kb/data/en.wikipedia.org/wiki/Regulation_of_nanotechnology-2.md

title	chunk	source	category	tags	date_saved	instance
Regulation of nanotechnology	3/6	https://en.wikipedia.org/wiki/Regulation_of_nanotechnology	reference	science, encyclopedia	2026-05-05T04:27:37.701684+00:00	kb-cron

=== 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. 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. 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. 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. Self-regulation attempts may well fail, due to the inherent conflict of interest in asking any organization to police itself. If the public becomes aware of this failure, an external, independent organization is often given the duty of policing them, sometimes with highly punitive measures taken against the organization. The Food and Drug Administration notes that it only regulates on the basis of voluntary claims made by the product manufacturer. If no claims are made by a manufacturer, then the FDA may be unaware of nanotechnology being employed. Yet regulations worldwide still fail to distinguish between materials in their nanoscale and bulk form. This means that nanomaterials remain effectively unregulated; there is no regulatory requirement for nanomaterials to face new health and safety testing or environmental impact assessment prior to their use in commercial products, if these materials have already been approved in bulk form. The health risks of nanomaterials are of particular concern for workers who may face occupational exposure to nanomaterials at higher levels, and on a more routine basis, than the general public.

=== International law === There is no international regulation of nanoproducts or the underlying nanotechnology. Nor are there any internationally agreed definitions or terminology for nanotechnology, no internationally agreed protocols for toxicity testing of nanoparticles, and no standardized protocols for evaluating the environmental impacts of nanoparticles. Moreover, nanomaterials do not fall within the scope of existing international treaties regulating toxic chemicals. Since products that are produced using nanotechnologies will likely enter international trade, it is argued that it will be necessary to harmonize nanotechnology standards across national borders. There is concern that some countries, most notably developing countries, will be excluded from international standards negotiations. The Institute for Food and Agricultural Standards notes that “developing countries should have a say in international nanotechnology standards development, even if they lack capacity to enforce the standards". (p. 14). Concerns about monopolies and concentrated control and ownership of new nanotechnologies were raised in community workshops in Australia in 2004.

== Arguments against regulation ==