1. A COORDINATED APPROACH TO HUMAN BIOMONITORING IN EUROPE: State of play Birgit Van Tongelen, European Commission, DG Environment Consultative Forum on Environment & Health Brussels, April 19th 2006

2. Content 1.Progress on implementation of Action 3 2. 2 nd Recommendation of the Implementation Group on HBM 3.Choice of pollutants 4.Next steps

3. ACTION 3 of Env &H Action Plan The Commission in close cooperation with the Member States will develop a coherent approach to HBM in Europe – starting from experiences in Member States, occupational health, similar activities in USA and WHO. To test the approach developed, the Commission will launch a EU Pilot Project in close cooperation with MS.

4. ACTION 3: Develop a coherent approach to HBM in Europe STEP-BY-STEP APPROACH I Develop comparable protocols addressing initiation, performance and follow-up of biomonitoring activities (2004-2006) II Develop tools to translate results into a response system : integration scenarios & communication strategies (2004-2006) III Start an EU Pilot Project

5. 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. 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.

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

7. ROADMAP: technical preparation Key deliverable = Protocol for Pilot Project z Two contracts y BiPRO y ESBIO (Scientific Support to Policy) zImplementation Group y 2 nd Recommendation, incl. draft protocol y Feedback to national governments Expert team to Support BIOmonitoring in Europe E SB O

8. ROADMAP: technical preparation (2) BiPRO deliverables: zWebsite: www.eu-humanbiomonitoring.org zProposal for methodology to select candidates zProposal 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 zRecommendations to integrate new technologies in toxicology (- OMICS) with the Pilot Project

9. ROADMAP: technical preparation (3) ESBIO deliverables: zUpdated inventory of HBM programmes Lisbon Conference zGuidelines 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 zScenarios to integrate HBM with env. & health monitoring zScenarios to translate HBM results into policy zEthical issues zCommunication strategies zSocio economic consequences zUtility and sensitivity of biomarkers zProtocol for pilot project October 2006

10. Lisbon Conference, 20-21 March z« State of the art on HBM in Europe » zESBIO-WP 1: European Inventory of HBM yTo ensure integration yTo initiate the creation of a platform for exchange of experiences/expertise zInternet platform:www.hbm-inventory.org zAbstracts published in special edition on HBM of International Journal of Hygiene & Environmental Health (end 2006)

11. 2 nd IG Recommendation zBasic scenario: all MS will biomonitor at least 1 common pollutant yMethylmercury, lead, cadmium, cotinine zExtended scenario: at least 5 MS will biomonitor additional pollutants yPhtalates, PAHs

12. Extended scenario zPhtalates zPAHs zSubstances with possible PBT, vPvB properties: yDodecylphenol (CAS 27193-86-8); yOctamethylcyclotetrasiloxan (CAS 556-67-2); y2,2',6,6'-Tetra-tert-butyl-4,4'-methylenediphenol (CAS 118-82- 1); yHexabromocyclododecan (CAS 25637-99-4). zOMICS (recommendations from BiPRO report) z… ??

13. Extended scenario (2) BIPRO RECOMMENDATIONS 1 st Recommendation (1 st priority - immediate inclusion possible): Biomarkers of exposure to reactive metabolites: - Mercapturic acids in urine; - Haemoglobin adducts. Biomarkers based on changes in profile of urinary excretion: - General metabonomics; - Metabolic profiling. 2 nd Recommendation (2 nd priority - high potential of developments): Biomarker of genotoxicity: - Chromosomal aberrations (FISH); - Micronucleus tests (reticulocytes). 3 rd Recommendation: Use the samples that have been taken on a EU-wide basis in the framework of the pilot project for further research and development of metabonomics or other new technologies in toxicology.

14. ESBIO/IG need to know which pollutants in basic & extended scenarios To elaborate a detailed protocol To calculate budgets To design a communication strategy To design organisational requirements

15. ESBIO/IG need your feedback on … 1.Basic scenario: y Which pollutants ? Methylmercury, lead, cadmium, cotinine y Which Member States ? 2.Extended scenario: y Which pollutants ? Phtalates, PAHs, ….. y Which Member States ? Please confirm by May 5th 2006

16. ROADMAP: political preparation Support from Member States is crucial ! Transparency & MS involvement via: 1.Governmental representatives: 2 ways ! 2.Member States meetings 3.Consultative Forum on Environment & Health

17. ROADMAP: financial preparation Pilot Project is a research effort in itself – 1st IG Recommendation Specific Cooperation Programme under the Seventh Framework Programme of the European Community for Research (2007-2013) Thematic area « Environment - Climate Change, pollution and risks …….. Research will aim at integrating research activities on human biomonitoring regarding scientific aspects, methodologies and tools to develop a coordinated and coherent approach. ……

18. ROADMAP: financial preparation (2) Meeting with national funders - 29/11/05 Aim: discuss MS participation in pilot project and correlated financial possibilities Participants: MS decisionmakers - funders of HBM programmes Organisation: Belgium (Flemisch Minister of Environment)

19. Conclusions NF meeting zSupport for Action 3 zNo consensus amongst MS on: yPopulation group ySelection criteria for pollutants zNeed for: yClarity about funding (extent and origin) yDecision making structure yWell-argued, concrete, policy relevant proposal

20. ROADMAP: communication Science-based communication integral component throughout the pilot project. ESBIO – communication aspects Communication campaign: yTo raise awareness yTo inform the public and stakeholders yTo support recruitment of study participants yTo communicate results and their significance for public health organised by Commission and Member States

21. ESBIO project needs your feedback on … 1.Basic scenario: y Which pollutants ? Methylmercury, lead, cadmium, cotinine y Which Member States ? 2.Extended scenario: y Which pollutants ? Phtalates, PAHs, ….. y Which Member States ? Please confirm by May 5th 2006

22. Next steps z5th May: input on choice pollutants zESBIO/IG will elaborate draft protocol z19th May: IG meeting in Berlin z6-7 September: IG meeting in Paris zSeptember: 3rd IG Recommendation zOctober: proposal for protocol

23. http://europa.eu.int/comm/environment/ health/index_en.htm http://eu-humanbiomonitoring.org Thank you for your attention !