Research & ScienceAdvancing Risk Assessment

Presentation March Association of Chemical Industry of the Czech Republic

Monique Marrec Fairley

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Cefic Research and Science

INDUSTRY PRIORITIES

• Innovation

• Risk Assessment

• Reach (RIPs)

• Precaution

• Product / Health

• Health &

Environment

• SCALE

R&S MAIN ACTIVITIES

SUSCHEM

LRI

Children’s Environment &

Health Issue Management

GLOBAL LINKS

ICCA LRI

•Bio-Monitoring Project

ICCA TAG

• Children’s Health

• Endocrine

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Long Range Initiative’s mission

• Identify and fill gaps in our understanding of the hazards posed by chemicals, to advance estimates of exposure and to improve the methods for assessing the associated risks

• Support informed risk management decisions

• Transparency to build trust

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Drivers of the LRI programme

• Public demand that industry “know” its products• Public impact of biomonitoring programmes• The draft European union chemicals policy (REACH)• Demands for human risk-related information• Demands for ecological risk-related information• Demands for knowledge of potential risks to children

(SCALE) • International public and governmental concerns over

endocrine-active compounds • Demands for Alternatives to animal testing

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REACH Implementation Projects (RIPs) Industry Involvement

• RIP 3.2 Chemical Assessment ReportBasis for Technical basis guidance

• RIP 3.3 Develop a general and cost-effective decision-making framework on information requirements based on Integrated Testing Strategy (ITS)Four endpoints: Aquatic toxicity; Degradation; Eye irritation; Reproduction

• Next step: Drafting technical guidance document(waiting for call from proposal from the European Commission)

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EU 3Rs Partnership

• 3Rs: Develop Alternative Methods to Animals – Reduce Refine Replace the number of animals used.

• Important to reduce the number of animals for cost and ethical purpose for the implementation of REACH

• Partnership signed in November 2005 between the European Commission and Industry Partners (Colipa; Efpia; Cefic; Europabio; Crop Protection Association; IFAH; AISE)

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Principles of the Partnership

• A voluntary bi-lateral relationship• Flexible/pragmatic structure • Commission to coordinate (provide

“platform”)• Stakeholders with secondary role, i.e.

recipients of output, no steering role)

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Research that makes a difference

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Environment Suite – modelling the environmental fate of Chemicals in risk assessment

Atmospheric: ADEPT Atmospheric: ADEPT

Estuarine: GEMCOEstuarine: GEMCO

Soil: Soil: TERRACE TERRACE

Rivers: GREAT-ER IIRivers: GREAT-ER II

Used by Used by UBA/DEFRA UBA/DEFRA

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Persistence & Bioaccumulation – Assessing the risks

ACC-HUMAN is a dynamic bioaccumulation model predicting ACC-HUMAN is a dynamic bioaccumulation model predicting human tissue levels from concentrations in air, soil and water.human tissue levels from concentrations in air, soil and water.

1. Dynamic effects through the food chain

2.2. Understanding PersistenceUnderstanding Persistence

The The project has investigated persistence and bio-project has investigated persistence and bio-concentration of a diverse range of chemical types, including concentration of a diverse range of chemical types, including man-made and naturally-occurring ones, in the oceans and man-made and naturally-occurring ones, in the oceans and on land.on land.

3.3. Relationships between Persistence and Bioaccumulation Relationships between Persistence and Bioaccumulation potentialpotential

Predicting human exposures from Predicting human exposures from bioaccumulation and magnification through the bioaccumulation and magnification through the food chainfood chain

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Improving Exposure Assessment

Exposure is the more subjective part of risk assessment

Creating relational databases for dispersed data on exposures to consumers, & workers, as regulatory tools to improve exposure estimates in risk assessment

Risk= f [Hazard, Exposure]

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Reducing Uncertainty in Exposure Estimates

Consumer Exposures- IERIE : inventory of research on indoor pollutants- EXPOLIS : European urban exposure patterns (implemented

within INDEX EU project on Indoor Air)- ExpoFacts : European Sourcebook of human exposures

Occupational Health- HEROX – inventory of European workplace exposure to

chemicals- EASE – understanding and reducing uncertainties within

the current regulatory model- Improved basis for the assessment and management of

risks arising from dermal exposures to chemicalsBiomarkers of exposure

- Background incidence on biomarkers of exposure to chemicals in UK – what is normal? How does it vary over time and between people?

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Animal Alternatives

1. Funded Secondment to OECD for policy development for QSARs• Access to EU/ECB/ECVAM network important

to REACH2. Existing LRI work to predict extended low dose

exposures and skin permeation for Risk assessment3. New portfolio from the Alternatives Issue

Management Team• Modelling approaches to skin irritation,

mutagenicity/genotoxicicity and bioconcentration

• Use of fish cells/embryo’s as model test substrates

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Conclusions

Science contribution directly relevant to:- The applicability and science of Risk Assessment- Practical tools for RIPs

Recommendation- Review processes to maximise advocacy impact

of R&S work relevant to PS• e.g. Use of QSAR’s in REACH

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More information

• European Technology Platform for Sustainable Chemistry

http://www.suschem.org

• Long Range Initiative

http://www.cefic.org/lri