1. VOLUNTARY EU RISK ASSESSMENT FOR LEAD Challenges and Opportunities for the Crystal Industry Craig Boreiko Waterford, Ireland October 2002

2. TOPICS  Why a voluntary effort?  Components of Official RARs  The Voluntary Lead Effort  Issues for the Crystal Industry

3. RECENT LEAD RESTRICTIONS  EU directives end–of–life vehicles waste electrical and electronic equipment construction and demolition waste  Danish lead ban

4. COMMON THEME  No sound science out of date information no assessment of risks  Product restrictions implemented with no demonstrable benefit

5. WHY A VOLUNTARY RISK ASSESSMENT?  Growing number of restrictions  No sound science  No prospect of official risk assessment

6. EU RISK ASSESSMENT  Systematic Assessment of risks for Human Health & Environment  >10,000 substances….4 priority lists  Links to EU Risk Management, e.g. Water Framework Directive Marketing & Use Directive (EU 76/769)  Technical Guidance Document  Rapporteur  Technical Meeting (TM) of EU Member States

7. EU RISK ASSESSMENT  Establishes classification (eg CMR)  For human health it evaluates risk From occupational exposure For consumer exposure From indirect exposure via environment  Assesses risk from production and use upon water sediment and soil compartments Local impacts Regional impacts

8. EU RISK ASSESSMENT  Three potential outcomes possible: Conclusion i: Need additional information Conclusion ii: No risk Conclusion iii: Potential risk and risk reduction needs.

9. A NEW APPROACH Established EU RAR procedure but no provision for voluntary approach Key issue – credibility Extensive discussions with European Commission and Member States Agreement reached December 2001

10. POLITICAL AGREEMENT  Agreement reached between European Commission (DG Enterprise & DG Environment) European Chemicals Bureau Dutch Government other Member States

11. INDUSTRY LDA International Overall project management Collect industry data on occupational exposure / environmental emissions

12. REVIEWING COUNTRY  The Netherlands Monitors entire process on behalf of all EU Member States Review methods & draft RARs Keep other Member States informed

13. INDEPENDENT SCIENTIFIC REVIEW PANELS Environment Prof Colin Janssen (University of Ghent) Prof Steve McGrath (Rothampstead Institute) Prof Dominic Di Toro (Manhattan College) Dr Rene Korenromp (TNO)

14. INDEPENDENT SCIENTIFIC REVIEW PANELS Health Prof. Bob Goyer (ex-University of Western Ontario) Dr Marjorie Smith (University of London) Dr Lars Gerhardsson (University Hospital, Lund) Dr. Gerhard Winneke (Heinrich-Heine University) Dr. Harry Roels (University of Louvain)

15. INDEPENDENT CONSULTANTS Environment Dr Patrick Van Sprang (EURAS, Belgium) Prof Erik Smolders (University of Leuven, Belgium) Health Dr Craig Boreiko (ILZRO, USA) Dr Rodger Battersby (EBRC, Germany)

16. Plastics - windows - pipes - cables Pb (metal) Glass - crystal - TVs, monitors Ceramics - tableware Cables Sheet - roofing - shielding Solders - electronics Alloys - vehicles Shot - shooting Pb stabilisers PbO, Pb 3 O 4 Batteries - vehicles - industrial - motive Electronics Gasoline Paints Other compounds SCOPE

17. OVERALL TIMETABLE Jan-April 2002draft lit. review & methods paper May-July 2002review proposals July 2002 – Sept 2003draft RARs Oct – Nov 2003review draft RARs Dec 2003- Sept 20042 nd draft RARs Oct-Nov 2004review 2 nd draft RAR Dec 2004completion of RA

18. PRIMARY HEALTH ISSUES OF CONCERN  Lead Specific Endpoints Neurobehavioral (pediatric) Male and Female Reproduction (occupational) Neuropsychological (occupational) Blood pressure (general population)

19. PRIMARY AT-RISK GROUPS  Children to age 6  Workers (male and female)  Women of child bearing age in general population?

20. OCCUPATIONAL EXPOSURE ASSESSMENT  Data collection: questionnaires tailored to each industry (site inspections, workplace descriptions) medical surveillance and exposure values published reviews/assessments

21. CONSUMER EXPOSURE ASSESSMENT Screening of published data Collection of industry data Determination of relevant exposure pathways/consumer products Historical vs. current situation

22. INDIRECT EXPOSURE VIA ENVIRONMENT Interaction with ENV RA: 1)Regional and local concentrations for soil, water air provided from single source 2)Dietary intake (predominate for adults) 3)Soil/dust exposure (predominate for children) 4)Long-term environmental loading

23. CRYSTAL INDUSTRY INPUT  Assist in questionnaire development  Contribute occupational exposure data  Contribute environmental emissions data  Provide material flow information  Help address “end of life” and recycling issue

24. CONSUMER EXPOSURE  Key issue for the crystal industry  Provide data on consumer use patterns  Define performance of modern product  Help establish consumer exposure profile

25. BENEFITS TO THE CRYSTAL INDUSTRY  Validation of consumer safety  Avoid arbitrary product restrictions  Establish occupational health performance  Establish environmental emissions  Achieve cooperative compliance with new EU Chemicals Policy