Attorneys at Governo Law Firm LLC were recently invited to participate in a conference on Global Regulation of Nanotechnologies for scientists and attorneys. The conference was specifically designed to bring together participants from every continent to discuss comparative legal systems and international approaches to nanotechnology laws, including areas of international cooperation and international standard setting. The conference also addressed guidelines for the safe development of nanotechnology, industrial hygiene practices and testing undertaken by two nanotechnology companies fabricating carbon nanotubes and nano-coatings, as well as ethics in nanotechnology regulation.
Though not well publicized, nanotechnologies are already widely used in products as diverse as sunscreens, anti-bacterials, automotive paints, cell phone batteries and electronics. Nanotechnology builds matter atom by atom into particles so small they are invisible to the eye. As the size of the particles is reduced, it increases the surface area and reactivity of the material, making it more potent. At the nanoscale, essential material properties can change. For example, there may be fewer atoms or actual changes in the shape of a molecule. In other cases, the color of the substance can change. For example, in the nanoscale, gold appears red because the diameter of gold nanoparticles determines the wavelengths of light absorbed.
Despite the potentially powerful and novel differences in material property, nanotechnology is unregulated in many respects because the volume of the material falls beneath legislative and regulatory thresholds. One important theme which emerged at the conference was the need to address volume and risk thresholds in chemical, occupational health and pollution control regulations to capture the smaller size and increased reactivity of nanosized particles. Another theme was the public’s right to know whether nanotechnology designed substances are contained in their products. Labeling laws offer one legal remedy for addressing this issue. In fact, the European Union has already passed laws making it mandatory for all products containing nanoparticles to identify those contents on the label.
While some environmental advocates argued for a ban on all nanotechnology marketing until the technology could be proven safe, marketing of these products has proceeded without adoption of the precautionary principle. However, developers generally agree that scientists must study the potential risks of the technology as they move ahead to develop new products. The implications of early studies showing that carbon nanotubes may be dangerous when inhaled have resulted in the implementation of special industrial hygiene practices by manufacturers. These developers and manufacturers argue that they have the necessary expertise and can self-regulate. Although the desire to avoid potential future liabilities is a potent motivator for well financed companies, self-regulation is less likely to be an effective solution for more entrepreneurial "garage" inventors without an investment in the long term. However, at this point, the need for nanotechnology regulation is not universally accepted. There is no discernible environmental damage or record of injury at this stage, only the anticipation of potential harm. Advocates of regulation point to scientific studies indicating carbon nanotubes are bio-persistent and can cause harm to people and animals. Some scientific studies have noted that behavior of carbon nanotubes at the cellular level mimics that of asbestos fibers.
Another issue discussed was classification of nanotechnology applications for regulatory purposes. One system of classification which is gaining acceptance is a three category division of: 1) free nanoparticles, 2) limited release nanoparticles, and 3) encased nanoparticles. An example of a free nanoparticle would be titanium dioxide in sunscreen which can be released into the body, the environment, and into water sources. An example of a limited release nanoparticle would be a medical use such as chemotherapy where the exposure group is limited – though the substances still may reach the environment and water supply if control measures for medical and bodily waste are not exercised. An example of an encased nanoparticle is the use of carbon nanotubes in electronics, such as cell phone batteries. It is thought that encased nanoparticles in the third category are safe as long as systems for disassembly and recycling are implemented.
Governo Law Firm is carefully monitoring developments in nanotechnology and its implications for public health and regulation. If you have an interest in nanotechnology law, please do not hesitate to contact David Governo (