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Nanotechnology offers huge potential and opportunities for the UK and international economies. However there are still reservations from some parties over the possibility of potential environmental, health or safety risks.
November 21st, 2011
Like all other products, nanomaterial based products need to have their risks considered on a cradle to grave basis i.e. throughout their whole life cycle. Indeed, free nanomaterials may only be in contact with man and the environment at the very beginning of this life cycle as most nanomaterials are included in a formulation or composite, with many other components in the final product, and so may have no direct exposure of concern. Their properties are exploited within the formulation or composite. There clearly is also the potential for further exposure to nanomaterials during product wear and ultimately disposal and in these cases, as at the beginning of the product's life cycle, information on exposure levels is critical to understanding the potential risk as well as defining the means of protecting man and the environment from undue exposure. It is primarily the novel properties of engineered nanoparticles which have, in recent years, caused some concern. Although fixed inside a component, a nanoscale material will need to have been researched, manufactured, used and disposed of at the end of its life, with the potential to be airborne. The questions of exposure in a variety of settings have been raised previously and are now starting to be researched, with results and questions becoming more pertinent as increasing numbers of products come onto the market.
An understanding of the hazards associated with each nanomaterial can be established via many different toxicology studies and, together with information on exposure, the potential risk can be determined, assuming the mode of potential exposure is also established.
Generating the body of data to conduct an effective risk assessment can take considerable time and can be very costly, but if these issues are not correctly addressed, there is the potential of a significant delay to commercialisation or, at worst, a loss of consumer confidence, constraining market growth and limiting potential solutions to societal problems. It also would undermine the significant investment from governments and industry across the globe.
Responsibility is therefore important in providing the confidence that nanomaterial based products are safe to use. International organisations are currently funding research in support of this. A recent global initiative led by the Organisation for Economic Co-operation and Development (OECD), through its working party on manufactured nanoscale materials, set up a significant programme with an estimated £45m investment from member states, to plug the gaps in information required to assess any health risks of manufacture, use and disposal of 14 of the most commercialised engineered nanoparticles and materials containing them.
So what can companies do?
Companies need to consider the social and perceptual uncertainties surrounding nanotechnologies as carefully as they consider the technical uncertainties. Businesses need to be active in shaping the debates on regulatory systems, standards and definitions.
The public perception of risk is dynamic, and while currently people are broadly well disposed towards nanotechnologies, this cannot be counted on indefinitely. These perceptual risks depend on the ability of companies and governments to minimise unintended consequences, develop beneficial technologies and adequately govern the exploitation of the technologies.
There has been concern in the past that existing systems of regulation and risk assessment could not cope with nano-risk and confusion relating to what role business should play in their development. In order to secure public support, it was clear that businesses should be fully involved in the processes of agreeing common definitions, standards and regulatory approaches.
Responsible Nanotechnology Code
The Nanotechnology Knowledge Transfer Network (NanoKTN) takes its role within the community as a facilitator and disseminator of information very seriously. To support its work, it works closely in partnership with industry to determine the requirements for new standards and how this can be turned into commercial advantage for the UK.
It participated with the Royal Society, Insight Investment, Nanotechnology Industries Association (NIA), multinational companies, an SME, NGOs, academia and a representative of the Unions, to develop the Responsible NanoCode
This voluntary code of conduct provides a set of Principles describing best practice for companies and other organisations involved in nanotechnologies. It also serves to provide guidance on what organisations can do to demonstrate responsible governance. The code can play an important role in helping organisations to develop nanotechnologies responsibly.
Health, safety and regulation
The NanoKTN, in its role as a national knowledge broker, published in 2009 a UK Nanotechnology HSE Directory which included over 30 institutes, Government departments, networks and commercial service providers who were recognised in some way in contributing to the HSE debate.
The objective of the Directory was to provide both researchers and industry access to the most appropriate sources of advice in the fields of toxicity testing through to regulatory affairs and standards.
This HSE Directory proved very popular with NanoKTN members, with well over 300 downloads in the year following its launch. To ensure up to date information is available to all NanoKTN members, a new version was produced in April 2011. This updated UK Nanotechnology Health, Safety and Environment Directory 2011 has 46 entries, comprising academic and industrial centres of excellence from across the UK, from Aberdeen to Plymouth and all points in between.
This new Directory is a major source of information on these centres with contact details for experts within the centres and can be found on the NanoKTN website.
In October 2011, the European Commission published its recommendation for defining a nanomaterial. Below is the recommended definition:-
"A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials."
[Source: Commission's webpage: http://ec.europa.eu/environment/chemicals/nanotech/index.htm ]
While this definition is currently only a recommendation, it will be reviewed in 2014 and actions determined, and may even have been incorporated in specific legislation by then.
In the EC, REACH is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a "substance" in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH, such as registration of substances manufactured at 1 tonne or more and providing information in the supply chain, apply as for any other substance.
The European Chemicals Agency's (ECHA) REACH Technical Guidance Documents currently give no specific guidance concerning nanomaterials. Work in the scientific community as well as in international organisations has been ongoing for almost a decade on methodologies for assessing risks associated with nanomaterials. On this basis the Commission launched a comprehensive REACH Implementation Project on Nanomaterials (RIPoN) in 2009 to provide advice on key aspects of the implementation of REACH with regard to nanomaterials concerning Information Requirements and Chemical Safety Assessment.
Final reports have been published from two REACH Implementation Projects on Nanomaterials (RIP-oN 2&3). The Objectives of the RIP-oN 2 project were to develop specific advice on firstly how REACH information requirements on intrinsic properties of nanomaterials can be fulfilled, including the appropriateness of the relevant test methods (and dosimetry) for nanomaterials and outline, where relevant, possible specific testing strategies and secondly the information that is needed for safety evaluation and risk management of nanomaterials and, in particular, if information is needed beyond or in addition to the current information requirements listed in REACH Annexes VI-X.
The Objectives of the RIP-oN 3 project were to firstly develop advice on how to do exposure assessment of nanomaterials within the REACH context to cover development scenarios, evaluation of operational conditions and risk management/mitigation measures and exposure estimation, and secondly to develop ideas for how to conduct hazard and risk characterisation for nanomaterials.
A third report of the RIPoN project relates to Substance Identity. The final report is available but as it was not possible to reach consensus amongst the experts on the recommendations, further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to the European Chemicals Agency.
In early 2011, the Technology Strategy Board in the UK funded feasibility projects to stimulate business led innovation with technologies that could address the potential environmental, health and safety aspects of the development of nanoscale technologies. Reports have been published and presentations given on the completed feasibility projects at a major national event in London. There is the potential for these feasibility projects to be funded further as part of major programmes either nationally or at a European level to continue the work. In addition, projects funded by the Technology Strategy Board have requirements for the recipients of their awards to consider EH&S issues as part of their project. Societal impacts generally also have to be considered as part of Research Council UK funding.
National Nanotechnology Initiative (NNI)
In the US, the National Nanotechnology Initiative which was begun during President Clinton's time at the White House, has continued to fund and direct research in nanotechnology including the responsible development and use of nanotechnology. Last month, the US Federal Government issued its 2011 National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy, a comprehensive, integrated approach to produce the research data that will ensure nanotechnology is developed safely. A copy of this strategy can be found here.
Nanomaterials have been with us in many guises for very many years as natural, anthropogenic and engineered materials, but it is very important that there is public confidence in the ongoing development of nanomaterial based products and technologies. Businesses, governments and NGOs must all recognise that evidence based risk assessments will provide confidence in the general public that industry is operating according to best practice, and that the regulatory framework is consistent with the needs for the commercialisation of all the future products that will depend on a nanomaterial as a key component.
For this to be most effective, consistency is key across national and regional boundaries so that industry can manufacture and market nanomaterial based products internationally without fear of local restrictions. Responsible nanotechnology is the basis for ensuring that such consistency prevails.
Further information about the NanoKTN can be found at www.nanoktn.com