Abstracts: Nanotechnologies - The Present State of Regulation
Nanoparticles and occupational health: exposure, hazards, and research coordination
Michael Riediker
Recent technological advances allow the targeted production of objects and material structures in the nanoscale (the size range between 1 and 100 nm). Novel chemical, physical and bioactive characteristics open new possibilities for numerous applications and the “nano”market is growing fast. Little is known about the exposure of workers and consumers to nanomaterials, and the effectiveness of existing health and safety measures for industrial processes and consumer products. This is a challenge for impact assessment studies. Despite recent advances in medical and toxicological research, it is still unclear exactly how nanomaterials interact with biological targets and which parameters of the nanomaterials drive these responses. Solid nano-particles (nano-particulate material confined in three dimensions at the nanoscale) and nano-rods (confined in two dimensions) in particular raise potential safety, health and environmental concerns. There is evidence that some of these materials pass through tissue barriers (including the blood-brain barrier) and cell membranes, and there have been reports of lipid oxidation, granulomatous tissue formation and other adverse responses to interaction with nanoparticles and nanorods. Thus, there are clear knowledge-gaps that need to be addressed as a European priority. This is recognized by NanoImpactNet, which is a FP7 coordination action that aims to create a scientific basis to ensure the safe and responsible development of engineered nanoparticles and nanotechnology-based materials and products, and to support the definition of regulatory measures and implementation of legislation in Europe.
Worker safety, TLV, ultrafine particles
Robert Piringer
The Austrian workers compensation board (AUVA) is the largest public work accident insurance in Austria. AUVA has more than 4,3 Million insurants, predominantly employees, pupils and students, but also independent tradesman.
AUVA holds a budget of more than 1000 million € per year. The main fields of activity are compensation payments (about 450 Mio €), medical treatment and rehabilitation (about 350 Mio €) and administration (about 80 Mio €). The budget for prevention activities runs up to 5 Mio €.
In 2007, AUVA registered 66 866 work accidents with a work loss of more than 3 days, that is more than 8,5% less than 2006. In the same period a number of 1344 industrial diseases were recorded, 4,1% more than 2006. No insurance benefits exist for workplace related diseases like strain injuries of the muscles, the skeleton or the heart, or exposure related illnesses to ultrafine particles. Exposure to chemical agents on workplaces is limited by TLVs (MAK).
The headquarters of the AUVA run among others a testing laboratory e.g. for personal protective equipment, for workplace related measurements and a research department for preventive measures. 4 physicians, 3 psychologists and about 35 technicians with various academic diplomas work in this department.
A few of them are dealing with nanotechnology.
There have been 4 research projects in cooperation with other Austrian institutes concerning ultrafine particles:
- 1) Detection of nanometer sized particles in living cells using modern fluorescence fluctuation methods (published 2005 in BBRC)
- 2) Health effects of occupational exposure to ultrafine particles (to be published soon)
- 3) Toxicological examinations to ultrafine particles – effects on human cell cultures (published as poster in Berlin 2007)
- 4) Nanotechnology: exposure profiles in nano - producing and nano-processing industry and effects on human cells (in progress).
In short terms, following results from the first 3 research projects can be reported:
- 1) Nanoparticles < 0,1 µm can penetrate directly into cells; no active incorporation system is necessary to penetrate the cell walls
- 2) There are no significant changes in lung function and blood parameters in healthy workers after a single high exposure to combustion derived nanoparticles
- 3) Cell viability testing showed a negative effect at high exposure (WST 1 assay)
In cells exposed to workplace atmosphere with nanoparticles an increased oxidative burst was detected (DHR-assay)
Exposure of co-cultures resulted in significant anhanced pro-inflammatory cytokine levels (BDTM CBA assay)
It is still necessary to have investigations on nanoparticles, and may be one day we will have a general TLV (MAK) for nanoparticles in Austria.
Nanotechnologies and Food Production
Frans W.H. Kampers
Micro- and Nanotechnologies are enabling technologies that will offer opportunities for innovations in virtually all areas of human activity, including food, food processing and the food industry. These innovative new technologies will lead to sensors and diagnostic instruments with improved sensitivity and selectivity that will be able to monitor food processes and assure food quality. These new instruments will enable much faster measurements in or near production lines by non-expert personnel. But micro- and nanotechnology will also result in new concepts for food production processes. Examples are microsieves for separation and fractionation which can also improve emulsification processes and can result in new products like low-fat mayonnaise. The use of drug delivery concepts for nutrient delivery will improve the nutritional quality of food products. Nanotechnology can be used to improve packaging materials. Combined with printable electronics and low cost sensors information about the product and its quality will become readily available to consumers.
The GMO issue has shown that consumer perception is crucial for the acceptance of a new technology. Objective information on risks, e.g. of nanoparticles, and good communication to enable individual consumers to evaluate risks and benefits are essential for the confidence in the new technology. A good system to provide information on the specific application of nanotechnology in a consumer product (labeling) is a way to allow consumers a choice in the supermarket. Regulation is an important element to build trust with the general public since it provides evidence that an independent body has evaluated the application and set up a framework in which it is safe to operate, but, maybe even more important, it has assigned a task to review activities in the field to an objective organization to make sure that companies stay within the safe limits of operation. The general public, not being able to overlook all the consequences of these sophisticated new technologies, rely on government to guard their safety and understand that the objective institutions are a good way of doing this. The biggest problem regarding regulation is the lack of a definition. Especially in food, in which most components are nanostructured, it is very difficult to make a distinction between naturally occurring nanotechnology and man-made naostructures. This allows industry to use nanotechnology without having to admit to it.
OECD’s programme on the safety of manufactured nanomaterials
Peter Kearns
This presentation will describe the activities of OECD’s Working Party on Manufactured Nanomaterials (WPMN), which was established in 2006. The WPMN brings together more than 100 experts from governments and other stakeholders from: a) OECD Countries; b) non-member economies such as Brazil, China, the Russian Federation, Singapore and Thailand; and c) observers and invited experts from a range of stakeholders including other international organisations, business, trade unions and environmental NGOs.
The objective of the WPMN is to promote international co-operation in human health and environmental safety aspects of manufactured nanomaterials, in order to assist in the development of rigorous safety evaluation of nanomaterials. The work is being implemented through eight projects listed below:
- Development of a Database on Human Health and Environmental Safety Research;
- Research Strategies on Manufactured Nanomaterials;
- Safety Testing of a Representative Set of Manufactured Nanomaterials;
- Manufactured Nanomaterials and Test Guidelines;
- Co-operation on Voluntary Schemes and Regulatory Programmes;
- Co-operation on Risk Assessment;
- The role of Alternative Methods in Nanotoxicology
- Exposure Measurement and Exposure Mitigation
These eight projects are being managed by eight steering groups which are implementing their “operational plans”, each with their specific objectives and timelines. This presentation will summarise the results of each of these activities to date. Special attention will be given to the project on the Safety Testing of a Representative Set of Manufactured Nanomaterials in which the delegations to the WPMN have agreed to work together to undertake safety testing on 14 nanomaterials.
Voluntary Codes of Conducts - The Responsible NanoCode
Steffi Friedrichs
Like any other emerging technology, the development of nanotechnologies gives rise to a variety of social and ethical issues - both in relation to their governance and the impact of specific applications. In particular, there is some uncertainty surrounding the potential environmental, health and safety risks of some nanoscale materials. In the absence of concrete scientific evidence about the true risks of nanotechnologies, businesses with an interest in this area will need strategies for dealing with these uncertainties.
In June 2007, a multi-stakeholder group, involving representatives from companies, industries associations, private technology funding organizations, consumer groups, independent scientific and policy advisors, NGOs and Trade Unions, commenced the development of a voluntary Code of Conduct for organisations involved in the research, development, manufacture, commercialisation, trade, use and disposal of nanotechnology-enabled products, now known as the "Responsible NanoCode". The draft version of the Code was subjected to a global public consultation process; consultation feedback was implemented at the beginning of 2008, and it is anticipated that the Code will be launched in the summer of 2008.
This presentation highlights the drivers that led to the development of the Responsible NanoCode, describes the Code development process, as well as its main format and content.
Nanomaterials and safe food production - Point of view of the Austrian Ministry of Health, Family and Youth
Alexander Zilberszac
Competent Authorities of the Member States of the EU are to an increasing degree faced with consumer organisation’s demand for concrete regulatory measures for applications of nanomaterials in the food sector. For safeguarding consumer health and safety they are called upon to apply the precautionary principle and to introduce obligatory labelling for “nanofood”.
In the “communication on regulatory aspects of nanomaterials”(17 June 2008) the European Commission concludes that current legislation covers in principle the potential health risks in relation to nanomaterials. Nevertheless the Member States are invited “to carefully monitor the market, and use Community market intervention mechanisms in case risks are identified for products already on the market” and to “exchange information or to intervene when products present or are likely to present a risk, even where they conform with legal requirements”. Evidently, the European Comission is keen to place the whole burden of responsibility for food safety aspects of nanotechnology on the MS.
There is some evidence that a number of big international food companies are currently using and testing nanotechnology for food processing and packaging. As neither an internationally accepted set of definitions for nanotechnology nor standartised test methods and risk assessment methods that serve as a basis for implementing legislation and administrative decisions are available at this point in time, the MS find themeselves in a rather challenging situation.
Management of Nanomaterials in Austria
Renate Paumann
The presentation will give an overview on the various activities of Members of the Austrian "Nano-Platform" which was established in 2007. The Austrian Nano-Platform consists of all Austrian Authorities which are involved in the topic Nanotechnology as well as other stakeholders such as Nongovernmental Organisations and representatives of business and Academia. The aim of this network is to exchange information, to discuss and implement activities in the field of nanotechnology and to coordinate Austrian input to relevant EU- and international working groups. The presentation will in particular focus on the Ministries role in the area of Chemicals Mangement (in particular REACH, OECD Working-Party on Manufactured Nanomaterials, EU Working-Party on Nano and REACH).
Political and Societal Aspects of the Regulation of Nanotechnologies
Torsten Fleischer
Nanotechnologies are among the most prominent emerging technologies. They are heralded as key technology for the 21st century that will contribute to economic prosperity and sustainable development by a broad alliance of policy-makers, scientists and industry representatives. As a number of applications of nanotechnologies have become a commercial reality, and many more appear on the horizon, political and public discussions of environmental, societal and ethical implications of nanotechnologies have begun. These debates include questions about the adequacy of current regulatory tools and future challenges for governance and regulation of these new technologies.
Although there are different understandings of nanotechnologies in the scientific community, and the definitions that can be found in research policy documents are varying, there are some uniting elements: Nanotechnologies comprise a wide range of approaches that concern the study of phenomena and manipulation of materials at atomic, molecular and macromolecular scales, where properties differ significantly from those at a larger scale, which may lead to materials, devices and systems with fundamentally new properties and functions. Therefore, nanotechnologies should be considered as an enabling technology, a broad technology platform for a variety of applications in numerous technological fields.
This is the reason why various public discourses about the regulation and governance of nanotechnologies can be identified. The most obvious one is the debate about the governance of risk of known and unknown risks of new properties of nanomaterials and their impact on humans and the environment. A second discourse focuses on the ethical, legal and societal implications of nanotechnologically enabled or improved technologies in other areas like in information technology, biotechnology and medicine, or food technology. Finally, nanotechnologies are taken as examples for ‘risk technologies’ in political debates about societal control of science, new models of governance and participation in science and technology policy, or trust in scientists and science organisations. These discourses are interwoven but the underlying issues appear to require different regulatory approaches.
The talk will give an overview of regulatory approaches towards different aspects of nanotechnologies, their pros and cons, and briefly discuss some observations in current nanotechnology policy.
The need to regulate nanotechnologies - An Environmental NGO perspective
Jurek Vengels
As of today, the Woodrow Wilson Center's inventory of nano consumer products already enlists 807 products from a large variety of sectors, including such sensitive applications as cosmetics, foods, and textiles. While more and more products containing nanomaterials enter the market, regulators lag behind in taking steps to control the potential risks associated with nanotechnology. The presentation will highlight the existing regulatory gaps in the view of an environmental non-profit organisation and will discuss potential initiatives for nano-specific regulation. At the European level, REACH is generally assumed to be the most appropriate legislation to cover nanomaterials. However, major adaptations within the law will be necessary to adequately regulate first generation nanomaterials within REACH. In addition, urgent steps are needed to address the potential risks of more advanced nanomaterials.
NanoTrust and Technology Assessment
Michael Nentwich
Technology assessment (TA) attempts to provide policy-makers with a rational basis for their decisions and informs society about their choices. It does not provide “super expert opinions”, but points out areas where spe-cialists are in general agreement, where controversy exists, what assump-tions or fears lie behind the differences of opinion, and what risks are asso-ciated with the various possible options. The classic aim of TA is to iden-tify technology-induced risks early enough, to analyse in detail the range of possible social, economic, legal, political, cultural and ecological effects, to process investigation results in a problem-oriented manner, to present alter-native decision-oriented options, and at the same time to point out the vari-ous social interests and value judgements linked with the development and use of new technologies.
Nanotechnology is an emerging branch of research and technology devel-opment and is hence a typical area of investigation for TA. Up to now, safety aspects have not yet been thoroughly researched enough in order to allow for conclusive assessments regarding postulated risks. At the same time, concerns about potential risks are being raised and there are first signs of a public debate. Not least against the background of the experiences in the area of biotechnology, a foresighted nanotechnology policy is neces-sary, which is based on profound and well presented analyses.
The Austrian Ministry of Innovation commissioned the Academy of Sci-ences in 2007 to carry out the project NanoTrust, which has the aim to con-tinually survey, analyse and summarise the state of knowledge on risk is-sues. For the first time in Austria, these important aspects of technology development are under systematic scrutiny and beyond single R&D pro-jects, that is investigated on a meta level. At the same time, research gaps will be identified and differing assessments made transparent.