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![Page 1: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/1.jpg)
Research & ScienceAdvancing Risk Assessment
Presentation March Association of Chemical Industry of the Czech Republic
Monique Marrec Fairley
![Page 2: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/2.jpg)
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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
![Page 3: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/3.jpg)
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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
![Page 4: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/4.jpg)
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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
![Page 5: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/5.jpg)
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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)
![Page 6: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/6.jpg)
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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)
![Page 7: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/7.jpg)
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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)
![Page 8: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/8.jpg)
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Research that makes a difference
![Page 9: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/9.jpg)
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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
![Page 10: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/10.jpg)
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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?
![Page 13: Research & Science Advancing Risk Assessment Presentation March Association of Chemical Industry of the Czech Republic Monique Marrec Fairley.](https://reader036.fdocuments.in/reader036/viewer/2022062518/56649eca5503460f94bd7f7d/html5/thumbnails/13.jpg)
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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