Nanotechnology refers to an increasing number of commercially available products – from socks and trousers to tennis racquets and cleaning cloths.
[1] Such nanotechnologies and their accompanying industries have triggered calls for increased community participation and effective regulatory arrangements.
[citation needed] 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.
An online journal article[8] identifies traditional approaches such as referendums, consultation documents, and advisory committees that include community members and other stakeholders.
[13] 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.
"[9] 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.
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".
[15] Discussion may act as a catalyst for upstream engagement by prompting accountability for individuals to seek and process additional information ("anticipatory elaboration").
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.
[17][18] 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.
[20] 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.
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.
[23] 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.
[2] Wide use of the term nanotechnology in recent years has created the impression that regulatory frameworks are suddenly having to contend with entirely new challenges that they are unequipped to deal with.
In the meantime, it has been argued that the immediate applications of nanomaterials raise challenges not much different from those of introducing any other new material, and can be dealt with by minor tweaks to existing regulatory schemes rather than sweeping regulation of entire scientific fields.
[30] A truly precautionary approach to regulation could severely impede development in the field of nanotechnology safety studies are required for each and every nanoscience application.
While the outcome of these studies can form the basis for government and international regulations, a more reasonable approach might be development of a risk matrix that identifies likely culprits.
Noting that there was “no obvious focus for an informed public debate of the type suggested by the Task Force”, the UK government's response was to accept the recommendations.
The Royal Society's 2004 report[16] identified two distinct governance issues: Rather than adopt a new nano-specific regulatory framework, the United States' Food and Drug Administration (FDA) convenes an 'interest group' each quarter with representatives of FDA centers that have responsibility for assessment and regulation of different substances and products.
This symposium provided an opportunity to hear from nanotechnology industry experts and discuss future regulatory considerations in California.
DTSC sent a formal information request letter[45] to forty manufacturers[46] who produce or import the six nanomaterials in California, or who may export them into the State.
In January 2008, a coalition of over 40 civil society groups endorsed a statement of principles[54] calling for precautionary action related to nanotechnology.
In Australia, Friends of the Earth propose the establishment of a Nanotechnology Regulatory Coordination Agency, overseen by a Foresight and Technology Assessment Board.
Regulatory mechanisms could vary from "hard law at one extreme through licensing and codes of practice to 'soft' self-regulation and negotiation in order to influence behavior.
The size-defining characteristic of nanotechnology is the subject of significant debate, and varies to include particles and materials in the scale of at least 100 to 300 nanometers (nm).
The UK Soil Association define nanotechnology to include manufactured nano-particles where the mean particle size is 200 nm or smaller.