Opportunities of nanomaterials and current state of knowledge about potential health and environmental risks what regu

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 2

3. Nanotechnology development milestones (II) 1990s: China adds nanotechnology to its S&T priorities in the 863 National High Technology Programme at MOST 2001: US National 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.] 3

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

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

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

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

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.] 8 Electronics and communications Data storage media with very high recording densities, new flat-panel plastic display technologies, new materials for semiconductors that increase processing speeds, the realisation of molecular or (bio)molecular electronics, spintronics and quantum computing. Materials and construction Use of nanoparticles and coatings for reinforced materials and machinery parts, super-hard and tough drill bits and cutting tools, �smart� magnetic fluids for vacuum seals and lubricants, scratch-proof or non-wettable surfaces, anti-bacterial construction material, self-cleaning and reactive eco-efficient windows. Pharmaceuticals and health care Potential applications include miniaturised diagnostics that could be implanted for the early diagnosis and monitoring of illnesses, nanoscale coatings to improve the bioactivity and biocompatibility of implants, ultra-precise nanostructured drug delivery systems, sensors for labs-on-a-chip, new materials for bone and tissue regeneration. Machinery and tools Nanopowders sintered into bulk materials giving special properties, extremely sensitive sensors to detect incipient failures and actuators to repair problems, chemical-mechanical polishing with nanoparticles, self-assembling of structures from molecules, bio-inspired materials and biostructures. Energy New types of batteries, artificial photosynthesis for clean energy, efficient 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 from industrial effluents, improved remediation methods (e.g. photo-catalytic techniques). Electronics and communications Data storage media with very high recording densities, new flat-panel plastic display technologies, new materials for semiconductors that increase processing speeds, the realisation of molecular or (bio)molecular electronics, spintronics and quantum computing. Materials and construction Use of nanoparticles and coatings for reinforced materials and machinery parts, super-hard and tough drill bits and cutting tools, �smart� magnetic fluids for vacuum seals and lubricants, scratch-proof or non-wettable surfaces, anti-bacterial construction material, self-cleaning and reactive eco-efficient windows. Pharmaceuticals and health care Potential applications include miniaturised diagnostics that could be implanted for the early diagnosis and monitoring of illnesses, nanoscale coatings to improve the bioactivity and biocompatibility of implants, ultra-precise nanostructured drug delivery systems, sensors for labs-on-a-chip, new materials for bone and tissue regeneration. Machinery and tools Nanopowders sintered into bulk materials giving special properties, extremely sensitive sensors to detect incipient failures and actuators to repair problems, chemical-mechanical polishing with nanoparticles, self-assembling of structures from molecules, bio-inspired materials and biostructures. Energy New types of batteries, artificial photosynthesis for clean energy, efficient 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 from industrial effluents, improved remediation methods (e.g. photo-catalytic techniques).

9. OECD Conference on �Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth  9

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) 10

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 11

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 12

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? 13

14.  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  14

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 15

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 16

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] 17

18. 18 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. 19

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 20

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] 21

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 22

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 23

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 24

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) 25

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 26

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) 27

28. *Asterisk indicates countries, which will conduct integrate alternative testing. Note: The table sponsors for phase 1 is updated every time that a delegations join the programme. The phrase �representative nanomaterials� was intended to mean those manufactured nanomaterials (MNs) now or soon to enter into commerce. Lead Sponsor(s) assume responsibility for conducting or coordinating all of the testing. Co- Sponsor(s) conduct some of the testing determined to be appropriate and feasible. A Contributor provides test data, reference or testing materials or other relevant information to the lead and co-Sponsors. *Asterisk indicates countries, which will conduct integrate alternative testing. Note: The table sponsors for phase 1 is updated every time that a delegations join the programme. The phrase �representative nanomaterials� was intended to mean those manufactured nanomaterials (MNs) now or soon to enter into commerce. Lead Sponsor(s) assume responsibility for conducting or coordinating all of the testing. Co- Sponsor(s) conduct some of the testing determined to be appropriate and feasible. A Contributor provides test data, reference or testing materials or other relevant information to the lead and co-Sponsors.

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 29

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. 30

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. 31

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