Australia: Nanotechnology - Nano Problem Or Time For Australian Business To Actively Manage Potential Risks?

Pharmaceutical Insights

Nanotechnology, the science of the small, is a complex and constantly evolving technology with the potential to help address many of the challenges facing the modern world. While no-one wants to curtail the potentially extraordinary benefits of this technology, past experience with "wonder products" and "wonder technologies" has taught prudent manufacturers and importers to exercise caution and to investigate whether there may be adverse health effects associated with the products before they are disseminated too widely.

Currently, products made using nanotechnology are entering the market without being fully tested for risks and without the risks of such technology being properly understood. The toxicity of some nanoparticles and nanomaterials has been established in animals and one recent study has suggested toxicity to humans.

This creates potential dangers for two groups of people: employees in workplaces which manufacture products using nanotechnology and consumers using products which are comprised of nanoparticles.

In this initial article, we look at the world of nanotechnology and identify issues for prudent manufacturers and importers to consider to address possible exposure. In the next edition, we will look more closely at recent national and international developments in this area.

What is nanotechnology?

There is no internationally recognized definition of nanotechnology but it is commonly used to describe a range of technologies, techniques and processes that involve the manipulation of matter at the nanoscale (which is the size range from approximately 1 nanometre to 100 nanometres) to create new materials, structures and devices. One nanometre (nm) = one millionth of a millimetre. In order to put this into some context, a human hair is approximately 80,000 nm wide.

The problem with this definition is that it may exclude numerous materials and devices (especially in the pharmaceutical space) and, therefore, some experts have warned against limiting the term to materials in this size range.

Examples of current nanoproducts, which are products which incorporate nanotechnology, are sunscreens, cars, clothing, computers, pharmaceuticals and clothing and household textiles made of wrinkle-, stain- and odour-resistant fabric.

The nanoscale form of a material often behaves differently in comparison to the larger form and can have different chemical, physical, electrical and biological characteristics. For example, an aluminium can is perfectly safe but nano-sized aluminium is highly combustible and can be used to make explosives. Nanoparticles may be potentially hazardous because of their relative size, surface area and potential toxicity. They can be inhaled or absorbed through the skin.

What regulation is there?

Currently, Australia has no nano-specific regulations. However, some existing regulations cover, albeit generically, products containing nanoparticles, for example: The Australian adopted national exposure standards for atmospheric contaminants in the occupational environment; National Model Regulations for the Control of Workplace Hazardous Substances [NOHSC: 1005 (1994)]; and Approved Criteria for Classifying Hazardous Substances [NOHSC: 1008 (2004)] Australian Standard: Safe Working in a Confined Space [AS2865-1995].

Despite the fact that various bodies have recommended that this new technology should be specifically regulated, the Federal Government has indicated that, at this stage, it will not be introducing nano-specific regulations nor does it currently have plans to introduce mandatory labelling or a federal register of companies dealing with nanomaterials.

Given the importance of this emerging technology, it is not surprising that there are a number of nanotechnology initiatives that have been considered and/or implemented in foreign jurisdictions. In particular, scientists and regulators in the United Kingdom, the United States (especially California), Canada, France and the European Union are focused on investigating the potential adverse health effects associated with the use of this new technology.

What should business be doing to guard against potential future liability?

If a company manufactures or imports products which utilise nanotechnology or contain nanomaterials, it may be prudent to consider taking the following action in order to effectively manage the potential impact of any adverse health consequences that may emerge:

  1. Awareness of health effects: identify someone within the organisation to periodically monitor the progress of research regarding the health effects of nanomaterials and nanotechnology. (This could be achieved by consulting sources such as the OECD database or the websites of organisations including the Australian Office of Nanotechnology, Safe Work Australia, Nanosafe Australia, or the Australian Nanotechnology Alliance).
  2. Assessment of products and work environment: Risk assessments should be periodically conducted to determine the levels of free nanoparticles in the workplace or in products. (Organisations such as Nanosafe Australia offer risk assessment services.)
  3. Consider changes to work practices: Consideration should be given to the OECD's voluntary Code of Conduct for Responsible Nanotechnology (which contains seven key principles). The Nanotechnologies Industries Association has prepared examples of "good practice" for each of the seven principles which may be worth considering as part of a risk assessment process.

Any discussions regarding assessing the actual risk which exists in the workplace or ways in which to manage potential liability got such risks necessarily have a legal dimension. Companies should seek input from their legal advisers in setting up, conducting and reviewing these investigations or assessments.


Mere mention of the term "nanotechnology" elicits great excitement from the scientific community and industrial entrepreneurs because of its anticipated, but as yet relatively unknown, potential to improve many aspects of human life and endeavour. When technology has such enormous promise, it is tempting to overlook, or at least to minimise the assessment of any potentially negative consequences. However, history and experience teach us that the potential health effects of nanotechnology do need to be investigated, and may possibly be regulated, before this technology becomes an intractable part of our world. To varying degrees, governments and organisations within Australia and around the world are engaged in this process.

At this stage there is very little conclusive evidence of the dangers of nanotechnology and nanoparticles in humans. Nonetheless, incomplete knowledge of toxicity should not defer effective consideration of these issues. Rather than waiting until conclusive evidence of a harmful association exists, it may be prudent for manufacturers and importers to take steps to ensure that their business is reasonably and effectively addressing potential dangers associated with this technology and with nanoparticles. This will assist the company's future legal position in the unfortunate event that this technology is conclusively associated with serious adverse health effects.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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