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Guidance on handling and use of nanomaterials

Guidance on handling and use of nanomaterials. Miriam Baron. Federal Institute for Occupational Safety and Health, Germany. Overview. Questionaire Guidance for Handling and Use of Nanomaterials at the Workplace Threshold limit values Nanodialog. BAuA-questionaire 2006.

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Guidance on handling and use of nanomaterials

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  1. Guidance on handling and use of nanomaterials Miriam Baron Federal Institute for Occupational Safety and Health, Germany

  2. Overview • Questionaire • Guidance for Handling and Use of Nanomaterials at the Workplace • Threshold limit values • Nanodialog

  3. BAuA-questionaire 2006 • Initiated by the stakeholder dialog event on engineered nanoparticles (october 2005) • Cooperation with: • German Chemical Industry Association (VCI) • Federation of German Industries (BDI) • 217 companies participated: • Industry • Small and medium enterprises • Research companies 4.6/Baron

  4. BAuA-questionaire 2006: Situation in Germany • Participation according to the criterion: use of nanomaterials above 10 kg/yr • 45 companies participated: • 51 % use above 100 kg/yr • Thereof 11 % above 100 t/yr • Thereof 7 % above 1000 t/yr (e.g. carbon black, silicic acid) • 56 % produce/use more than one nanomaterial • 71 % less than 10 exposed employees • Reported products: 70 4.6/Baron 4

  5. Questionary: Activities (out of 70 products) • 96 working situations: • 37 mixing and dispersing • 31 filling and baging • 17 loading and decanting • 7 drying • 4 milling • Multiple responses possible 4.6/Baron

  6. Questionary: Knowledge gaps (out of 70 products) • No knowledge on particle size and number 59 • No measurement (unknown exposure) 31 • No knowledge about potential health effects 28 • No particle-specific health complaints among the workers were reported • Multiple responses possible 4.6/Baron

  7. Questionary: Protection measures (out of 70 products) • Protection Measures • Engineering controls 54 • Ventilation 63 • Personal protective equipment 55 (respiratory protection) • Multiple responses possible 4.6/Baron

  8. Questionary: Protection measures – Engineering Controls • Engineering controls (54 cases) • Wet processing 37 • Closed system 27 • Automatic processing 13 • Multiple responses possible 4.6/Baron 8

  9. Questionary: Protection measures - ventilation • Ventilation (63 cases) • Open ventilation 29 • Semi-open ventilation 21 • Automatic ventilation 18 • Closed ventilation 13 • Natural ventilation 9 • Multiple responses possible 4.6/Baron 9

  10. Questionary: Protection measures – personal protective equipment • For 80 % of the activities: usage of respiratory • protection (additionally to engineering controls and • ventilation) • Wide spectrum, ranging from general masks to • specific respirators (FFP1 to FFP3) • Multiple responses possible 4.6/Baron 10

  11. Guidance for Handling and Use of Nanomaterials at the Workplace • Cooperation with the German Chemical Industry Association (VCI) • Published 2007 • To be updated this year • To be amended by industry sector specific Guidance (under progress: for laboratories) 4.6/Baron

  12. Contents 1 Introduction 2 General occupational health and safety rules 3 Recommendations for workers' protection in the handling and use of nanomaterials 4 Current situation and development of measuring methods for nanoparticles Annex Flowchart on Hazard Assessment for Nanomaterials at the Workplace 4.6/Baron

  13. General occupational health and safety rules Duties according to the Hazardous Substances Ordinance: 1. Information gathering 2. Hazard assessment 3. Determination of protection measures 4. Review of effectiveness of measures 5. Documentation 4.6/Baron

  14. Information gathering • Used product (properties, volume, type and form of use). • Activity (possible intake: by inhalation, dermal or oral). For oxidizable materials, also fire and explosion risks must be included • Substitution options (including any use of processes or preparations of the substance that result in lower hazard) 4.6/Baron

  15. Information gathering • • Effectiveness of protection measures already in place • Implemented activities in preventive occupational medicine • • In case of data gaps, this lack of information must be adequately taken into account when determining protection measures. 4.6/Baron 15

  16. Determination of protection measures • STOP-Principle • Substitution options • Technical measures • Organizational measures • Personal protection measures 4.6/Baron

  17. Determination of protection measures • Review of measure effectiveness in place • Comparative inspection with measurement • Documentation • Firstly hazard assessment including: • Substances used • Working conditions • Protection measures taken • Available measurement data • To be used for assessment at a later stage 4.6/Baron

  18. Substitution options • Replacing health-endangering substances or technical processes by less ones • Binding powder nanomaterials in liquid or solid media • Using dispersions, pastes or compounds instead of powder substances wherever technically feasible and economically acceptable 4.6/Baron

  19. Technical protection measures • Contained installations, wherever possible • Otherwise avoid the formation of dusts or aerosols • Extract possibly forming dusts or aerosols directly at their source (e.g. in filling and emptying processes) • Ensure regular maintenance and function testing of extraction facilities • No recirculation without exhaust air purification 4.6/Baron

  20. Organizational protection measures I • Instructions to the workers, including • Specific physical properties of free nanoparticles • Need for special measures • Potential long-term effects of dusts • Relevant information in the operating instructions • Limitation of exposed persons • Keep the number of potentially exposed workers as small as possible (e.g. by time arrangements) • Deny unauthorized persons access to the relevant work areas 4.6/Baron

  21. Organizational protection measures II • Ensure clean work wear • Work wear must be cleaned by the employer • Work wear and private clothing must be stored separately • Ensure the regular cleaning of workplaces • Removing of deposits or spilled substances by • Suction device • Wiping up with a moist cloth • No blowing for removal 4.6/Baron 21

  22. Personal protection measures • Only where technical protection measures are not sufficient or cannot be put into place • Depending on substance properties • Protective gloves • Protection goggles with side protection • Protective clothing • Respiratory protection equipment 4.6/Baron

  23. Personal protection measures (respiratory protection) • Efficacy of filters increases with decreasing particle size in the size range between 2-200 nm • Measuring data from BGIA(on sodium chloride particles from 14 to 100 nm) • “Total number penetration efficiency" P3 filters penetration less than 0.026% (particle count)P2 filters penetration of 0.2% (particle count) • Effectiveness must be reviewed 4.6/Baron 23

  24. Personal protection measures (dermal protection) • Selection of gloves: • Material must be suitable • Material must fulfill requirements for maximum wearing time under practical conditions • Permeation time is important relevant criterion • Additional protection of other areas of skin by • Protective suits • Aprons • Boots 4.6/Baron 24

  25. Further protection measures • Depending on the properties of specific nanomaterials • Anti-explosion measures in the handling of oxidizable nanomaterials • Specific protection measures in the handling of reactive or catalytic nanomaterials • Conventional measures resulting from the hazard assessment 4.6/Baron 25

  26. Organizational measures Personal protective equipment Efficiency testing in regular intervals, instruction, demarcation of work area No Hazard Efficiency testing in regular intervals, instruction General occupational Hygiene measures Examine substitutionsoptions Work in extractor, requirementsaccording to TRGS 526 Specific hazard assessment Flowchart: Hazard assessment for Nanoparticles at the Workplace (respiratory route) No Yes Yes Yes Activities in laboratories or small volumes? Risks due to explosions, reactive or catalyticallyactive nanoparticles? Does the activity involve dust formation? Is there a low hazard? No Yes No No Can dispersion, solid granules,compounds be used? Open systems? Sucking up with integrated or highly efficient equipment? Process avoids dust and aerosol formation because of closed system? No No No Yes Yes Yes Yes 4.6/Baron 26

  27. Hazard assessment • With respect to: • Substance related hazards including • Properties • Physical state • Processing options • Further hazards (e.g. electrical or mechanical) 4.6/Baron

  28. Hazardous Substances Ordinance - Principles • Risk assessment by the employer before starting activities • Eliminating Risks • Minimize Risks • In case of uncertainty: • Precautionary principle • „The need for control measures increases with both the level of possible harm and the degree of uncertainty.“ 4.6/Baron 28

  29. European Community/German Legislation • Placing on the market: • REACH (European regulation 2006/1907/EC) • Applicable for nanomaterials • With reference to the substance • (optionally) consideration of the nanoform in the Chemical Safety • Report (CSR) • if necessary additional proofs concerning the special nanoform • Handling: • Hazardous Substances Ordinance • (based on European directive 98/24/EC) 4.6/Baron 29

  30. Data gaps (TRGS 400/TRGS 526) Minimal hazard properties in case of uncertainties: R20/21/22 Harmful by inhalation, in contact with skin and if swallowed. R38 Irritating to skin R43 May cause sensitization by skin contact R68 Possible risk of irreversible effects Unknown new substances in research: Toxic by inhalation, in contact with skin and if swallowed Additionally: corrosive, (spontaneous) flammable, explosive 4.6/Baron

  31. Information down the supply chain Technical Data Sheet for Application Material Safety Data Sheet Accompanying Letter 4.6/Baron

  32. Material safety data sheet (MSDS) • Information about substance properties and occupational safety measures. • Problem: Handling of nano properties is not regulated • Usual MSDS states: “This substance has no dangerous properties” • Standard test methods are used to derive risks • Measures are not justified with risks 4.6/Baron

  33. Existing threshold limit values (TLV’s) • TLVs for poorly soluble dusts/fibers with specific toxicity • Quartz: 0.075 – 0.3 mg/m³ • Silver (metal): 0.01 – 0.1 mg/m³ • Asbestos: 0.01 – 2 fibres/cm³ • Generic TLVs: dusts with no specific toxicity • Inhalable dust/total dust : 4 - 15 mg/m³ • Respirable fraction (fine dust, lung) : 1.5 - 10 mg/m3e. g. for titanium dioxide, graphite, iron oxide • Covering also the nano sized fraction • Legally binding TLVs specifically for nanomaterials are very rare (Amorphous silica: 2 to 6 mg/m³) 4.6/Baron 33

  34. Approaches for setting a TLV for nanomaterials (1) • Draft exposure limits from NIOSH (USA, 2005) • for titanium dioxide: • Nanoscale titanium dioxide:0.1 mg/m3 • Microscale titanium dioxide:1.5 mg/m3 • Potency factor 15between nanoparticles and microparticles based on long-term in vivo studies • Reduction of risk of lung cancer below 1 in 1000 • Surface determines toxicity potential 4.6/Baron 34

  35. Approaches for setting a TLV for nanomaterials (2) • Benchmark levels (BL) from BSI (UK, 2007) for four • classes of nanomaterials • Nano-BL • Fibrousnanomaterials (high aspect ratio):0.01 fibres/cm3 • Nano-BL in relation to established TLVs • Insolublenanomaterials:0.066of TLV (NIOSH relation of 15) • CMARnanomaterials: 0.1of TLV • Solublenanomaterials:0.5of TLV 4.6/Baron 35

  36. Nano dialog • Stakeholder dialog:NGO, Researcher, Industry, Other involved persons • Leaded by the Nano commission (temporary project group) • Three Working parties on • Chances for environment and health • Risks and safety research • Principles for a responsible use of nanomaterials • First period 2006 – 2008, will be elongated to 2010 • First Report just released 4.6/Baron 36

  37. Nano commission: Five basic Principles for a Responsible Use of Nanomaterials • Defined Responsibility and management disclosed (Good Governance) • Transparency regarding nanotechnology relevant Information, Data and Processes • Willingness to the dialogue with Interest groups • Established Risk management • Responsibility down the supply chain 4.6/Baron 37

  38. Thanks to • My co-workers at BAuA • Dr Torsten Wolf (Hazardous substances management) • Dr Rolf Packroff (Hazardous and biological substances) • Dr Bruno Orthen (Toxicology) • Judith kleine Balderhaar (Database research) • Sabine Plitzko (Measurement) • Dr. Eva Lechtenberg-Auffahrt (Occupational safety) 4.6/Baron 38

  39. Further questions: Miriam Baron Federal Institute for Occupational Safety and Health (BAuA) Unit 4.6 “Hazardous Substances Management” Friedrich-Henkel-Weg 1-25D-44149 Dortmund Germany mail-to: baron.miriam@baua.bund.de www: http://www.baua.de 4.6/Baron 39

  40. Useful links/sources • Questionaire: • http://www.baua.de/nn_49456/en/Topics-from-A-to-Z/Hazardous-Substances/Nanotechnology/pdf/survey.pdf • Guidance: • http://www.vci.de/Default2~cmd~get_dwnld~docnr~121306~file~LeitfadenNano%5Fengl%5FFINAL%2Epdf.htm • Nano-Dialog: • http://www.bundesumweltministerium.de/english/nanotechnology/nanodialog/doc/40549.php • Other: • http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/Nanotechnology/Nanotechnology.html?__nnn=true&__nnn=true • http://www.ilo.org/public/english/protection/safework/ctrl_banding/toolkit/other_toolkits/nanotool_synopsis.pdf • http://www.bmu.de/gesundheit_und_umwelt/nanotechnologie/doc/37643.php • http://www.baua.de/nn_39406/en/Topics-from-A-to-Z/Hazardous-Substances/TRGS/pdf/Hazardous-Substances-Ordinance.pdf • http://www.vci.de/template_downloads/tmp_VCIInternet/122301Guidance%20SDS%20for%20Nanomaterials%20_06%20March%202008~DokNr~122301~p~101.pdf • http://www.bmbf.de/en/nanotechnologie.php 4.6/Baron

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