2.Political preparation 3.Financial preparation 4.Communication campaign

ROADMAP: (1) Technical preparation Implementation Group –To prepare Recommendations for Member States/Consultative Group –To ensure feedback to and from national governments Two contracts –BiPRO : June 2005 till February 2006 –ESBIO : October 2005 till October 2007

Deliverables in the preparation of the Pilot Project Website Proposal for methodology to select candidates Proposal environmental pollutants, related biomarkers, human tissues/fluids to be monitored in the EU Pilot Project including pros/cons, estimated costs, policy relevance, link Information System Recommendations to integrate new technologies in toxicology (- OMICS) with the Pilot Project

Deliverables in the preparation of the Pilot Project Updated inventory of HBM programmes Guidelines coordinated approach: proposals for study design, protocol for harmonised way of data collection, analysis, evaluation, data management, protocol for interlaboratory comparison + organisation of laboratory work Scenarios to integrate HBM with environment and health monitoring Scenarios to translate HBM results into policy Ethical issues Communication strategies (to stakeholders, to study participants, …) Socio economic consequences Utility and sensitivity of biomarkers

First BiPRO report discussed by IG in Ispra –Proposal for methodology to select candid. –Table of env. pollutants, related biomarkers, human tissues/fluids to be monitored in the EU Pilot Project, including pros/cons, estimated costs,… –First assessment on possibilities of new technologies in toxicology (- OMICS) –Website IG Recommendations by 10/10 for –MS meeting on 18/10 –Consultative Forum on 19/10

Next steps in technical preparation 2nd BiPRO report by 7/11 to be discussed in Cyprus –Elaborated assessment –OMICS –Overview & results of selection process for biomarkers Final BiPRO report by 15/1/2006 to be discussed in Brussels IG recommendations –Final overview –OMICS, possible links with EU coordinated approach, recommendations to integrate with Pilot Project –Final overview selection process First ESBIO report by 1/4/2006 –Updated inventory of HBM programmes (identification of actors involved) –Assessment of the utility of bio indicators for pollutants –Estimates of the sensitivity of individual biomarkers 21/11: DG RTD Workshop « research in support to HBM » in Brussels

Research in support to HBM Workshop on 21/11 on the different projects in DG RTD dealing with HBM: NewGeneris, Phime, Athon, Intarese, Nomiracle, Ecnis, Ga2Len, Pioneer, Seafoodplus, Nugo, P-mark, ….. Outcome: Synthesis report How can these projects contribute to the EU coordinated approach to HBM as envisaged in Action 3 and to the Pilot Project to be launched end of 2006 ?

ROADMAP: (2) Political preparation Full Member States involvement via: 1.Governmental representatives responsible for HBM in Env, Health, Research ministries List 2.Informal Member States meetings 18/10/2005 in Luxembourg 3.Consultative Forum: 19/10/2005 in Luxembourg 4.Environment Policy Review Group (EPRG) & High Level Committee on Health (HLCH) EPRG: 29 November 2005 – HLCH: December 2005

Formal commitment from Member States at the appropriate moment.

ROADMAP:(4) Communication campaign Launch of EU Pilot Project accompanied by a large communication campaign. organised by the Commission + MS start preparation in early 2006

ROADMAP: (3) Financial preparation HBM is included in FP7 Specific Programmes under Theme « Environment - Environment & Health »: « … Research will aim at integrating activities on HBM regarding scientific aspects, methodologies and tools, with a view to developing a coordinated and coherent approach at EU level… »

12 MS sent a letter of intent Belgium Czech Republic France Denmark Sweden Hungary Spain Poland Portugal Slovakia AustriaCyprus Meeting with national funders organised by Belgium

Link with Information System Information System: HBM will be addressed in the assessment of all exposure routes HBM: the link with the Information System will be ensured via WP3 in ESBIO which will elaborate scenarios to link HBM data to environmental exposure data and, to available data on population health

WP3 in ESBIO Identify environmental monitoring data, environmental indicators relevant to link with biomarkers of exposure/effect to be measured in a HBM programme Search for strategies, databases and registers which may contain this information

Identify health data and health indicators relevant to link with biomarkers of exposure/effect to be measured in a HBM programme Search for existing health registers, databases which may contain this information