1. HERA European Stakeholders Workshop: Brussels, Oct 20011 European Stakeholders Workshop ( October 11, 2001) Human Health Risk Assessment - Progress and Lessons Learned - Dr. Christeine Lally Chair: HERA Human Health Task Force

2. HERA European Stakeholders Workshop: Brussels, Oct 20012 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)

3. HERA European Stakeholders Workshop: Brussels, Oct 20013 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 from common accidents focus on hazards of greatest concern for the general public from the use of these products

4. HERA European Stakeholders Workshop: Brussels, Oct 20014  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 Human Health Task Force

5. HERA European Stakeholders Workshop: Brussels, Oct 20015 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? Human Health Task Force

6. HERA European Stakeholders Workshop: Brussels, Oct 20016 What do consumers do with HERA products ? ?

7. HERA European Stakeholders Workshop: Brussels, Oct 20017 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 Human Health Task Force

8. HERA European Stakeholders Workshop: Brussels, Oct 20018 HERA brings Formulators together….

9. HERA European Stakeholders Workshop: Brussels, Oct 20019 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 brings Formulators together….

10. HERA European Stakeholders Workshop: Brussels, Oct 200110 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 Human Health Task Force

11. HERA European Stakeholders Workshop: Brussels, Oct 200111 EXPOSURE (from end-users or formulators) Identify where chemical used Finished product category and form (e.g. gel, tablet…) Concentration range of ingredient in product Consumer Contact with product Use scenarios (recommended, foreseeable uses, accidents) Relevant exposure routes Indirect Exposures (via the Environment) Estimate Exposure using Simple Models Apply H&P data, defaults, models Use measured data where available Combine Exposure Estimates Use additive approach to give consumer ‘dose’ Include indirect exposure estimates from Environment TF Estimate of Consumer Exposure HERA brings Formulators together….

12. HERA European Stakeholders Workshop: Brussels, Oct 200112 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 +

13. HERA European Stakeholders Workshop: Brussels, Oct 200113 HAZARD (from producers, with input from end-users if needed) Collect toxicological data on chemical Identify critical endpoints of greatest concern and data gaps Consider bridging data, SAR and finished product safety data Validate the data required Criteria for reliability, human experience data Summarise relevant data (robust summaries) focused on relevant exposures and endpoints Potential for Consumer Hazard

14. HERA European Stakeholders Workshop: Brussels, Oct 200114 HAZARD Collect toxicological data on chemical Identify critical endpoints of concern and data gaps Consider bridging data, SAR and product safety data Validate the data required Criteria for reliability, human experience data Summarise data (robust summaries) focused on relevant exposures and endpoints EXPOSURE Identify where chemical used Product category and form (e.g. gel, tablet…) Concentration range of ingredient in product Consumer Contact with product Use scenarios (recommended, foreseeable uses, accidents) Relevant exposure routes Indirect Exposures (via the Environment) Estimate Exposure using Simple Models Apply H&P data, defaults, models Use measured data where available Combine Exposure Estimates Use additive approach to give consumer ‘dose’ Include indirect exposure estimates from Environment TF HERA Risk Assessment elements….

15. HERA European Stakeholders Workshop: Brussels, Oct 200115 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 brings Producers & Formulators together….

16. HERA European Stakeholders Workshop: Brussels, Oct 200116 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 ?

17. HERA European Stakeholders Workshop: Brussels, Oct 200117 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

18. HERA European Stakeholders Workshop: Brussels, Oct 200118 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 Is the consumer at risk…?

19. HERA European Stakeholders Workshop: Brussels, Oct 200119 The Human Health Risk Assessment conclusion …. 4uses the combined knowledge about chemicals from the Producers and Formulators – the Partnership 4uses the expert judgement of experienced toxicologists and builds on their familiarity with products 4provides transparency in arguments and decisions and a consensus opinion 4provides a common basis to allow risk management decisions to be considered Human Health Task Force

20. HERA European Stakeholders Workshop: Brussels, Oct 200120 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 Human Health Task Force

21. HERA European Stakeholders Workshop: Brussels, Oct 200121 On behalf of the HERA Human Health Task Force……… Thank you!