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The Regulation of Nanotechnology

Thursday, November 20, 2008

Over the last two decades, advancements in nanotechnology have prompted a wide range of new products and applications, especially in the areas of energy, medicine, and the environment.  Products currently utilizing nanoscale materials include batteries, displays on cell phones and laptops, neutralizing powder for gas and liquid toxins, and jumbotron lamps in athletic stadiums – but this is only a small sample of the broad applications of nanotechnology.  Its rapid development is leading to more innovations in drugs that can access targeted parts of the body, sensors to detect diseases in their early stages, and greater possibilities for nanomanufacturing.  New water-filtration techniques, moreover, may prove effective in helping people around the world gain access to clean water.  Everything from transistors to sunglasses to solar plastics can and have been improved due to these exciting studies. 

As the field of nanotechnology continues to impress the world with its seemingly unlimited applications, scientists and policymakers are working together to ensure its responsible development.  All players involved in the research, development, and application of these new technologies are working to maximize benefits to society while also paying careful attention to potential risks and risk management strategies.  Because nanotechnology is so revolutionary, it requires the development of an equally innovative regulatory framework to oversee its progress.

In an effort to create that regulatory structure, government regulatory bodies are springing up all over the world.  The US, for instance, established the FDA Nanotechnology Task Force in 2006 and also created the National Nanotechnology Initiative to support safe and ethical research.  Similar methods are being implemented by the European Commission across the EU.  Nonetheless, engineered nanoparticles are not currently subject to much special regulation, especially in the areas of production, handling, and labeling, and there are few studies on which to base our knowledge of the potential risks.  With a highly interdependent world, it is, moreover, vital that cooperation across borders – among governments, academia, and industry – exists as well to mitigate future regulatory problems.

Those few studies, however, give reason for concern as they show that the smaller airborne particles, the more toxic and the higher their chemical reactivity become.  Everyone agrees that risk assessment methods currently in place cannot adequately address these potential issues.  Likewise, little information is available on the effects of these particles on human physiology. 

The threat of nanoparticles comes from two arenas: the free nanoparticles that may be airborne and those which form composites with other materials.  The health and environmental impact of free nanoparticles is the area most focused on due to the particles’ great mobility and reactivity.  These particles may be injected, inhaled, absorbed, or swallowed, and yet data on how they behave once inside an organ is still limited.  In addition to getting inside our bodies, nanoparticles can also contaminate our water, air, soil, and plants.  Again, at this time the effects of these pollutants are relatively unknown. 

Despite the great uncertainties, the demonstrated benefits of nanotechnology make the furthering of knowledge in this field worth some risk.  To mitigate any potential harms, a carefully considered system to regulate the advances is necessary.  Because its uses fall under so many categories, nanotechnology must be defined as a “combination product” and product review is somewhat more complex than normal due to its extreme size.  In response to these difficulties, many recommendations have been made regarding the proper regulatory framework. 

Without a doubt, the most essential element is continued research into the effects of nanoscale materials and the effectiveness of products.  Rules guiding required disclosure of information by manufacturers may also assist in the accumulation of this data.  The global scientific community, moreover, plays an important role and cooperation must be encouraged.  Despite the rapidly changing scene, transparent and reliable regulatory pathways should be put in place – narrow enough to be meaningful, but general enough to accommodate for future developments.

While regulation is absolutely essential, policymakers must also be cautious that they do not stifle the development of this now booming industry.  The excitement generated over the ways in which nanotechnology is already employed is only matched by the very real and significant impact that it promises to make in the next year, two years, ten years, and beyond.  In the not-so-distant future, we can expect to see rising prominence of nanoscale innovations in the drugs we use, the energy we generate, the digital technologies we use, and so much more.

By Lauren Barr

posted by Dan Lawner, 1:57 PM

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