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

Content

1. Progress on implementation of Action 3

2. 2nd Recommendation of the Implementation Group on HBM

3. Choice of pollutants 4. Next steps

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.

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

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.

ROADMAP

EU PILOT PROJECT:

1. Technical preparation2. Financial preparation3. Political preparation4. Communication campaign

ROADMAP: technical preparation

Key deliverable = Protocol for Pilot Project

Two contracts BiPRO ESBIO (Scientific Support to Policy)

Implementation Group 2nd Recommendation, incl. draft

protocol Feedback to national governments

Expert team to Support

BIOmonitoring in Europe

ESB O

ROADMAP: technical preparation (2)

BiPRO deliverables:Website: www.eu-humanbiomonitoring.org

Proposal for methodology to select candidates

Proposal environmental pollutants, related biomarkers, human tissues/fluids to be monitored in the EU Pilot Projectincluding pro’s/con’s, estimated costs, policy relevance, link Information System

Recommendations to integrate new technologies in toxicology (- OMICS) with the Pilot Project

ROADMAP: technical preparation (3)

ESBIO deliverables: Updated inventory of HBM programmes Lisbon

Conference 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 env. & health monitoring Scenarios to translate HBM results into policy Ethical issues Communication strategies Socio economic consequences Utility and sensitivity of biomarkers Protocol for pilot project October 2006

Lisbon Conference, 20-21 March

« State of the art on HBM in Europe »ESBIO-WP 1: European Inventory of

HBM To ensure integration To initiate the creation of a platform for

exchange of experiences/expertiseInternet platform:www.hbm-

inventory.orgAbstracts published in special edition on

HBM of International Journal of Hygiene & Environmental Health (end 2006)

2nd IG Recommendation

Basic scenario: all MS will biomonitor at least 1 common pollutant Methylmercury, lead, cadmium,

cotinine

Extended scenario: at least 5 MS will biomonitor additional pollutants Phtalates, PAHs

Extended scenario

Phtalates PAHs Substances with possible PBT,

vPvB properties: Dodecylphenol (CAS 27193-86-8); Octamethylcyclotetrasiloxan (CAS 556-67-2); 2,2',6,6'-Tetra-tert-butyl-4,4'-methylenediphenol (CAS

118-82-1); Hexabromocyclododecan (CAS 25637-99-4).

OMICS (recommendations from BiPRO report)

… ??

Extended scenario (2)BIPRO RECOMMENDATIONS

1st Recommendation (1st 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.

2nd Recommendation (2nd priority - high potential of developments):Biomarker of genotoxicity:- Chromosomal aberrations (FISH);- Micronucleus tests (reticulocytes).

3rd 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.

ESBIO/IG need to know which pollutants in basic & extended scenario’s To elaborate a detailed protocolTo calculate budgetsTo design a communication strategyTo design organisational requirements

ESBIO/IG need your feedback on …

1. Basic scenario: Which pollutants ?

Methylmercury, lead, cadmium, cotinine Which Member States ?

2. Extended scenario: Which pollutants ?

Phtalates, PAHs, ….. Which Member States ?

Please confirm by May 5th 2006

ROADMAP: political preparation

Support from Member States is crucial !

Transparency & MS involvement via:

1. Governmental representatives: 2 ways !

2. Member States meetings3. Consultative Forum on

Environment & Health

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. ……

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)

Conclusions NF meeting

Support for Action 3No consensus amongst MS on:

Population group Selection criteria for pollutants

Need for: Clarity about funding (extent and origin) Decision making structure Well-argued, concrete, policy relevant

proposal

ROADMAP: communication

Science-based communication integral component throughout the pilot project.ESBIO – communication aspectsCommunication campaign: To raise awareness To inform the public and stakeholders To support recruitment of study participants To communicate results and their significance

for public health

organised by Commission and Member States

ESBIO project needs your feedback on …

1. Basic scenario: Which pollutants ?

Methylmercury, lead, cadmium, cotinine

Which Member States ?

2. Extended scenario: Which pollutants ?

Phtalates, PAHs, ….. Which Member States ?

Please confirm by May 5th 2006

Next steps

5th May: input on choice pollutantsESBIO/IG will elaborate draft protocol19th May: IG meeting in Berlin 6-7 September: IG meeting in ParisSeptember: 3rd IG Recommendation October: proposal for protocol

http://europa.eu.int/comm/environment/health/index_en.htm

http://eu-humanbiomonitoring.org

Thank you for your attention !