European Stakeholders Workshop ( October 11, 2001) Human Health Risk Assessment

1. European Stakeholders Workshop • ( October 11, 2001) • Human Health Risk Assessment • - Progress and Lessons Learned - • Dr. Christeine Lally • Chair: HERA Human Health Task Force HERA European Stakeholders Workshop: Brussels, Oct 2001

2. Human Health Task Force C. Poelloth, C. Arregui, J. Backmann – HERA Secretariat • C. Lally (P&G) - Chair • G. Holland (Unilever) • F. Bartnik (Henkel) • N. Fedtke (Henkel) • J. Boyd (Colgate) • G. Helmlinger (P&G) • S. Kirkwood (McBride) • F. Bielen (P&G) • W. Aulmann (Cognis) • O. Grundler (BASF) • S. Jacobi (Degussa) • R. Kreiling (Clariant) • T. Roth (Clariant) • M. Maier (ZEODET) • P. Martin (Rhodia) • H. Messinger (Cognis) • J.R. Plautz (Ciba) • G. Veenstra (Shell) HERA European Stakeholders Workshop: Brussels, Oct 2001

3. Human Health Task Force • THE PROCESS: • Focus on a tiered approach to both hazard and exposure assessment; on chemicals used primarily in household detergent and cleaning products; on consumer use of these products (i.e. not professional use or workplace exposure) • focus on intended use but also consider other foreseeable uses and exposure fromcommon accidents • focus on hazards of greatest concern for the general public from the use of these products HERA European Stakeholders Workshop: Brussels, Oct 2001

4. Human Health Task Force • Human Health Conclusions • valid for European Usage • and HERA product categories HERA Human Health Risk Assessment builds on EU Technical Guidance Document for New and Existing substances HERA European Stakeholders Workshop: Brussels, Oct 2001

5. Human Health Task Force • The HERA methodology follows a tiered approach: • Consider possible uses of chemicals in household detergent and cleaning products • Consider consumer activity during cleaning tasks - review also foreseeable other uses of products • Consider hazards which are most likely to be relevant for known product uses and exposures (e.g. is dermal contact likely? could ingestion occur inadvertently?) • Consider the likelihood that the consumer could be exposed at levels which could be harmful to health i.e. is the consumer at risk? HERA European Stakeholders Workshop: Brussels, Oct 2001

6. What do consumers do with HERA products ? ? HERA European Stakeholders Workshop: Brussels, Oct 2001

7. Human Health Task Force • USE & EXPOSURE • Identify • which finished product category (laundry compact, fabric conditioner, toilet cleaner….) • chemical concentration (% in finished product, range) • type of application (powder, tablet, spray, wipe….) and how is product used HERA European Stakeholders Workshop: Brussels, Oct 2001

8. HERA brings Formulators together…. HERA European Stakeholders Workshop: Brussels, Oct 2001

9. HERA brings Formulators together…. Formulator companies asked to provide (in confidence): • Use levels of Phase 1A and 1B chemicals in their finished products • List of product categories where chemicals are currently used • Published or in-house data on consumer habits and practices for product categories (at least provide ‘recommended use’) HERA European Stakeholders Workshop: Brussels, Oct 2001

10. Human Health Task Force • USE & EXPOSURE • HERA provides simple multiplicative mathematical models – building on consumer exposure equations in EU TGD and in ECETOC Technical Reports • HERA uses real data (formulators) or, if unavailable, it uses ‘reasonable’ defaults (based on expert judgement) • HERA uses a ‘reasonable worst case’ scenario in first step (tiered approach) • HERA checks exposure estimate for ‘realism’ • HERA considers need for more refined exposure estimate HERA European Stakeholders Workshop: Brussels, Oct 2001

11. HERA brings Formulators together…. Estimate of Consumer Exposure HERA European Stakeholders Workshop: Brussels, Oct 2001

12. + • HAZARD • Producer companies asked to: • collect available toxicology data on chemical – IUCLID, SIDS, IPCS, in-house company data etc. • consider toxicological endpoints most relevant for use - endpoints of interest largely driven by predicted exposure; identify no-effect-levels and possible data gaps • validate data based on current standards (e.g. Klimisch) - evaluate relevant older data; consider human experience And Formulator companies asked to provide: • finished product safety data where available and useful HERA European Stakeholders Workshop: Brussels, Oct 2001

13. Potential for Consumer Hazard HERA European Stakeholders Workshop: Brussels, Oct 2001

14. HERA Risk Assessment elements…. HERA European Stakeholders Workshop: Brussels, Oct 2001

15. HERA brings Producers & Formulators together…. • HOWEVER….these assessment activities are not two distinct processes running in isolation ! • HERA identifies a Substance Team for each chemical in programme • Substance Team is a unique ‘platform of cooperation’ between producer and formulator • Team dialogue ensures that Exposure and Hazard exercises are linked; • highlight early on any potential issues needing more attention • apply team resources to areas of concern and uncertainty • compare ‘bridging data’ – exchange expert judgement opinions • identify needs for new approach or further research HERA European Stakeholders Workshop: Brussels, Oct 2001

16. Is the consumer at risk…? • compare relevant hazard(s) with foreseeable exposure(s) for consumer • ratio of “no observed adverse effect level” and “exposure”  Margin of Exposure or MOE [NOAEL/Exposure = MOE] • how does the MOE help to develop the human health conclusions of the risk assessment ? HERA European Stakeholders Workshop: Brussels, Oct 2001

17. Human Health Task Force • The MOE needs to take account of: ….the Uncertainties and Variabilities in the Hazard and Exposure assessments e.g. • assumptions and reliability of exposure estimates (both from modelling and from measured data) • adequacy and relevancy of hazard data set • the data extrapolations between and within species • use of less-than-lifetime exposures HERA European Stakeholders Workshop: Brussels, Oct 2001

18. Is the consumer at risk…? • The MOE may indicate that product use is safe…… or • There may be a need to revise the assessment…… ACTION: • review exposure estimates • review hazard dataset • consider product safety data • use human experience data • get more data…. (exposure, hazard…) • consider the option of risk management HERA European Stakeholders Workshop: Brussels, Oct 2001

19. Human Health Task Force The Human Health Risk Assessment conclusion …. • uses the combined knowledge about chemicals from the Producers and Formulators – the Partnership • uses the expert judgement of experienced toxicologists and builds on their familiarity with products • provides transparency in arguments and decisions and a consensus opinion • provides a common basis to allow risk management decisions to be considered HERA European Stakeholders Workshop: Brussels, Oct 2001

20. Human Health Task Force • SOME LEARNINGS… • collection and comparing exposure data is not easy – downstream use is complex • exposure from indirect contact with chemicals is difficult to estimate • Poison Control Centre (PCC) reports helpful for ‘safety’ after accidental exposures • combined expertise and experience of toxicologists from Producer and Formulator companies adds a synergistic value to the HERA risk assessments HERA European Stakeholders Workshop: Brussels, Oct 2001

21. On behalf of the HERA Human Health Task Force……… Thank you! HERA European Stakeholders Workshop: Brussels, Oct 2001