European Stakeholders Workshop ( October 11, 2001) Human Health Risk Assessment
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Transcript of European Stakeholders Workshop ( October 11, 2001) Human Health Risk Assessment
HERA European Stakeholders Workshop: Brussels, Oct 2001 1
European Stakeholders Workshop( October 11, 2001)
Human Health Risk Assessment
- Progress and Lessons Learned -
Dr. Christeine Lally
Chair: HERA Human Health Task Force
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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)
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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
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Human Health Conclusionsvalid for European Usageand HERA product categories
HERA Human Health Risk Assessmentbuilds on EU Technical Guidance Document for New and Existing substances
Human Health Task Force
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The HERA methodology follows a tiered approach:
Consider possible uses of chemicals in household detergent and cleaning productsConsider consumer activity during cleaning tasks - review also foreseeable other uses of productsConsider 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
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What do consumers do with HERA products ?
?
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USE & EXPOSUREIdentify
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
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G. Helmlinger, version.3.1 – 25/02/2000
CATEGORY Amount Use Frequency
Duration of Task
Other Uses Region
Tasks / week Tasks / day
LAUNDRY REGULAR
Powder Liquid
LAUNDRY COMPACT
Powder
Liquid Tablet Gel
FABRIC CONDITIONERS
Liquid Regular
Liquid Concentrate
Others (SPECIFY)
LAUNDRY ADDITIVE
HERA brings Formulators together….
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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….
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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
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EXPOSURE (from end-users or formulators)
Identify where chemical usedFinished product category and form (e.g. gel, tablet…)Concentration range of ingredient in product
Consumer Contact with productUse scenarios (recommended, foreseeable uses, accidents)Relevant exposure routesIndirect Exposures (via the Environment)
Estimate Exposure using Simple ModelsApply H&P data, defaults, modelsUse measured data where available
Combine Exposure EstimatesUse additive approach to give consumer ‘dose’Include indirect exposure estimates from Environment TF
Estimate of
Consumer
Exposure
HERA brings Formulators together….
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HAZARDProducer 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
+
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HAZARD (from producers, with input from end-users if
needed)
Collect toxicological data on chemical
Identify critical endpoints of greatest concern and data gapsConsider bridging data, SAR and finished product safety data
Validate the data requiredCriteria for reliability, human experience data
Summarise relevant data (robust summaries) focused on relevant exposures and endpoints
Potential for
Consumer
Hazard
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HAZARDCollect toxicological data on chemical
Identify critical endpoints of concern and data gapsConsider bridging data, SAR and product safety data
Validate the data requiredCriteria for reliability, human experience data
Summarise data (robust summaries) focused on relevant exposures and endpoints
EXPOSUREIdentify where chemical usedProduct category and form (e.g. gel, tablet…)Concentration range of ingredient in product
Consumer Contact with productUse scenarios (recommended, foreseeable uses, accidents)Relevant exposure routesIndirect Exposures (via the Environment)
Estimate Exposure using Simple ModelsApply H&P data, defaults, modelsUse measured data where available
Combine Exposure EstimatesUse additive approach to give consumer ‘dose’Include indirect exposure estimates from Environment TF
HERA Risk Assessment elements….
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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….
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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 ?
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Human Health Task Force
The MOE needs to take account of:
….the Uncertainties and Variabilities in theHazard 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
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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…?
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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
Human Health Task Force
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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
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On behalf of the HERA Human Health Task Force………
Thank you!