Bayer Technology Services a Bayer Subsidiary

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1 Exposure Assessment über den Lebenszyklus von Nanomaterialien nanotoxcom-kolloquium Dr. Matthias Voetz Bayer Technology Services a Bayer Subsidiary Holding company Group Management Board Bayer AG Corporate Center Business areas Service areas Bayer HealthCare Bayer CropScience Bayer MaterialScience Bayer Business Services Bayer Technology Services Currenta Page 2 1

2 Bayer Technology Services Full Year 2011 Employees 2,700 * Full Year Sales EUR 460 million Global network 20 offices in 10 countries * as permanent or fixed-term contracts, in FTE Page 3 Bayer Technology Services A Leading Technology Company Technology solutions, services, know-how our core competencies for your success. Competent service partner for value-generating, holistic solutions along the entire life cycle of chemical/pharmaceutical products, processes and plants we initiate, implement and support technological innovations over the long term from development through engineering and construction to process optimization. Complete technology packages go beyond our spectrum of services. Technology Development Project Management & Engineering Operation Support & Safety Page 4 2

3 Global Network & Local Offices Mexico-City Leverkusen (global headquarters) Bergkamen, Berlin, Dormagen, Krefeld, Wuppertal, Wendelsheim Moscow Beijing Shanghai Pittsburgh Berkeley Baytown Antwerp Mumbai New Martinsville Belford Roxo Dubai Singapore Page 5 Bayer Technology Services Mission Sustainable competitive advantage through leading technologies and solutions across the entire life cycle of products, processes and plants for our customers. Bayer Technology Services creates value with three key value drivers: Delivering innovative technological solutions to sustain the competitiveness of customers manufacturing processes Providing prime CAPEX efficiency and economics by complementing customers project organizations with project management and lead engineering teams Expertise, methods and tools for safe and reliable operation of processes and plants Our values of Leadership, Integrity, Flexibility and Efficiency, combined under the term LIFE provide us with guidance as we seek precisely tailored technology solutions, in line with our mission Bayer: Science For A Better Life. Page 6 3

4 93390 : 1 B028202RE nm 13/07/2012 Working Group Nanotechnology bei Bayer: Bayer AG Subgroups Group Management Board Service companies Bayer HealthCare Bayer CropScience Bayer MaterialScience Bayer Business Services Bayer Technology Services Currenta Working Group Nanotechnology Netzwerk innerhalb der Bayer Gruppe: WG-NT ist eine Querschnittsplattform für interne und externe Informationen und Know How Austausch und Koordination der Untergruppen mit Nanotechnologie Aktivitäten : Empfehlungen für F&E im Bereich Nanotechnologie Identifizierung von new business Möglichkeiten Networking und Stakeholder Kontakt; Koordination der internen und externen Kommunikation z.b. Verbänden, Behörden, öffentlichen Hand, öffentlicher Förderung Nanotechnologie bei Bayer Nanokomposite Flammgeschütze Kunstoffe: Bayblend FR mit dispergierten Nanopartikeln 200 nm Nanoobjekte / - additive Carbon nanotubes Baytubes Quantendots BayDots, Nanokomposite für dünne Schichten und Oberflächen Oberflächenmodifikation: Kratzfest, UV-Schutz, Easy-to-Clean Klebtechnik: Haftfestigkeit Thermische Stabilität Verarbeitung Nanobiotechnologie Liposome, Diagnostics, Drug Delivery 20 nm 4

5 Definition Nanomaterial EU-Kommission EMPFEHLUNG DER KOMMISSION vom 18. Oktober 2011 zur Definition von Nanomaterialien - natural, incidential or manufactured Material - Particles in an unbound state or as aggregate (fused) or agglomerate - 50% or more in the number size distribution, one or more external dimensions in size range nm (Nanoobjects nach ISO ) - included: Fulleren, Graphene, SWCNT - SSAV > 60m²/cm³ kann zur positiv Bestimmung NM herangezogen werden < 60 Bedarf aber einer Messung der Anzahlverteilung Kommentar: Diese Definition ist messtechnisch nur schwer mit dem Stand der Technik pragmatisch zu erfassen sinngemäß aus: Page 9 Begriffe 1: epidemiology simulation insilico Risk = Hazard x Exposure invitro invivo Messung Nachstellung ( Risk= f(hazard, Exposure) ) Page 10 BTS 4:3 Template 2010 June

6 Begriffe 2: Release: Liberation of material from a matrix Exposure: Amount of chemical available at the exchange boundaries of the organism (e.g.; skin, lungs, gut) and available for absorption. Release Scenario Operational and/or environmental conditions of any treatment or stress of nanomaterials during all life-cycle phases Description of release of Nanoobject/ composite material into indoor environments, e.g. workplace, residential, and/or environmental compartments, i.e. air, water, soil and sediments Set of parameters to describe the type, form and magnitude of release. * Aus NanoRelease Workshop Juni 2012 Washington Page 11 BTS 4:3 Template 2010 June 2011 Lifecycle Life-cycle stages Recycling ENM synthesis Fabrication of Masterbatch Manufacturing Use End of life Release Exposure for Professional Users Exposure for Consumers Release to Environment * Aus NanoRelease Workshop Juni 2012 Washington Page 12 BTS 4:3 Template 2010 June

7 Tiered Approach - Arbeitsplatz The VCIconcept e.g. Tiered-Approach.pdf Nanoparticle exposure at nanotechnology workplaces: A review Page 13 BTS 4:3 Template 2010 June 2011 Kuhlbusch et al.; Particle and Fibre Toxicology 2011; 8:22, doi: / The nanogemconcept yes Tier 1 Data Gathering Can the releaseofnanoscale particlesintothe workplaceair bereasonably excludedduring? production, handling orprcessing? no SOP M Screening Tier 2a.1 Screening (e.g. with CPC) Tier2b permanent monitoring no? 1 Maybe Tier 2a.2 temporary monitoring yes 1 Significant increase ofconcentrationover background? no? 1 yes? 1 yes no SOP M Sampling Tier 3 Expert Assessment (e.g. with SMPS, CPC, filter sampler, offline analysis) SOP M Expanded Measurements no 2 2 noenm from activity; chemical identity ofenm known; their origin iselsewhere yes? Clear evidenceofchemcial identityofthe ENM? Download Take additional risk managementmeasuresto mitigateexposure Are riskmanagement measures efficient? yes? no Back to tier 2 Documentand archive Page 14 BTS 4:3 Template 2010 June 2011 Check after 2 yearsor in case ofchanges 7

8 Production Processing Weathering Incineration Handling Use Recycling landfilling Workplace Measurements/Simulation CarboSafe/NanoGEM Simulation of process CarboLifecycle/NanoGEM Simulation of process? Open field Page 15 BTS 4:3 Template 2010 June 2011 Beispiel CNT Komposite - Workplace measurements in production site and compounding - Over 20 measurement campaign in the last years with - Size distribution on Nano - Size distribution Mikro - Sampling Nano TEM - Sampling Mikro REM - Sampling 10m³ ICP-MS - Background: same procedure without CNT - Use simulation in zero background Box - over 10 different CNT-Compounds tested with sanding - over 5 different CNT-Compounds tested with drilling - validation of sawing process in progress - Size distribution on Nano - Size distribution Mikro - Sampling Nano TEM - Sampling Mikro REM Page 16 BTS 4:3 Template 2010 June

9 Page 17 BTS 4:3 Template 2010 June 2011 Page 17 Bayer Technology Services November 2011 Workplace CNT-Production Labscale SMPS NAS/TEM Page 18 BTS 4:3 Template 2010 June

10 Sanding of brittle matrix with insufficient dispersed CNT => No difference in number with/without CNT Page 19 BTS 4:3 Template 2010 June 2011 Sanding of dried CNT-Dispersion Substrate Substrate with dried CNT- Dispersion Page 20 BTS 4:3 Template 2010 June

11 * CNT means here only Baytubes Conclusion for CNT Composites - abrasion/sanding/drilling of Polymer/CNT Compounds well dispersed and with good connection CNT-Polymer produce no isolated or small agglomerates of CNT - Mechanical stress applied to brittle matrix with not well dispersed CNT could lead to a emission of airborne isolated CNT or small agglomerates - Under normal production or processing conditions no CNT Exposure is detectable - Handling of CNT-Powder can produce airborne agglomerates, but no isolated CNT - Threshold from 50µg/m³ was reached at no time (detected over Co Concentration Page 21 BTS 4:3 Template 2010 June 2011 Forschungslandschaft D: NanoNature/NanoCare USA: Nanorelease ndation/pages/nanorelease1.a spx EU FP7 WP2013 NMP (Call end July): NMP Safety in nanoscale production and products NMP : Development of a systematic framework for naming and assessing safety of the next generations of nanomaterials being developed for industrial applications. NMP Development of methods and standards supporting the implementation of the Commission recommendation for a definition of nanomaterial Page 22 BTS 4:3 Template 2010 June

12 Normung ISO TC 229 Nanotechnology Page 23 BTS 4:3 Template 2010 June 2011 Page 24 BTS 4:3 Template 2010 June

13 CEN 352 Nanotechnology / Mandat M Methodologies for Nanomaterial characterization in the manufactured form and before toxicity and eco-toxicity testing - Sampeling and measurement of workplace, consumer and environment exposure to nanomaterials - Methods to simulate exposure to nanomaterials rch.detail&id=443 Page 25 BTS 4:3 Template 2010 June 2011 Zusammenfassung Messen kann man viel... aber um valide und vergleichbare Ergebnisse zu erhalten bedarf es einer Menge Expertise und Standardisierung Page 26 BTS 4:3 Template 2010 June

14 Danke für die Aufmerksamkeit Dr. Matthias Voetz BTS-TD-ET-MS 0214/ Page 27 14