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


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)



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


Human Health Conclusionsvalid for European Usageand HERA product categories

HERA Human Health Risk Assessmentbuilds on EU Technical Guidance Document for New and Existing substances



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?



What do consumers do with HERA products ?

?


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



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….


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’)



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



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



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

+


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


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….


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….


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 ?



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


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…?


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



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



On behalf of the HERA Human Health Task Force………

Thank you!

european stakeholders workshop ( october 11, 2001) human health risk assessment

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