Behind the buzz and beyond the hype:
Our Nanowerk-exclusive feature articles
Posted: Apr 03, 2013
Nanotechnology policy making - mandatory tools
(Nanowerk Spotlight) Governments are charged with determining whether chemical substances, and products that include those substances, can be used without adversely affecting humans and other living beings. Science helps inform policy decisions by providing information on the benefits and drawbacks of a technology or a product of that technology. So much for the theory. Currently, there are significant limitations in the environmental, health and safety (EHS) data available for nanomaterials. Furthermore, although a wide variety of test methods and guidance for regulatory testing of bulk chemicals is available, a number of them will need significant modification before being applicable to nanomaterials.
Complicating things, science is quite divided on how to assess nanotechnology materials and applications. Consequently, as the public discussion about the regulation of nanotechnology in general, and nanomaterials in particular, heats up, emerging opinions on the applicability of existing regulation differ substantially (read more: "Regulating nanotechnology – how adequate is current regulation?") and so do views on which regulatory options best address the current lack of information about environment, health and safety risks of nanomaterials, as well as the regulatory uncertainty and concerns expressed by the politicians, members of the public and industry, and investors (read more in our previous Nanowerk Spotlight: "Science policy considerations for responsible nanotechnology decisions").
As we will see, In nanotechnology, there are many initiatives of voluntary regulation. These constitute new layers of regulation that stakeholders decide to add to the mandatory ones which they must comply with.
Geographic level of regulation
Regulation happens at different levels, from the local one to the international one. The terms ‘international’, ‘regional’, ‘national’ and ‘local’ usually refer to the bodies which pass the said regulations, not to the areas covered by them. The geographic scope of some regulations goes beyond that of the body that passed them. To continue with the example of the EU regulation, when a specific law targets the products or substances manufactured or imported in the EU, its scope may in effect be much larger since it may impact producers globally.
The targets of regulation
Regulation has two broad targets, either the products or substances themselves, or those exposed to them, like people or the environment. The distinction is not always clear-cut, but in the case of nanotechnology regulation there is a trend to move from the former to the latter.
The following is a list of existing tools of mandatory nanotechnology governance:
REACH, the Registration, Evaluation, Authorization and Restriction of Chemical Substances - EC 1907/2006
REACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The law entered into force on 1 June 2007.
REACH is a general framework and it does not apply specifically to nano substances. Critics of the law say that because most nano substances are so small, they are produced in quantities that are below one tonne per year, which means that they go unregulated.
REACH can in fact apply to substances produced or imported in volumes below 1 tonne per year if they are considered to be of very high concern. This means in effect that risks from certain nano scale substances could be addressed through REACH if they were identified as being ‘substances of very high concern’ as defined in Article 57, for example as being persistent, bio accumulative and toxic (PBT) substances.
This European regulation laid out rules for the authorisation of 'novel' foods. According to a European Parliament press release of March 2011 the use of nanotechnology in food production, for example as an antibacterial agent, or to alter flavour or color is growing and the European Parliament called for further checks to be developed to adequately assess the safety of such foods. They also wanted food containing nano ingredients to be labelled. However, due to a failure to reach agreement on the new rules ‘there will continue to be no special measures regarding nanomaterials in food’ the EP statement said.
Regulation (EC) no 1223 / 2009 of the European Parliament and of the council of 30 November 2009 on cosmetic products
This law – the first international law specifically designed for nanotechnologies – includes a review of the safety of nanomaterials and will take effect in July 2013, with gradual implementation started in December 2010. All cosmetic products will be subject to a safety assessment and to a premarket notification and approval procedure.
This law specifically syayes: "The Regulation prohibits the use of substances recognised as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products."
The regulation also requires traceability of a cosmetic product throughout the whole supply chain, as well as clear labelling including the name and address of the responsible person, and the presence of all ingredients containing nanomaterials, with their names followed by (nano).
Toxic substances control act inventory status of carbon nanotubes
Generally speaking, the US Toxic Substances Control Act (TSCA) regulates all chemical substances. However, since the passing of the TSCA Inventory Status of Carbon Nanotubes in 2008, some nanomaterials have been considered as specific chemical substances and are therefore subject to special regulation.
Federal insecticide, fungicide, and rodenticide act
Under this U.S. federal regulation, all pesticides distributed or sold in the U.S. must be registered by the Environmental Protection Agency (EPA). The EPA ruled in 2006 that the Samsung silver ion generating washing machine, which released nano silver ions into wash water, was subject to registration requirements under FIFRA because it incorporated a substance intended to prevent, destroy or mitigate pests, and was therefore considered a pesticide.
DTSC chemical call in: carbon nanotubes, quantum dots, nanosilver, nano cerium oxide, nano titanium dioxide, and nano zinc oxide
California law authorizes the Department of Toxic Substances Control to request information regarding analytical test methods, fate and transport in the environment, and other relevant information about specified chemicals. The Department has conducted two chemical information call-ins. In 2010, Round One sought information on carbon nanotubes. In 2011, Round Two sought information on quantum dots, nanosilver, nano zero valent iron, nanocerium oxide, nanotitanium dioxide, and nanozinc oxide. Visit Round One and Round Two for the responses from manufacturers and importers of these chemical substances.
The manufactured nano scale health and safety ordinance. Section 15.12.040 Berkeley city council ordinance
This municipal ordinance was passed in December 2006 by the city council of Berkeley, CA, and was the first case in the world of mandatory regulation specifically targeted at nanotechnologies. It amended existing health and safety rules to demand a full toxicological report from all facilities manufacturing nanoparticles.
NIOSH Current Intelligence Bulletin (CIB) 63 on occupational exposure to titanium dioxide
This NIOSH CIB, based on NIOSH's assessment of the current available scientific information about this widely used material, 1) reviews the animal and human data relevant to assessing the carcinogenicity and other adverse health effects of TiO2; 2) provides a quantitative risk assessment using dose-response information from the rat and human lung dosimetry modeling and recommended occupational exposure limits for fine and ultrafine (including engineered nanoscale) TiO2; and 3) describes exposure monitoring techniques, exposure control strategies, and research needs.
NIOSH recommendations are nonbinding, and should therefore be listed under the voluntary initiatives. However, they can be seen as an initial step to mandatory regulation enacted by OSHA, which is why CIB 63 was considered a landmark in nanotechnology regulation.
French code de l’environnement, Livre V, Titre II, Chapitre III, (articles l523-1 to l523-5)
According to this text, manufacturers, importers or distributers of nanoparticulates must inform relevant authorities, and provide information about the substances involved. The information relates to intended use of substance, quantities involved, identity of the professional users, and danger relative to exposure in terms of health or of environmental risks. The data provided can be made available to the public. The code states that national interest may lead to a request to opt out of REACH regulation.
Auplat concludes that there is currently no strong backbone to global nanotechnology policy making. "On the one hand, there are various pieces of regulation which are disconnected and seem to emerge more or less in an ad hoc way. On the other hand, at the international level, the position of large international organizations like the EU is not stable: they have until now not favoured specific regulation of nanotechnologies considering that existing frameworks were sufficient, and they seem to be changing their minds."