Human Biomonitoring in EU- Funded Research: an update

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1 Human Biomonitoring in EU- Funded Research: an update Dr Tuomo Karjalainen Research Programme Officer Research and Innovation Directorate-General Climate Change and Natural Hazards Unit Expert meeting of EU authorities on the use of human biomonitoring as policy tool in chemical risk assessment Brussels, February 2, /02/2012

2 HBM-related issues in the European Commission: history and actors involved

3 Funding of research Policy making Main DGs and agencies of the Commission addressing E&H health issues Environment Directorate Health Directorate Biotechnologies, Agriculture, Food Directorate Industrial Technologies Directorate Policies on chemicals, EDC strategy, air pollution, noise, water pollution, biodiversity, LIFE+ programme, 6th Environment Action Programme. Public health issues (EMF, indoor air, ETS), EU legislation on food contaminants, risk assessment committees (Scientific Committee on Health and Environmental Risks, Scientific Committee on Emerging and Newly Identified Health Risks), Programme of Community Action in the Field of Health Policies on safety of goods, REACH Occupational health Other actors Reporting, analyses, advice Implementation of REACH Chemical testing, monitoring, policy support, research

4 Human exposure monitoring and surveillance: what do policies say? HBM? Responsible DG/agency? European Environment and Health Action Plan Yes Stockholm convention on persistent organic pollutants (POPs) EC Directive 98/24/EC (the Chemical Agents Directive ), as supplemented by Directives 2000/39/EC and 2006/15/EC Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides Community strategy for endocrine disrupters Community Strategy for dioxins, furans and polychlorinated biphenyls EU water framework directive Yes Yes No, but No No No EU air quality directive The REACH regulation No No

5 Stockholm Convention on Persistent Organic Pollutants (POPs) as amended in 2009 ARTICLE 11 Research, development and monitoring 1. The Parties shall, within their capabilities, at the national and international levels, encourage and/or undertake appropriate research, development, monitoring and cooperation pertaining to persistent organic pollutants and, where relevant, to their alternatives and to candidate persistent organic pollutants, including on their: (a) Sources and releases into the environment; (b) Presence, levels and trends in humans and the environment; (c) Environmental transport, fate and transformation; (d) Effects on human health and the environment; (e) Socio-economic and cultural impacts; (f) Release reduction and/or elimination; and (g) Harmonized methodologies for making inventories of generating sources and analytical techniques for the measurement of releases. 2. In undertaking action under paragraph 1, the Parties shall, within their capabilities: (a) Support and further develop, as appropriate, international programmes, networks and organizations aimed at defining, conducting, assessing and financing research, data collection and monitoring, taking into account the need to minimize duplication of effort; (b) Support national and international efforts to strengthen national scientific and technical research capabilities, particularly in developing countries and countries with economies in transition, and to promote access to, and the exchange of, data and analyses; (c) Take into account the concerns and needs, particularly in the field of financial and technical resources, of developing countries and countries with economies in transition and cooperate in improving their capability to participate in the efforts referred to in subparagraphs (a) and (b); (d) Undertake research work geared towards alleviating the effects of persistent organic pollutants on reproductive health; (e) Make the results of their research, development and monitoring activities referred to in this paragraph accessible to the public on a timely and regular basis; and (f) Encourage and/or undertake cooperation with regard to storage and maintenance of information generated from research, development and monitoring.

6 EC Directive 98/24/EC (the Chemical Agents Directive ) Unless the employer clearly demonstrates by other means of evaluation that, in accordance with paragraph 2, adequate prevention and protection have been achieved, the employer shall carry out on a regular basis, and when any change occurs in the conditions which may affect workers' exposure to chemical agents, such measurements of chemical agents which may present a risk to worker's health at the workplace as are necessary, in particular in relation to the occupational exposure limit values. Health and exposure records shall contain a summary of the results of health surveillance carried out and of any monitoring data representative of the exposure of the individual. Biological monitoring and related requirements may form part of health surveillance.

7 Directive on the sustainable use of pesticides To enhance the comparability of information, the Commission, in cooperation with the Member States, shall develop by 14 December 2012 a strategic guidance document on monitoring and surveying of impacts of pesticide use on human health and the environment.

8 Final conference 6-7 March 2012 Brussels

9 HBM and research HBM has many potential benefits: provides a potentially rich picture of an individual s past exposures; may identify long-term trends in the population; can identify locations with high body burdens; can evaluate effectiveness of policy decisions etc. Research aspects: improvement of biomarkers (exposure, effect if linked to health data; susceptibility). Investigation of real-life chemical mixtures. HBM can reveal priorities for research. My opinion: Investigations of the presence and significance of health effects after a given level of exposure should be the main purpose of research funding related to HBM

10 DG Research and Innovation: Involvement in HBM Parallel activities in MS (German Environmental Survey (GerES), VL ) and in the world (US the National Health and Nutrition Examination Survey (NHANES), Canada, Japan)

11 Societal challenge Health, Demographic Change and Wellbeing, Specific activity 1.1. Understanding the determinants of health, improving health promotion and disease prevention A better understanding of the determinants of health is required in order to provide evidence for effective health promotion and disease prevention, and will also allow the development of comprehensive health and wellbeing indicators in the Union. Environmental, behavioural (including life-style), socio-economic and genetic factors, in their broadest senses will be studied. Approaches will include the long term study of cohorts and their linkage with data derived from "-omics" research, and other methods. In particular, a better understanding of the environment as a determinant of health will require integrated molecular biological, epidemiological and toxicological approaches to investigate health-environment relationships, including studies of modes of action of chemicals, combined exposures to pollution and other environmental and climate related stressors, integrated toxicological testing as well as alternatives to animal testing. Innovative approaches to exposure assessment are needed using new-generation biomarkers based on 'omics' and epigenetics, human biomonitoring, personal exposure assessments and modelling to understand combined, cumulative and emerging exposures, integrating socio-economic and behavioural factors. Improved links with environmental data using advanced information systems will be supported. In this way, existing and planned policies and programmes can be assessed and policy support provided. Similarly, improved behavioural interventions, prevention and education programmes can be developed including those pertaining to health literacy in nutrition, vaccination and other primary care interventions.

12 Unresolved issues with HBM Surveillance is observational in nature and is at the interface between research and policy : who should fund it? Funding in Horizon 2020? Link to EHES? New EHAP? Any new policy initiatives to propose HBM?

13 Additional information available

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