Nanotechnology is a broad term which describes a range of technologies which operate at a scale of 1 to 100 nm (1 billionth of a metre). Materials at this scale display novel properties, which creates the potential for new applications with enhanced functionalities. Nanomaterials or (‘nano-objects’) are generally defined materials with one, two, or three external dimensions in the size range from approximately 1 – 100 nm. These include nanoplates, nanofibres and nanoparticles. The definition adopted by the EU Commission, which remains under review, is available here.
Worldwide research, surveys and projects have identified the principal areas involved in the use of engineered nanoparticles as information and communication technology; research and development of medical devices, diagnostic devices and pharmaceuticals; and industrial sectors such as the manufacture of paints and composites.
In the Irish context, several health and safety instruments for the manufacture, import or use of chemical substances exist. Whilst nanomaterials are not explicitly mentioned in these instruments, the existing legislation for chemicals encompasses all chemical substances. Consequently, potential hazards associated with nanomaterials in the workplace must be identified, risk assessed and controlled. Although the same principles of risk management are applicable, it is important to take into account the data gaps that currently exist relating to the properties of nanomaterials and their interactions with living systems.
- REACH is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a "substance" in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH, such as registration of substances manufactured at 1 tonne or more and providing information in the supply chain, apply as for any other substance. The Commission are currently considering modification of the technical provisions of the REACH annexes to explicity indicate information requirements for substances in the nano-range, for more information please see the EU Commission website.
- The classification, labelling and packaging of nanomaterials is similarly regulated through the CLP Regulation, although not explicitly mentioned, the regulation applies to nanomaterials as substances in their own right, or nanomaterials as special forms of a substance. The provisions of CLP are independent of the tonnage of the substance manufactured or imported, and as such are applicable to substances in the nano-range. In April 2014, the UN indicated that they are undertaking a review of GHS (CLP in the EU) and it's applicability to nanomaterials, for more information please see their communication.
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Identifying the hazards arising from the different types of nanoparticles and related technologies is difficult because research on the health effects of some of these novel particles is still at an early stage. Substances may be evaluated based on the information in the safety data sheet(s), sections nine and eleven may indicate the particle size and any known effects on health, where that information is available. Please contact your supplier if you require further information.
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Owing to the information gaps in nanomaterial risk management, a cautious approach is advised, including providing higher levels of controls due to the level of uncertainty associated with their effect on human health, i.e. the worker. Risk management strategies should be reviewed regularly, particularly when new information becomes available.
Risk considerations include: the chemical composition; the hazard classification; physical state (solid, liquid or gas); physical characteristics; potential exposure pathway; quantity handled; duration of activity; frequency of activity; controls in place and degree of reliance on personal protective equipment (PPE). The following four groupings may assist in the categorisation and risk assessment of nanomaterials, in no particular order:
- Fibrous nanomaterials (i.e. insoluble and of a high aspect ratio)
- Nanomaterials from CMR substances (i.e. the larger form particle of the substance is already classified as a carcinogenic, mutagenic or reproductive toxin)
- Insoluble nanomaterials (i.e. insoluble or poorly soluble nanomaterials, but not fibrous or a CMR)
- Soluble nanomaterials (i.e. soluble nanomaterials not fibrous or a CMR)
As with any chemical substance, inhalable and poorly soluble nanomaterials in addition to nanomaterials derived from known CMR substances represent the greatest concern. Nano-sized materials in general have an increased capacity to reach and interact with tissues in the body, potentially enhancing any adverse effects on health.
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Employers must apply the hierarchy of controls in order to protect their workers from nanomaterials, in the absence of specifically developed occupational monitoring methodologies.
- Engineering controls to completely enclose the process and/or containment: All operations in which there is deliberate release of nanomaterials into the air should be performed in contained installations, or where employees are otherwise isolated from the processes (i.e. in a cabin) to minimise employee exposure. This includes gas phase nanomaterial production and spray drying. All other processes involving the use of dry nanomaterials should be performed in enclosed installations where possible. Based on current knowledge, systems normally used to contain gaseous emissions would be appropriate. All processes where there is a likelihood of dust formation should be carried out with extract ventilation.
- Administrative controls to minimise exposure: Procedural controls should accompany engineering controls, and as far as reasonably practicable, work with nanomaterials should be planned and proceduralised to prevent unforeseen exposure potentials. Administrative controls should include all work, including cleaning and maintenance operations.
- Personal Protective Equipment (PPE): Respiratory protective equipment (RPE), dermal (hand) and/or dermal (full body) protection may be used as a last option in the hierarchy of controls. The (US) National Institute for Occupational Safety and Health (NIOSH) is currently evaluating the effectiveness of RPE and other types of PPE such as gloves with respect to protection from nano-sized materials.
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Occupational Exposure Monitoring
Evaluation of occupational exposure has traditionally been carried out using qualitative and quantitative tools. However, conventional sampling and detection methods for carrying out occupational hygiene monitoring may not be adequate for nanomaterial sampling and detection. As a result, such methods are currently under review by the (US) National Institute for Occupational Safety and Health (NIOSH).
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