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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. - PowerPoint PPT Presentation
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23.04.2009
Guidance on handling and use of nanomaterials
Miriam Baron
Federal Institute for Occupational Safety and Health, Germany
23.04.
2009
Overview
• Questionaire
• Guidance for Handling and Use of Nanomaterials at
the Workplace
• Threshold limit values
• Nanodialog
23.04.
2009
4.6/Baron3
• 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
BAuA-questionaire 2006
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2009
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• 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
BAuA-questionaire 2006: Situation in Germany
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2009
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96 working situations:
• 37 mixing and dispersing
• 31 filling and baging
• 17 loading and decanting
• 7 drying
• 4 milling
Multiple responses possible
Questionary: Activities (out of 70 products)
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• 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
Questionary: Knowledge gaps (out of 70 products)
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Protection Measures
• Engineering controls 54
• Ventilation 63
• Personal protective equipment 55
(respiratory protection)
Multiple responses possible
Questionary: Protection measures (out of 70 products)
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Engineering controls (54 cases)
• Wet processing
37
• Closed system
27
• Automatic processing
13
Multiple responses possible
Questionary: Protection measures – Engineering Controls
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Ventilation (63 cases)
• Open ventilation
29
• Semi-open ventilation
21
• Automatic ventilation
18
• Closed ventilation
13
• Natural ventilation
9
Multiple responses possible
Questionary: Protection measures - ventilation
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2009
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• 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
Questionary: Protection measures – personal protective equipment
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2009
4.6/Baron11
• 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)
Guidance for Handling and Use of Nanomaterials at the Workplace
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2009
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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
Contents
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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
General occupational health and safety rules
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• 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)
Information gathering
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• 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.
Information gathering
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STOP-Principle
1. Substitution options
2. Technical measures
3. Organizational measures
4. Personal protection measures
Determination of protection measures
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• 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
Determination of protection measures
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• 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
Substitution options
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2009
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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
Technical protection measures
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• 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
Organizational protection measures I
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• 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
Organizational protection measures II
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2009
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• 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
Personal protection measures
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• 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
Personal protection measures (respiratory protection)
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2009
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• 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
Personal protection measures (dermal protection)
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• 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
Further protection measures
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2009
Specific hazard assessment
Risks due to explosions, reactive or catalyticallyactive nanoparticles?
Does the activity involve dust formation?
No Hazard
Is there a low hazard?
General occupationalHygiene measures
Activities in laboratories or small volumes?
Work in extractor, requirements
according to TRGS 526
Can dispersion, solid granules,
compounds be used?
Examine substitutionsoptions
Process avoids dust and aerosol formation
because of closed system?
Efficiency testing in regular intervals, instruction
Efficiency testing in regular intervals, instruction,
demarcation of work area
Sucking up with integrated or
highly efficient equipment?Open systems?
Organizational measuresPersonal protective
equipment
Flowchart: Hazard assessment for Nanoparticles at the Workplace (respiratory route)
Yes No Yes Yes
YesYesYesYes
No Yes No
No
NoNoNo
4.6/Baron26
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With respect to:
• Substance related hazards including
• Properties
• Physical state
• Processing options
• Further hazards (e.g. electrical or mechanical)
Hazard assessment
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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.“
Hazardous Substances Ordinance - Principles
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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)
European Community/German Legislation
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Minimal hazard properties in case of uncertainties:R20/21/22 Harmful by inhalation,
in contact with skin and if swallowed.R38 Irritating to skinR43 May cause sensitization by skin contactR68 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
Data gaps (TRGS 400/TRGS 526)
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Technical Data Sheet for Application
Material Safety Data Sheet
Accompanying Letter
Information down the supply chain
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• 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
Material safety data sheet (MSDS)
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2009
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/m3
e. 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/Baron33
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2009
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 15 between 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/Baron34
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2009
Approaches for setting a TLV for nanomaterials (2)
Benchmark levels (BL) from BSI (UK, 2007) for fourclasses of nanomaterials
Nano-BL• Fibrous nanomaterials (high aspect ratio): 0.01 fibres/cm3
Nano-BL in relation to established TLVs• Insoluble nanomaterials: 0.066 of TLV (NIOSH relation of
15)• CMAR nanomaterials: 0.1 of TLV
• Soluble nanomaterials: 0.5 of TLV
4.6/Baron35
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2009
4.6/Baron36
• 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
Nano dialog
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1. Defined Responsibility and management disclosed
(Good Governance)
2. Transparency regarding nanotechnology relevant
Information, Data and Processes
3. Willingness to the dialogue with Interest groups
4. Established Risk management
5. Responsibility down the supply chain
Nano commission: Five basic Principles for a Responsible Use of Nanomaterials
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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)
Thanks to
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Miriam BaronFederal Institute for Occupational Safety and Health (BAuA)Unit 4.6 “Hazardous Substances Management” Friedrich-Henkel-Weg 1-25D-44149 Dortmund
Germany
mail-to: [email protected]
www: http://www.baua.de
Further questions:
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2009
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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