INSIGHT: New rules must apply in the nano world

13 July 2007 16:43  [Source: ICIS news]

By Nigel Davis

LONDON (ICIS news)--Can existing regulatory frameworks and systems cope with nanotechnology?

New markets for nano products are found every day. The projections are staggering.

By 2014 the nanotechnology sector will account for 15% of global manufactured goods output, according to the US-based Project on Emerging Nanotechnologies (PEN), quoting a Lux Research report from 2004.

That represents a market value of close to $2.6 trillion.

The use of nano-particles in products as diverse as plastics and water treatment systems has prompted producers like DuPont to look closely at nanotechnology risk assessment.

The manufacturers’ responsibility to ensure that their products are safe for consumers and workers has been very much brought to the fore.

The point is that regulatory systems are being pushed hard simply to keep up with the new technologies.

The US Environmental Protection Agency (EPA) said this week that nanotechnology products should be reviewed on a case-by-case basis under the Toxic Substances Control Act (TSCA).

Industry likes that seemingly hands-off approach.

“EPA is doing the right thing,” said Joseph Acker, president of the Synthetic Organic Chemical Manufacturers Association (SOCMA) president. 

“It is quite rare that the agency gets the chance to establish a risk management programme ahead of the markets. The number of different chemistries at the nanoscale is still small," said Acker.

“It’s smart for EPA to establish this programme and collect valuable risk-related information before the markets really start to expand.”

But can the EPA move fast and far enough if nanotechnology product markets are expanding as rapidly as some suggest?

The PEN believes the EPA’s approach is inadequate.

"Because of the weaknesses in the law, the agency is not even able to identify which substances are nanomaterials, much less determine whether they pose a hazard," says PEN senior adviser J Clarence Davies.

EPA has issued consultation documents covering the proposed establishment of a voluntary industry Nanoscale Materials Stewardship Programme (NMSP).

Creation of the NMSP would be a positive step, Davies says.

But why not establish the programme in tandem with a modified TSCA?

“This voluntary programme for nanomaterials is already behind schedule. The British government put in place a Voluntary Reporting Scheme in September 2006 and appears to be on a faster track to develop appropriate controls and to give a predictable nanotechnology regulatory environment for industry and consumers,” he adds.

Nanotechnology risk assessment is complex to say the least.

Some believe that as many as six dimensions of risk need to be incorporated into a new product evaluation. Producers may be best placed to initially to do this work, but the regulators have to keep up.

There is so much talk of keeping up in the nanotechnology race and many questions raised about the level of national and regional government funding for the new technologies.

But the calls for a slowdown until risk assessment mechanisms are better established are not misplaced.

Nano-scale materials are finding their way into numerous products of the chemical industry. Nanotechnology will really take off when its impact is felt across a broad range of commercial sectors, including healthcare.

To facilitate that change, risk assessment procedures have to develop faster and encompass a great deal more health and environmental research.

Industry has to respond responsibly to the nano boom.

Alongside the commercial there is an ethical imperative.

By: Nigel Davis
+44 20 8652 3214

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