Current status of Nanotechnology Law
Monday, March 6, 2006
Movanet
Market share for nanomaterials and nanoscale technologies are expected to reach US$ 1 trillion within 5 years. As international trade in this particular field increases, demands over its regulation have also increased, along with the development of researches in this field.
There is currently no single Nanotechnology Law legislation in the world. From the legal point of view, Nanotechnology is really at the stage of its infancy. Authorities and governments have attempted to regulate nanomaterials and nanoscale technologies by applying an "extensive interpretation", that is to say to regulate a new thing using the current laws. The current discussion of Nanotech Laws hovers around the issue of Environmental, Health and Intellectual Property (copyright, patent, industrial design, IC topographies, trade secret).
US EPA has attempted to regulate Nanotech products as new chemicals under which has a significant new use. The FDA meanwhile, for the time being dismisses the possibility of regulating it as a specific Law. The EU will likely to regulate nanomaterials under its new Registration, Evaluation, Authorization, & Restriction of Chemicals directive. It will force manufacturers to register 30,000 chemicals and inform authorities on how it will be used by companies.
Disagreement on how nanotech products should be regulated has arises mainly in the field of environmental and health laws. Most of the researches in IP Law find it sufficient for Nanotech to be regulated through existing regulations. This is understandable as IP reform is currently underway in many countries with or without nanotech.
Meanwhile, experts still have no consensus on what effects will nanomaterials bring to the environment and health. Some researchers found that carbon nanotubes squirted into the trachea of mice caused serious inflammation of the lungs and granulomas while some others not only found granulomas in the lungs, but also damage to mitochondrial DNA in the heart and the aortic artery, and substantial oxidative damage, both foreshadowing atherosclerosis. Other research showed that within a minute of contacting the mice’s tiniest airways, carbon nanotubes began to burrow through gaps between the surface lining cells and into the blood capillaries, where the negatively charged nanoparticles latched onto the normally positively charged red blood cells surface, thereby potentially causing the red blood cells to clump and the blood to clot. In the other hand, there is also a research conducted by Centre for Drug Delivery Research at the University of London's School of Pharmacy showed that Functionalized carbon nanotubes are rapidly cleared from blood and excreted in urine.
The unique behavior of nanoparticles that deviates from matter at the macroscale (if at macroscale they are isolators, they can be conductors at nanoscale) triggers the possibility of adverse effects on environment and health. These conditions sparked demand for an entirely new Nanotechnology Law.
For years to come, one can expect to have a new set of Nanotech Laws especially in the field of Health and Environment, with the European Union posibly taking a more restrictive approach (See: WTO on GMO). However, it might be important to take note that any of these new laws will become obsolete once Molecular Nanotechnology (MNT) is discovered. Consequently, it may be necessery to develop a regulatory timeline.
Mohamad Mova Al 'Afghani
There is currently no single Nanotechnology Law legislation in the world. From the legal point of view, Nanotechnology is really at the stage of its infancy. Authorities and governments have attempted to regulate nanomaterials and nanoscale technologies by applying an "extensive interpretation", that is to say to regulate a new thing using the current laws. The current discussion of Nanotech Laws hovers around the issue of Environmental, Health and Intellectual Property (copyright, patent, industrial design, IC topographies, trade secret).
US EPA has attempted to regulate Nanotech products as new chemicals under which has a significant new use. The FDA meanwhile, for the time being dismisses the possibility of regulating it as a specific Law. The EU will likely to regulate nanomaterials under its new Registration, Evaluation, Authorization, & Restriction of Chemicals directive. It will force manufacturers to register 30,000 chemicals and inform authorities on how it will be used by companies.
Disagreement on how nanotech products should be regulated has arises mainly in the field of environmental and health laws. Most of the researches in IP Law find it sufficient for Nanotech to be regulated through existing regulations. This is understandable as IP reform is currently underway in many countries with or without nanotech.
Meanwhile, experts still have no consensus on what effects will nanomaterials bring to the environment and health. Some researchers found that carbon nanotubes squirted into the trachea of mice caused serious inflammation of the lungs and granulomas while some others not only found granulomas in the lungs, but also damage to mitochondrial DNA in the heart and the aortic artery, and substantial oxidative damage, both foreshadowing atherosclerosis. Other research showed that within a minute of contacting the mice’s tiniest airways, carbon nanotubes began to burrow through gaps between the surface lining cells and into the blood capillaries, where the negatively charged nanoparticles latched onto the normally positively charged red blood cells surface, thereby potentially causing the red blood cells to clump and the blood to clot. In the other hand, there is also a research conducted by Centre for Drug Delivery Research at the University of London's School of Pharmacy showed that Functionalized carbon nanotubes are rapidly cleared from blood and excreted in urine.
The unique behavior of nanoparticles that deviates from matter at the macroscale (if at macroscale they are isolators, they can be conductors at nanoscale) triggers the possibility of adverse effects on environment and health. These conditions sparked demand for an entirely new Nanotechnology Law.
For years to come, one can expect to have a new set of Nanotech Laws especially in the field of Health and Environment, with the European Union posibly taking a more restrictive approach (See: WTO on GMO). However, it might be important to take note that any of these new laws will become obsolete once Molecular Nanotechnology (MNT) is discovered. Consequently, it may be necessery to develop a regulatory timeline.
Mohamad Mova Al 'Afghani
Technorati Tags : Nanotechnology+Law, GMO, WTO, EU, International+Trade