1. Voluntary Risk Assessment on Lead - background and environmental issues Dr Andy Bush Lead Development Association International

2. Structure of Presentation u Why a lead risk assessment? u Risk assessment process u Environment conclusions for crystal producers u Health assessment (Craig Boreiko…)

3. Why a Lead Risk Assessment? u Renewed pressure on lead in EU (1999) –European Commission (DG Environment) »End of Life Vehicles Directive »RoHS in EEE Directive »Construction and Demolition Waste Green Paper –Individual EU Member States »Denmark – general ban on lead in many applications »Sweden – national policy to phase out lead

4. Why a Lead Risk Assessment? u Common theme to restrictions: –No sound science & out of date information –No prospect of official EU risk assessment u EU lead producers agreed to undertake a VRAL –In compliance with official EU risk assessment methods –With full support of European Commission and EU Member States

5. Participants uIndustry (LDA International) –Overall project management, funding ($3 million) uReviewing Country (Netherlands) –Review risk assessment reports uIndependent Scientific Review Panels (H&E) –Provide scientific advice on risk assessment reports uIndependent Consultants –Produce risk assessment report

6. Scope –Lead metal –Lead oxides (PbO, Pb 3 O 4 ) –Lead stabilizers (ten) –95% of lead use –Human health and environmental impacts –Production / use / recycling / disposal

7. Principles of EU Environment Risk Assessment 1. Determine safe concentrations of Pb in environment - Predicted No Effects Concentration (PNEC) 2. Determine actual concentrations of Pb in environment - Predicted Environmental Concentration 3. Compare safe levels and exposure concs: - PEC > PNEC RISK - PEC < PNEC NO RISK

8. EU Risk Assessment Formal Conclusions uThree official EU RA conclusions: –Conclusion (ii)no risk –Conclusion (iii) risk –Conclusion (i)insufficient data available to reach a conclusion, therefore further research is required

9. Implications of risk assessment conclusions uConclusion (i) – insufficient data –Industry must proceed with further research according to protocols and time schedules developed in consultation with the Reviewing Country (Netherlands) uConclusion (iii) - risk –Industry must submit a proposal for risk management to European Commission for review and approval –Industry must implement approved (voluntary) risk reduction measures –Or, where regulatory action is deemed necessary, EC will develop legislative proposals

10. Environmental assessment of crystal production u Data provided by 11 EU production sites –Lead emissions to air, soil, water, waste, sewer –Lead levels in receiving environment u EU model calculates Predicted Environmental Concentration (PEC) of lead in environment –or monitoring data used if available u PECs are compared to Predicted No Effects Concentrations to determine risk

11. Environmental risks from crystal production CompartmentPNECRegional risk?Local risk? Freshwater 14.5  g/l NoYes (1/11) Marine water 8.3  g/l NoN/A Freshwater sediments53.4 mg/kg*Further work Marine sediments80.1 mg/kgFurther workN/A Soil317.6 mg/kg**No Secondary poisoning (aq)49 mg/kgNo Secondary poisoning (soil)49 mg/kgNo STP effluent1 mg/lNo * Excluding bioavailability correction ** Including lab/field correction factor

12. Sediment risks from crystal production uBased on current data: –Theoretical risks to sediments in vicinity of : »4 sites (using modelled regional data) »ALL sites (measured regional data) uBut PNEC is not considered realistic (too few ecotoxicity studies) uRAR concludes need for further research - additional ecotox research already underway - results expected summer 2006

13. What next? u May 05 – submitted risk assessment reports to EC u 2005/6 – review of reports by EU Member States u2006/7 – risk management strategy and further work proposals to be submitted for review

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