Because of the ongoing controversy on the implications of nanotechnology, there is significant debate concerning whether nanotechnology or nanotechnology-based products merit special government regulation. This mainly relates to when to assess new substances prior to their release into the market, community and environment.
Nanotechnology refers to an increasing number of commercially available products – from socks and trousers to tennis racquets and cleaning cloths. Such nanotechnologies and their accompanying industries have triggered calls for increased community participation and effective regulatory arrangements. However, these calls have presently not led to such comprehensive regulation to oversee research and the commercial application of nanotechnologies, or any comprehensive labeling for products that contain nanoparticles or are derived from nano-processes.
Regulatory bodies such as the United States Environmental Protection Agency and the Food and Drug Administration in the U.S. or the Health and Consumer Protection Directorate of the European Commission have started dealing with the potential risks posed by nanoparticles. So far, neither engineered nanoparticles nor the products and materials that contain them are subject to any special regulation regarding production, handling or labelling.
Managing risks: human and environmental health and safety
Studies of the health impact of airborne particles generally shown that for toxic materials, smaller particles are more toxic. This is due in part to the fact that, given the same mass per volume, the dose in terms of particle numbers increases as particle size decreases.
Based upon available data, it has been argued that current risk assessment methodologies are not suited to the hazards associated with nanoparticles; in particular, existing toxicological and eco-toxicological methods are not up to the task; exposure evaluation (dose) needs to be expressed as quantity of nanoparticles and/or surface area rather than simply mass; equipment for routine detecting and measuring nanoparticles in air, water, or soil is inadequate; and very little is known about the physiological responses to nanoparticles.
Regulatory bodies in the U.S. as well as in the EU have concluded that nanoparticles form the potential for an entirely new risk and that it is necessary to carry out an extensive analysis of the risk. The challenge for regulators is whether a matrix can be developed which would identify nanoparticles and more complex nanoformulations which are likely to have special toxicological properties or whether it is more reasonable for each particle or formulation to be tested separately.
The International Council on Nanotechnology maintains a database and Virtual Journal of scientific papers on environmental, health and safety research on nanoparticles.Virtual Journal of Nanotechnology Environment, Health and Safety The database currently has over 2000 entries indexed by particle type, exposure pathway and other criteria. The Project on Emerging Nanotechnologies (PEN) currently lists 807 products that manufacturers have voluntarily identified that use nanotechnology. No labeling is required by the FDA so that number could be significantly higher. "The use of nanotechnology in consumer products and industrial applications is growing rapidly, with the products listed in the PEN inventory showing just the tip of the iceberg" according to PEN Project Director David Rejesk.
The Material Safety Data Sheet that must be issued for certain materials often does not differentiate between bulk and nanoscale size of the material in question and even when it does these MSDS are advisory only.
Democratic governance Many, such as the Nanotechnology Engagement group, argue that government has a responsibility to provide opportunities for the public to be involved in the development of new forms of science and technology. Community engagement can be achieved through various means or mechanisms such as referendums, consultation documents, and advisory committees that include community members and other stakeholders as possible governance structures for nanotechnologies. Other conventional approaches include public meetings and "closed" dialog with stakeholders. More contemporary engagement processes that have been employed to include community members in decisions about nanotechnology include citizens' juries and consensus conferences. Leach and Scoones argue that since that "most debates about science and technology options involve uncertainty, and often ignorance, public debate about regulatory regimes is essential."
It has been argued by researchers such as Diana M. Bowman, Graeme A. Hodge and Thomas A Faunce that limited nanotechnology labeling and regulation may exacerbate potential human and environmental health and safety issues associated with nanotechnology, and that the development of comprehensive regulation of nanotechnology will be vital to ensure that the potential risks associated with the research and commercial application of nanotechnology do not overshadow its potential benefits. Regulation may also be required to meet community expectations about responsible development of nanotechnology, as well as ensuring that public interests are included in shaping the development of nanotechnology.
Community education, engagement and consultation tend to occur "downstream": once there is at least a moderate level of awareness, and often during the process of disseminating and adapting technologies. "Upstream" engagement, by contrast, occurs much earlier in the innovation cycle and involves: "dialogue and debate about future technology options and pathways, bringing the often expert-led approaches to horizon scanning, technology foresight and scenario planning to involve a wider range of perspectives and inputs." Daniel Sarewitz Director of Arizona State University's Consortium on Science, Policy and Outcomes, argues that "by the time new devices reach the stage of commercialization and regulation, it is usually too late to alter them to correct problems." However, Xenos, et al. argue that upstream engagement can be utilized in this area through anticipated discussion with peers. Upstream engagement in this sense is meant to "create the best possible conditions for sound policy making and public judgments based on careful assessment of objective information". Discussion may act as a catalyst for upstream engagement by prompting accountability for individuals to seek and process additional information ("anticipatory elaboration"). However, though anticipated discussion did lead to participants seeking further information, Xenos et al. found that factual information was not primarily sought out; instead, individuals sought out opinion pieces and editorials.
The stance that the research, development and use of nanotechnology should be subject to control by the public sector, or that favors participatory politics to guide state intervention in the effort to manage the transition to a society revolutionized by molecular nanotechnology, is sometimes referred to as nanosocialism. The term was coined by USC professor David M. Berube, who argued that nanotechnological projections need to be tempered by technorealism about the implications of nanotechnology in a technocapitalist society, but that its applications also offer enormous opportunities for economic abundance and social progress.
Newness The question of whether nanotechnology represents something 'new' must be answered to decide how best nanotechnology should be regulated. The Royal Society recommended that the UK government assess chemicals in the form of nanoparticles or nanotubes as new substances. Subsequent to this, in 2007 a coalition of over forty groups called for nanomaterials to be classified as new substances, and regulated as such.
Despite these recommendations, chemicals comprising nanoparticles that have previously been subject to assessment and regulation may be exempt from regulation, regardless of the potential for different risks and impacts. In contrast, nanomaterials are often recognized as 'new' from the perspective of intellectual property rights (IPRs), and as such are commercially protected via patenting laws.
There is significant debate about who is responsible for the regulation of nanotechnology. While some non-nanotechnology specific regulatory agencies currently cover some products and processes (to varying degrees) – by "bolting on" nanotechnology to existing regulations – there are clear gaps in these regimes. This enables some nanotechnology applications to figuratively "slip through the cracks" without being covered by any regulations. An example of this has occurred in the US, and involves nanoparticles of titanium dioxide (TiO2) for use in sunscreen where they create a clearer cosmetic appearance. In this case, the US Food and Drug Administration (FDA) reviewed the immediate health effects of exposure to nanoparticles of TiO2 for consumers. However, they did not review its impacts for aquatic ecosystems when the sunscreen rubs off, nor did the EPA, or any other agency.
Similarly the Australian equivalent of the FDA, the Therapeutic Goods Administration (TGA) approved the use of nanoparticles in sunscreens (without the requirement for package labelling) after a thorough review of the literature, on the basis that although nanoparticles of TiO2 and zinc oxide (ZnO) in sunscreens do produce free radicals and oxidative DNA damage in vitro, such particles were unlikely to pass the dead outer cells of the stratum corneum of human skin; a finding which some academics have argued seemed not to apply the precautionary principle in relation to prolonged use on children with cut skin, the elderly with thin skin, people with diseased skin or use over flexural creases. Doubts over the TGA's decision were raised with publication of a paper showing that the uncoated anatase form of TiO2 used in some Australian sunscreens caused a photocatalytic reaction that degraded the surface of newly installed prepainted steel roofs in places where they came in contact with the sunscreen coated hands of workmen.Barker PJ and Branch A. The interaction of modern sunscreen formulations with surface coatings. Progress in Organic Coatings 2008; 62: 313-320 Such gaps in regulation are likely to continue alongside the development and commercialization of increasingly complex second and third generation nanotechnologies.
Nanomedicines are just beginning to enter drug regulatory processes, but within a few decades could comprise a dominant group within the class of innovative pharmaceuticals, the current thinking of government safety and cost-effectiveness regulators appearing to be that these products give rise to few if any nano-specific issues.Vines T and Faunce TA Assessing the safety and cost-effectiveness of early nanodrugs Journal of Law and Medicine 2007; 16: 822-845 Some academics (such as Thomas Alured Faunce) have challenged that proposition and suggest that nanomedicines may create unique or heightened policy challenges for government systems of cost-effectiveness as well as safety regulation.Faunce TA Policy challenges of nanomedicine for Australia's PBS. Australian Health Review 2009; 33 (2): 258-267 There are also significant public good aspects to the regulation of nanotechnology, particularly with regard to ensuring that industry involvement in standard-setting does not become a means of reducing competition and that nanotechnology policy and regulation encourages new models of safe drug discovery and development more systematically targeted at the global burden of disease.Faunce TA, White JW, Matthaei KI. Integrated Research into the Nanoparticle-protein Corona: A New Focus for Safe, Sustainable and Equitable Development of Nanomedicines Nanomedicine 2008;(6): 859-66