Report delves into the great unknown of nanotech

As the saying goes, you don't know what you don't know – and being faced with the unfamiliar can bring out the worst in people. Case in point: the recent attacks on nanotech scientists, which has seen letter bombs sent to labs in Mexico, France, Chile and Spain.

In fact, increasing use of nanotechnology in consumer products has triggered interest in whether the potential risks arising from the technology are being adequately regulated, and the government has just released a report on the issue.

The Review of the Adequacy of New Zealand's Regulatory Systems to Manage the Possible Impacts of Manufactured Nanomaterials by Colin Gavaghan (in Dunedin) and Jennifer Moore (in Wellington) was spurred by the Royal Society of New Zealand, which gathered scientists, regulators and other parties in 2009 to discuss nanotechnology. It lists three possible levels of regulatory gaps, but points to a lack of consensus on just what constitutes a regulatory "gap".

Otago University's Centre for Law and Policy in Emerging Technologies reviewed existing legislation covering products and processes involving nanomaterials, and reported back to the Ministry of Science and Innovation. 

It concluded that in most instances current legislation was capable of dealing with manufactured nanomaterials.

The authors primarily focused on first and second generation products and said that as they evolve, more work will need to be done on regulation.

"Some reviews of this topic have suggested that subsequent generations of nanotechnologies are likely to present a much more significant challenge to existing regulatory structures."

Professor Shaun Hendy, deputy director of the MacDiarmid Institute for Advanced Materials and Nanotechnology, said while manufactured nanomaterials have been present both in goods and in the environment for hundreds of years, they have become more prevalent over the past decade.

"The report concludes that in most instances current legislation is capable of dealing with manufactured nanomaterials," he said.

He said close cooperation would be required between scientists, manufacturers and regulators to deal effectively to any ambiguities.

Fellow deputy director Professor Simon Brown said manufacturers would benefit from regulations, which would give them the certainty they needed to invest in new products.

The report recommended that before implementing any measure to address nano-safety concerns, consideration should be given to the practical necessity of monitoring and compliance.

"This may involve a range of measures, from merely reminding manufacturers in clear terms of their obligations, to invoking such legal sanctions as are considered appropriate. Where regulators are not empowered to conduct such monitoring and enforcement roles, amendment of their foundation statutes may be required. More often, we suspect, lack of monitoring and enforcement will result from policy decisions by the regulators themselves, and the resource realities within which they operate."

Even the most comprehensive regulatory framework, the authors warned, would be an ineffective safeguard of public health if no effective mechanism exists to monitor and enforce compliance.

"This is what we identified as a third level regulatory gap. For example, the notification requirement of the presence of NMs in cosmetics relies upon the voluntary compliance of manufacturers. It appears, however, that this requirement has, at least until recently, been widely ignored.

"This gap is far from unique to New Zealand; in Australia, a voluntary call for data by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) produced ‘disappointing’ results, while a voluntary reporting scheme operated by the UK’s DEFRA has yielded a similarly low number of reports."

The labelling of products that contain nanomaterials is a contentious one, and one that the authors said they had not had the opportunity to fully evaluate.

There are no nano-specific labelling requirements in New Zealand at present. The European Union has recently legislated for compulsory labelling of cosmetics containing nanomaterials, while a proposal to require nano-specific labelling of novel foods is currently the subject of proceedings involving the EU Parliament, Council and Commission.

Particular care would have to be paid to the wording of any labels, if they were to impart "genuinely useful information to prospective consumers without causing unjustified alarm".

According to the report, the limited body of knowledge about the risks posed by some nanomaterials is an obstacle to any regulation attempts.

"In some cases, regulatory triggers require the identification of a product as being likely to present a risk ... More challenging, however, is the question of how to proceed in situations of uncertainty."

It said an approach could potentially be adapted from criminal law, in which anyone objecting to a nanomaterial would bear an evidentiary burden of demonstrating some risk of harm. Having passed that threshold, the burden of proof would then transfer to the manufacturer to prove that the risk was unfounded.

The Sustainability Council's projects director Stephanie Howard said what was most striking about the report was the lack of a serious response from the government.

"Take traceability of nanoproducts: Knowing what to regulate is the basis of good governance. At present, regulators would struggle to identify what nanotech products are on the market and in the workplace.  

"The study identifies ways that the Environmental Protection Authority (EPA)  could track the whereabouts of nanomaterials now. The EPA agrees it could do this, but has effectively said 'no'.

As a result, she said nanomaterials were entering the marketplace untracked and before their safety could be determined.

"Good governance is not about assuming that all nanomaterials will be harmful. It does assume, however, that all are risky until proven otherwise."

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