Lin ink Resea earch rch outputs ts to St Standard rdiza izati - PowerPoint PPT Presentation

Lin ink Resea earch rch outputs ts to St Standard rdiza izati tion on bodie ies s fo for in r innova vatio ion n obje jecti tives ves Ca Case of FP f FP7 CSA CSA nanoST STAIR IR Dr. Dr . Hdr Emeri ric Frejaf afon Scientific Deputy, Chronic Division Head of the TaskForce on Nanotech Risk Assessment French National Institute for Industrial Environment and Risks US-EU nanoEHS CORs, 3 rd December 2013

INERIS activities related to Nanotechnology Risk Assessment METROLOGY PROCESS SAFETY LIFE CYCLE STUDIES  On-line monitoring, sampling  Fire, explosion hazards  Dustiness of nano powders  Characterization (decret …)  Electrical charging hazard  Use and aging (emissivity…)  Loss of containment  Nanosafety bench  End of life & recycling capabilities Calorimeter Tewarson Online CNT detection unit ASTM E 2058 – NFPA 287 Fire test for ENM battery MODELISATION TOXICOLOGY  nucleation, agglomeration  Vitro models (cells, barriers models)  Reactivity-Transport  Inhalation exposure (Vivo)  QSARS, QSPRs, Q. Meca. Help Industries & Lab. to RSIK ANALYSIS develop safer nanotech.  “Control banding” tools ECOTOXICOLOGY Processes & products  Safety barriers management  Experimental (Ageing, OECD )  Large scale (mesocosm) EXPOSURE ASSESSMENT GLP facilities ies  Occupational exposure  Environmental exposure STANDARDIZATION LIFE CYCLE ASSESSMENT TRAINING CERTIFICATION  nanoREACH, Decret Integration of LCA and LCC results Workers, H&S dept.  NANOCERT  ISO, CEN & AFNOR  Cost/benefit /efficiency (CBA, CEA)  nanosafety /workplace  Workers, H&S dept.  OECD  Multi-criteria analysis (MCA)  risk assessment  Collective protection www.ineris.fr

Methods & tools transfer to standards Env. fate Regulatory advices (OECD, Experts groups) Manage nager Reference data Focus ... Recommendations to policy maker Case study/ benchmark LCA, SEA DEMCAME AMER NECOBAUT BAUT Risk Asses. MARIN INA SANOWORK ORK Exposures H & Env. NanoREG REG ENVIRO RO QNano no Moni nito tor Life Cycle SCAFFOL FOLD studies NanoD oDEV EVICE NanoST STAIR AIR NanoFOL oFOL NanoGeno Genoto tox Hazards NanoM oMIL ILE MODE DENA Applications Validations R&T Developments INERIS contribution in European Projects, 2013

Creating link with standardization, why ? World Economic Forum in Davos 2007 :  The importance of technical standards was reported  Standardization : also a tool for promoting innovation  Research and innovation are to be more closely interlinked with standardization Standardization related to the safety of NM  Support the spreading of good practices and rationalize the communication between the authorities, the industry and other stakeholders

Inn nnovation ation needs ds  KET, , Market ket Promoting innovation New materials, safer by design Knowledge dge of all l life cycle of ENM Substitution or new market strategies Resear search ch capabil abilit ities ies Intensive R&D on Toxicology Poor research on Exposure & envir fate Standar tandardiz izatio ation objec ective tives Nothing done on end of life/recycling Identify candidate/new standard Support validation actions Supporting Technical Groups nanoEHS anoEHS CORs Rs actio ions ns Innovation is Hazard knowledge: Tox, ecoTox, safety parameters challenged with  Data, methods and tools  inputs for prediction cost/effective Exposu sure re knowledge on mains routes studies  risk ?  Both worker and consumer point of view ? Focus on Hazard (intensive research) or Exposure ( a regulatory concern) ?  Both as barriers mean costs  need to be adjusted to be competitive  As effect on an existing market of a common new UN GHS nano code based on most hazardous ENM would be huge.

Standards activities can address US-EU nanoEHS in : ENM measurement infrastructure CORs  Define and validate metrics, methods, instruments & share best practice or ref data infrastructures (inhalation facility, metrology lab, mesocosm …) ENM Toxicology, eco toxicology tests  Develop or adapt & validate reference methods for main exposure routes Exposure during all life cycle (production, use, end of life, recycling)  Share & validate methods (emissivity, transfer, including aging if needed Risk assessment and management  adapt, share and validate methods on case studies  inputs for ISO  Up to risk assessment models (develop or adapt existing methods) Database, informatics and modeling :  Define descriptors for grouping, prediction, built ref. data for benchmarking We can find ideas (results) but the main problem is to link communities (Tox/ ecotox/ metrology, or research-industry- standardization, …) and moreover to know if expression of needs can be understood and if it can fit research capabilities.

From Sept. 2012 to March 2014 Establishing a process and a platform to support standardization for nanotechnologies Bringing research results to standardization …a sustainab inable le process and platform rm in the field of nanotechnologies to support the transfer er of knowled edge e gained through research to to documen umentary ary standards rds in the context of the STAIR approach ch

nanoSTAIR, the Turbine concept !!! Bridges between stakeholders All nanotec techno nologies ogies & especially : “Characterization of and exposure from MNMs” and “Health, Safety & Environment”

www.nanostair.eu-vri.eu How the nanoSTAIR tool works? ISO_TC ISO_TC ISO_TC Representation tation of results of partic ticle le size analy lysis is — Part ISO/TR1 ISO/TR1 1:Graphical representation1 Scope 1: ISO/TS1 ISO/TS1 This part of ISO 9276 specifies ISO/TS2 ISO/TS2 rules for the graphical representation of particle size analysis data in histograms,density distributions and cumulative distributions. It also establishes a standard nomenclature to be followed to obtain the distributions mentioned above from the measured data. This part of ISO bbles covering all size ranges.2 Collect standards Merge standards Calculate distribution frequency Targets Research paper ISO_TC ISO_TC ISO_TC particle particle 40 sample sample 35 30 method method 25 TC229-WG4 12805 11811 20 measurement measurement 15 TC229-WG4 0,00 0,58 0,46 distribution distribution 10 12805 0,23 0,00 0,85 5 volume volume 0 11811 0,24 0,88 0,00 sample protocol detection plate reader phenomenon definition sop management publication budget size size pore pore liquid liquid material material Evaluate project Define keywords for all TCs Select most relevant keywords

List of targets : TCs - case of the mandate M/461 CEN/TC 137 Assessment of workplace exposure to chemical &biological agents CEN/TC 138 Non-destructive testing CEN/TC 162 Protective clothing including hand and arm protection.... CEN/TC 195 Air filters for general air cleaning CEN/TC 230 Water analysis CEN/TC 352 Nanotechnologies ISO/TC 24/SC4 Particle characterization ISO/TC 142 Cleaning equipment for air and other gases ISO/TC 194 Biological evaluation of medical devices ISO/TC 201 Surface chemical analysis ISO/TC 202 Microbeam analysis ISO/TC 209 Clean room and safe environment ISO/TC 229 Nanotechnologies IEC/TC113 Nanotechnology std for electrical and electronic products and systems nanoSTAIR official links with research & standardization activities : Official liaison with CEN T 352 In charge of NSC WG 7, Subgroup on Standardization Link with QNANO expert group on standardization Link with SIINN ERANET, national funding agencies

Already working  Check made on canidates Doc. # Topic of research candidate Type of candidate Atomic Force Microscopy Based Micro/Nanomanipulation PhD Thesis [10] ACOSTA Considerations on the EU definition of a nanomaterial: Science to support Paper of Scientific journal [11] BLEEKER policy making. Size characterization of airborne SiO2 nanoparticles with on-line and off- Paper in JNR - Springer (source: MOTZKUS line measurement techniques: an interlaboratory comparison study VAMAS : J.M. Aublant) Study on RAFT Polymerization and Nano-structured Hybrid System of POSS PhD Thesis [13] DENG macromers Working Safely with Nanomaterials in Research & Development NanoSafety Cluster document [14] UKNSPG Facilitating the safety evaluation of manufactured nanomaterials by NANOGENOTOX Scientific Report [15] . SCOPE OF GUIDANCE characterising their potential genotoxic hazard Experimental protocol validation to design a standard using 2’7 - Paper in grey literature (source: M. dichlorodihydrofluorescin (DCFH) for nanoparticle oxidative reactivity Riedeker) [16] . RIEDEKER detection SOURCE SPECIFIC RISK ASSESSMENT OF INDOOR AEROSOL PARTICLES PhD Thesis - KOIVISTO KOIVISTO Labelling nanoparticles with non-radioactive isotopes Paper of scientific journal - Lynch LYNCH Hydrochemical reactivity and biodurability of nanoparticles used for toxicity Project report-NANODEVICE NANODEVICE studies in NANODEVICE NANOGENOTOX Hydrochemical reactivity, solubility, and biodurability of NANOGENOTOX Project Report-NANOGENOTOX nanomaterials Data on metal leaching and dissolution rates of NPs under different Project Report-HINAMOX HINAMOX physiological conditions Physical-chemical Data for QSAR-like modelling -In vitro sedimentation Project report- ENPRA ENPRA rates, dissolution and hydrochemical reactivity of the ENPRA nanomaterials