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Posted: July 25, 2008
Australia reviews nanotechnology impact on its regulatory system
(Nanowerk News) Australia's regulatory systems are well placed to respond to the introduction of nanotechnology products. Two documents released this month identify areas for further work and the way the Government will address emerging nanotechnology issues.
Senator Kim Carr, Minister for Innovation, Industry, Science and Research said: "Nanotechnology is developing very quickly on a global scale. Governments, industry and research need to be flexible and active to keep pace with these developments. We need a long-term effort across multiple Government agencies and we are committed to that.
"In the interests of open government we are today publishing two documents on the regulation and application of this emerging technology."
A Review of Possible Impacts of Nanotechnology on Australia's Regulatory Framework, was independently conducted by the Centre for Regulatory Studies at Monash University. The review found that whilst there is no immediate need for major changes to the regulatory regime, there are many areas which potentially will need amending.
"At the same time I am issuing the Australian Government Approach to the Responsible Management of Nanotechnology," Senator Carr said.
This document identifies three guiding objectives for nanotechnology management:
protect the health and safety of humans and the environment;
foster informed community debate, and
achieve economic and social benefits from the responsible adoption of nanotechnology.
"The Government is committed to capturing the benefits of nanotechnology, while addressing any potential health, safety and environmental risks," Senator Carr said.
Key regulatory issues
The Monash Report, Review of Possible Impacts of Nanotechnology on Australia's Regulatory Frameworks, identified six regulatory issues which may need addressing in the regulatory framework. These are:
1. 'New' or 'Existing' substances or Products?
The most significant potential gap concerns the uncertainty as to whether new nanoforms of conventional products will be considered as ‘different’ to traditional products.
2. Weight or volume
Many regulatory triggers currently exist on the basis of a threshold weight or volume. For nanomaterials such thresholds may not be meaningful.
3. Knowledge of presence or implications of presence of nanomaterials
In some instances appropriate regulation requires particular knowledge of either the presence of nanomaterials and/or the risks posed by nanomaterials.
4. Risk assessment protocols or conventional techniques
Australia’s current regulatory regimes often rely on risk assessment protocols as a means of ensuring human or environmental safety of products or applications. However it is uncertain whether the current risk assessment methodologies being employed by various regulatory agencies are suitable for goods that contain nanomaterials.
4. Research and Development exemptions
There are some gaps relevant to research and development, which although not unique to nanomaterials may apply when there are regulatory exemptions for R&D purposes that are based on weight thresholds.
6. International documents
Many of our regulatory frameworks refer to international documents or documents sourced outside regulators. If these documents themselves do not adequately address health, safety and environment concerns raised by nanomaterials, this may lead to a further potential regulatory gap.