There has been plenty of discussion from all quarters about how the UK failed to grasp the significance of nanotechnology, and instead spent years fretting over heath and safety implications. Without any real nanotechnology related activity in UK industry, worrying about the potential downside is like spending all your time planning what you will do if you win the lottery. But you have to be in it to win it.

The UKs Nanotechnology knowledge Transfer Network, the body charged with”accelerating innovation in nanoscale technologies” has contributed an article to Nanotechnology Nowlooking at responsible nanotechnology. There’s nothing wrong with it per se, it’s a good round up, but after ten years of dealing with every part of the UK government that touches on nanotechnology, from the Treasury to DEFRA (the Department for Environment, Food and Rural Affairs) I can’t remember anyone extolling the potential economic benefits of nanotechnology, and it’s a real tragedy.

The UK has thousands of word class scientists beavering away on everything from graphene to cancer treatment and instead of being encouraged and aided to spin out their research into world-class companies, the government attitude is solely concerned with what might happen if someone “accidentally” inhaled a kilo of carbon nanotubes or managed to munch their way through a family sized bucket of fried chicken laced with quantum dots. It is probably why our rankings indicate that there is not too much difference between India and the UK as a place to commercialise nanotech.

Most sciences and technologies develop faster than regulators can regulate. This is no secret.

Altough this is “normal”, the special case of nanotechnology and its adoption in several fields (including medicine and biomedicine) may be critical. While nanotechnology shows a huge potential for tremendous benefits, this emerging and fast developing field of science and technology also s has the potential to engender a wide range of dangers, risks and menaces.

According to the Científica Limited’s great report “The Nanoparticle Drug Delivery Market Report”, “there are long admission procedures including for example several clinical trials. Due to the close interface between technology and Human beings there is a special velocity of development which is reflected in long and preferably well defined admission procedures, including for example several clinical trials. In some cases, it is not the nanoparticles to be the constraint or limiting factor but the pharmaceuticals. Most of the basic things that will slow many developments will certainly be the lack of understanding of complex biological systems”.

While regulation has been discussed for a long time there has been little in the way of concrete action.  Nevertheless, many other organizations have demonstrated significant efforts in order to develop a qualified work in nanoregulation, for example regulatory entities such as the United States Environmental Protection Agency and the Health & Consumer Protection Directorate of the European Commission already started working with the potential risks of nanoparticles.

Still according to Científica Limited’s report “The Nanoparticle Drug Delivery Market Report”, “market development is being slowed down by lack of regulatory case law, manifest over public concern over the potential health and environmental impacts of manufactured nanoparticles. This will be improved as new products emerge onto the market and more in the United States especially, this is attracting attention and investigation from governmental organisations, and strong collaborations are being set up with academia, with particular regard to the International Council on Nanotechnology (ICON), established at Rice University’s Center for Biological and Environmental Nanotechnology, is conducting comprehensive safety studies for the FDA”.

The Organisation for Economic Co-operation and Development (OECD) is also working on Safety of Manufactured Nanomaterials.

The World Health Organization (WHO) is developing Guidelines for “Protecting Workers from Potential Risks of Manufactured Nanomaterials” in order to address occupational risks of nanomaterials.

In 1995, the Inter-Organization Programme for the Sound Management of Chemicals (IOMC) was founded to strengthen cooperation and increase coordination in the field of chemical safety. The IOMC organizations organize regular meetings together to ensure co-ordination. At these meetings, the status of activities related to nanotechnology has been discussed.

The WHO together with Food and Agriculture Organization (FAO) of the United Nations is providing member states with scientific advisory on the assessment of foods related to nanotechnology.

Finally, during the current year, regulatory entities have shown a significant increase in work regarding concerns about nanosafety. Almost everyday Google news provides us with up-to-date advances in nanoregulation with the FDA being especially active  regarding the adoption of nanotechnology in medicine and biomedicine.

Reading reports of government plans for the regulation of nanotechnology sometimes feels like being on death row. The outcome is inevitable, and all you can do is hope that it will be short and painless. The European Commission has been debating regulations for the best part of a decade,and now apparently has been given a deadline of 2011 by the European Parliament to “properly regulate nanotechnology.”

Plastics & Rubber Weekly reports that the Belgian Environment Minister, Paul Magnette proposed five elements that should be included in nanotechnology legislation, including

• A register of nanomaterials used within the EU is established, so regulators can trace the origin of any nanoparticles to their source if they cause health or environmental problems.
• Manufacturers and retailers inform consumers of the presence of nanomaterials in their products
• Regulations provide for risk evaluation and management of nanomaterials at an EU level
• Member states also draft integrated national strategies for nanotechnology risk management, information dissemination and monitoring
• Claims made on labels of products containing nanomaterials are controlled

As with any legislation the devil will be in the detail, and that will determine whether the result is to shift all production of basic nanomaterials out of the EU or simply create a lot of meaningless labels that consumers won’t understand. Unfortunately, that plays into the hands of pressure groups who managed to influence public opinion against all forms of GMOs based on some rather dodgy science, and leaves companies using nanomaterials between a rock and hard place. Do they add a (nano) suffix to ingredients and risk a consumer backlash, or do they simply fudge the definition – many commonly used materials contain quite a range of particle sizes, and so adjusting to the mean size to 100.001nm could easily sidestep any EU legislation.

But the bottom line is that anyone involved in nanomaterials would like the politicians to make their minds up about regulation. Many companies are unwilling to spend large sums on developing technologies and products they may be outlawed or perceived differently by consumers as a result of pending legislation. The sooner that rules are in place the easier it will be to justify developing nanomaterial based products.

The European Union is to make the labelling of nanomaterials in cosmetics mandatory according to Chemistry World.

The cosmetic regulation states that all ingredients present in the product in the form of nanomaterials should be clearly indicated in the list of ingredients, by inserting the word ‘nano’ in brackets after the ingredient listing. The ruling defines nanomaterial as ‘an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm’.

As always, the devil is in the details and the detail in question is the definition. While one of the advantages of nanotechnology is that it allows you to control very tightly the size range of the particles that you are creating, top down technologies such as milling and grinding tend to produce particles with a wide range of different sizes, and while the mean size may be above 100nm, that does not mean that there will not be any sub 100 nm particles present. I suppose the definition of ‘intentionally manufactured’ is also open to question.

I have seen a number of ads recently for ‘chemical free’ cosmetics – which once again depends on whether you class tea tree oil and water as chemicals or not, and nanoparticle free cosmetics are a similar oxymoron. Depending on the production method used, the mean particle size could have to be as large as gravel in order to be even 99% nanoparticle free.

Germany has adopted the EU proposals with the caveat that

the general mention on labels of nano-scale materials in cosmetic products using the term “nano” might be misunderstood by consumers as a warning.’

While labelling may assuage some of the regulatory concerns, will the average consumer would be any more concerned with labelling the nanoparticle containing ingredients than they are with currently permissible constituents. Grabbing a bottle at random from my wife’s dresser I find a long list of ingredients such as Methyl Glucech-20, PEG-12 Dimethicone, and Polyquaternium-4, and I can’t really see that putting Hydroxyethyl cellulose dimethyl diallylammonium chloride copolymer (nano), or (C₈H₁₆N)_x^.xCl^.(C₂H₆O₂)_x (nano) would make much difference compared with the power of the cosmetic company’s marketing machine.

And that’s before I get into another debate with a polymer chemist about whether or not polymers are nanotech!

Following on from the recent spat of name calling, there do seem to be opposing camps in the nanotech world, let’s call them the super optimists and the super pessimists.

The super optimists, and here I include the folks at Foresight, Institute of Molecular Manufacturing etc, tend to be people who spend a lot of time sitting in front of a computer but have little understanding of the wider world. Hence for them the path from reading Engines of Creation to terraforming Mars and curing all known disease is straight and clutter free.

The super pessimists on the other side tend to think dark gloomy thoughts about all kinds on things – I’m thinking of a number of NGO’s here – and use scare tactics to add two and two together to make 27.581 in the sense of taking pieces of real science and although failing to understand what the science actually means, conclusions are still drawn and regulation demanded.

Both groups tend to be somewhat idealistic and take a very black and white view of a world that is quite gloriously and defiantly Technicolour, as the rest us know only too well.  I’m reminded of Peter Bruegel the Youngers 1559 painting “The Battle of Carnival and Lent” and its imagery still speak to us after almost four hundred and fifty years.

As a footnote about regulation, one of the rather simplistic views of nanotechnology is that if it can be regulated than that somehow makes the problem go away. Nothing could be more wrong – hazards are intrinsic and risks can be minimised but any regulation needs a system of policing to allow it to have any effect. The failure of various financial watchdogs on both sides of the Atlantic to spot the danger of highly leveraged investors or the actions of Bernie Madoff and Alan Stanford, through the recent tainted baby milk scandal in China to the failure of almost every ‘war on drugs’ shows how easy it is to set up a regulatory system, but how hard it is to have any effect on the real world.