FramingNano Stakeholders’ Workshop,
Brussels, 26 February 2009

Preliminary FramingNano survey results reveal concerns over hazard identification

Early indications from the first Delphi consultation exercise, which forms a central part of the FramingNano FP7 Project, suggest there is concern over risk assessment, hazard identification, and exposure to nanomaterials. A majority of respondents also see safety in manufacturing, product safety testing and environmental issues as important, according to preliminary results of the study presented in Brussels on 26 February 2009 by Richard Moore, Institute of Nanotechnology, and a member of the FramingNano project consortium.

Risk management processes, waste streams, safety in the laboratory and public perception were also viewed as crucial, while labelling and standardized nomenclature were highlighted as being very important.

Provisions concerning nanotechnology in chemical substances and food were deemed inadequate by more than half of the respondents, with some concern also about nanoparticles in cosmetics and the environment. A lower level of concern had been expressed so far over medical applications and occupational safety.

Lack of knowledge concerning nanotechnology risks was viewed as a major barrier to the development of the technology, and the inability of regulation to keep pace with scientific developments might also stand in the way of responsible development in this area.

Mapping study points towards need for standards

There is a need for an international approach to the management of nanomaterial risks, with a particular emphasis on the development of harmonised standards and guidance, according to Dr Elvio Mantovani, AIRI/Nanotech IT (Italian Centre for Nanotechnology).

The research revealed a consensus that there is an urgent need to develop, at least for some nanomaterials, new approaches and methods for their risk assessment. Stakeholders also believe there is a need to improve the knowledge base on the characteristics and behaviours of nanotechnologies. The major source of concern regarding potential risks of nanotechnology is "free" manufactured nanomaterials during their entire life cycles, according to the study.

According to Mantovani, building trust in regulatory bodies and between stakeholders is crucial to developing a credible regulatory framework for nanomaterials. He reminded participants that the ultimate goal of FramingNano is to craft "a proposal for a 'Governance Plan/Platform' defining practicable regulatory solutions assuring that the development of nanotechnology takes place responsibly and to the benefit of the individuals and the society" which is expected to emerge from the project towards the end of 2009.

“Assessing risk can pose practical challenges”

A range of practical difficulties make risk assessment of nanomaterials extraordinarily difficult, according to a leading European expert.

Speaking at the FramingNano multi-stakeholder workshop in Brussels, Dr Wim De Jong, Vice-Chair of the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), said nanomaterials are difficult to handle and unpredictable in their behaviour.

"In vitro studies indicate the possibility for cell damage but the relevance of such work for risk assessment is limited. It is impossible to extrapolate what happens in cell culture to real world risk," he said. "Particles may change in vivo meaning assessments made in Petri dishes often do not reflect conditions in the body".

He said there is disagreement between experts as to what exposure dose to use when assessing nanoparticles. Some research papers on the subject neglect to specify what size particles they are referring to when discussing safety evaluations. This is crucial as the size of the molecules can determine how materials affect organs, according to De Jong. Proper characterization of engineered nanomaterials is necessary and risk assessors are working to find the optimal ways of handling these particles, he added.

Commission “disappointed” by response to code of conduct on nanotechnology

A European Commission official expressed disappointment at how EU member states have responded so far to a code of conduct on nanotechnology.

Speaking at the FramingNano multi-stakeholder workshop in Brussels, René Von Schomberg, from the European Commission Directorate General for Research, said the Commission had done significant work to address nanotechnology issues but this had not always been reflected in countries across Europe.

"The Commission started work on this very early but has been somewhat disappointed by the response from member states, particularly by inaction concerning the code of conduct," he said.

He called for greater communication amongst stakeholders about the risks and expectations on the future of nanotechnology and added that the precautionary principle applies to all novel technology issues incorporating poorly understood risks, including nanotechnology.

Trust, not “engineered consent”, is key to safer nanotechnology

Dr Francoise Roure, Vice-Chairperson of the OECD working party on nanotechnology, told the FramingNano multi-stakeholder workshop in Brussels that meaningful public engagement is essential to future nanotechnology development. However, she warned against attempting to coerce the public into backing the science as experience suggests this tactic is doomed to failure.

"What we should strive for is not the engineering of consent but trust" she said "…hoping for passive ‘acceptance' by the public is out of step with modern theories of reflexive government".

"Engaging with the public is a complex process and must not be taken lightly", Roure said, "…engagment without explaining the possible outcomes of advances in nanotechnology is not reasonable". She stressed that those communicating with the public should be independent as it is unlikely that those with vested interests will be fully capable of building trust.

Boundaries between stakeholders “blurred”

Long-standing boundaries between industry, policy makers and environmentalists have been dissolving, according to Dr Gernot Klotz, Executive Director of the European Chemical Industry Council (CEFIC).

"Traditional roles are becoming blurred: businesses are going green, NGOs are becoming more businesslike – and are selling their services – governments are outsourcing work to agencies, and academics have become entrepreneurs…" said Klotz.

He said REACH, the European regulation on the safe use of chemicals, represents a "paradigm shift" in how industry views the safety of its products. Klotz said he agreed with the view of the European Commission that the current regulatory frameworks in Europe are sufficient to cover the specific case of nanomaterials. He was critical, however, of how regulators sometimes change the rules while companies are developing new products. Dr Klotz also urged stakeholders to look at gaps in governance systems rather than trying to redesign what is already in place.

Common terminology essential to future debate

Agreed definitions and a common terminology are needed in order to make progress in the ongoing debate on nanotechnology, according to several experts who gathered in Brussels for the FramingNano multi-stakeholder workshop.

"We need good definitions for what we are debating. At the moment, part of the problem is that people are discussing different things when it comes to nanotechnology. There are different interpretations and understandings when it comes to nanoparticles and I have the impression that regulators and innovators have different ideas on this," said Dr Ulrich Fiedler, of the Australian Academy of Sciences Institute of Technology Assessment.

Dr Rolf Hertel, Bundesinstitut für Risikobewertung, said his institute had developed "running definitions" for food safety which define nanomaterials as those with dimensions smaller than 500nm. "We have found that restricting the definition only to particles smaller than 100nm is not helpful in practice. Some entities are larger than 100nm but exhibit nanoscale properties. "

Input needed on standardisation

A global effort is required for the terminology used for nanotechnology to be standardised, according to Dr Peter Hatto, Chairman of the British, European and ISO standards committees for nanotechnologies.

Hatto said the International Organization for Standardization can only make substantial progress on nanotechnology if its members are willing to tackle this difficult subject.

"People believe standardisation is something that happens somewhere else. In practice, the membership of ISO propose, write and approve the standards. Unless we receive support from members it won't happen. It's not something that happens by itself, it's a membership-driven process," he warned.

Communication essential to building trust

Deciding what information to communicate and how to share it with the public will be central to earning public trust in nanotechnologies, according to several speakers at the FramingNano workshop.

Madeline Laffont, CEFIC, said it is crucial to decide "what needs to be communicated, in what form and by whom". She said stakeholders must try to avoid asking the same questions and should try to learn from the research of others.

Jenny Holmqvist of CEFIC said improved communication was required on several levels. She said experts, the European Commission and member states must step up their communication, and that public communication is also crucial. Holmqvist said it was understandable that the public might be uneasy with having new technologies incorporated into food. "If you feel in control of the risks, you are more comfortable with it."

However, Christoph Meili of Swiss-based consultancy The Innovation Society said the public will not be satisfied with information alone. "Consumers are not interested in data; regulators are interested in data. The regulators say 'no data, no market' but consumers say 'no trust, no market'. Data is not necessarily the source of trust," he told the workshop.

Media plays a role in perception of technologies

Studying the role of new media, including interactive websites and blogs, can help provide insight into public opinion on nanotechnologies, the FramingNano workshop in Brussels was told.

Dr Francoise Roure, Vice-Chairperson of the OECD working party on nanotechnology, said research has been conducted on newspaper content but it would also be useful to look at new forums where discussion is taking place.

"We could do the same kind of analysis of the blogosphere as has already been done for newspapers. This would help improve understanding of how public opinion is evolving," she said.

“No time to lose” in regulating nanotechnology

Sufficient data already exists to allow regulation of nanotechnologies, according to Christoph Studer scientific advisor to the Industrial Chemicals Section of Switzerland's Federal Office for the Environment. Studer, who chaired a workshop at the FramingNano multi-stakeholder seminar in Brussels , said the timing of developing a governance plan for nanotechnologies is important and he acknowledged there are several gaps in current knowledge which will take time to fill.

"In the meantime we can't just wait to legislate; we can't cross our fingers and hope nothing happens. We can easily generate regulations today based on the data we have right now," he said.

Dr Arila Pochet, representative of the French Ministry of Health, said it is important to have a regulatory approach now but also to look to the future. "A combination of voluntary measures and legislation are needed for now, and hard legislation is absolutely necessary," she said. Pochet said public authorities need to know precisely what is on the market in order to regulate products effectively.

Concerns over the effectiveness of labelling

Branding products with a ‘nanotechnology' label might not be useful given the wide variety of goods that would be grouped together, according to several speakers at the FramingNano workshop in Brussels .

Laura Pleasants, of the Royal Commission on Environmental Pollution, UK, said labels tent to suggest that there is reason to be concerned. "We looked at labelling and found that if you label products with ‘nano' you imply that all nanomaterials are similar. It also implies that you are communicating a hazard," she said.

Delphi Questionnaire 2

A second round Delphi questionnaire will be disseminated during June which will build upon the feedback received from the first Delphi consultation and from the multi-stakeholder workshop as reported above.