reportRegulation & Standards
1 Executive Abstract
The umbrella terms of nanoscience and nanotechnology are still not precisely defined, however, one thing which is clear, and which all definitions share, is the ambition to understand and control the fundamental structure and behaviour of matter at the atomic and molecular level. The realm of nanotechnology is generally agreed to lie within the range of 1 and 100 nanometres. A further restriction of the definition of nanoscience and nanotechnology is that new functionalities are made available by manipulation of matter at this scale or through specificities of the nano dimensions, where the physical, chemical and biological properties of materials differ from those of the bulk matter. Nanotechnology promises advances in controlling and manipulating matter and with this promise a vision of novel ways of creating and developing a new generation of products with original features, performances and functionalities.
In the main, nanoscience and nanotechnology will form part of microsystems and macro devices or materials and thus is termed an enabler of innovations. This enabling character promises to augment innovations in a wide variety of industrial sectors, but creates difficulties in the development of regulations because it is generally part of a system of elements in a profuce. Thus nanoregulation is an entanglement of nano-specific and sector specific regulation and standards.
Over the past 10 years, anticipation has been rife around the potential benefits nanotechnolgies may bring, leading to large resources being poured into the emerging area. Equally anticipation on potential risks of nanotechnologies have become increasingly high on the agenda. With expected risks becoming ever more specific (observe the shift from broad societal changes to concerns about toxicity, privacy, transparency etc.) and the nano-enabled products on the market increasing at a rapid pace, the need to embrace the complexities of regulation nanotechnologies as they emerge has become apparent.
With little alignment in regulatory stances from the many potential stakeholders, there is a general feeling that a regulatory framework needs to be in place both to enable and constrain developments in nanotechnology to create societal beneficial technologies. This report gives a brief overview of the present situation on nanotechnology regulation. As part of the ObservatoryNANO project, it is an evolving document, taking into consideration the changes in the regulation landscape (and governance more broadly).
Currently the report identifies several factors[1], briefly indicated below, which are making the implementation of effective regulatory schemes complex:
- The wide variety of materials and applications under the umbrella term of nanotechnology
- The limited knowledge of toxicity nanomaterials on living systems and their transport in living and environmental systems The proprietary nature of information on novel nanomaterials making access to relevant information a difficult issue
- The lack of harmonised standards or guidance
- The potential inadequacy of statutory authorities
Much of the concern is focused on "free" engineered nanomaterials and their effects on the environment, health and security (EHS) during their entire life cycle Combined with the ethical, legal and social aspects (ELSA) of nanotechnology R&D the question of what could be an integrated nanotechnology governance approach is rapidly becoming the most discussed topic in the nanotechnology area.
In spite of this attention, there is no specific regulation for nanotechnology-related products. In some cases, studies on nanotechnologies in specific sectors show that existing regulatory schemes should be adequate (such as the food sector[2] and for medical technologies[3]) although there is still a request for improved EHS data. In other cases there is less agreement, for example in the area of cosmetics[4]). The European Commission[5] also shows this, highlighting that, with the necessary adaptations for nanotechnologies, existing regulatory schemes can go some way in regulating the emrging field without constraining the growth too much. With this in mind, the focus is more on the improvement of instruments to ensure compliance with existing legislation.
Addressing these issues properly is essential and many countries with active nanotechnology RTD are promoting initiatives which highlight the needs for tailored standards and regulation, and the development of expertise and technical capabilities to cope with the proliferation of nanotechnologies. There have been a number of review of regulatory regimes, identifying actions and priorities, (in the main) advising the increase of funding for research aiming to better characterise nanomaterials and understand their effects on the environment, human health and security.
In Europe, within the European Commission, different Technical Committees and Agencies have published scientific opinions and reviews of regulation with respect to nanotechnology and a number of them have created dedicated working groups to this end. In June 2008 most of these activities have been condensed into the report "Regulatory Aspects of Nanomaterials" [6].
Though on regulatory matters, the European member states tend to follow the inputs from the EC, several countries have activities at the national level. France, Germany, Switzerland, The Netherlands, UK and a number of the Scandinavian countries have been active in this area, with commitment at institutional level to deepen knowledge on EHS and regulatory issues.
Looking beyond Europe, the USA, Canada and Australia have also been active already for several years. EHS and regulatory issues are getting increasing resources within their national strategies for nanotechnology, and regulatory agencies and other interested bodies are becoming more proactive in coping with the complexity of nanoregulation. Canada and Australia in particular are countries explicitly identifying the need to adopt a precautionary approach.
At the moment, related regulatory regimes under investigation refer in to:
- chemicals and materials
- cosmetics
- foods
- occupational health and worker safety
- environmental safety,
- medical devices and pharmaceuticals.
Existing regulatory provisions regarding chemicals and materials have begun to include nanomaterials in their listings and the requirements to monitor/control the introduction of them into the market. Different regulatory agencies in Europe (EC/ECHA), USA (EPA), Canada (Environment Canada) and Australia (NICNAS), have already introduced into these provisions specific notification requirements to this end.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), in particular, which regulates in Europe the production, use and commercialisation of chemicals, is at present, the most compelling legislation for nanomaterials although questions still remain in some quarters concerning its effectiveness, such as threshold levels and exemption of particular materials.. On March 2008, ECHA (European Chemicals Agency) established for this purpose the Competent Authorities Sub Group on Nanomaterials (CASG Nano).
In the US, nanomaterials fall under TSCA (Toxic Substances Control Act) of the EPA which is the US equivalent of REACH and regulates chemicals. However, a large separation exists between the two regulatory schemes. In Europe (REACH) it is up to the producer to demonstrate that a chemical is safe before it enters the market, whilst in the US (EPA-TSCA), it is the responsibility of the regulators to prove that a chemical is harmful before it can be restricted or removed from the market. An agreement for a common approach is fundamental to avoid barriers and mismatches.
The use of nanotechnology in cosmetics and foods is under strong scrutiny reflected by the recent EU parliament move for a revision of the cosmetic regulation, including a specific definition of (insoluble) manufactured nanomaterials and requirements for safety assessment procedures for all products containing these kind of nanomaterials. A similar initiative concerning food regulation is under discussion.
Regarding occupational health and workers safety, most efforts are devoted to evaluating and adapting the existing risk management methods, and to develop appropriate guidance for the handling and disposal of engineered nanoparticles/nanomaterials. Reference documents have been produced by the National Institute for Occupational Safety and Health (NIOSH) in USA, the German Chemical Industry Association (VCI), the Federal Office of Public Health (FOPH) in Switzerland, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) in Canada among others.
The lack of appropriate measurement and monitoring tools, of detailed information on hazards and exposure levels and use of nanomaterials are evident challenges to provide comprehensive indications on these matters.
With respect to medical devices and pharmaceuticals products, the existing provisions are generally considered adequate also for nano-related products, due to the detailed authorisation procedures required, but a case by case approach in the evaluation and authorisation procedures is envisaged to take into account their peculiar properties. One issue is the blurring of regulatory routes for advnced nanotechnologies, such as implantable biomaterials or nanoparticles based drug delivery systems where technologies can be defined as a device, drug and biomaterial. This can be seen outside the relams of nanotechnology, but is predicted to be particularly prevalent in this area.
Alongside the activities regarding existing "hard" regulation, other soft law approaches are being implemented or developed. Such self-regulation instruments are presently used to address the safe use of nanomaterials. In particular: reporting schemes (stewardship programmes) and voluntary measures (code of conduct, risk management systems).
Examples of the first instrument are the initiatives of USA-EPA and UK-DEFRA, or others carried out at EC level (EFSA), in Germany (UBA-VCI) and Australia (NICNAS). Most of the attention is currently focused on regulatory triggers (e.g threshold levels) and classification issues, thus on the ability to regulate and control the introduction and use of nanomaterials and nano-related products into the market. These initiatives are extremely important to build a firmer base of knowledge to support policy and regulatory decisions, and for this reason alos under consideration are mandatory reporting schemes (for example in Canada and France).
Codes of conduct and risk management systems are measures that can have a important role to cope with the current uncertainties about the impact of nanotechnologies during the redefinition of existing hard regulation and to raise trust on their use, through creating a culture of responsibility..
The most relevant example of code of conduct aiming to contribute to this culture of responsibility is the EC "Code of Conduct for responsible nanoscience and nanotechnologies research" (February 2008) which provides principles and indications that should guide the research activity in this field. Its objectives are far reaching and among the principles that must be respected with particular relevance are (a) Sustainability, (b) Precaution and (c) Inclusiveness
The EC is actively promoting the Code and strongly recommends all Member States to adopt it.
In addition, based on the current uncertainty in the regulatory situation, some stakeholders, mainly at industrial level, have developed (or are developing) their own risk management systems, defining best practises and procedure for safety control and handling of nanomaterials in occupational settings. The DuPont/Envrionmental Defence NanoRiskFramework and the CENARIOS risk management and monitoring system, are two examples of this approach.
The availability of appropriate standards to name, describe, specify, measure and characterise nanomaterials is pivotal to implement an appropriate regulation for nanotechnology-related products.
Currently, it is the ISO TC229, in conjunction with IEC TC 113, that dictate the line of the activities on nanotechnology standards at the international level, but also other standard bodies have started to work on nanotechnology since 2004. Various ISO Technical Committees (TC), national standards bodies, such as BSI/NT1 in UK, SAC/TC279 in China, ANSI-NSP in USA, and Standard Developing Organisations such as ASTM and IEEE have all produced standards relevant for nanotechnology. Most of these activity are in liaison with ISO TC229 and IEC TC 113, analogously to the work of CEN, CENELEC and ETSI, that received a specific mandate on the matter from the EC.
ISO TC 229 is organised into 4 working groups that focus on issues that are crucial for the development of an effective regulation for nanotechnology-related products. In particular:
- Terminology and Nomenclature
- Measurements and Characterisation
- Health, Safety, and Environment
- Materials Specification
At present more than 30 standards documents related to the above themes are under development, but due to the lengthy process, it will be some time before the matter is thoroughly addressed. So far ISO TC 229 has produced two documents:
- ISO/TS27687 (Technical Specification): Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplates;
- ISO/TR 12885 (Technical Report): Health and safety practices in occupational settings relevant to nanotechnologies.
A contribution to the standardisation activities, will also be made by the eight Steering Groups of OECD WPMN (Working Party on Manufactured Nanomaterials) who are gathering reference data and information on characterisation and safety of nanomaterials.
In particular, in the OECD sponsorship programme, launched in 2007 (Steering Group 3), several countries are sharing the testing of a representative set of manufactured nanomaterials. More than 30 countries worldwide are currently participating to OECD-WPMN and most of them are also actively engaged in the sponsorship program The Working Party agreed a priority list of 14 nanomaterials for testing [7] (based on materials which are in or close to commerce) as well as a list of 61 endpoints for which they should be tested.
In conclusion, the activity linked to nanoregulation is is increasing in intensity across the globe, nevertheless, given the gaps in the scientific knowledge and the different positions and stances of regulatory agencies around the world, it seems unlikely that new laws specific for nanotechnology will be introduced in the short term.
The demand to clarify the existing uncertainties and, at least in some cases, of specific provisions, is mounting. Recently the EU parliament has approved a resolution asking for tighter rules for the marketing of nanomaterials, invoking the principle "no data, no market".
The serious lack of data regarding risks for human health and the environment means that governments and other governing actors need to be proactive to find appropriate and proportionate actions for enabling and constraining the development of nanotechnologies. Some countries are introducing procedures for the reporting of manufactured/produced/used engineered nanomaterials on a voluntary base, and a number of authorities are considering to make these procedures mandatory.
Nanoregulation requires a dynamic approach: it must adapt to the evolution of the scientific knowledge, to the increase of applications, to the concern and attitude of current and potential stakeholders. Continuous research, cooperation and productive and constructive dialogue are key to support nanotech development and to build justified trust among stakeholders, including civil society.
The productive mixing of hard and self regulation approaches seem an appropriate option in the short-term.
Finally, except for standards, so far there is no a concerted effort aimed to elaborate common rules fro nanoregulation that could be shared at an international level. The various countries active in nanoregulation have initiatives independent from each other, although in Europe the situation is less disparate and the EC is active to foster this aim providing a glue between the activities, both within Europe and outside. The Code of Conduct if largely adopted among the Member States, could be the first step in determining a common ground for research whilst REACH provides a certain degree of coherence for product development, at least on nanomaterials. However, the development of a regulatory framework accepted at global level is necessary to have common rules for safety do as tofacilitate trade and avoid regional divide. Thus the promotion of international cooperation in nanoregulation is fundamental.
[1] These are mirrored in: Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges, US Congressional Research Service (CRS) report, (January 2008) - http://www.fas.org/sgp/crs/misc/RL34332.pdf
[2] EFSA (2009) Scientific Opinion of the Scientific Committee Concerning The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety. The EFSA Journal 958, 1-39
[3] Roszek B., de Jong W.H. and Geertsma R.E. (2005) Nanotechnology in medical applications: state-of-the-art in materials and devices. RIVM report 265001001/2005
[4] For an interesting assessment of strengths and weaknesses of European cosmetic regulation concerning nanotechnologies, see Bowman and van Calster (2008) Flawless or Fallible? A Review of the Applicability of the European Union's Cosmetics Directive in Relation to Nano-CosmeticsStudies in Ethics, Law, and Technology. Volume 2, Issue 3 2008 Article 6
[5] http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf
[6] http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf
[7] Nanomaterials indicated by OECD WPMN are: Silver nanoparticles, Iron nanoparticles, Carbon black, Titanium dioxide Aluminium oxide, Cerium oxide, Zinc oxide, Silicon dioxide, Polystyrene, Dendrimers, Nanoclays [12]
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Tags: nanoregulation, voluntary measures, standards and nanotechnology