Development of a risk assessment strategy within the GUIDEnano project

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1 Development of a risk assessment strateg within the GUIDEnano project Dr. Susan Wijnhoven RIVM Sustainable Nanotechnolog Conference 2015 Development of a risk assessment strateg within the GUIDEnano project March 10, 2015

2 Universities & Research Centers Project Consortium Industr 2

3 Main Goal Develop innovative methodologies to evaluate and manage human and environmental health risks of NM-enabled products, considering the whole product life ccle Interactive digital Guidance Tool 3

4 Target and scope Refine RA THE TARGET NM-enabled product Life Ccle SCOPE OF THE GUIDANCE Risk Assessment NM production NM-enabled product manufacturing Nano-enabled product X Reccling Use End-of-life Release/Exposure Assessment Environmental Fate Risk Management Safer-b-design Exposure control Waste Management NO Impact evaluation in Target Organisms RISKS acceptable? YES No further action required: NM-enabled product considered safe 4

5 WP2 Scientific Coordination Organization in WPs WP1 Management WP3 Release WP4 Exposure WP7 Risk Assessment WP9 Development of the GUIDEnanoTool WP5 Fate WP8 WP6 Hazard Risk reduction and management WP10 Testing of GUIDEnano Tool in real casestudies WP11 Dissemination, Standardization and IPR 5

6 Project Timeline GUIDEnano Project Experts (State-of-the-art knowledge) Structure and main input data GUIDEnano Tool.v1 Experts (GUIDEnano hpothesis-driven experiments + new data from other projects) GUIDEnano Tool.v2 Validation & Refinement GUIDEnano Tool.v3 Validation & Refinement Experts (selected case-studies) Validation & Refinement Industrial partners (8 case-studies) Stakeholders (representing the interests of Industr, Regulators, Insurance, Consumers) 6

7 The Tool Activit cards Default Decision tree Model Release to relevant environmental / human compartments Environmental fate modelling Exposure levels and NM form in relevant environmental / human compartments WoE / Prioritization algorithm Read-across Relevance / Qualit score Hazard endpoints values Toxicit studies available to the user Read-across NMs 7

8 Risk assessment Decrease risk b RMM/ safe b design

9 Risk assessment Risk assessment decision flow: Divided in 4 main elements Input and information requirements (exposure and hazard assessment) Risk assessment (calculation of risk and classification into 3 categories) Recommendation for follow-up actions (reduction of uncertaint, risk mitigation) Output report GUIDEnano SCM Meeting Leiden, 16 th -17 th September 2014

10 Risk assessment

11 Information requirements Risk characterisation ratio (RCR): Exposure: relevant exposure routes/ duration model output, exposure libraries, direct measurement data Hazard: relevant endpoints with (if possible) quantitative exposure estimate with uncertaint

12 Hazard endpoints Identification of human hazard endpoints to be addressed for each exposure scenario route duration endpoints to be evaluated Endpoints Quantitative? inhalation single 1,3,4,6, 7 1 Irritation/corrosion repeated 1,2,3,5,6,7,8 2 sensitisation dermal single 1,3,4,6, 7 3 absorption/accumulation/elimination repeated 1,2,3,5,6,7,8 4 acute toxicit oral single 1,3,4,6,7 5 repeated dose toxicit repeated 1,2,3,5,6,7,8 6 mutagenicit 7 carcinogenicit 8 reproductive and developmental toxicit N N Y Y Y N N/Y Y

Risk assessment qualitative endpoints Exposure YES NO Yes/No answer with

uncertaint Medium Uncertaint High uncertaint Low uncertaint Risk No Risk YES

Risk No Risk No Risk No Risk No Risk Uncertaint Ratio Y/N Low 70-90 / 10-30

13 Risk assessment qualitative endpoints Exposure YES NO Yes/No answer with uncertaint value Hazard Low uncertaint Medium Uncertaint High uncertaint Low uncertaint Medium Uncertaint High uncertaint Low uncertaint Risk No Risk YES Medium Uncertaint No Risk High uncertaint No Risk Low uncertaint No Risk No Risk No Risk No Risk No Risk No Risk Uncertaint Ratio Y/N Low / NO Medium Uncertaint High uncertaint No Risk No Risk Medium / High 50/50

14 Risk assessment quantitative endpoints Exposure = certain amount per time in mass/ time or surface area/ time or number of particles/ time Hazard = lowest exposure level at which an adverse event can be expected ( DNEL, default, PNEC)

15 What risk is acceptable? ~5% chance of risk Relativel high chance of high exposure level? 50% chance of risk >95% chance of risk RCR = Exposure / Hazard

16 Risk assessment quantitative endpoints Change from acceptable to probabilit of risk Defaults: Acceptable risk, low probabilit of risk : <5% probabilit on a ratio of > 1. Possible risk, medium probabilit of risk: 5-75% probabilit on a ratio of > 1. Unacceptable risk, high probabilit of risk: >75% probabilit on a ratio of > 1

17 Follow up actions Possible risk: reduction of risk or reduction of uncertaint

18 Unacceptable risk: reduction of risk Follow up actions

19 Continue with tool development Future work: risk assessment Discuss and review definition of (acceptable) risk Further development of uncertaint/ sensitivit analsis Definition of content of output report Stakeholder analsis of tool Validation with case studies

20 Acknowlegdements GUIDEnano project consortium All partners Gemma Janer (LEITAT) Socorro Vazquez (LEITAT) Margriet Park (RIVM) Ralph Vanhauten (TW) Lion Traas (TW) WP7 Petra van Kesteren (RIVM) Maria Luisa Cruz- Fernandez (INIA) Derk Brouwer (TNO) Thies Oosterwijk (TNO) Joost Westerhout (TNO) Manoj Vaghela (Pinsent Masons)

22 SUBSTANCE What is uncertaint? Measured data can be summarized with an average value and standard deviation. This is the variance in the data. Extrapolation of the data (e.g. from one scenario to the next, or from animals to humans) will introduce uncertaint. Model estimation of parameter values will also introduce uncertaint. Introduced level of uncertaint SCENARIO IDENTICAL COMPARABLE DIFFERENT IDENTICAL None Low High COMPARABLE Medium Medium/High High/Ver high DIFFERENT High High/Ver high Ver high What is considered as high uncertaint? A 10-fold deviation? Or a 1000-fold deviation? The level of uncertaint needs to be quantifiable. Average ± variance Uncertaint Uncertaint when defining the appropriate reference scenario

7) Conduct Risk Characterization + RMMs 8) Document Outcomes

Step by Step Approach for GPS Risk Assessment 7) Conduct Risk Characterization + RMMs 8) Document Outcomes By Ms. Suppawan Rattanapirom BASF (Thai) Ltd., Vice Chairman of Responsible Care Management Committee