Transcript Folie 1

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
23.04.2009
• Nanodialog
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
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• Small and medium enterprises
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• Research companies
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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)
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• 56 % produce/use more than one nanomaterial
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• 71 % less than 10 exposed employees
• Reported products: 70
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Questionary: Activities (out of 70 products)
96 working situations:
• 37 mixing and dispersing
• 31 filling and baging
• 17 loading and decanting
• 7 drying
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• 4 milling
Multiple responses possible
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Questionary: Knowledge gaps (out of 70
products)
• No knowledge on particle size and number
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• No measurement (unknown exposure)
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• No knowledge about potential health effects
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No particle-specific health complaints among the
workers were reported
Multiple responses possible
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Questionary: Protection measures (out of 70
products)
Protection Measures
54
• Ventilation
63
• Personal protective equipment
(respiratory protection)
55
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• Engineering controls
Multiple responses possible
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Questionary: Protection measures –
Engineering Controls
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Engineering controls (54 cases)
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• Wet processing
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• Closed system
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• Automatic processing
13
Multiple responses possible
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Questionary: Protection measures ventilation
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Ventilation (63 cases)
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• Open ventilation
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• Semi-open ventilation
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• Automatic ventilation
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• Closed ventilation
13
• Natural ventilation
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Multiple responses possible
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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
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specific respirators (FFP1 to FFP3)
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Multiple responses possible
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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
23.04.2009
• To be amended by industry sector specific
Guidance (under progress: for laboratories)
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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
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Annex
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Flowchart on Hazard Assessment for
Nanomaterials at the Workplace
General occupational health and safety rules
Duties according to the Hazardous Substances
Ordinance:
Information gathering
2.
Hazard assessment
3.
Determination of protection measures
4.
Review of effectiveness of measures
5.
Documentation
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1.
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Information gathering
• Used product
(properties, volume, type and form of use).
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• Activity
(possible intake: by inhalation, dermal or oral).
For oxidizable materials, also fire and explosion
risks must be included
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• Substitution options (including any use of processes
or preparations of the substance that result in lower
hazard)
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Information gathering
• Effectiveness of protection measures already in
place
• Implemented activities in preventive occupational
medicine
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• In case of data gaps, this lack of information must
be adequately taken into account when determining
protection measures.
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Determination of protection measures
STOP-Principle
1. Substitution options
2. Technical measures
3. Organizational measures
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4. Personal protection measures
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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
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• Available measurement data
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• To be used for assessment at a later stage
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Substitution options
• Replacing health-endangering substances or
technical processes by less ones
• Binding powder nanomaterials in liquid or solid
media
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• Using dispersions, pastes or compounds instead of
powder substances wherever technically feasible
and economically acceptable
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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
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• No recirculation without exhaust air purification
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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
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• Keep the number of potentially exposed workers as small as
possible (e.g. by time arrangements)
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• Deny unauthorized persons access to the relevant work areas
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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
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• Wiping up with a moist cloth
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• No blowing for removal
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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
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• Respiratory protection equipment
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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)
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• “Total number penetration efficiency"
P3 filters penetration less than 0.026% (particle count)
P2 filters penetration of 0.2% (particle count)
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• Effectiveness must be reviewed
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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
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• Additional protection of other areas of skin by
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• Protective suits
• Aprons
• Boots
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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
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• Conventional measures resulting from the hazard
assessment
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Flowchart: Hazard assessment for Nanoparticles at the
Workplace (respiratory route)
Specific hazard
assessment
No Hazard
No
Yes
Risks due to explosions,
reactive or catalytically
active nanoparticles?
Work in extractor,
requirements
according to TRGS 526
General occupational
Hygiene measures
Yes
Does the activity involve
dust formation?
No
Yes
Activities in laboratories
or small volumes?
Is there a low hazard?
Yes
No
No
Open systems?
No
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Yes
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Organizational measures
Personal protective
equipment
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Sucking up
with integrated or
highly efficient equipment?
Yes
Efficiency testing in regular
intervals, instruction,
demarcation of work area
Process avoids dust
and aerosol formation
because of closed system?
No
Yes
Efficiency testing in regular
intervals, instruction
No
Can dispersion,
solid granules,
compounds be used?
Yes
Examine substitutions
options
Hazard assessment
With respect to:
• Substance related hazards including
• Properties
• Physical state
• Processing options
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• Further hazards (e.g. electrical or mechanical)
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Hazardous Substances Ordinance - Principles
Risk assessment by the employer before starting activities
•
Eliminating Risks
•
Minimize Risks
In case of uncertainty:
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•
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Precautionary principle
„The need for control measures increases with both the
level of possible harm and the degree of uncertainty.“
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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
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Handling:
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Hazardous Substances Ordinance
(based on European directive 98/24/EC)
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Data gaps (TRGS 400/TRGS 526)
Minimal hazard properties in case of uncertainties:
R20/21/22
R38
R43
R68
Harmful by inhalation,
in contact with skin and if swallowed.
Irritating to skin
May cause sensitization by skin contact
Possible risk of irreversible effects
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Unknown new substances in research:
Toxic by inhalation, in contact with skin and if swallowed
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Additionally: corrosive, (spontaneous) flammable,
explosive
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Information down the supply chain
Technical Data Sheet for Application
Material Safety Data Sheet
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Accompanying Letter
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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”
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• Standard test methods are used to derive risks
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• Measures are not justified with risks
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Existing threshold limit values (TLV’s)
TLVs for poorly soluble dusts/fibers with specific toxicity
•Quartz:
•Silver (metal):
•Asbestos:
0.075
0.01
0.01
– 0.3
– 0.1
–2
mg/m³
mg/m³
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
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Covering also the nano sized fraction
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•
Legally binding TLVs specifically for nanomaterials are very rare
(Amorphous silica: 2 to 6 mg/m³)
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Approaches for setting a TLV for
nanomaterials (1)
Draft exposure limits from NIOSH (USA, 2005)
for titanium dioxide:
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•
•
•
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•
•
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
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Approaches for setting a TLV for
nanomaterials (2)
Benchmark levels (BL) from BSI (UK, 2007) for four
classes of nanomaterials
Nano-BL
•
Fibrous nanomaterials (high aspect ratio): 0.01 fibres/cm3
Nano-BL in relation to established TLVs
Insoluble nanomaterials:
CMAR nanomaterials:
Soluble nanomaterials:
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•
•
•
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0.066 of TLV (NIOSH relation of 15)
0.1 of TLV
0.5 of TLV
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
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• First period 2006 – 2008, will be elongated to 2010
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• First Report just released
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Nano commission: Five basic Principles
for a Responsible Use of Nanomaterials
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
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4. Established Risk management
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5. Responsibility down the supply chain
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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)
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• Dr. Eva Lechtenberg-Auffahrt (Occupational safety)
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Further questions:
Miriam Baron
Federal Institute for Occupational Safety and Health (BAuA)
Unit 4.6 “Hazardous Substances Management”
Friedrich-Henkel-Weg 1-25
D-44149 Dortmund
Germany
23.04.2009
mail-to: [email protected]
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www:
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http://www.baua.de
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/HazardousSubstances/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-SubstancesOrdinance.pdf
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http://www.vci.de/template_downloads/tmp_VCIInternet/122301Guidance%20SDS%20for%20Nanomaterials%20
_06%20March%202008~DokNr~122301~p~101.pdf
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http://www.bmbf.de/en/nanotechnologie.php
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