Risk Assessment in Nanosafety - Tools for Now and the Future , Professor Keld Alstrup Jensen, Ph.D., cand.scient. kaj@nrcwe.dk

Principal Risk Assessment and Risk Management Communication and Consulting Monitoring and Review Establishing the context Risk Identification Risk Analysis Risk Evaluation Risk Treatment ISO/IS/31000 (2009)

”Current” situation – Example REACH risk assessment approach REACH Tier 1 estimates ECETOC TRA EMKG EXPO Tool ConsExpo (Risk of Derm) Stoffenmanager Advanced REACH Tool … No official OELs available - NM limits values are just slowly emerging (+grouping issues) No proper emission potentials for NM in tools No default exposure scenarios in the tools Lack of product categories for nanoproducts Gaps in application domains Need for suitable data and “validation” of existing or new nano-specific Risk Assessment and – Management approaches Reliable risk assessments with REACH model is either impossible or should be done with GREAT care!

From Risk Assessment to Emerging Risk Management and Governance Emerging Risk Management Framework [CEN Workshop Agreement 16649 (2013)] Ability to ID a new risk Applicable data or methods and tools Applicable data knowledge Knowledge Applicable methods, tools, data In the stage-gate innovation funnel, knowledge increases along the funnel and where Env. and Health Safety (EHS) by industry is normally first considered very late during innovation, then regulation and insurance (risk transfer). If the materal or product fails, this late assessment can result in great losses. Idea is to add EHS assessments in the gates of the Cooper-like stage-gate innovation funnel model. Different?; Unsafe? Regulation? … Methods, Measurement, Read-across, Grouping, .. Efficacy of RMM, “risk-knowledge”,.. Methods, Systems, Data-bases,..

Substance identification and grouping: Substance identification and grouping: Essential for ID of new risks in REACH

Substance identification and grouping: Substance identification and grouping: Essential for ID of new risks in REACH https://winpure.com/ https://buckleyecology.wordpress.com/

“Standards” takes leaders, time, cost: “Standards” takes leaders, time, cost: Leveraging on national and EU research results NANODEVICE ENPRA DK NANOKEM DK NSC 1 NANOGENOTOX NANOREG SUN DK NSC 2 NANODEFINE caLIBRAte (RA) NANOFASE ACEnano PATROLS GOV4NANO Malta initiative Modified from Jukka Ahtiainen og Mar Gonzales (OECD HQ, Paris)

From Emerging Risk Management to Nano-risk (innovation) Governance + Emerging Risk Management Framework [CEN Workshop Agreement 16649 (2013)] Idea screen Gate 1 Scoping Screen Gate 2 Go to development Gate 3 Go to test Gate 4 Go to Launch Gate 5 Post-Launch review Gate 6 Discovery and ideas Stage 1 business case Build Research and development and Validation Testing Launch Horizon Scanning/ Monitoring Cooper Stage-Gate® Idea to launch model In the stage-gate innovation funnel, knowledge increases along the funnel and where Env. and Health Safety (EHS) by industry is normally first considered very late during innovation, then regulation and insurance (risk transfer). If the materal or product fails, this late assessment can result in great losses. Idea is to add EHS assessments in the gates of the Cooper-like stage-gate innovation funnel model.

From Emerging Risk Management to Nano-risk (innovation) Governance Building and maintainence of confidence in the risk assessment for trustworthy risk communication and governance Idea screen Gate 1 Scoping Screen Gate 2 Go to development Gate 3 Go to test Gate 4 Go to Launch Gate 5 Post-Launch review Gate 6 Discovery and ideas Stage 1 business case Build Research and development and Validation Testing Launch Horizon Scanning/ Monitoring Cooper Stage-Gate® Idea to launch model ERM ERM ERMF ERM (E)RM (E)RM Quantitative predictive / Test Data Driven Qualitative / Semiquantitative predictive

In line with stakeholder opinions! Unpublished caLIBRAte results

Do we already have the nano-specific Risk Assessment tools? Common for all! Often restricted to specific application domains Users often have challenges in finding input data Limited use and low general knowledge about them NOT VALIDATED

Performance testing for validation: Ongoing work MDL Risk of Derm NanoQSAR Env. Hazard model

Future steps: Include new approach Future steps: Include new approach methodologies (NAMs) MN Risk Assessment Nymark et al. Applicability of new approach methodologies to innovation and safety assessment of nanomaterials. In preparation

Further development in NMBP-13 and NMBP14 projects H2020 NANOREG2 Further development in NMBP-13 and NMBP14 projects

Far Future: We may reach >90% Predictive “Chemical” Risk Assessment Technical and safety information level Understanding Physics, Exposure Environment, Biology Validated material test methods Computing Chemical Safety Further Research and Methods standardization Data Further Research and Methods standardization Data

Thank you for your attention Webpage: www.nanocalibrate.eu See also: www.researchgate.net/profile/Keld_Jensen Thank you for your attention www.nanocalibrate.eu www.researchgate.net/profile/Keld_Jensen calibrate@nrcwe.dk kaj@nrcwe.dk