Nano-regulation creeps closer

Canada has introduced a mandatory safety reporting scheme for companies producing nanomaterials, becoming the first country in the world to do so. However, regulators in the US and Europe continue to dither over the issue - despite scientists’ concern that there are too many gaps in the basic knowledge of nanoparticles’ properties to support the development of informed regulation. 

On both sides of the Atlantic, government bodies responsible for the control of potentially hazardous materials have been widely criticised for a too-slow response to the burgeoning nanotechnology industry, failing even to collect the necessary nanoparticle safety data needed to guide policy. 

'Even the definition of "nano" is still under debate'

SCENIHR report

However, the Canadian government has once again showed its willingness to be that little bit tougher on industry than other developed nations, in a bid to protect people’s health and the environment. Under its new scheme - published in the February issue of the Canada Gazette, the official newspaper of the Canadian government - companies and institutions that manufactured or imported more than 1kg of a nanomaterial in 2008 will be required to submit all of the information they have - physical and chemical properties, toxicological data, and methods of manufacture and use. The government agencies, Health Canada and Environment Canada, will use the information for ’the assessment and future risk management of nanomaterials’. 

Data capture  

The European Commission (EC), the US Environmental Protection Agency (EPA) and the UK Department for environment, farming and rural affairs (Defra) have all previously launched their own schemes to gather information on nanomaterials. However, all three have shied away from making Canadian-style demands for information from industry, and opted instead for voluntary schemes, asking manufacturers to take part and provide them with information about what materials they make, in what quantities, and how they are used. 

In Europe, the recently introduced Reach (Registration, evaluation, authorisation and restriction of chemicals) regulations already apply to nanoparticles, and regulators are reviewing the legislation to clarify how it deals with nanomaterials. 

However, as Reach currently stands, the quantities produced are often too small to be considered. ’The regulatory trigger for Reach is one tonne per year,’ explains Qasim Chaudhry, senior scientist at the UK’s Central Science Laboratory, who has led regulatory reviews on nanotechnology for Defra. ’But if someone is producing 999kg, that regulation won’t cover it. And that amount is a huge number of nanoparticles. The threshold limits should be revisited.’ 

The fact that the Canadian government has opted to set the lower limit for its safety reporting scheme at only 1kg suggests a clear discrepancy. However, according to Barbara Helfferich, spokeswoman for environment at the EC, there are no plans to change the regulatory threshold. But Reach is up for a full review in 2012, at which time all recommendations will be considered. 

Working together

In the US, the EPA’s nanomaterials stewardship program (NMSP), launched in 2008 and due to be concluded in 2010, was split into two: the basic program, whereby companies were simply required to submit information about the materials they produce; and the in-depth program, which offered companies the opportunity to work with the EPA to identify what additional information might be useful in regulatory decision-making, and to devise methods to generate this information. 

An EPA interim report, released in January 2009, claimed the NMSP had been successful - despite a notable lack of participation from industry. According to the EPA, approximately 90 per cent of the different nanoscale materials likely to be commercially available were not reported under the basic program, and there were ’important gaps’ in the information that was reported. For example, some submissions didn’t contain exposure or hazard-related data. 

The very low rate of engagement in the in-depth program (only four companies have so far agreed to participate) ’suggests that most companies are not inclined to voluntarily test their nanoscale materials,’ the report concluded. 

Defra says its own voluntary scheme was a quick and efficient way to gather information. ’The UK’s approach is to try to work with industry and business first,’ said a Defra spokesperson. ’To go down the legal route takes much longer.’ 

But Chaudhry, who led a 2005 project that resulted in recommendations to Defra that it collate information from the industry, says that a voluntary scheme was ’not the idea’. ’The upshot is that it has not been very successful - not many companies took part,’ he says. 

Filling the gaps  

Ann Dowling is professor of mechanical engineering at the University of Cambridge, UK. She chaired a working group on nanotechnology in 2004, which was commissioned by the UK’s Royal Society and the Royal Academy of Engineering to produce a report on the potential risks and benefits. That report recommended tighter controls on the industry to protect consumers, and particularly pointed out that safety tests specific to nanomaterials needed to be developed. 

’So far the voluntary scheme doesn’t seem to be working. I think it may be time to review it,’ says Dowling. ’But that certainly doesn’t seem to have slowed down the introduction of manufactured nanomaterials into consumer products. This is increasing faster than we thought it would.’ 

However, the regulatory grey area is leaving some within the industry in a precarious position. ’I heard one case of a company making carbon nanotubes, that was storing all of their waste, waiting for guidance on how to dispose of it from the regulators,’ says Dowling. 

What is now urgent, Dowling adds, is that the gaps in safety data be filled. However, she says that not enough research has been done to underpin regulations, and progress continues to be slow. ’There’s no earmarked budget set aside for this testing,’ says Dowling. ’The funding councils are putting it into the same category as all nanotechnology, so the health and safety testing has to compete with everything else. Panels deciding which grant to fund are more likely to want to support research into new nanotechnologies - it appears more exciting.’ 

In the meantime, the regulators say that they can work with existing regulations to protect consumers and the environment, while supporting the growth of the industry. In spring of this year, Defra will edge closer to introducing its own regulations, when it responds to the Royal Commission on Environmental Pollution’s recommendations about the governance of novel materials. 

EPA also defends its current stance. ’Since 2005, [we have] received over 50 new chemicals notices for nanoscale materials, and have taken steps to control or limit exposures to all of these chemicals, including limiting the uses of the nanoscale materials, requiring the use of personal protective equipment,’ says the EPA. ’[We] will consider issuing regulations at any time to protect human health and the environment.’ 

However, fundamental issues - including consensus over what data should be collected - remain. According to a report published this year by the EC Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), there is as yet no generally applicable paradigm to test the safety of nanomaterials, and so the committee recommended a ’a case by case approach’ for their risk assessment. And as the report points out, even the definition of ’nano’ is still under debate.