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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. Nanotechnology development milestones (I).

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rob visser acting director environment directorate oecd

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

nanotechnology development milestones i
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
nanotechnology development milestones ii
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.]

slide6
Share of nanotechnology and all patents by country from 2005Source: OECD, Patent database, January 2008
slide7

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

examples of nanotechnology applications
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.]

slide9
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.
key points applications
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)
much information derived from oecd projects of the working party of nanotechnology
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

but there are regulatory challenges are nanomaterials safe
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
focus on safety testing
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?
slide14

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
why are oecd test guidelines important cont d
Why are OECD Test Guidelines important? (cont’d)

The use of OECD Test Guidelines

+

OECD Principles for Good Laboratory practice

=

Mutual Acceptance of Data

oecd s work of oecd s working party on manufactured nanomaterials
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
focus on safety testing do existing methods work
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]

slide18

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
manufactured nanomaterials and test guidelines
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
manufactured nanomaterials and test guidelines21
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]

alternative methods in nano toxicology to reduce animal testing
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

sponsorship programme implementation two stages
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

sponsorship programme stage 1 list of manufactured nanomaterials 14
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
sponsorship programme stage 1 list of endpoints
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)
stage 2 sponsorship programme
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
sponsorship programme for testing manufactured nanomaterials steps to date
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)
wpmn projects summary next steps i
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
wpmn projects summary next steps ii
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.
summary
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.
more information
More information

E-mail: nanosafety@oecd.org

Public website:http://www.oecd.org/nanosafety/