Is NZ’s regulation of nanomaterials adequate?

Increasing use of nanotechnology in consumer products has sparked interest in whether the potential risks arising from the technology are correctly regulated.

A report on nanotechnology regulation has just been released by the Ministry of Science and Innovation. The report was spurred by the Royal Society of New Zealand, which gathered scientists, regulators and other parties in 2009 to discuss nanotechnology.

Otago University’s Centre for Law and Policy in Emerging Technologies has reviewed existing legislation covering products and processes involving nanomaterials, and reported to the Government.

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) lists three possible levels of regulatory gaps, but points to a lack of consensus on just what constitutes a “gap”.

The authors note where such nanomaterials are not covered by existing regulation, and where these regulations are triggered by the presence of the nanomaterials. They focus on first and second generation products and say that as nanomaterials 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,” the authors say.

The SMC sought comment from other experts who have closely watched the issue develop in New Zealand:

Professor Simon Brown, Deputy Director of the MacDiarmid Institute for Advanced Materials and Nanotechnology, and Professor in the Department of Physics and Astronomy, University of Canterbury:

“Products that incorporate nanoparticles have been appearing in consumer products over the last 10 years present challenges for regulatory systems. Many nanomaterials are used because they have properties that are new compared to large particles of the same materials – and it also why they may need to be regulated differently.

“A review of NZ regulations was suggested in 2009. It is disappointing that it took so long for this report to be commissioned and released, and that it has been released in such a low-key way: it seems clear that regulators are determined not to respond to the challenges of nanotechnology.

“That’s a great shame, because in New Zealand we’re missing an opportunity to maximise the benefits from nanotechnology, and at the same time making ourselves vulnerable to new hazards. I believe that manufacturers would benefit from regulations that give them the certainty they need to allow them to invest in new products.

“This new report points out a lot of the difficulties in applying the current regulations to nanoproducts (like sunscreens, cosmetics, foods, washing machines and “health” products) that are already available to consumers. For example:

* under the HSNO Act it is not clear how hazardous a product has to be before regulation is required.

* There is no clarity as to what would actually be defined as ‘nano’.

* “Manufactured articles” – like certain fridges and washing machines containing nanoparticles – may not be covered by NZ legislation at all.,

* The current regulatory system lacks the ability to ensure compliance with regulations or to enforcement them.

“The regulators are clearly concerned that these issues should not be called ‘regulatory gaps’ but this is semantics: this report shows that – whether these are technically ‘gaps’ or not – the regulatory system is simply not working.”

Professor Shaun Hendy, Deputy Director of the MacDiarmid Institute for Advanced Materials and Nanotechnology:

“Manufactured nanomaterials have been present both in goods and in the environment for hundreds of years. However, they have become moreprevalent in the past decade as our understanding of nanotechnology has grown.

“This report examines whether our existing regulatory frameworks are equipped to deal with the presence of manufactured nanomaterials in consumer goods. The report concludes that in most instances current legislation is capable of dealing with manufactured nanomaterials.

“This report will be useful for regulators, as it identifies a number of areas where further oversight may be desirable.

“For instance, it finds that there is the potential for ambiguities to arise in differentiating between the bulk substance and any novel nanostructured form of that substance.

In my opinion, this is something that would be difficult to capture rigorously in legislation.

“I believe that close cooperation will be required between scientists, manufacturers and regulators to ensure that these ambiguities are dealt with in an informed manner.

“It will also be important that the relevant regulatory agencies stay informed with developments in nanotechnology, both in New Zealand and overseas.

Stephanie Howard, Projects Director, Sustainability Council of New Zealand:

“What is most striking about the study is the lack of serious response from Government.

“Not a single piece of protective legislation reviewed is certain to be invoked when nanomaterials are used. In practice, that means worker safety, human health, food and environmental safety laws may not provide New Zealanders the protections they assume.

“You would expect the Government to provide a plan for plugging those gaps. There is, however, no serious plan and actual regulation of nanotechnology will remain missing in action for some time without it.

“The good news from the report is that little law change is required to regulate nanotech products now. If this is so, why are these products going unregulated? Government and regulators, it appears, are not interested.

“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’.

“The net effect is that nanomaterials are entering the marketplace untracked and before their safety or otherwise can be determined. Regulating to remove this uncertainty is the challenge that Government needs to step up to. Good governance is not about assuming that all nanomaterials will be harmful. It does assume, however, that all are risky until proven otherwise. Government can no longer claim ignorance of ‘leaky law’, and so its part in knowingly exposing people to those risks in cases where the law fails.”