SURVEY ON NANOTECHNOLOGY GOVERNANCE

Transcription

1 INTERNATIONAL RISK GOVERNANCE COUNCIL SURVEY ON NANOTECHNOLOGY GOVERNANCE Volume C. The Role of Risk Research Organisations IRGC WORKING GROUP ON NANOTECHNOLOGY Chair: M.C. Roco, Member IRGC Scientific and Technical Council Project Manager: E. Litten Geneva, June 2006 Date of survey request: September 2005

2 The International Risk Governance Council is a Private Foundation established under Articles 80 and thereafter of the Swiss Civil Code. international risk governance council, geneva, june 2006 international risk governance council 7-9 Chemin de Balexert, Châtelaine CH-1219 Geneva, Switzerland Tel +41 (0) Fax +41 (0) IRGC Working Group on Nanotechnology working paper no. 4 Disclaimer The contents of this working paper have been peer reviewed by the respondents to the IRGC Survey on Nanotechnology Governance: the role of industry and the IRGC Nanotechnology Working Group. The IRGC does not accept responsibility for the validity of the opinions expressed within this report which are a reflection of the opinions of the survey respondents and not of IRGC itself. 2

3 CONTENTS OVERVIEW 1. BACKGROUND LIST OF SURVEY PARTICIPANTS WHAT ARE THE MAIN FINDINGS?...6 Summary of current governance strategies...6 Recommended governance strategies RESEARCH AND DEVELOPMENT STRATEGY...9 Areas of research and development strategy...9 Research focus nanotechnology risks REGULATIONS FOR NANOTECHNOLOGY CURRENT GOVERNANCE STRUCTURES IN PLACE COOPERATION RECOMMENDATIONS FOR RISK GOVERNANCE Risk research recommendations Stakeholder engagement recommendations Risk communication recommendations Governance approaches REFERENCES ANNEXES Annex A About the IRGC Annex B A definition of risk governance Annex C Acknowledgements Annex D - Overview of current regulations, standards and practices mentioned in the survey Annex E The IRGC questionnaire to Research Organisations Annex F Questionnaire responses F1. Questionnaire responses from Kazuo Katao, Ochanomizu University, Japan F2. Questionnaire response from Michael Riediker, Institute for Occupational Health Sciences, Switzerland F3. Questionnaire Response from Bruce Bimber, Center for Nanotechnology in Society at the University of California, US F4. Questionnaire response from Jennifer Kuzma, Center for Science, Technology and Public Policy at the University of Minnesota, US F5. Questionnaire response from Andrew Maynard, Woodrow Wilson International Center for Scholars, US

4 TABLES Table 1: Survey participants... 6 Table 2: Risk governance recommendations from NGOs (suggested in the survey)... 8 Table 3: Current regulations and standards mentioned by the survey respondents

5 1. BACKGROUND This survey on the role of research in nanotechnology risk governance, conducted between September and November 2005, is the third in a series that IRGC has undertaken as part of the preparatory work for their project Nanotechnology Risk Governance ("Addressing the need for adequate risk governance approaches at the national and international levels in the development of nanotechnology and nanoscale products"). Surveys have also been undertaken among governments (Volume A, published in January 2006), industry (Volume B, published in June 2006) and NGOs (Volume D, also published in June 2006). All of these reports can be accessed at The main objective of the IRGC project is to develop a conceptual framework for the risk governance of nanotechnology, with the intention being to provide recommendations to decision makers in government, industry, NGOs, research institutions and other organisations. Findings from these surveys, together with the outcomes of two expert workshops held in May 2005 and January 2006, and the IRGC White Paper Nanotechnology Risk Governance (published in June 2006), will be used to develop initial risk governance recommendations which will be presented, discussed and enhanced at an international conference to be held on 6 and 7 July 2006 in Zurich, Switzerland. IRGC s final recommendations for appropriate risk governance strategies will be published after the conference. The survey was originally sent to 15 potential participants (see Annex E for the IRGC Questionnaire to Research Organisations). During the relevant time period 5 responses were received from Ochanomizu University (Japan), the Institute for Occupational Health Sciences (IST) (Switzerland), the Center for Nanotechnology in Society (University of California, US), the Center for Science, Technology and Public Policy (University of Minnesota, US) and the Woodrow Wilson International Center for Scholars (US). These organisations research a range of nanotechnology-related topics, at a general level focusing on: improvements to the regulatory system; occupational health; basic research and development (R&D); and the societal implications of nanotechnology in areas such as health, environment, agriculture and public perception. The majority of the survey respondents were individually involved in assessing the implications of nanotechnology on society rather than the technical issues and all of the organisations were based in developed countries, predominantly the US. That being said, should any additional organisations wish to contribute to the survey we would be pleased to update this report with their responses. We also wish to make clear that the responses are based on the personal recommendations and suggestions for risk governance of the individual respondents and should not be viewed as necessarily representative of the organisation that these respondents represent. The following summary represents only a sample of opinions on the research approach to the governance of nanotechnology. The findings included are those which are most relevant to IRGC s Nanotechnology project and have been interpreted for this purpose. There has been no weighting or relative ranking of the answers, however, where there is commonality of thought or differences in opinion this has been directly stated in the text. Full responses from each of the respondents can be found in Annex F. 5

6 2. LIST OF SURVEY PARTICIPANTS Listed in the following table are those participants who contributed to this survey report, named in country alphabetical order. Table 1: Survey participants Country Respondents Title and organisation Japan Prof. Kazuo Katao Ochanomizu University Switzerland Dr. Michael Riediker Group Leader: Particles, Aerosols and Microorganisms, Institute for Occupational Health Sciences US Prof. Bruce Bimber Director, Center for Information Technology and Society and Center for Nanotechnology in Society, University of California US Dr. Jennifer Kuzma Associate Director and Affiliate, Faculty Center for Science, Technology, and Public Policy, Humphrey Institute University of Minnesota US Dr. Andrew Maynard Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars RESULTS OF THE SURVEY The following summary includes selected findings which are most relevant to the IRGC project and have been interpreted for this purpose. These answers are not inclusive of all responses and further details can be found in the Annexes which contain the full survey responses from each participant. 3. WHAT ARE THE MAIN FINDINGS? SUMMARY OF CURRENT GOVERNANCE STRATEGIES The research organisations were focused on societal risks and benefits The responses to this survey on the role of risk research organisations had significant commonality of focus. The respondents were all involved in researching possible changes to risk assessment, risk management and policy frameworks, and the survey responses were all focused on the potential benefits that nanotechnology could bring for society, such as innovations in health, environment, energy and minimal impact production methods, rather than potential economic gains. This commonality of focus resulted in many similar answers but also a significant depth of response that allowed the issues to be investigated in some detail. The organisations were concerned with both EHS and with ELSI, as well as with policy aspects. The initial phase of research generally encompassed the collation and dissemination of available EHS information, and the second phase developed recommendations to policymakers. Finally, both the shortterm and long-term implications of nanotechnology development were considered to be important, although in all cases there was a clear emphasis on the shorter-term issues. Environment, Health and Safety Issues (EHS). The individuals surveyed were researching projects concerning the properties of ambient particles, the implications to human health of nanostructure 6

7 toxicity and body penetration, the development of toxicity screening strategies and critical research needs, and the potential for developing green nanotechnologies. Ethical, Legal and Social Issues (ELSI) in conjunction with policy issues. The individuals surveyed were assessing issues such as frameworks for the improvement of risk evaluation and management of nanomaterials, agrifood nanotechnology, the development of strategies for addressing critical societal issues and the impact of risk perception. The primary concern of the respondents was the inability of current political and social frameworks to deal with potential nanotechnology risks in the longer term. Efficient characterisation of risk was believed to be dependent on many unknown factors such as, toxicity, release and dispersion rates, exposure, doseresponse relationships, and severity of the consequences. Nevertheless, the survey responses did include reference to specific risks and these were predominantly focused on ELSI and political risks such as new functions at the nanoscale, nanoscale structures in consumer products, loss of potential benefits, the potential pervasiveness of nanotechnology and international inequality. Health risks were also referred to, such as the ability to enter organs, tissues and cells. Collaboration and communication is the key to reducing risk The two most important factors in the respondents ability to impact on risk reduction were highlighted as being co-operation with other sectors both nationally and internationally and communication of potential risks to the attention of policymakers and other interested parties. The survey respondents were collaborating with a wide range of individuals and organisations, primarily from government, industry, nongovernmental organisations (NGOs) and other research organisations. Their ability to raise awareness about the possible impacts of risk was based predominantly on participation in advisory boards, forming partnerships with other like-minded organisations and informal networking through meetings such as workshops and conferences. The survey respondents also underlined the importance of openness and transparency in risk communication in particular when communicating with the general public. Key risk communication factors noted included the importance of the media in public perception, the impact of intellectual property rights on the ability of companies to share risk information and the need for communication to be multi-directional. Regulation, standards, best practices and international governance regimes The most significant regulatory concern raised by the survey respondents was that current regulatory structures and practices may be insufficiently responsive and flexible to cope with the individual characteristics of nano-materials or products. One respondent felt that society should be careful not to regulate science and technology, but rather more to focus on individual products and their applications. In the same context, another response considered that the usual regulatory practices for new chemical substances would be sufficient provided that nanostructures are treated as new substances. Finally, the survey responses considered the ability for international governance regimes to address the social and economic risks and benefits as well as the technical EHS issues and, additionally, whether all nations would be able to act under a global risk governance framework. The respondents highlighted the important role to be played by international organisations in providing independent and effective advice, by national governments in adapting guidance to their own social and political contexts and by industryled initiatives and self-regulation. Alongside these roles the survey responses also highlighted the need for public access to information about products and their potential benefits and risks. The following table provides a listing of the recommendations for risk governance made by the survey respondents. The list includes all of the recommendations proposed but does not imply that each suggestion is endorsed by all of the survey respondents. 7

8 RECOMMENDED GOVERNANCE STRATEGIES Table 2: Risk governance recommendations from risk research organisations (suggested in the survey) Type of governance strategy Risk research recommendations Stakeholder engagement recommendations Risk communication recommendations Governance approaches Recommendations, suggestions and ideas A Hippocratic Oath that sets out moral and ethical obligations for nanotechnology developers. Institutional review boards (IRB) to assess the risks and benefits of the research undertaken. Coordination of research and prevention strategies. Common understanding of important categories of nanomaterials. Global consensus on broad issues regarding EHS implications. Self-governance based on the models used in medical research. Development of processes that enforce rigorous and analytic approaches to assessing the causes, likelihood s, and effects of negative scenarios. Investigation of the worst-case scenarios. Involvement of all sectors of society in discussing risks and benefits rather than just the experts. Orchestration of sustained dialogue among interested parties by one umbrella organisation. Engagement of developing countries early. Open and collaborative communication of the risks and benefits. Rapid communication of new findings. Transparency about the contents of products. Education about the use and disposal of products. Avoidance of communicating extreme views. Broadly accessible information on nanotechnology through a number of outlets in the short-term. Integration of risk communication into education in the long-term. Understandable, but semi-technical reports by independent organisations (directed to interested parties outside of government, industry and polarised NGOs). Fair and balanced translation of results by independent organisations in collaboration with good science reporters (directed towards the general public). Organisation of focus or stakeholder groups at the grassroots level. Public education at local libraries. For international expert bodies Coordinate currently leading nations and anticipate the rise of nanotechnology in developing nations by getting them involved in the conversation early. Communicate the known risks and identified research gaps and what the worst-case scenarios could be. Develop knowledge networks that incorporate the media and the public and that set the agenda for national action by calling attention to risk issues, sharing concerns and attempting to engage national legislators. Disseminate internationally accepted risk assessment and management models. Elaborate strategic plans for identifying and addressing information gaps Publish reports that provide specific, yet flexible guidance on governance. Create dustiness standards for nanopowders. Communicate international guidelines and standards on ecotoxicity tests. For self-regulation (by industry, research organisations and NGOs) Conduct lifecycle analysis which is independently and publicly evaluated by a third party. Undertake independent research about potential risks. Use of good occupational hygiene practices. Elaborate risk evaluation and management frameworks that address the specific characteristics of nanomaterials. Disseminate hazard information on engineered nanomaterials. Develop material safety data sheets (MSDS) relevant to engineered nanomaterials. Use of cost-effective personal exposure monitors for airborne nanostructured particles. Harmonise safe working practiceguidelines, approaches and standardsglobally. 8

9 Type of governance strategy Recommendations, suggestions and ideas Use of cost-effective rapid-response ecotoxicity screening tests. Use of cost-effective monitoring methods for nanomaterials in soil and water. For government Include research and analysis, systematic planning and allocation of resources in government investment to create organisational or network capabilities. Follow the usual regulatory processes for new chemical substances but consider nanoparticles to be a new substance. Develop national and global strategic plans for identifying and addressing information gaps. Increase substantially R&D spending on risk-based research. Develop R&D effectiveness and impact models that reward proactive risk-based research and development. Increase public funding for applications geared towards sustainable development, both for developing countries (e.g. food security, water quality, energy infrastructure, vaccines, medical treatments for developing world illnesses, etc.) and for applications for which there are not immediate financial returns (e.g. energy and environmental applications in all countries). Encourage adequate investment in capacity building, primarily of education and institutions. 4. RESEARCH AND DEVELOPMENT STRATEGY Question 1 of the survey addressed research programmes into particular issues, including a description of the organisations focus. Also included in this section of the report is an analysis of questions 5 and 6 which considered the potential risks and benefits of nanotechnology. The following provides a summary of key points identified. AREAS OF RESEARCH AND DEVELOPMENT STRATEGY All of the respondents were positive about the potential benefits of nanotechnology development, with the majority stressing societal rather than economic benefits. For example, the Center for Science, Technology and Public Policy emphasised the detection of animal or human pathogens through nanosensors, targeted drug or gene delivery, environmental remediation of pollutants and cleaner or renewable energy sources. The Institute of Occupational Health Sciences focused on products that might reduce the usage of hazardous chemicals or dangerous physical processes and Woodrow Wilson saw the big potential benefits as including: dispersed energy sources, efficient renewable energy sources, atsource water filtration/purification, targeted medical diagnostics and treatment, extremely strong, light materials and efficient or minimal impact production methods. However, the Center for Nanotechnology in Society added a cautionary note against relying on nanotechnology development to ensure equitable and sustainable development. Rather more they emphasised that some benefits would create an advantage for some and a disadvantage for others and also noted that the benefits and risks of technologies would not be uniformly distributed. Three general observations about R&D focus can be garnered from the survey responses, the first two of which are similar to the views expressed in IRGC s survey on the role of NGOs (Volume D). First, both the short-term and long-term implications were considered to be important, although there was a clear emphasis on the shorter-term issues. Second, the benefits to society were seen to be extensive and the expressed need for the minimisation of risk was partly due to ensuring that these benefits were achievable. Third, there was an equal focus on EHS and ELSI, with the initial phase of research encompassing the collation and dissemination of available EHS information and the identification of critical research needs, and the second phase being to make recommendations to policymakers on how 9

10 to promote and support appropriate R&D and how to develop appropriate regulatory frameworks. The following are examples of the particular areas where the respondents were focusing their research. Environment, Health and Safety Issues (EHS) o o o Occupational safety. For example, the Institute for Occupational Health Sciences was exploring issues such as the properties of ambient particles and the health effects of manufactured nanoparticles. Human health. For example, the Center for Nanotechnology in Society was examining the implications of nanotechnology in terms of nanostructure toxicity and body penetration and Woodrow Wilson was investigating toxicity screening strategies and critical research needs. Environment. For example, both Woodrow Wilson and the Center for Nanotechnology in Society were exploring potential environmental impacts and Woodrow Wilson in particular was looking at the potential for developing green nanotechnologies. Ethical, Legal and Social Issues (ELSI) in conjunction with policy issues o o o Science and technology policy. For example, the Center for Science, Technology and Public Policy was assessing the potential applications of agrifood nanotechnology and in the future will evaluate its impact on existing or potential government frameworks in the US. Regulatory frameworks. For example, Ochanomizu University was researching ways in which the risk evaluation and management of nanomaterials within Japan s regulatory system can be improved, including an assessment of the range or boundary of current regulatory practices. In addition, Woodrow Wilson Center was exploring alternative risk assessment and management frameworks and developing strategies, frameworks and recommendations for addressing critical societal issues. Risk perception. For example, both the Center for Nanotechnology in Society and Woodrow Wilson were investigating issues related to the field of risk perception. RESEARCH FOCUS NANOTECHNOLOGY RISKS The following section investigates the aspects of nanotechnology which survey respondents considered to have the most potential for risk. All of the research organisations surveyed felt that there was a possibility for risk, and in most instances their primary concern was the inability of current political and social structures and processes to deal with these risks. Several respondents considered that society did not have enough information to effectively determine or rank risk, although it was thought possible to be able to prioritise risk research needs. Additionally, two respondents were of the opinion that risks could not be generalised as levels of risk would be specific to groups of materials and therefore dependent on factors such as toxicity, release and dispersion rates, levels of exposure, dose-response relationships, and severity of the consequences. Nevertheless, all of the respondents did identify risks and these are categorised into ELSI and EHS risks below, with the primary focus being ELSI in conjunction with policy issues. ELSI Risks o o New functions at the nanoscale. For example, Ochanomizu University considered that current risk governance systems and processes would be unable to cope if previously unknown risks are encountered when new chemical substances such as nanotubes begin to be widely used. Woodrow Wilson suggested that the applications and associated benefits of these new functions would be at risk if appropriate risk models and management frameworks were not proactively developed. Nanoscale structures in consumer products. For example, the Center for Nanotechnology in Society was concerned about the widespread use of nanoparticles in products such as consumer products, beauty products, dental products, foul resistant coatings and food and drink additives. 10

11 o o o Loss of potential benefits. For example, Woodrow Wilson felt that benefits could be forgone if uninformed public perceptions or the unsafe working practices of even one operator led to low acceptance. The pervasiveness of nanotechnology. For example, the Institute for Occupational Health Sciences focused on potential challenges for occupational safety managers due to the multisectoral natural of nanotechnology. International inequality. For example, Woodrow Wilson was concerned that rapid nanotechnology development in industrialised countries would further polarise the technical capabilities of developed and developing countries. EHS risks o Health risks. For example, the Center for Science, Technology and Public Policy considered that nanoparticles have special properties and abilities to enter organs, tissues and cells and at large doses would be toxic, even if the material itself is not toxic; and the Institute for Occupational Health Sciences was concerned about the long-term effect on the heart and the brain. Additionally, some respondents also indicated areas which they felt to be of higher risk than others and these areas of highest concern are listed below: The Institute for Occupational Health Sciences was most concerned about applications which would release particles into the air, such as spray applications of particles that are in solutions. The Center for Nanotechnology in Society and Woodrow Wilson considered free or quasi-free nanoparticles (passive) with unknown properties for health and the environment to be of highest risk. In the short-term Woodrow Wilson was concerned about single-walled and multi-walled carbon nanotubes as a hazard during production (rather than when incorporated into a matrix material) and respirable particles of nanomaterials and nanocomposites. In the longer-term they considered that active nanoparticles were of most risk because of their unknown hazard and exposure profiles. The Center for Science, Technology and Public Policy considered that the release or consumption of nanomaterials on a wide-scale might pose the greatest risk. 5. REGULATIONS FOR NANOTECHNOLOGY Respondents were not able to identify any national or international regulations for nanotechnology, although several responses pointed out that current decision-making structures and processes could be applicable. For example, the Institute for Occupational Health Sciences was of the opinion that all laws which ask for the declaration of product content and product safety would also apply to nanotechnology and Ochanomizu University specified related regulations for radioactive substances, weapons, toxic substances, medicines and pesticides. That being said, many of the respondents were concerned that, as the current regulatory systems vary depending on areas of application and not by size, it is unclear whether they will be sufficiently responsive and flexible for individual nano-materials or products. For illustration, the Institute for Occupational Health Sciences posed the question - how will it be possible to regulate a substance that changes its physical and chemical properties simply because of a change in its size? Furthermore, the Center for Science, Technology and Public Policy thought that badly-defined nanotechnology risk evaluation processes, such as test methods, definition of terminology and development of particular technologies, would reduce the ability of current regulations to apply to nanotechnology. For example, Woodrow Wilson mentioned the weakness of governance systems in environmental impact, and particularly in evaluation of the lifecycle (including ecotoxicity testing, emissions thresholds, persistence and bioaccumulation). The question of how and when government should act was also evaluated by the survey respondents. For the Center for Science, Technology and Public Policy a key question was the extent to which international governance regimes would be able to address the technical issues as well as the social and economic risks and benefits. In the same context, Woodrow Wilson noted that in the short-term particular 11

12 emphasis was being placed on addressing EHS issue, such as occupational health, whilst ELSI, such as regulatory frameworks, were often treated as longer-term issues. 6. CURRENT GOVERNANCE STRUCTURES IN PLACE Three nanotechnology-specific practices were identified by the survey participants: the US Environmental Protection Agency (EPA) proposed voluntary programme for nanomaterials; the international harmonisation of standards through the International Organization for Standardization (ISO); and the international collaboration on the safety of nano-materials through the Organisation for Economic Cooperation and Development (OECD). In addition, potential candidates for addressing international governance issues were suggested by the Center for Science, Technology and Public Policy (the Cartagena Protocol on Biosafety and the Codex Alimentarius standards on food safety) and Woodrow Wilson (Control Banding for working with hazardous materials through the International Labor Organization). Annex D provides an overview of current regulations, standards and practices mentioned by the survey respondents, although no analysis was made of their applicability to nanotechnology. 7. COOPERATION Question 3 considered issues of national and international cooperation in nanotechnology, including with other research organisations, international organisations, national governments and regulators, NGOs and the public. The following section summaries the key areas in which cooperation is taking place. The survey respondents were collaborating with a wide range of individuals and organisations. Predominantly with other research bodies and international organisations but also, where appropriate, with national governments, industry, trade associations, NGOs and the public, although this latter collaboration was based more on an analysis of public perceptions and provision of information rather than public engagement. For example, at the time of the survey, Woodrow Wilson was evaluating public perceptions to nanotechnology and advising on a 3-part national public broadcasting television series on nanotechnology entitled "Nanotechnology: The Convergence of Science & Society". Nevertheless, the perceived neutrality of these risk research organisations allowed them to provide an effective conduit for providing information about science and technology to the public and many of the respondents were holding public meetings and publishing papers which were designed for public consumption rather than just for an academic audience. As was noted by the Institute for Occupational Health Sciences, this transfer of information tended to be one-dimensional and, in practical terms, there was no direct way for the public to exert influence, although it was also noted that, where possible, researchers do pay attention to known public concerns. Collaboration was both national and international in breadth. For example, the Center for Nanotechnology in Society was collaborating internationally with large and small corporations and with university based research centres, and Woodrow Wilson had national and international connections with NGOs, industry, government agencies and academic institutions. For all of the respondents their primary modes of raising risk awareness were through partnerships with like-minded organisations (for example, the Center for Science, Technology and Public Policy were collaborating with Woodrow Wilson on their agrifood nanotechnology work), provision of advice to nanotechnology-related initiatives (for example, the Center for Science, Technology and Public Policy held regular briefing sessions for media and policymakers) and through extensive informal networking (for example, the Centre for Science, Technology and Public Policy had hosted a conference on the 12

13 Nanotechnology-Biology Interface: Exploring Models for Oversight ). The following sections explore more fully how the survey respondents are collaborating and who they are collaborating with. COLLABORATION WITH OTHER RESEARCH ORGANISATIONS Extensive collaboration was taking place with other research organisations in order to share their knowledge and coordinate research. The three main forms of cooperation mentioned in the surveys were networking, participating in an advisory committee and membership of a research institute. Networking. For example, the Institute for Occupational Health Sciences was a member of European Cooperation in the field of Scientific and Technical Research (COST) a networking tool for European Researchers. Their current work in the field of nanotechnology included Action 633, which looked at the properties of ambient particles in relation to health effects, and a potential Action B38, on the health effects of manufactured nanoparticles. (Remark: COST recently rejected proposal B38 which was supported in its final version by 70 researchers from 19 European countries - the network continues to exist but it is currently looking for other funding sources). The Institute was also a member of Cercl Air, an association which promotes the protection of air quality and the coordination and implementation of state implementation efforts in Switzerland by bringing together representatives from the Swiss authorities and academia. As a further example, the Center for Nanotechnology in Society had horizontal connections with the national Nanoscale Science and Engineering Centers (NSEC) funded by the US National Science Foundation. Advisory committees. For example, the Centre for Science, Technology and Public Policy has been represented on various nanotechnology-related committees at the University of Minnesota including: the Executive Committee of the Consortium on Law and Values in the Health, Life, and Environmental Sciences; the Board of Directors of the Minnesota BioBusiness Alliance; and the Steering Committee of the Ecosystem Science and Sustainability Initiative. Members of research institutes. For example, Ochanomizu University was represented on the Chemical-Bio Integrated Management Society (CBIMS) and the Chemicals Evaluation and Research Institute (CERI) which is part of the Science Council of Japan. COLLABORATION WITH INTERNATIONAL ORGANISATIONS All of the risk research organisations surveyed were involved with international cooperation in some form, for example, the Institute for Occupational Health Sciences was a collaborating member of the World Health Organization (WHO). The nanotechnology-specific examples provided by the respondents involved membership of international organisations focused on transforming knowledge learnt through research into practical methods of risk governance. The two main reasons given for international cooperation were to facilitate the development of best practices and standards. International best practices. For example, Woodrow Wilson was participating in Control Banding through the International Labour Organization (ILO) for the purpose of developing an international framework for selecting control strategies when working with hazardous substances. According to Woodrow Wilson, current control banding guidelines were not nanomaterials-specific however discussions had taken place as to how this approach could be adapted to new engineered nanomaterials. International Standards. For example, according to Woodrow Wilson, the International Organization for Standardization (ISO) working group on particle size-selective sampling and analysis had written a report on the exposure characterisation and assessment of nanometer-diameter and nano-structured aerosol particles. This working group was situated in Technical Committee (TC) 146 on air quality and Sub Committee (SC) 2 on workplace atmosphere. In addition, ISO TC 229 had been established to develop international nanotechnology-specific standards and ASTM International had formed TC E056. TC E056 had subcommittees that addressed: terminology and nomenclature, characterization, environmental and occupational health and safety, international law and intellectual property, risk management and product stewardship. 13

14 COLLABORATION WITH GOVERNMENT The surveyed organisations had all been involved with government to a certain extent and, in particular, the respondent from Ochanomizu University identified their most important tasks as being to bring the potential risks of nano-materials to the attention of government and to provide government with information that allowed them to develop soundly-based action plans. Specific examples of cooperation with government were provided by Woodrow Wilson who was collaborating with the US National Nanotechnology Initiative (NNI), the US Environmental Protection Agency (EPA) Science Advisory Board, the US National Institute for Occupational Safety and Health (NIOSH), the US National Institutes of Health (NIH) and the NNI Consultative Boards on Advancing Nanotechnology. COLLABORATION WITH NGOS Many of the respondents were cooperating with NGOs, although for the most part this was mentioned on a general basis. Specific examples were provided by the Center for Science, Technology and Public Policy, who were collaborating with the International Council on Nanotechnology (ICON) on industry participation in their agrifood nanotechnology survey, and Woodrow Wilson who were collaborating with both ICON and Environmental Defense. 8. RECOMMENDATIONS FOR RISK GOVERNANCE Questions 5-14 addressed aspects of risk governance and the recommendations of the participants in addressing this issue. The following sections provide thoughts and suggestions made by the survey respondents: no weighting has been attributed to the answers. Where there is commonality of thought this has been directly stated. RISK RESEARCH RECOMMENDATIONS The importance of risk guidance in research was stressed in all of the responses including that of the Center for Nanotechnology in Society who saw R&D experts as tending to work on the assumption of good outcomes leading them to underestimate risk. The survey responses elaborated three primary recommendations for risk guidance: first, formal methods to ensure the social and ethical obligations of nanotechnology developers, second, coordination of strategies to create a common understanding of the issues and third, the use of models and frameworks in scenario planning. In terms of actual strategies to assess safety and health risks, the Institute for Occupational Health Sciences felt that, when implemented correctly and subjected to suitable modifications, current practices such as organisational measures, technical process controls and provision of protective measures were likely to be sufficient to address occupational safety and health concerns until the risks were better evaluated. The following risk research recommendations were made by the respondents: A Hippocratic Oath that sets out moral and ethical obligations for nanotechnology developers. Institutional review boards (IRB) to assess the risks and benefits of the research undertaken. Coordination of research and prevention strategies. Common understanding of important categories of nanomaterials. Global consensus on broad issues regarding EHS implications. Self-governance based on the models used in medical research. Development of processes that enforce rigorous and analytic approaches to assessing the causes, likelihood s, and effects of negative scenarios. Investigation of the worst-case scenarios. 14

15 STAKEHOLDER ENGAGEMENT RECOMMENDATIONS Stakeholder engagement was largely associated with ensuring there was international dialogue about the risks and benefits. There was no specific mention made of public engagement, although some respondents did express the need to involve non-experts in the debate. The following stakeholder engagement recommendations were made by the respondents: Involvement of all sectors of society in discussing risks and benefits rather than just the experts. Orchestration of sustained dialogue among interested parties by one umbrella organisation. Engagement of developing countries early. RISK COMMUNICATION RECOMMENDATIONS In the surveys the importance of openness and transparency in risk communication was highlighted, in particular when communicating with the general public. According to the Institute for Occupational Health Sciences many new processes and products are treated as a production secret creating a situation whereby the public do not have access to all available information. This can lead to repercussions in the way that the public react to risk, for example, the Center for Nanotechnology in Society emphasised the importance of the media in risk communication who more-often-than-not will respond to events such as big developments, crises, spills, accidents and product withdrawals rather than to reports from bodies making level-headed cases. That being said, the Center for Science, Technology and Public Policy also noted that communication should be bi-directional, and should be designed to learn from the public and stakeholders about their concerns, experiences, and viewpoints, rather than to simply convince. The following detailed recommendations were made by the respondents: Open and collaborative communication of the risks and benefits. Rapid communication of new findings. Transparency about the contents of products. Education about the use and disposal of products. Avoidance of communicating extreme views. Broadly accessible information on nanotechnology through a number of outlets in the short-term. Integration of risk communication into education in the long-term. Understandable, but semi-technical reports by independent organisations (directed to interested parties outside of government, industry and polarised NGOs). Fair and balanced translation of results by independent organisations in collaboration with good science reporters (directed towards the general public). Organisation of focus or stakeholder groups at the grassroots level. Public education at local libraries. GOVERNANCE APPROACHES A role for international expert bodies The most effective roles for international expert bodies were associated with the communication of risks and benefits, the establishment of knowledge networks and the preparation of international strategic plans. The Center for Science, Technology and Public Policy recommended that the language used in international reports should be specific and designed to help policymakers act. Furthermore, they were of the opinion that recommendations should allow individual nations to adapt standards or guidance to their own social and political contexts. The following detailed recommendations were made by the respondents: Coordinate currently leading nations and anticipate the rise of nanotechnology in developing nations by getting them involved in the conversation early. Communicate the known risks and identified research gaps and what the worst-case scenarios could be. 15

16 Develop knowledge networks that incorporate the media and the public and that set the agenda for national action by calling attention to risk issues, sharing concerns and attempting to engage national legislators. Disseminate internationally accepted risk assessment and management models. Elaborate strategic plans for identifying and addressing information gaps. Publish reports that provide specific, yet flexible guidance on governance. Create dustiness standards for nanopowders. Communicate international guidelines and standards on ecotoxicity tests. A role for self regulation (by industry, research organisations and NGOs) Self-regulation and government action encompassed the majority of the respondent s recommendations. In particular, it was proposed that industry should take the initiative to address risk issues at the same time as the technology is being developed. Although, many of the respondents also felt that this type of initiative would only be effective when implemented alongside appropriate and consistent government regulations. The majority of the recommendations that follow were provided by Woodrow Wilson and therefore very little consistency of response can be claimed. However, those recommendations which were mentioned more than once were focused on lifecycle analysis, independent risk research and international guidelines and standards. Conduct lifecycle analysis which is independently and publicly evaluated by a third party. Undertake independent research about potential risks. Use of good occupational hygiene practices. Elaborate risk evaluation and management frameworks that address the specific characteristics of nanomaterials. Disseminate hazard information on engineered nanomaterials. Develop material safety data sheets (MSDS) relevant to engineered nanomaterials. Use of cost-effective personal exposure monitors for airborne nanostructured particles. Harmonise safe working practice guidelines, approaches and standards globally. Use of cost-effective rapid-response ecotoxicity screening tests. Use of cost-effective monitoring methods for nanomaterials in soil and water. A role for government in governance approaches A general opinion among the respondents was that a precautionary approach needed to be taken by government, but that this should be focused on the development and use of nanotechnology products and applications rather than on the regulation of R&D. According to the respondent from Ochanomizu University, measures to prevent the abuse of technological developments by groups and individuals for their own purposes should not focus on the limitation of science and technology innovation. On the contrary, the majority of the respondents urged that government take the lead in nanotechnology R&D with the specific purpose of directing apposite development. Rather than regulation, the respondents focused on the development of adaptable frameworks that could respond to critical issues as they arise. For Woodrow Wilson this type of flexible framework, rather than a simple cost-benefit analysis, was a necessity due to nanotechnology s highly complex and interdisciplinary nature. However, there was also a cautionary word about the viability of international cooperation from the Center for Nanotechnology in Society who felt that not all nations would be prepared to cooperate or indeed be able to do so. Ultimately, they considered that regulation of risk would most effectively occur within states through national regulatory apparatuses. The following detailed recommendations were made by the respondents: Include research and analysis, systematic planning and allocation of resources in government investment to create organisational or network capabilities. Follow the usual regulatory processes for new chemical substances but consider nanoparticles to be a new substance. Develop national and global strategic plans for identifying and addressing information gaps. Increase substantially R&D spending on risk-based research. 16

17 Develop R&D effectiveness and impact models that reward proactive risk-based research and development. Increase public funding for applications geared towards sustainable development, both for developing countries (e.g. food security, water quality, energy infrastructure, vaccines, medical treatments for developing world illnesses, etc.) and for applications for which there are not immediate financial returns (e.g. energy and environmental applications in all countries). Encourage adequate investment in capacity building, primarily of education and institutions. 9. REFERENCES All descriptions are taken from the websites of the organisations. All references are to internet sites last accessed in June ASTM International a voluntary international standards development organisation that seeks to develop technical standards for materials, products, systems, and services BioBusiness Alliance of Minnesota a non-profit organisation committed to ensuring the long-term prosperity of biobusiness in the state of Minnesota. Members include representatives of Minnesota companies, colleges and universities, state government, and healthcare institutions Center for Biological and Environmental Nanotechnology (CBEN) - a National Science Foundation funded Nanoscale Science and Engineering Center focusing on research at the interface between "dry" nanomaterials and aqueous media such as biology and the environment Center for Nanotechnology in Society at the University of California (US) - serves as a national research and education center, a network hub among researchers and educators concerned with nanotechnologies' societal impacts, and a resource base for studying these impacts in the US and abroad Center for Science Technology and Public Policy at the University of Minnesota (US) - fosters understanding of the role of science and technology in society, particularly relationships to economic growth, health, the environment, education, and national security Cercl Air an association which promotes the protection of air quality and the coordination of federal and state implementation efforts in Switzerland by bringing together representatives from the Swiss authorities and academia Chemical-Bio Integrated Management Society (CBIMS, Japan) - an academic society established in January 2004 to appraise the risks of chemical substances for society and the management of that risk by business and scientific researchers Chemicals Evaluation and Research Institute (CERI, Japan) an impartial, independent entity that provides an interface between human beings, chemicals and the environment. CERI performs tests, assessments, and R&D aimed at solving problems related to chemicals The Codex Alimentarius Commission - created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by 17