by Dr. Howard Morris
Nanotechnologies bring the potential for enormous benefit, but there are also
some risks associated with its use, given the limited knowledge about the health
effects of new nanomaterials. Workers may have the greatest exposure to these
nanomaterials and therefore may bear the greatest risks for adverse human health
and safety effects. The development and application of effective health and
safety standards will help protect the health and safety of people working with
There are many different types of safety and health standards including those
- International organisations, such as the Organisation for Economic
Cooperation and Development (OECD) and the International Organization for
- Regulatory agencies - examples are standards and specifications such as
national workplace exposure standards1 (Safe Work
Australia 2010), and Codes of Practice, including those for safety data sheets
and labels, which become mandatory when adopted in regulations.
- National standard-setting bodies such as Standards Australia and
the British Standards Institution (BSI) - e.g. the BSI's A guide to
safe handling and disposal of manufactured nanomaterials (BSI 2007).
- Industry associations.
This article examines how standards2 and related
documents can support effective health and safety management by nanotechnology
organisations, considers issues associated with the development and use of standards
and identifies the potential focus of future work. Australia-specific information
is used to illustrate these issues.
known as occupational exposure limits or workplace exposure limits
2 For the purpose of this
article, instruments such as regulations are considered to be standards
- they set the standards which need to be achieved
3 Currently, OHS chemical
regulations in Australia are based on the National Model Regulations
for the Control of Workplace Hazardous Substances (NOHSC 1994) and the
National Standard for the Storage and Handling of Dangerous Goods (NOHSC
2001). These are currently being revised and combined for inclusion
as hazardous chemicals regulations as part of the development of national
4 Some organisations have
proposed that the size range in the definition be extended, e.g. Friends
of the Earth Australia (FOEA 2010).
5 NIOSH (2005) recommended
exposure limits of 1.5 mg/m3 for fine TiO2 and
0.1 mg/m3 for ultrafine TiO2, as time-weighted
average concentrations (TWA) for up to 10 hours/day during a 40-hour
Effective Health and Safety Management
Nanotechnology organisations can protect the health and safety of workers by
implementation and maintenance of effective standard practices for working with
nanotechnologies. However, these practices need to be scientifically sound and
effective in practice.
What needs to be in place to achieve effective health and safety management?
Key areas for consideration, shown schematically in Figure 1, are:
- appropriate regulation, i.e. defining what needs to be done
- having useful and reliable information to explain how to manage
health and safety effectively
- external support for organisations
- internal resources to manage work health and safety effectively,
- verifying the effectiveness of standard practices.
Effective health and safety management
International Standards Development for Nanotechnologies
For nanotechnologies, international health and safety standards and related
documents including technical specifications, technical reports and guidance
materials are being developed through the ISO Nanotechnology Technical Committee
(TC 229) Working Group 3 and through the OECD Working Party for Manufactured
The focus areas for ISO TC 229 Working Group 3 are shown in Figure 2 and these
form the basis of the roadmap for the working group. Specific Working Group
3 projects are shown in Table 1, and ISO published a Technical Report on Health
and Safety Practices in Occupational Settings Relevant to Nanotechnologies in
2008 (ISO 2008).
ISO TC229 Working Group 3 Focus Areas
Table 1: ISO TC229 Working Group 3 Projects
| Project Group
|| Leading Country
|| Health & safety practices in occupational settings
relevant to nanotechnologies ISO/TR 12885:2008 published (2008)
||Endotoxin test for nanomaterial samples
|| Nanomaterials generation for inhalation toxicity testing
||Characterisation of nanomaterials for inhalation toxicity
|| Physicochemical parameters for toxicology assessment
||Guide to safe handling & disposal of manufactured nanomaterials
|| Nanomaterials risk evaluation process
||Occupational risk management based on control banding approach
|| Preparing Safety Data Sheets (SDS) for manufactured nanomaterials
||Surface characterization of gold nanoparticles for nanomaterial
specific toxicity screening: FT-IR method
Details of the OECD Working Party for Manufactured Nanomaterials (WPMN) Program
are in Table 2 and a number of reports on work under this program have been
published (OECD 2010). A formal liaison has been established between ISO TC229
and OECD WPMN to ensure coherency between the work programs.
These standards support work health and safety management through:
- supporting the regulation of nanotechnologies, and
- providing information, e.g. through guidance documents, to directly support
Table 2: OECD WPMN Program
OECD Database on
Manufactured Nanomaterials to Inform and Analyse EHS Research Activities
Safety Testing of a Representative
Set of Manufactured Nanomaterials: The "Sponsorship Programme for Testing
and Test Guidelines
Co-operation on Voluntary Schemes
and Regulatory Programmes
The Role of Alternative Methods in
and Exposure Mitigation
Co-operation on the Environmentally
Sustainable Use of Nanotechnology
Regulation of Nanotechnologies
The regulation of nanotechnologies needs to clearly define for duty holders
what needs to be done. This section covers:
- The current approach to regulation in Australia.
- Issues impacting on the regulation of nanomaterials.
- Actions being taken in Australia to progress these issues.
- Key documents that are adopted into regulation, or referenced by
regulation - thus becoming regulatory or mandatory standards.
Issues relating to the regulation of nanotechnologies are summarised in Figure
Regulation of nanotechnologies
Approach to Regulation of Nanotechnologies in Australia
Australia's work health and safety legal duties require that (DIISR
- manufacturers ensure that, so far as reasonably practicable, substances
are manufactured to be safe if they are used as intended
- suppliers ensure that, so far as reasonably practicable, substances
supplied to research laboratories and workplaces are safe if they are used
- employers provide and maintain a working environment that is safe,
- workers follow work health and safety requirements to protect their
own health and safety, and that of others who may be affected by the work
they are doing.
General obligations under work health and safety legislation, including chemical
regulations for hazardous substances and dangerous goods, need to be met for
nanomaterials and nanotechnologies3. Engineered
nanomaterials may continue to be regulated under the current work health and
safety regulatory framework. However, a number of issues need to be addressed
to ensure the effective regulation of engineered nanomaterials, for example
to support effective compliance activity by regulators.
The Australian National Industrial Chemicals Notification and Assessment Scheme
(NICNAS) has recently developed a proposal for regulatory reform of industrial
nanomaterials in Australia (NICNAS 2009), which will contribute to work health
and safety regulation.
Currently there is only limited hazard and risk information for most nanomaterials.
Where there is a lack of information, the use of a precautionary approach when
handling engineered nanomaterials is warranted, until evidence of their hazardous
properties is generated. This may be interpreted as, where there is the potential
for worker exposure, organisations working with nanomaterials should use the
highest levels of controls that are practicable and reduce exposures as low
as practicable. This differs from the current requirements of legislation which
are limited to providing what is reasonably practicable, and are based on a
sound understanding of hazards and risks.
Issues Impacting on the Regulation of Nanotechnologies
Definition of Nanomaterials
ISO has developed a working definition of nanotechnology as: The application
of scientific knowledge to control and utilize matter at the nanoscale, where
size-related properties or phenomena can emerge. Nanoscale has been defined
as the size range from approximately 1nm to 100nm4
(ISO 2008a), with a note which states that Properties that are not extrapolations
from a larger size will typically, but not exclusively, be exhibited in this
size range. For such properties the size limits are considered approximate.
This added note is critically important from a work health and safety management
The basis of work health and safety management is managing the hazard associated
with the material and thus whether a particle is 80 nm or 120 nm (i.e. inside
and outside the nanoscale range) is somewhat irrelevant from a work health and
safety viewpoint if the hazard associated with the material is unchanged. Poland
et al (2008) showed that exposing the mesothelial lining of the body cavity
of mice to; (a) dispersed bundles and singlets of long and intermediate length
multi-walled carbon nanotubes with mean diameter of 85 nm, and (b) long bundles
and ropes of multi-walled carbon nanotubes with mean diameter of 165 nm, resulted
in asbestos-like, pathogenic behaviour in both cases.
General issues that impact on the regulation of nanotechnologies include:
- adding detail within the frameworks to cover nanotechnologies appropriately
- improving understanding of the hazardous properties of engineered
- developing nanotechnology work health and safety measurement capability
- improving understanding of the effectiveness of workplace controls,
- ensuring consistency internationally.
Australian Program to Progress These Issues
In order to progress these issues, Safe Work Australia is implementing the
Nanotechnology OHS Program (Safe Work Australia 2010a) and a significant number
of nanotechnology work health and safety research projects have been commissioned
to support the program (Table 3).
Table 3: Projects commissioned under Safe Work
Australia's Nanotechnology OHS Program
Effectiveness of workplace controls
for engineered nanomaterials
RMIT University (Published, November
Toxicology and health effects associated
with engineered nanomaterials
Toxikos Pty Ltd (Published, November
Review of Material Safety Data Sheets
(MSDS) & workplace labelling for engineered nanomaterials
Toxikos Pty Ltd
Review of physicochemical (safety)
Toxikos Pty Ltd
Review of opportunities for substitution/modification
to reduce potential hazards
Examination of laser printer emissions
Queensland University of Technology
and Workplace Health & Safety Queensland
Feasibility of group-based exposure
standards and application of control banding for engineered nanomaterials
Detection of carbon nanotubes in workplace
Experimental research into durability
& bio-persistence of carbon nanotubes
CSIRO, UK Institute of Occupational
Medicine, and Edinburgh University
Assessment of measurement techniques
for different types of engineered nanomaterials & measurement of exposures
in workplace settings
Queensland University of Technology
and Workplace Health & Safety Queensland
Assessment of exposures to engineered
nanomaterials in workplace settings.
Key Documents that are Adopted into Regulation, or Referenced by Regulation
- thus becoming Regulatory or Mandatory Standards
Regarding national standards and Codes of Practice with legal standing, the
detail within these is being examined to check that it covers nanomaterials
appropriately. A specific issue under consideration is how these instruments
can appropriately cover the current situation, with the levels of uncertainty
about hazards and risks associated with new engineered nanomaterials.
Safe Work Australia is drafting
information to cover nanomaterials for a number of regulatory policy documents
(Safe Work Australia 2009), supporting work on the development of model work
health and safety laws for Australia (Safe Work Australia 2009a). These include:
- Draft National Code of Practice for the Preparation of Safety Data
Sheets (SDS). Section 5.9 contains new extra physicochemical parameters to
- Draft Australian Criteria for the Classification of Hazardous Chemicals.
Section 1.5 specifically covers the classification of engineered nanomaterials.
These draft documents have been through a public comment process and are currently
being reviewed and revised based on comments received.
Safety Data Sheets and Labels
The ISO TC229 Working Group 3 project on Preparing Safety Data Sheets (SDS)
for Manufactured Nanomaterials is a good example of how regulatory standards
can be supported by the development of non-regulatory international standards
and related documents. This project directly supports regulation. The project
acknowledges the existence of current documents (e.g. the Australian National
Code of Practice for MSDS) and is developing advice on what to put in each of
the 16 sections of a Safety Data Sheet, i.e. in the Globally Harmonized System
of Classification and Labelling of Chemicals (GHS) format, for nanomaterials
Labelling is an issue which is the source of concern globally. There have
been a number of calls for mandatory labelling of nanomaterials for workplace
use, e.g. by the Australian Council of Trade Unions (ACTU 2009). Current work
health and safety legislative requirements for labelling of workplace chemicals
require that the specific hazardous properties of the material be identified
on the label, irrespective of the form of the material. Therefore this information
must be provided for any nanomaterials or products containing nanomaterials
which have hazardous properties. However, this system relies on hazard information
being available. The issue of what precautionary information should be provided
for nanomaterials of uncertain hazards remains. A further important issue is
maintaining consistency with the GHS.
Exposure standards are important occupational hygiene standards that support
regulation. There are a small number of exposure standards for nanomaterials
which are not new, e.g. a number of forms of carbon black and fumed silica nanoscale,
and these substances have Australian National Exposure Standards of 3mg/m3
and 2mg/m3 respectively (Safe Work Australia 2010). The US NIOSH
has proposed exposure limits for fine and ultrafine TiO2 of 1.5mg/m3
and 0.1 mg/m3 respectively5 (NIOSH 2005),
and for comparison, the Australian National Exposure Standard for TiO2
is 10mg/m3 (Safe Work Australia 2010).
The British Standards Institution (BSI) in the guide to safe handling and
disposal of manufactured nanomaterials (BSI 2007) proposed Benchmark Exposure
Levels (BELs) for groups of manufactured nanomaterials, with the note that:
"These are intended to provide reasonably cautious
levels and are based in each case on the assumption that the hazard potential
of the nanoparticle form is greater than the large particle form. This assumption
will not be valid in all cases. Although these benchmark levels relate to current
exposure limits, they have not been rigorously developed. Rather, they are intended
as pragmatic guidance levels only and should not be assumed to be safe workplace
The proposed BELs are:
- Fibrous nanomaterials - 0.01 fibres/ml.
- Nanomaterials classified as carcinogenic, mutagenic, asthmagenic
or reproductive toxins (CMAR) - 0.1x Workplace Exposure Limit (WEL) bulk material.
- Insoluble nanomaterials - 0.066 x WEL bulk material.
- Soluble nanomaterials - 0.5 x WEL bulk material.
While there has been debate about the BELs quantification, the grouping of
materials and the potential application of the BELs (e.g. on how to measure
fibrous nanomaterials), they give a starting point for consideration of exposure
standards. Grouping nanomaterials may be the most practical approach for defining
standards rather than on a nanomaterial-by-nanomaterial basis, given the ever
expanding number of engineered nanomaterials being used. Grouping is also effective
in facilitating the use of control banding approaches. These BELs are currently
being examined in a Safe Work Australia
In a recent review of the toxicology and health hazards of engineered nanomaterials
(Drew et al 2009), noted that:
"evidence leads to a conclusion that as a precautionary
default all biopersistent CNTs, or aggregates of CNTs, of pathogenic fibre dimensions
could be considered as presenting a potential fibrogenic and mesothelioma hazard
unless demonstrated otherwise by appropriate tests"
Given there may potentially be serious adverse health effects from inhalation
exposure to carbon nanotubes, to clarify requlatory requirements and thus to
inform mandatory standards, Safe Work Australia has commissioned NICNAS to undertake
a health hazard assessment of carbon nanotubes for classification. In addition,
to support regulation and organisations handling carbon nanotubes, the Australian
Commonwealth Scientific Industrial Research Organisation (CSIRO) has been commissioned
to develop guidance for the safe handling and disposal of carbon nanotubes.
Nanotechnology Health and Safety Information
In this section, information on how to protect the health and safety of workers
is examined, including the notable contribution of non-regulatory (non-mandatory)
Nanotechnology organisations are of various forms and include research laboratories
within universities, small commercial concerns and units within large companies.
The information needs of these organisations are different, for example due
to varying internal resources to support work health and safety and therefore
standards development should reflect the range of needs.
Sources of Health and Safety Information
There are many different sources of non-regulatory nanotechnology health and
safety information, including national and international standards, as shown
on Figure 4. A recent Australian nanotechnology community attitude and awareness
survey (DIISR 2010) noted the importance of the internet in providing information
to people on new developments in science and technology and most people advised
they would do a Google search.
A growing amount of information is available on:
- Nanomaterial hazards, in particular health hazards. There is a lesser
amount of information relating to safety hazards, but a report by the British
Health and Safety Laboratories (HSL) on the Fire and explosion properties
of nanopowders was recently published (HSE 2010).
- Practices to prevent and control workplace emissions and exposures
- Measurement of nanomaterials emissions and exposures in workplaces
- Risk management approaches.
Nanotechnology Health & Safety Information
Verifying the Effectiveness of Standard Practices
Verifying the effectiveness of standard practices will require measurement
of exposures and emissions, during development of the practices e.g. for inclusion
in standards, and when implemented in workplaces. The development of measurement
standards will be described below. Where there is potential exposure, the use
of health surveillance may be appropriate.
However for nanotechnologies, health surveillance practices are not yet available,
except where defined for substances without nano-size specificity, e.g. for
cadmium and lead (NOHSC 1995). Health surveillance for workers potentially exposed
to engineered nanoparticles has been considered by Schulte et al (2008) and
the US National Institute for Occupational Safety and Health (NIOSH 2009). This
topic will be examined further in a forthcoming conference in July 2010 on Nanomaterials
and Worker Health: Medical Surveillance, Exposure Registries, and Epidemiologic
Research, arranged by the US NIOSH.
Development of Nanotechnology OHS Measurement Standards
A number of studies have now demonstrated through measurement that conventional
occupational hygiene controls (e.g. process enclosure and local exhaust ventilation)
can help prevent inhalation exposure to manufactured nanomaterials (Jackson
et al 2009).
However, measurement of nanomaterial emissions and exposures is critical in
supporting work health and safety management. In relation to development of
a standard, a basis may be provided by the Nanoparticle Emission Assessment
Technique (NEAT) (Methner et al 2010), developed by the US NIOSH. This is based
- the simultaneous use of a Condensation Particle Counter (CPC) and
Optical Particle Counter (OPC) to measure the number concentration of airborne
particles, and to indicate whether these particles are nanoscale particles,
or larger particles, e.g. aggregates and agglomerates of nanoparticles, and
- filter-based air sampling for mass concentration measurement and
particle characterisation (composition, shape).
This procedure is the basis of the guidance on initial assessment of nanomaterial
emissions published by the OECD WPMN in 2009 (OECD 2009). Safe Work Australia
has commissioned two projects to validate the use of the OECD WPMN procedure
for a range of engineered nanomaterials.
Use of Control Banding for Nanotechnologies
While information on hazards, measurement and controls is being generated,
organisations have to control exposures effectively. With limited hazard and
risk information available, the control banding approach is a risk management
approach to consider. There are a number of ways control banding can be used,
- organisations can undertake a control banding evaluation, e.g.
by use of the Control Banding Nanotool (Paik et al 2008, Zalk et al 2009),
- experts can develop guidance based on control banding, e.g. Figure
3 in the BSI guide to safe handling and disposal of manufactured nanomaterials
(BSI 2007). Organisations can then use this guidance as part of a conventional
risk assessment process, choosing the right control guidance sheets, developed
by experts, for their materials/processes/tasks.
The most suitable approach will depend on the nature of the nanotechnology
organisation (as discussed above). ISO TC 229 Working Group 3 Project 8 (Table
1) is examining occupational risk management based on the control banding approach
and is considering different approaches to control banding.
External Support for Nanotechnology Organisations
External support may be provided by a number of organisations, such as regulators,
policy agencies, industry associations, occupational hygienists or unions (Figure
5). But in order to be able to provide this support, developments are needed
- standards for measurement of nanomaterials emissions and exposures,
- specific validated guidance for control of processes.
This article has examined how health and safety standards development for
nanotechnologies is critical in helping to protect the health and safety of
workers. A range of international, national and other standards and related
documents are now being developed using information gained by targeted research
to support work health and safety management for nanotechnologies. This work
- adding detail to the work health and safety regulatory framework
to cover nanotechnologies appropriately
- supporting toxicology research into the hazardous properties of
new engineered nanomaterials
- developing standards for nanotechnology work health and safety
- providing guidance on effective workplace controls to support organisations.
The author acknowledges the contributions of Dr John Miles and Dr Vladimir
Murashov for their review and comments on this article.
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Copyright AZoNano.com, Dr Howard Morris (Safe Work Australia)