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Human & Environmental Risk Assessment

Human Health Risk Assessment under HERA: Challenges and Solutions

Christeine Lally

Co-Chair of the HERA Human Health Task Force

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C. Poelloth, C. Arregui, J. Backmann – AISE Secretariat

Human Health Task Force

G. Holland (Unilever) * C. Lally (P&G) * F. Bartnik (Henkel) J. Boyd (Colgate) G. Helmlinger (P&G) S. Kirkwood (McBride)

( * = co-chairs )

W. Aulmann (Cognis) O. Grundler (BASF) S. Jacobi (Degussa) R. Kreiling (Clariant) M. Maier (ZEODET) P. Martin (Rhodia) H. Messinger (Cognis) J.R. Plautz (Ciba) G. Veenstra (Shell)

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The GOAL

propose a Methodology for a Human Health Risk Assessment (hazard + exposure)

test the Methodology with 3 initial chemicals – alkyl sulphates, a zeolite, an optical brightener (Phase IA)

seek peer consultation from scientific stakeholders

refine Methodology -“Framework Document”

deploy Methodology to Phase IB (15-20) and refine further (lessons learned!)

Human Health Task Force

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Human Health Task Force

The Process focus on a tiered approach to both hazard and exposure assessment

focus on chemicals used primarily in AISE products – hazard profiles and potential exposure for humans

focus 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 accidental use

focus on endpoints of concern for the consumer from the exposures expected from AISE products

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Human Health ConclusionsSpecific for European Usage

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

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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 relevant for known product uses and exposures (e.g. is dermal contact likely? could ingestion occur inadvertently?)Consider also serious adverse effects (e.g. cancer, reproductive toxicity) and review relevance for consumer exposure through product useDetermine whether the consumer is at risk? (is the Margin of Exposure adequate for consumer safety?)

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What do consumers do with products ?

?

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USE & EXPOSUREIdentify

which product category (laundry compact, fabric conditioner, toilet cleaner….)

product concentration (% in product, range)

type of application (powder, tablet, spray, wipe….) and how is product used

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Formulator companies asked to provide (in confidence):

Use levels of Phase 1A and 1B ingredients in their products

List of product categories where ingredients are currently used

Published or in-house data on consumer habits and practices for product categories (at least provide ‘recommended use’)

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G. Helmlinger, version.3.1 – 25/02/2000

CATEGORY Grams/Task (grams/use)

Use Frequency (Fill in LEFT or RIGHT column)

Duration of Task

(minutes)

Other uses of product

Geography where data apply & Data source

# Tasks per week

(A) # Tasks / day (B) # Days / week

LAUNDRY REGULAR

Powder Liquid

LAUNDRY COMPACT

Powder Liquid Tablet Gel

FABRIC CONDITIONERS

Liquid Regular Liquid Concentrate Others (SPECIFY)

LAUNDRY ADDITIVE

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USE & EXPOSURE

HERA provides simple multiplicative mathematical models – based on exposure equations in EU TGD and in ECETOC Technical Reports

HERA uses real data (formulators) or, if unavailable, it uses ‘reasonable’ defaults

HERA uses a conservative ‘worst case’ scenario in first step (tiered approach)

HERA checks exposure estimate for ‘realism’

HERA considers need for more refined exposure estimate

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EXPOSURE

Identify where ingredient 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

Consumer

Exposure

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HAZARDProducer companies asked to:

collect available toxicology data on ingredient – IUCLID, SIDS, IPCS, in-house company data etc. validate data based on current standards - but do not discard older data; consider human experience consider toxicological endpoints most relevant for use - endpoints of interest largely driven by predicted exposure; identify no-effect-levels and possible data gaps

And Formulator companies asked to provide: product safety data where available and useful

+

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HAZARD

Collect toxicological data on ingredient

Validate the data requiredCriteria for reliability

Identify critical endpoints of concern and data gapsConsider bridging data, QSAR and product safety data

Summarise relevant data (robust summaries) focused on relevant exposures and endpoints

Consumer

“Hazard”

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EXPOSUREIdentify where ingredient 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

HAZARDCollect toxicological data on ingredient

Validate the data requiredCriteria for reliability

Identify critical endpoints of concern and data gapsConsider bridging data, QSAR and product safety data

Summarise data (robust summaries) focused on relevant exposures and endpoints

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Is the consumer at risk…?

compare relevant hazard(s) with foreseeable exposure(s) for consumer

ratio of “no effect level” and “exposure” MOS or “margin of safety” [NOAEL/Exposure = MOS].

consider whether MOS is adequate to protect the consumer – follow guidance in Technical Reports from ECETOC and in EU TGD

how good is the answer ? (Uncertainty….)

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Is the consumer at risk…? If MOS is unacceptable……..

review exposure estimates review hazard dataset consider product safety data use human experience data get more data…. (exposure, hazard…)

Expert judgement Transparency in arguments & decisions !

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Thank You !

Gracias !