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Research & Science Advancing Risk Assessment

Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley. Cefic Research and Science. INDUSTRY PRIORITIES. GLOBAL LINKS. R&S MAIN ACTIVITIES. Innovation Risk Assessment Reach (RIPs) Precaution

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Research & Science Advancing Risk Assessment

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  1. Research & Science Advancing Risk Assessment Presentation MarchAssociation of Chemical Industry of the Czech Republic Monique Marrec Fairley

  2. Cefic Research and Science INDUSTRY PRIORITIES GLOBALLINKS R&S MAIN ACTIVITIES • Innovation • Risk Assessment • Reach (RIPs) • Precaution • Product / Health • Health & • Environment • SCALE SUSCHEM LRI Children’s Environment & Health Issue Management • ICCA LRI • Bio-Monitoring Project • ICCA TAG • Children’s Health • Endocrine

  3. Long Range Initiative’s mission • Identify and fill gaps in our understanding of the hazards posed by chemicals, to advance estimates of exposure and to improve the methods for assessing the associated risks • Support informed risk management decisions • Transparency to build trust

  4. Drivers of the LRI programme • Public demand that industry “know” its products • Public impact of biomonitoring programmes • The draft European union chemicals policy (REACH) • Demands for human risk-related information • Demands for ecological risk-related information • Demands for knowledge of potential risks to children (SCALE) • International public and governmental concerns over endocrine-active compounds • Demands for Alternatives to animal testing

  5. REACH Implementation Projects (RIPs) Industry Involvement • RIP 3.2 Chemical Assessment Report • Basis for Technical basis guidance • RIP 3.3 Develop a general and cost-effective decision-making framework on information requirements based on Integrated Testing Strategy (ITS) • Four endpoints: Aquatic toxicity; Degradation; Eye irritation; Reproduction • Next step: Drafting technical guidance document • (waiting for call from proposal from the European Commission)

  6. EU 3Rs Partnership • 3Rs: Develop Alternative Methods to Animals – Reduce Refine Replace the number of animals used. • Important to reduce the number of animals for cost and ethical purpose for the implementation of REACH • Partnership signed in November 2005 between the European Commission and Industry Partners (Colipa; Efpia; Cefic; Europabio; Crop Protection Association; IFAH; AISE)

  7. Principles of the Partnership • A voluntary bi-lateral relationship • Flexible/pragmatic structure • Commission to coordinate (provide “platform”) • Stakeholders with secondary role, i.e. recipients of output, no steering role)

  8. Research that makes a difference

  9. Environment Suite – modelling the environmental fate of Chemicals in risk assessment Atmospheric: ADEPT Rivers: GREAT-ER II Used by UBA/DEFRA Soil: TERRACE Estuarine: GEMCO

  10. Persistence & Bioaccumulation – Assessing the risks • Dynamic effects through the food chain ACC-HUMAN is a dynamic bioaccumulation model predicting human tissue levels from concentrations in air, soil and water. • Understanding Persistence The project has investigated persistence and bio-concentration of a diverse range of chemical types, including man-made and naturally-occurring ones, in the oceans and on land. • Relationships between Persistence and Bioaccumulation potential Predicting human exposures from bioaccumulation and magnification through the food chain

  11. Improving Exposure Assessment • Exposure is the more subjective part of risk assessment • Creating relational databases for dispersed data on exposures to consumers, & workers, as regulatory tools to improve exposure estimates in risk assessment • Risk= f [Hazard, Exposure]

  12. Reducing Uncertainty in Exposure Estimates • Consumer Exposures • IERIE : inventory of research on indoor pollutants • EXPOLIS : European urban exposure patterns (implemented within INDEX EU project on Indoor Air) • ExpoFacts : European Sourcebook of human exposures • Occupational Health • HEROX – inventory of European workplace exposure to chemicals • EASE – understanding and reducing uncertainties within the current regulatory model • Improved basis for the assessment and management of risks arising from dermal exposures to chemicals • Biomarkers of exposure • Background incidence on biomarkers of exposure to chemicals in UK – what is normal? How does it vary over time and between people?

  13. Animal Alternatives • Funded Secondment to OECD for policy development for QSARs • Access to EU/ECB/ECVAM network important to REACH • Existing LRI work to predict extended low dose exposures and skin permeation for Risk assessment • New portfolio from the Alternatives Issue Management Team • Modelling approaches to skin irritation, mutagenicity/genotoxicicity and bioconcentration • Use of fish cells/embryo’s as model test substrates

  14. Conclusions • Science contribution directly relevant to: • The applicability and science of Risk Assessment • Practical tools for RIPs • Recommendation • Review processes to maximise advocacy impact of R&S work relevant to PS • e.g. Use of QSAR’s in REACH

  15. More information • European Technology Platform for Sustainable Chemistry • http://www.suschem.org • Long Range Initiative http://www.cefic.org/lri

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