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Posted: February 28, 2008
Nanotechnology at the OECD
(Nanowerk News) The OECD has prepared an overview of its work on nanotechnologies for Forum VI of the Intergovernmental Forum on Chemical Safety (IFCS). This event will be held in Dakar, Senegal, September 15-19, 2008.
The paper, titled "Nanotechnologies at the OECD" (Word download, 136 KB), describes the two activities of OECD related to nanotechnologies: i) the activities of the Working Party on Manufactured Nanomaterials (WPMN); and ii) the Working Party on Nanotechnology (WPN).
Project 1: An OECD Database on Human Health and Environmental Safety Research
The WPMN is developing a Database of Research into the Safety of Manufactured Nanomaterials. This database is intended to hold details of completed, current and planned research projects on safety, which are to be updated (electronically) by delegations. Although this database is still a prototype, it already includes over 200 records which have been migrated from the database of the Woodrow Wilson Center. The database will be accessible online for editing and/or adding new records. This database is intended to be a resource for (amongst other things) each of the other projects of the WPMN. The public launch will be in 2008.
Project 2: Research Strategy(ies) on Human Health and Environmental Safety Research
The WPMN is developing a research strategy. This work is based on the knowledge that large sums of money are being devoted to R&D for future applications of nanotechnology. By contrast, it appears that relatively small sums are being made available for human health and environmental safety research. The objective of this project is to strengthen the international cooperation on safety research related to manufactured nanomaterial through: i) identifying priority research areas; ii) considering mechanisms for co-operative international research; and iii) to draw recommendations on research priorities for the short, medium and longer term.
With this in mind, the WPMN has developed a comprehensive list of research themes on environment and human health safety. An analysis (based on the research priorities provided by delegations) on gaps in research currently being undertaken, from which it will draw a set of preliminary recommendations on priorities or needs for research for consideration during 2008.
Project 3: Testing a Representative Set of Nanomaterials
This project is built around the concept that much valuable information on the safety of manufactured nanomaterials (MNs), as well as the methods to assess safety, can be derived by testing certain nanomaterials for human health and environmental safety effects. The objective of this project is to develop a programme to create an understanding of the kind of information on intrinsic properties that may be relevant for exposure and effects assessment of nanomaterials through testing.
As a result of the background work undertaken so far, the WPMN has selected a priority list of MNs for testing (based on materials which are in commerce or close to commercialisation). The WPMN also agreed a minimal base set of endpoints or effects for which these NMs should be tested. As a follow-up, the WPMN launched a “sponsorship programme” at the end of 2007 for the testing of specific MNs. The sponsorship programme is an international effort to share the testing of those manufactured nanomaterials selected by the WPMN. The first phase of the programme will test each nanomaterial for a minimal base set of endpoints (phase 1 of the project). This will produce Dossier Developments Plans for each nanomaterial tested. This work is being supported by the development of a guidance manual for sponsors of the testing programme. In addition, it is expected that this will identify those cross-cutting issues or tests, that will need further consideration (phase 2).
Project 4: Manufactured Nanomaterials and Test Guidelines
It is important to know whether existing test guidelines (used for “traditional chemicals”) can be successfully applied to MNs. Some information on this question will be derived from the work on testing MNs implemented by sponsors as a part of Project 3. In parallel, this project is reviewing existing test guidelines [especially the OECD Test Guidelines (TGs)] with view to establishing whether they are suitable for MNs. A preliminary review of Test Guidelines related to physical chemical properties has been finalised and work is planned to review non-OECD testing methods including international and national standards. This project is also reviewing Test Guidelines related to: effects on biotic systems; degradation and accumulation; and health effects.
The WPMN may also begin work on the preparation of guidance documents for testing MNs to address specific issues such as how to prepare and administer materials in appropriate doses for in vivo and in vitro studies.
Project 5: Co-operation on Voluntary Schemes and Regulatory Programmes
A number of countries have put “voluntary schemes” or “stewardship programmes” in place to assess the safety of MNs. This project is analysing these programmes with the aim of: i) identifying common elements, which encourage industry and other entities to submit existing information and data and/or generate new data on risk assessment and risk management of nanomaterials; ii) preparing recommendations to countries on approaches and elements to consider for information gathering initiatives; iii) to identify current and proposed regulatory regimes and how they address information requirements, hazard identification, risk assessment and exposure mitigation/ risk management of MNs; and iv) to share information on existing or proposed guidance documents on practices to reduce occupational or environmental exposure to MNs.
Accordingly, an Analysis of Information Gathering Initiatives has been completed. Amongst other things, it addresses the similarities and differences identified in these national initiatives. This analysis also includes a number of considerations and recommendations on approaches and elements for consideration by those countries wishing to launch similar initiatives.
In addition, a Comparison of Regulatory Regimes for Manufactured Nanomaterials has been completed. This exercise identified how current and proposed regulatory regimes address the risk assessment of MNs. In addition, a “template” form has been suggested to identify the various components of regulatory regimes which are or may be applicable to NMs.
As a result of this project, the WPMN has decided to undertake an additional activity on “International Sharing and Comparison of Data on Manufactured Nanomaterials”. The concept behind this proposal is to share, amongst member countries, information on MNs, reported through national information gathering initiatives, including voluntary programmes. A centralised list with summary level data is being prepared. This list will be held on the WPMN password-protected site, and it will include contact information in the relevant countries to enable delegations to exchange information on a bilateral basis.
Project 6: Co-operation on Risk Assessment
This project aims at identifying existing risk assessment schemes and is currently reviewing them to establish if they are suitable for the assessment of MNs. This project aims to: i) compile information on risk assessment approaches for chemicals that may be applied to MNs; ii) analyse current risk assessment approaches as these apply to MNs; iii) prepare recommendations for addressing and filling identified gaps.
Accordingly, this project is currently compiling existing risk assessment strategies and methodologies for chemicals that are being currently used for - or may be extended to include - MNs. At the same time, supporting tools will be identified that are currently available which offer the potential to strengthen and enhance risk assessment.
Project 7: The Role of Alternative Methods in Nanotoxicology
This project has been established to: i) assess available in vitro methods and evaluate how they might be used in an overall assessment plan for hazard testing of MNs; ii) prepare an analysis by comparing in vivo and in vitro studies through testing MNs (human and ecotoxity endpoints); and iii) to produce a guidance document for the longer term and for more general use on the use of alternative approaches, including in vitro methods, for the hazard evaluation of MNs.
As a first step, a report is being prepared including: i) a list of in vitro endpoints on human health and ecotoxicity; ii) the kind of information that the in vitro tests will provide; iii) a list of validated in vitro tests that might be used for testing NMs; and iv) a background document on the feasibility for validating further in vitro methods and to consider the development of further in vitro tests.
Project 8: Exposure Measurement and Exposure Mitigation
The objective of this project is to exchange information on guidance documents for exposure measurement and exposure mitigation and to develop recommendations on future work that needs to be undertaken. Specifically, the project aims to address: 1) exposure in occupational settings; 2) exposure to humans resulting from contact with consumer products and environmental releases of MNs; 3) exposure to environmental species resulting from environmental releases of MNs including releases from consumer products containing MNs. The WPMN recognizes that exposure measurement and exposure mitigation information developed for incidental nanoscale particles is highly relevant to this project and thus it will be considered.
Project A: Statistics and Measurement
The objectives of this project are twofold. The first objective is to overview of the current status, importance and development of nanotechnology using currently scantly available and internationally comparable science, technology and innovation indicators and statistics. This overview will draw on available national and international sources, including member government reports. It will also draw on private sources, where relevant, and assess the quality and comparability of such indicators and statistics. This overview will be published as an OECD report entitled “Nanotechnology at a Glance”. The report will be a building block for further efforts in developing internationally comparable statistics and indicators.
The second objective of this project is to develop a framework for internationally comparable and validated statistics, according to agreed definitions and classifications, supported by possible firm-level model surveys. This objective will be undertaken in conjunction and subsequent to the first objective and will involve cooperative work with OECD’s Working Party on National Experts in Science and Technology Indicators (NESTI).
Project B: Nanotechnology Impacts on Companies and the Business Environment
The overall objective of this project is to contribute to an improved understanding of the current and potential specific implications of nanotechnology for innovation and economic growth and for policymaking in these areas. The project foremost uses qualitative case study approaches for achieving its objectives. The primary source of information about the impacts of nanotechnology on companies and business environments will be face-to-face interviews with the relevant company representatives using a pre-designed questionnaire. In addition to the qualitative company case studies will also be complemented with a questionnaire on broader characteristics and developments of science, technology and innovation policies across countries.
This questionnaire will highlight challenges and opportunities of policymaking in this field and is also intended to facilitate a policy dialogue. The results of the project will be presented in a final report to the WPN. Project outcomes may also be discussed at a Workshop to be held in 2008 to which business leaders, policymakers, and other experts will be invited.
Project C: International R&D collaboration
This objective of this project is to map research infrastructures, science and technology agreements across countries in order to increase the awareness of countries about opportunities for international R&D collaboration and thereby facilitate this cross-country activity. The information collected in this project can also provide insights about the development of nanosciences and technologies, and assess whether new types and patterns of R&D collaboration at the global level are emerging due to the specificities of this field.
Project D: Communication and public engagement
The objective of this project is to gather experiences from member countries on communication and outreach activities related to nanotechnology in order to support public engagement and foster a dialogue among stakeholder communities (including industry, researchers, policy makers, and the public). The OECD secretariat is currently developing, together with this project steering group, a questionnaire which will be sent to countries delegates and specialists in the area of emerging technologies agencies, to know more about actual and foreseen activities in communicating around nanotechnology and engage the general public in the debates. Combined with other available material and a dedicated workshops this questionnaire will be used for identifying and supporting further good practices in this area..
Project E: Policy Dialogue
The first objective of this project is to develop an inventory of current S&T policies covering OECD member countries and some non-member countries that can form the basis of a synthesising report on the nature, organization, objectives and recent changes in S&T policies related to nanotechnology across countries. The inventory will be based on information that has been identified from public sources and on a dedicated questionnaire which has been sent out to the WPN delegates. The synthesising report will contribute to highlighting common challenges and opportunities of S&T policies in nanotechnology across countries and constitute one basis for a policy dialogue.
The second objective of this project is to facilitate a policy dialogue. As suggested above the synthesising report could form a basis for the dialogue. The other facilitating activity will take the form of one or two workshops in summer or autumn 2008. This workshop will involve OECD member and non-member delegates, as well as invited S&T policy experts and a number of other key stakeholders.
Project F: Global Challenges: Nano and Water
The objective of this project is to examine nanotechnology developments, opportunities and diffusion barriers in the area of water purification. The access to affordable and clean water is a major global challenge, especially for developing countries. Nanotechnology offers a range of interesting technologies such as enhanced membranes, filters, catalysts, sensors etc. that can provide concrete solutions in this context. Nonetheless the further development and diffusion of these technologies are still in an early phase, and might face various barriers to adoption. This project will undertake expert interviews and focused analyses in this field to help address some of the key challenges in delivering policies that can unlock the potential that nanotechnology can have.
This project has recently received additional funding and is presently in an intensive design and start-up phase with scheduled expert panel interviews in February as well as preparations for a workshop session at the Nanotechnology in Northern Europe 2008 conference to be held in September 23-25 in Copenhagen. This project also hopes to contribute to the fifth World Water Forum conference to be held in March 2009 in Istanbul.