Rob Visser Acting Director Environment Directorate OECD

1. Opportunities of nanomaterials and current state of knowledge about potential health and environmental risks – what regulators need to know. Rob Visser Acting Director Environment Directorate OECD

2. Nanotechnology development milestones (I) • 1959: Nobel prize winner in physics Robert Feynman’s (US) “There’s plenty of room at the bottom” • 1974: “Nanotechnology” concept proposed by Norio Taniguchi of the Tokyo University of Science • 1984: Fullerenes discovered by Richard Smiley and colleagues at Rice University in the US • 1986: Eric Drexler of the MIT in the US publishes “Engines of Creation: The Coming Era of Nanotechnology” • 1986: Foresight Nanotech Institute established as the first one to educate society about the benefits and risks • 1991: Carbon nanotubes discovered by Sumio Ijima of NEC, Japan

3. Nanotechnology development milestones (II) • 1990s: China adds nanotechnology to its S&T priorities in the 863 National High Technology Programme at MOST • 2001: USNational Nanotechnology Initiative launched • 2002: The European Commission designated nanotechnology a priority area in the Sixth Framework Program • 2005: The Japanese “Strategic Technology Roadmap” published • 2006: The EU “Roadmaps at 2015 on Nanotechnology Application” published • 2007: Russia announces USD 8 billion investment in nanotechnology from 2007-2015 • 2008: The US “Technology Roadmap for Productive Nanosystems” published • 2008: Korean “Nanotechnology Roadmap” published [Source: Adapted from True Nano, Kaiser (2006), various websites.]

4. Public R&D investments in nanotechnology globally Source: (Roco, 2007)

5. Number of nanotechnology-related publicationsSource: ISI Web of Knowledge database, January 2008

6. Share of nanotechnology and all patents by country from 2005Source: OECD, Patent database, January 2008

7. Selection of global market forecasts for nanotech-enabled products, billion USDSource: Publicly available information on private market forecasts.

8. Examples of nanotechnology applications • Electronics and communications • Data storage media • Semiconductors • (bio)molecular electronics, • Materials and construction • reinforced materials • “smart” magnetic fluids • scratch-proof or non-wettable surfaces, • self-cleaning and reactive eco-efficient windows. • Pharmaceuticals and health care • miniaturised diagnostics • nanoscale coatings (to improve the bioactivity and biocompatibility of implants) • ultra-precise nano-structured drug delivery systems • new materials for bone and tissue regeneration • Machinery and tools • extremely sensitive sensors (to detect incipient failures and actuators to repair problems) • chemical-mechanical polishing • self-assembling of structures from molecules • Energy • Batteries • artificial photosynthesis for clean energy • low-cost photovoltaic solar cells (e.g. solar “paint”) • safe storage of hydrogen for use as a clean fuel. • Environment and water • Enhanced membranes for water purification, • nanostructured filters for removing pollutants • improved remediation methods (e.g. photo-catalytic techniques). [Source : OECD (2005), OECD (2008) and others.]

9. OECD Conference on  Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth • Discussed in depth, through case studies, potential applications including in the following areas: • Energy generation, storage and conservation  • Agricultural nanotechnology (e.g. pesticide encapsulation, and slow release fertilizers); • Cleaner production (e.g. car emission control); • Water treatment and purification; • Remediation of hazardous sites; • Environmental monitoring of pollutants; and • Green chemistry – synthesis and processing of chemicals.

10. Key Points: Applications • Clearly, nanotechnology is set to have a major impact on many industries • An early forecast suggests that 2 million nano-related jobs could be created by 2015 • Currently, mainly impacts on consumer products (e.g. cosmetics, clothing, personal care, sports equipment) • Could address global challenges (e.g. energy constraints, climate change, affordable health care, access to clean water)

11. Much information derived from OECD projects of the Working Party of Nanotechnology • Statistical framework for nanotechnology • Monitoring and benchmarking nanotechnology developments • Addressing challenges in the business environment specific to nanotechnology • Fostering nanotechnology to address global challenges (e.g. cleaner water) • Fostering international scientific co-operation in nanotechnology • Policy roundtables on key policy issues related to nanotechnology www.oecd.org/sti/nano

12. But there are regulatory challenges: Are nanomaterials safe? To determine safety information is needed on: • The effects of nanomaterials (testing) • Exposure determination (occupational, consumers and environment) • Hazard assessment • Risk assessment

13. Focus on Safety Testing • What information currently exists? • Are existing test methods (e.g. OECD test guidelines) suitable for nanomaterials? • How can comparability of testing be verified?

14. Why are OECD Test Guidelines important ? 120 Internationally agreed OECD’s guidelines for the testing of chemicals covering: • Physical Chemical Properties • Effects on Biotic Systems • Degradation and Accumulation • Health Effects • Other Test Guidelines

15. Why are OECD Test Guidelines important? (cont’d) The use of OECD Test Guidelines + OECD Principles for Good Laboratory practice = Mutual Acceptance of Data

16. OECD’s Work of OECD’s Working Party on Manufactured Nanomaterials Who participates? • 30 OECD Member Countries and the European Commission • Non-member economies: A5; EE; Singapore, and Thailand. • Inter-governmental organizations: (IOMC) • International Standards Organisation (ISO TC229) • Other stakeholders: business/ industry; organized labour; environmental NGOs, and animal welfare organizations

17. Focus on Safety Testing: do existing methods work? Objective: To test an agreed representative set of manufactured nanomaterials using appropriate test methods. Aim: To understand the types of information on intrinsic properties that may be relevant to exposure and the effects assessment of MNs. [In close co-ordination with other OECD work on Chemical Safety: Test Guidelines, Mutual Acceptance of Data]

18. www.oecd.org/env/nanosafety/database • What information already exists: • Database launched , 1 April 2009 • Shows completed, current and planned research on human health and environmental safety • Projects’search based on: • Name of the nanomaterial • OECD Test Guideline used; and • endpoints

19. Advanced Search

20. Manufactured Nanomaterials and Test Guidelines Preliminary conclusions from the review of the OECD Test Guidelines: • Most test guidelines (though not all) are appropriate for nanomaterials • Some may need adjustment

21. Manufactured Nanomaterials and Test Guidelines Recommendations from the review of the OECD Test Guidelines: There is a strong need to develop guidance on: • Sample Preparation and Dosimetry (as a top priority) • Also, the need for a comparison of Instillation vs. Inhalation studies [Both under preparation by OECD WPMN]

22. Alternative Methods in Nano Toxicology to reduce Animal Testing Status: • Review of currently validated in vitro methods to evaluate their applicability for testing nanomaterials • Integration with other OECD projects • Testing needs to be considered during sponsorship programme Project to evaluate and, where applicable, validate in vitro and other methodologies

23. Sponsorship Programme Implementation - Two Stages Stage 1 Agreement on: i) A list of MNs (based on materials which are now, or soon to enter, commerce) ; and ii) A list of endpoints for which these MNs should be tested. Stage 2Development of a sponsorship programme to test MNs for human health and environmental safety

24. Sponsorship Programme Stage 1:List of Manufactured Nanomaterials (14) • Fullerenes (C60) • Single-walled carbon nanotubes (SWCNTs) • Multi-walled carbon nanotubes (MWCNTs) • Silver nanoparticles • Iron nanoparticles • Carbon black • Titanium dioxide • Aluminium oxide • Cerium oxide • Zinc oxide • Silicon dioxide • Polystyrene • Dendrimers • Nanoclays

25. Sponsorship Programme Stage 1: List of Endpoints • Nanomaterial Information/Identification (9 endpoints) • Physical-Chemical Properties and Material Characterization (16 endpoints) • Environmental Fate (14 endpoints) • Environmental Toxicology (5 endpoints) • Mammalian Toxicology (8 endpoints) • Material Safety (3 endpoints)

26. Stage 2: Sponsorship Programme The sponsorship programme is an international effort to share the testing of an agreed set of manufactured nanomaterials selected by the WPMN. Two phases: • Phase 1: To test selected MNs for the selected endpoints (official launch of phase 1: November 2007) • Phase 2: consideration of those cross-cutting issues or tests that are identified by phase 1 by the WPMN

27. Sponsorship Programme for testing manufactured Nanomaterials:Steps to date • Launched November 2007 • OECD Secretariat is the clearing house to ensure co-ordination • Publication of a guidance manual for sponsors to guide the testing • 10 Draft Dossier Development Plans were considered by the 5th WPMN (March 2009) • Discussion of the phase 2 at the 6th WPMN (28-30 October 2009)

29. WPMN projects: Summary/ Next steps (I) • Project 1: Database on Human Health and Environmental Safety Research: Launched in April 1st, 2009 • Project 2: Research Strategy(ies) on Human Health and Environmental Safety Research: Review of current research programmes has identified research themes which already have wide coverage globally and those less well covered • Project 3: Testing a Representative Set of Manufactured Nanomaterials (MN): Sponsorship programme for the testing of 14 MNs for 53 endpoints • Project 4: Manufactured Nanomaterials and Test Guidelines: Development of guidance on sample preparation and dosimetry for the testing of manufactured nanomaterials

30. WPMN projects: Summary/ Next steps (II) • Project 5: Co-operation on Voluntary Schemes and Regulatory Programmes: Analysis of national information gathering programmes • Project 6: Co-operation on Risk Assessment: Review of existing risk assessment schemes and their relevance to nanomaterials • Project 7: The Role of Alternative Methods in Nanotoxicology: Reviewing alternative test methods which will avoid animal tests and which will be applicable to manufactured nanomaterials. • Project 8: Exposure Measurement and Exposure Mitigation: Recommendations on exposure and measurement techniques in the workplace, consumers and environment.

31. Summary • Nanotechnology presents many opportunities across a wide-range of economic sectors; • At the same time, there are many challenges related to safety; • Many areas are currently being addressed. • It is a global challenge, and there is time to address this in an inclusive way with all the stakeholders involved • SAICM/ UNITAR/ OECD/ IOMC are engaged to address the challenge in developing countries.

32. More information E-mail: nanosafety@oecd.org Public website:http://www.oecd.org/nanosafety/