VOLUNTARY EU RISK ASSESSMENT FOR LEAD

Challenges and Opportunities for the Crystal Industry

Craig BoreikoWaterford, Ireland

October 2002

TOPICS

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

RECENT LEAD RESTRICTIONS

EU directives end–of–life vehicles waste electrical and electronic equipment construction and demolition waste

Danish lead ban

COMMON THEME

No sound science out of date information no assessment of risks

Product restrictions implemented with no demonstrable benefit

WHY A VOLUNTARY RISK ASSESSMENT?

Growing number of restrictions No sound science No prospect of official risk assessment

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

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

EU RISK ASSESSMENT

Three potential outcomes possible: Conclusion i: Need additional

information Conclusion ii: No risk Conclusion iii: Potential risk and risk

reduction needs.

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

POLITICAL AGREEMENT

Agreement reached between European Commission (DG Enterprise &

DG Environment) European Chemicals Bureau Dutch Government other Member States

INDUSTRY

LDA International Overall project management Collect industry data on occupational

exposure / environmental emissions

REVIEWING COUNTRY

The Netherlands Monitors entire process on behalf of all

EU Member States Review methods & draft RARs Keep other Member States informed

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)

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)

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)

Plastics - windows - pipes - cables

Pb (metal)

Glass - crystal - TVs, monitorsCeramics - tableware

CablesSheet - roofing - shieldingSolders - electronicsAlloys - vehiclesShot - shooting

Pb stabilisersPbO, Pb3O4

Batteries - vehicles - industrial - motive

ElectronicsGasolinePaints

Other compounds

SCOPE

OVERALL TIMETABLEJan-April 2002 draft lit. review & methods paper

May-July 2002 review proposals

July 2002 – Sept 2003 draft RARs

Oct – Nov 2003 review draft RARs

Dec 2003- Sept 2004 2nd draft RARs

Oct-Nov 2004 review 2nd draft RAR

Dec 2004 completion of RA

PRIMARY HEALTH ISSUES OF CONCERN

Lead Specific Endpoints Neurobehavioral (pediatric) Male and Female Reproduction (occupational) Neuropsychological (occupational) Blood pressure (general population)

PRIMARY AT-RISK GROUPS

Children to age 6 Workers (male and female) Women of child bearing age in general

population?

OCCUPATIONAL EXPOSURE ASSESSMENT

Data collection: questionnaires tailored to each industry

(site inspections, workplace descriptions) medical surveillance and exposure values published reviews/assessments

CONSUMER EXPOSURE ASSESSMENT

Screening of published data Collection of industry data Determination of relevant exposure

pathways/consumer products Historical vs. current situation

INDIRECT EXPOSURE VIA ENVIRONMENT

Interaction with ENV RA:1) Regional and local concentrations for soil,

water air provided from single source2) Dietary intake (predominate for adults)3) Soil/dust exposure (predominate for

children)4) Long-term environmental loading

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

CONSUMER EXPOSURE

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

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