OECD Work on the Safety of Manufactured Nanomaterials Environment, Health and Safety Division Environment Directorate OECD November 2009

OECD Work on the Safety of Manufactured Nanomaterials

Environment, Health and Safety DivisionEnvironment Directorate OECD

November 2009

Table of Contents

I. Organization for Economic Co-operation and Development

II. Why safety of nanotechnologies?

III. Human Health and Environmental Safety

IV. OECD Working Party on Manufactured Nanomaterials

V. Current WPMN Projects

VI. OECD Conference on Potential Environmental Benefit of Nanotechnology

www.oecd.org/env/nanosafety

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Finland

Canada

Australia

GreeceIreland

Korea

Netherlands

Poland

Sweden

UK

AustriaCzechRepublic

FranceHungary

Italy

Luxembourg

New Zealand

Portugal

Switzerland

US

Belgium

Denmark

Germany

IcelandJapan

MexicoNorway

Turkey

Spain

Slovak Republic

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I. Organization for Economic Co-operation and Development

II. Why Safety of Nanomaterials?

• Nanotechnologies are likely to have a major impact across a range of economic sector:

(e.g.) energy production, health industry, cosmetics, information technology, textiles

• Global Market of Nanotechnologies has increased over time

- By 2015, 2 million jobs & $1 trillion production (referred by National Nanotechnology Initiative(NNI))

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• Safety information is needed on Effects of nanomaterials (testing)

Exposure Measurement (occupational, consumers and environment)

Hazard assessment

Risk assessment

•


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III. Human Health and Environmental Safety

IV. OECD Working Party on Manufactured Nanomaterials

• Background - Safety of Nanotechnologies first addressed at OECD (Nov 2004, Chemicals Committee)

- Special Session on the potential implications of manufactured nanomaterials for human health and environmental safety (June 2005) - Workshop on the Safety of Manufactured Nanomaterials (Dec 2005)

• Establishment of the WPMN (Sep 2006)

• WPMN Meetings - 1st WPMN (Oct 2006) – 6th WPMN (Oct 2009)

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• Participants to the WPMN

OECD member countries:

- Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Slovak Republic, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States, European Commission.

Observers:

- Brazil, China, Singapore, South Africa, Thailand and the Russian Federation; - Inter-governmental Organisations: IOMC, FAO, UNEP, UNITAR and WHO; and - Other Organisations: BIAC, ICAPO, ISO(TC 229), TUAC and Environmental NGOs


V. Current WPMN Projects• OECD database on Manufactured Nanomaterials to Inform and Analyse EHS Research Activities;• Safety Testing of a Representative Set of

Manufactured Nanomaterials;• Manufactured Nanomaterials and Test Guidelines;• Co-operation on Voluntary Schemes and

Regulatory Programmes;• Co-operation on Risk Assessment;• The Role of Alternative Methods in Nano

Toxicology; • Co-operation on Exposure Measurement and

Exposure Mitigation; and • Co-operation on the Environmentally Sustainable

Use of Nanotechnology 8www.oecd.org/env/nanosafety

OECD Database on Manufactured Nanomaterials to Inform and Analyse

EHS Research Activities• Objective - To develop a global resource (Database), which details research projects and identifies research needs - To provide opportunities to identify the similar fields, and lead to create new collaboration and networks

• Status - Database was publicly launched (April 2009), and includes more than 730 research data (Oct 2009) - Comprehensive compilation document “EHS Research Strategies on MNs” was published (May 2009)

• Next Step - Evaluating the database for data quality, user-usefulness to identify research priorities and gap analysis


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Safety Testing of a Representative Set of Manufactured Nanomaterials:

Sponsorship Programme

• Objective

- To test a representative set of Manufactured Nanomaterials (14)

• Status/Next steps

- Stage 1 (completed)

A list of MNs (based on materials which are now or soon to enter, commerce) and a list of endpoints

- Stage 2 (July 2009~) Implementation of the Sponsorship Programmes for the

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Sponsorship Programme for Testing Manufactured Nanomaterials

International effort to share the testingof an agreed set of manufactured nanomaterials selected by WPMN

• Two phases:

- Phase 1: to test selected MNs for the selected endpoints (launched Nov 2007)

- Phase 2: consideration of those cross-cutting issues or tests that identified by phase 1


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Lead sponsor(s

)Co-sponsor(s) Contributors

Fullerenes(C60) Japan, US Denmark, China

SWCNTs Japan, USCanada, France, Germany,

EC, China, BIAC

MWCNTs Japan, US Korea, BIACCanada , Germany, France,

EC, China, BIAC

Silver nanoparticles Korea, US

Australia, Canada, Germany,

Nordic Council of Ministers

France, EC, China, Netherlands

Iron nanoparticles BIAC, ChinaCanada, US,

Nordic Council of MinistersCarbon black Denmark, Germany, US

Titanium dioxideFrance,

GermanyAustria, Canada, Korea,

Spain, US, EC, BIAC China, Denmark, Japan, UK

Aluminium oxide Germany, US, Japan

Cerium oxide US, UK/BIACAustralia, Netherlands,

Spain

Denmark, Germany, Switzerland, EC, Japan,

Netherlands

Zinc oxide UK/BIAC Australia, Spain, US, BIACCanada, Denmark, Japan,

Germany, NetherlandsSilicon dioxide France, EC Belgium, Korea, BIAC Denmark, Japan

Polystyrene Austria, KoreaDendrimers Spain, USNanoclays Denmark, US, EC


List of Endpoints for phase 1

► Nanomaterial Information/Identification (9 endpoints)

► Physical-Chemical Properties and Material Characterization (17 endpoints)

► Environmental Fate (15 endpoints)

► Environmental Toxicology (6 endpoints)

► Mammalian Toxicology (9 endpoints)

► Material Safety (3 endpoints)www.oecd.org/env/nanosafety 13

Manufactured Nanomaterials and Test Guidelines


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• Objective

- To review existing OECD Test Guidelines for adequacy in addressing MNs

- To identify need for new or revised test guidelines


- Preliminary conclusions: Most test guidelines are appropriate (some might need adjustment)

- Preliminary Guidance Notes on Sample Preparation

and Dosimetry (to be published in early 2010)

- Elaborating the Work Plan/Proposal for Test Guidelines

(~ 2012)

Co-operation on Voluntary Schemes and Regulatory Programmes


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• Objective

- To develop a report on regulatory regimes

- To gather Information on the lessons learned from information gathering initiatives on MNs

• Status - Finalized a regulatory regime report and an analysis of Information gathering schemes (Oct 2009)

• Next steps

- To develop follow-up surveys to the regulatory regime and information gathering schemes (Late 2009~)

Trends relating to activity or changes can be seen through these follow-ups

Co-operation on Risk Assessment


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• Objective

- To evaluate risk assessment approach for MNs• Status

- Workshop on Risk Assessment of Manufactured Nanomaterials in a Regulatory Context* (Sep 2009, Washington D.C, co-hosted by BIAC/SRA)

• Next Step

- Report on Issues critical to Risk Assessment of Manufactured Nanomaterials (2010)

- Analysis of how research results can contribute to current risk assessment approaches ( 2012)

*Workshop Report will be published (early 2010)

Role of Alternative Methods in Nano Toxicology


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• Objective

- To address the use of alternative test methods and testing strategies (in parallel with the Sponsorship Programme)


- A text on alternative methods will be included in the Guidance manual for the Testing of Manufactured Nanomaterials (early 2010)

Co-operation on Exposure Measurement and Exposure Mitigation: occupational,

consumers and environment


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• Objective - To exchange information on guidance for exposure measurement and

exposure mitigation for Manufactured Nanomaterials

• Status - Prioritized list of project on occupational, consumers and environment (Oct

2009)

• On-going Projects - Evaluating data and provide recommendation on measurement

technologies and sampling protocols for determining concentrations of manufactured nanomaterials in air (led by Australia)

- Comparing exposure mitigation guidance for laboratories (led by Germany)

• Next Step - Developing Case Studies for exposure assessment on Manufactured Nanomaterials (late 2009~) - Participating in Aerosol Society Symposium (mid-2010)

Co-operation on the Environmentally Sustainable Use of Nanotechnology


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• Background

- OECD Conference on Potential Environmental Benefits of Nanotechnology:

Fostering Safe Innovation-Led Growth (15-17 July 2009, Paris)

- As a follow up of the conference, WPMN agreed to establish a new project

• Purpose

- To develop tools and frameworks based on life cycle considerations for different nano-enabled applications that : i) directly address an environmental problem; and ii) indirectly contribute to environmental objectives.

• Next Step

- To finalize the Operational Plan (2009-2012) and start the implementation of the project

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

• The conference on Potential Environmental Benefits of Nanotechnology took place on 15-17 July 2009 in Paris

This event was jointly organized with the OECD’s Working Party on Nanotechnology (WPN)

• Focused on:

Nano-applications; Their potential environmental benefits; EHS concerns; as well as Policy considerations

• The areas of these applications discussed were:

water treatment and purification; environmental sensing; Clean car technology; Cellulose nano fibres; Site remediation; Better batteries; Agricultural nanotechnology; and Greener nanotechnology

• Conference report (to be published 2010) www.oecd.org/env/

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• IOMC/OECD/UNITAR Awareness-Raising Workshop for Developing and Transition Countries on Nanotechnology

and Manufactured Nanomaterials - 27 November 2009, in Beijing, China

- 11 December 2009, in Lodz, Poland

- 26-27 January 2010, in Abidjan, Cote d’lvoire

- 12 March 2010, in Kingston, Jamaica

- 2010 (TBD), in Alexandria, Egypt

• 6th Working Party on Nanotechnology (1-2 December 2009, OECD Conference Centre, Paris)

• 7th Meeting of the Working Party on Manufactured Nanomaterials

(26-28 May 2010, OECD Conference Centre, Paris)


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Forthcoming Events

Recent Publications on Manufactured Nanomaterials(published in 2009)

• Manufactured Nanomaterials: Roadmap for Activities during 2009 and 2010 • Current Developments in Delegations and other International Organizations on the

Safety of Manufactured Nanomaterials - Tour de Table • Manufactured Nanomaterials: Work Programme 2009-2012 • Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured

Nanomaterials • Guidance Manual for the Testing of Manufactured Nanomaterials: OECD

Sponsorship Programme • Report of an OECD Workshop on Exposure Assessment and Exposure Mitigation:

Manufactured Nanomaterials• Comparison of Guidance on Selection of Skin Protective Equipment and

Respirators for Use in the Workplace: Manufactured Nanomaterials • Emission Assessment for the Identification of Sources and Release of Airborne

Manufactured Nanomaterials in the Workplace: Compilation of Existing Guidance • Identification, Compilation and Analysis of Guidance Information for Exposure

Measurement and Exposure Mitigation: Manufactured Nanomaterials • EHS Research Strategies On Manufactured Nanomaterials: Compilation Of Outputs • Preliminary Analysis of Exposure Measurement and Exposure Mitigation in

Occupational Settings: Manufactured Nanomaterials These publications can be downloaded at: www.oecd.org/env/nanosafety


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Upcoming Publications on Manufactured Nanomaterials

• Analysis Information Gathering Initiatives on Manufactured Nanomaterials

• Preliminary Guidance Notes on Sample Preparation and Dosimetry

• Alternative Methods: Annex to the Guidance Manual for the Testing of Manufactured Nanomaterials: OECD’s Sponsorship Programme

• Critical Issues in the Risk Assessment of Manufactured Nanomaterials

• Current Developments/ Activities on the Safety of Manufactured Nanomaterials: Tour de table at the 6th Meeting of the Working Party on Manufactured Nanomaterials


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More information

Safety of Manufactured Nanomaterials


Contact OECD [email protected]


http://www.oecd.org/env/nanosafety

mailto:[email protected]

Documents

OECD Work on the Safety of Manufactured Nanomaterials Environment, Health and Safety Division Environment Directorate OECD November 2009