European Stakeholders Workshop October 11 2001 Human

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 1

Human Health Task Force C. Poelloth, C. Arregui, J. Backmann – HERA Secretariat n n n n C. Lally (P&G) - Chair G. Holland (Unilever) F. Bartnik (Henkel) N. Fedtke (Henkel) J. Boyd (Colgate) G. Helmlinger (P&G) S. Kirkwood (Mc. Bride) F. Bielen (P&G) n n n n n 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 2

Human Health Task Force è 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) l focus on intended use but also consider other foreseeable uses and exposure from common accidents l focus on hazards of greatest concern for the general public from the use of these products l HERA European Stakeholders Workshop: Brussels, Oct 2001 3

Human Health Task Force Ø 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 4

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 5

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

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 7

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

HERA brings Formulators together…. Formulator companies asked to provide (in confidence): Ï Use levels of Phase 1 A and 1 B chemicals in their finished products Ï List of product categories where chemicals are currently used Ï 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 9

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

HERA brings Formulators together…. 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 Estimate of Consumer Exposure Use additive approach to give consumer ‘dose’ Include indirect exposure estimates from Environment TF HERA European Stakeholders Workshop: Brussels, Oct 2001 11

+ 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 12

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

HERA Risk Assessment elements…. EXPOSURE Identify where chemical used Product category and form (e. g. gel, tablet…) Concentration range of ingredient in product HAZARD Collect toxicological data on chemical Consumer Contact with product Identify critical endpoints of Use scenarios (recommended, foreseeable concern and data gaps uses, accidents) Relevant exposure routes Indirect Exposures (via the Environment) Consider bridging data, SAR and product safety data Estimate Exposure using Simple Validate the data required Criteria for reliability, human experience data 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 Summarise data (robust summaries) focused on relevant exposures and endpoints HERA European Stakeholders Workshop: Brussels, Oct 2001 14

HERA brings Producers & Formulators together…. HOWEVER…. these assessment activities are not two distinct processes running in isolation ! Æ HERA identifies a Substance Team for each chemical in programme Æ Substance Team is a unique ‘platform of cooperation’ between producer and formulator Æ Team dialogue ensures that Exposure and Hazard exercises are linked; Æ Æ 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 15

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

Human Health Task Force The MOE needs to take account of: …. the Uncertainties and Variabilities in the Hazard and Exposure assessments e. g. 8 assumptions and reliability of exposure estimates (both from modelling and from measured data) 8 adequacy and relevancy of hazard data set 8 the data extrapolations between and within species 8 use of less-than-lifetime exposures HERA European Stakeholders Workshop: Brussels, Oct 2001 17

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: è review exposure estimates è review hazard dataset è consider product safety data è use human experience data è get more data…. (exposure, hazard…) è consider the option of risk management HERA European Stakeholders Workshop: Brussels, Oct 2001 18

Human Health Task Force The Human Health Risk Assessment conclusion …. 4 uses the combined knowledge about chemicals from the Producers and Formulators – the Partnership 4 uses the expert judgement of experienced toxicologists and builds on their familiarity with products 4 provides transparency in arguments and decisions and a consensus opinion 4 provides a common basis to allow risk management decisions to be considered HERA European Stakeholders Workshop: Brussels, Oct 2001 19

Human Health Task Force SOME LEARNINGS… u collection and comparing exposure data is not easy – downstream use is complex u exposure from indirect contact with chemicals is difficult to estimate u Poison Control Centre (PCC) reports helpful for ‘safety’ after accidental exposures u 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 20

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