Multi-Criteria Decision Analysis and Environmental Risk Assessment for Nanomaterials
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Multi-Criteria Decision Analysis and Environmental Risk Assessment for Nanomaterials Igor Linkov and Rick Pleus Intertox Inc. 83 Winchester Street Suite 1 Brookline, MA 02446 [email protected] Jeff Steevens and Elizabeth Ferguson Environmental Laboratory Engineering Research and Development Center US Army Corps of Engineers Waterways Experiment Station, Vicksburg MS US Army Engineer Research and Development Center # 1 Main Points • Relation of pattern, structure-activity and physico-chemical properties of nanoparticles on toxicity and risk is widely unknown • Challenges of risk assessment for situations with a limited knowledge base and high uncertainty and variability require coupling traditional risk assessment with multicriteria decision analysis (MCDA) to support regulatory decision making • Adaptive Management and Value of Information analysis (VOI) would provide a systematic tool for the dynamic linkage of Nanotechnology Risk Assessment and Risk Management with nanomaterial development goals as well as with new information on social and economic priorities US Army Engineer Research and Development Center # 2 EPA Nanotechnology White Paper: Peer Review Panel Summary • Risk Assessment Challenges – Current risk assessment experience is for chemicals and stable agents and not for engineered materials – Relation of pattern, structure-activity and physicochemical properties of nanoparticles on toxicity and risk is widely unknown – Uncertainty in exposure assessment, risk characterization and dose-response is unprecedented • Regulatory Challenges – Immediate regulatory need – Environmental evaluations and decisions are growing more complex and current RA paradigm may not be appropriate US Army Engineer Research and Development Center # 4 Problem: Model Uncertainty y = 3x - 0.6667 10 9 8 7 Y 6 5 4 3 2 1 0 0 1 2 3 4 X Polynom ial Model y = 2x2 - 5x + 6 10 9 8 7 6 Y • Model Uncertainty – Differences in model structure resulting from: model objectives computational capabilities data availability knowledge and technical expertise of the group – Can be addressed by considering alternative model structures weighting and combining models Eliciting expert judgment Linear Model 5 4 3 2 1 0 0 1 2 3 X Mechanistic models for nanoparticle toxicity and exposure are very uncretain and expert judgement is required US Army Engineer Research and Development Center # 5 4 Problem: Parameter Uncertainty • Parameter Uncertainty – Uncertainty and variability in model parameters resulting from data availability expert judgment empirical distributions – Can be addressed by Probabilistic Simulations (MonteCarlo) Analytical techniques (uncertainty propagation) Expert estimates O il a n dG re a s einS e d im e n t 5 9 V A R 1 5 5 .0 0 0 5 0 .0 0 0 5 7 .0 0 0 5 7 Concentration(ppm) 5 5 5 3 5 1 4 9 V A R 1 M e a n + S D M e a n -S D M e a n + S E M e a n -S E M e a n Nanomaterial properties are not well known, reported ranges are large and often unquantifiable US Army Engineer Research and Development Center # 6 Decision-Making Processes for Nanomaterial Risk Assessment and Regulation Decision-Maker(s) AD HOC Process Include/Exclude? •Detailed/Vague? •Certain/Uncertain? •Consensus/Fragmented? • Iterative? • Rigid/unstructured? Quantitative? Tools Risk Analysis Qualitative? Modeling / Monitoring Cost or Benefits Stakeholders’ Opinion US Army Engineer Research and Development Center # 7 Challenges to Complex Decision-making • “Humans are quite bad at making complex, unaided decisions” (Slovic et al., 1977). • Individuals respond to complex challenges by using intuition and/or personal experience to find the easiest solution. • At best, groups can do about as well as a well-informed individuals if the group has some natural systems thinkers within it. • Groups can devolve into entrenched positions resistant to compromise • “There is a temptation to think that honesty and common sense will suffice” (IWR-Drought Study p.vi) US Army Engineer Research and Development Center # 8 Evolving Decision-Making Processes Decision-Maker(s) Decision Analytical Frameworks • Agency-relevant/Stakeholder-selected • Currently available software •Variety of structuring techniques • Iteration/reflection encouraged •Identify areas for discussion/compromise Decision Integration Tool Integration Risk Analysis Modeling / Monitoring Cost Stakeholders’ Opinion Sharing Data,Concepts and Opinions US Army Engineer Research and Development Center # 9 Multi-Criteria Decision Analysis and Tools • Multi-Criteria Decision Analysis (MCDA) methods: – Evolved as a response to the observed inability of people to effectively analyze multiple streams of dissimilar information – Many different MCDA approaches based on different theoretical foundations (or combinations) • MCDA methods provide a means of integrating various inputs with stakeholder/technical expert values • MCDA methods provide a means of communicating model/monitoring outputs for regulation, planning and stakeholder understanding • Risk-based MCDA offers an approach for organizing and integrating varied types of information to perform rankings and to better inform decisions US Army Engineer Research and Development Center # 10 How can CRA, MCDA and AM improve the quality and acceptability of decisions? Adaptive Management Problems Alternatives Criteria Evaluation MCDA Feeds RA Decision Matrix Weights RA Synthesis RA Feeds MCDA Decision MCDA Case Study 1: Use of MCDA to Select the Best Nanomaterial • Problem: Several nanomaterials have been identified for specific application with varying costs and benefits and potential risks • Societal importance and public aceptability may be important for selection/prioritization decision US Army Engineer Research and Development Center # 12 AHP : Case Study - Results US Army Engineer Research and Development Center # 13 Case Study 2: Use of MCDA to Support Support Weight-of-evidence Evaluation for Nanoparticle Toxicity • Problem: Toxic effects of nanomaterials are uncertain. Multiple experimental studies are available that results in contradictory conclusions. Experimental studies have varying degree of scientific credibility and trust US Army Engineer Research and Development Center # 14 Eco Risk Assessment: Assessment Endpoints US Army Engineer Research and Development Center # 15 Summary: Essential Decision Ingredients People: Policy Decision Maker(s) Scientists and Engineers Stakeholders (Public, Business, Interest groups) Process: Identify criteria to compare alternatives Define Problem & Generate Alternatives Gather value judgments on relative importance of the criteria Screen/eliminate clearly inferior alternatives Determine performance of alternatives for criteria Rank/Select final alternative(s) Tools: Environmental Assessment/Modeling (Risk/Ecological/Environmental Assessment and Simulation Models) Decision Analysis (Group Decision Making Techniques/Decision Methodologies and Software) US Army Engineer Research and Development Center # 16 Main Points • Relation of pattern, structure-activity and physico-chemical properties of nanoparticles on toxicity and risk is widely unknown • Challenges of risk assessment for situations with a limited knowledge base and high uncertainty and variability require coupling traditional risk assessment with multicriteria decision analysis (MCDA) to support regulatory decision making • Adaptive Management and Value of Information analysis (VOI) would provide a systematic tool for the dynamic linkage of Nanotechnology Risk Assessment and Risk Management with nanomaterial development goals as well as with new information on social and economic priorities US Army Engineer Research and Development Center # 17