Opportunities of nanomaterials and current state of knowledge about potential health and environment

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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

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Nanotechnology development milestones (I)

• 1959 Nobel prize winner in physics Robert
  Feynmans (US) Theres 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

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Nanotechnology development milestones (II)

• 1990s China adds nanotechnology to its ST
  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.

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Public RD investments in nanotechnology globally
Source (Roco, 2007)
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Number of nanotechnology-related publications
Source ISI Web of Knowledge database, January
2008
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Share of nanotechnology and all patents by
country from 2005 Source OECD, Patent database,
January 2008
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Selection of global market forecasts for
nanotech-enabled products, billion USDSource
Publicly available information on private market
forecasts.
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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

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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.

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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)

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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

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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

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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?

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Why are OECD Test Guidelines important ?

• 120 Internationally agreed OECDs guidelines for
  the testing of chemicals covering
• Physical Chemical Properties
• Effects on Biotic Systems
• Degradation and Accumulation
• Health Effects
• Other Test Guidelines

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Why are OECD Test Guidelines important?
(contd)

• The use of OECD Test Guidelines
• OECD Principles for Good Laboratory practice
• Mutual Acceptance of Data

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OECDs Work of OECDs 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

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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

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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
• Projectssearch based on
• Name of the nanomaterial
• OECD Test Guideline used and
• endpoints

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Advanced Search
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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

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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

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Alternative Methods in Nano Toxicology to reduce
Animal Testing
Project to evaluate and, where applicable,
validate in vitro and other methodologies

• 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

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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

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Sponsorship Programme Stage 1List 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

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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)

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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

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Sponsorship Programme for testing manufactured
NanomaterialsSteps 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)

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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

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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.

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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.

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More information

• E-mail nanosafety_at_oecd.org
• Public website http//www.oecd.org/nanosafety/