Nanotechnology policy making – mandatory tools

Posted: Apr 3rd, 2013  By Michael Berger. Copyright © Nanowerk

(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”).

A new, two-part survey in Global Policy (“The Challenges of Nanotechnology Policy Making PART 1. Discussing  Mandatory Frameworks” and “The Challenges of Nanotechnology Policy Making PART  2. Discussing Voluntary Frameworks and Options”), compiled by Claire  Auplat, a professor at the Novancia Business School, Paris, France, outlines  the different frameworks policy makers have developed. The first part of the  survey, which we are covering today in this Nanowerk Spotlight,  introduces nanotechnology policy making and the reasons for its complexity, and  offers a panorama of the set of mandatory tools that are currently  available to regulate nanotechnologies.

The second part, which will appear in  our Spotlight tomorrow, provides an outlook of the set of voluntary tools  that coexist with the mandatory ones. First, let’s look at the typology involved: Mandatory or voluntary regulationAs 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 regulationRegulation 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 regulationRegulation 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 1907/2006REACH 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. Novel food regulation, regulation EC 258 /  97-1997This 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 sayes: “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.”

By Michael Berger. Copyright © Nanowerk

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