International Developments for Nanotechnology Standardization

Nov 1, 2012Ne3LS Network International Conference 2012Session V: Risk management and regulation in nanotechnology

Roland Hosein PhDChair, Standards Council Canada Mirror Committee (SMC) for ISO TC 229, Nanotechnology, facilitated by CSA Group (Canadian Standards Association)

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Context for standards

• The almost simultaneous emergence of Nano science, engineering, medicine, pharmacology, materials and Nano-bio over the past 10 years is evidence that no one region or establishment can cope with the volume of standards required

• Then the almost simultaneous appearance of Nano materials and Nano enhanced products in the market place has caught society off guard regarding standards and regulations

• Despite the 10 years of evolution, little has appeared as new regulatory tools by regions. Voluntary standards for nanotechnologies are available, but applicability due to their horizontal nature may be confusing, due to the size and complexity of the field

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Context for standards – cont’d

• Regions struggle whether existing tools and principles can be used to incorporate Nano materials and Nano technology or do they have to be Nano specific

• So far from the small amount of standards published it seems like a they are evolving from a combination of both Nano and classical principles

• And in the cases of classical toxicology, epidemiology, metrology, analyses, standards, risk assessment models and controls, they are not easily fitted to the Nano models

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ISO/TC229, Standards for Nanotechnologies

• Standards development in nanotechnologies is active,fostering worldwide research to answer uncertainty questions and fill gaps

• Standards help facilitate trade, on a common platform, between nations to ensure safety in materials, components, products and systems

• World order is maintained because of standards

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Birth of International Standardization in Nanotechnology

• Eight years ago, international standards development bodies started seeing the needs for standardization in the sector

• ASTM, ISO, IEC, CEN, BSI and OECD went out to member bodies seeking agreement and support

• The lead was quickly taken by ISO, OECD and IEC. Other bodies saw the need for cooperation to develop the best standards with the limited global expertise available

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ISO- Processes for Participation

• ISO notifies member bodies (countries) about the need to develop standards and seek a vote to move forward

• Hence TC 229 on Nanotechnology was formed. Member bodies nominate country experts on the subject matter

• Countries can volunteer to be active participants (34 countries - P) or observers (12 countries - O)

• To avoid duplication and improve other standards, internal liaisons are developed with other internal TC’s (30) and external international bodies (10)

• The ISO tables tend to represent broad stakeholder involvement (Business, Government, Institutional, NGO, Associations)

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ISO- Processes for Work Items

• Member bodies can suggest or propose ideas, or table national standards for work items

• A transparent process is followed to move forward

• Experts typically nominate a project leader and set the agenda

• Work items developed towards a final document in 3-5 years of meetings, emails, conference calls, votes

• End products can be an International Standard, Technical Specification or Technical Report which member states vote

• Once published, member countries have the ability to use as is, convert to a national standard, with or without some customization

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ISO and IEC nano-standards, begun in 2005

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JWG1: Terms and Definitions

ISO/IEC 80004 Nanotechnology – Vocabulary series Oct 2012

• Part 1: Core terms – published 2010

• Part 2: Nano-objects– Nanoparticle, nanofibre and nanoplate -published 2008

• Part 3: Carbon nano-objects – published 2010

• Part 4: Nanostructured materials – published 2011

• Part 5: Nano/bio interface – published 2011

• Part 6: Nanoscale measurement and instrumentation – at ballot

• Part 7: Diagnostics and therapeutics for healthcare – published 2011

• Part 8: Nanomanufacturing processes – near ballot

• Part 9: Electrotechnical products and systems – work has begun

• Part 10: Photonics components and systems – work has begun

• Part 11: Nanolayers, nanocoatings and nanofilms – proposed

• Part 12: Quantum phenomena in nanotechnology – proposed

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Hierarchical Relationship

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JWG2: Measurement and characterization

Sampling of work items (8 standards published)

•TEM - transmission electron microscopy

•SEM/EDXA- scanning electron microscopy and energy dispersive X-ray spectrometry analysis

•NIR-PLS - near infrared photoluminescence spectroscopy

•UV-Vis-NIR - ultraviolet-visible-near infrared (UV-Vis-NIR) spectroscopy

•EGA-GCMS - evolved gas analysis/gas chromatograph-mass spectrometry

•TGA- thermo gravimetric analysis

• ICP-MS - inductively coupled plasma-mass spectroscopy

• documented measurement methods for characterization of nanomaterials with focus on carbon nanotubes; other subjects are underway

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WG3 of ISO/TC229 and IEC/TC 113

Nanotechnologies: WG3 Environment, Health, and Safety

• Toxicity/Hazard Potential• Occupational Exposure• Risk Evaluation• Environmental Protection

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• Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment

• Guidelines for occupational risk management applied to engineered nanomaterials – Part 1: Principles and approaches

• Occupational risk management applied to engineered nanomaterials – Part 2: Use of the control banding approach

• Safety Data Sheet (SDS) preparation for manufactured nanomaterials

Important ISO/TC229 WG3 standards completed and near completion

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• Nanotechnologies - Guidance on the voluntary labeling of consumer products

• Guidance on sample preparation methods and dosimetry considerations for manufactured nanomaterials

• Guidance on toxicological screening methods for manufactured nanomaterials

• NEW: General framework for OEL (Occupational Exposure Limits) development for nano-objects and their aggregates and agglomerates

Other important ISO/TC229 WG3 work item re-starting and under consideration

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Other WGs of ISO/TC229 and IEC/TC 113

WG4 of ISO/TC229: Material Specification • Commercialization and Trade

• Specifying nano-objects• Nano-calcium carbonate• Nano-titanium dioxide

WG3 of IEC/TC113: Performance Assessment • Electrical and Electronic Products

• Luminescent nanomaterials• Photovoltaic devices• Lithium-ion batteries• Quantum dots • Graphene

Nano-Standards Participation and Progress

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ISO/TC229(international)

IEC/TC113(international)

Canada’s CSA Nano SMC / CSA TC (national)

Number of Countries Participating / Observer

P: 34O: 12

P: 16O: 16

Members:SMC: 89 TC: 26

Number of delegates at last international meeting

180 (8 from Canada)(14th Plenary at Stresa, Italy; Jun 2012)

20 (2 from Canada)(7th Plenary at Milpitas, USA; Oct 2012)

29(22nd SMC at Montreal; Mar 2012)

Number of standards published

26 4 1 (Oct. 11, 2012)

Number of standards in-progress

17 underwayand 5+ pre- and new work items

10 underwayand 11 pre- and new work items

1 (at TC ballot); others to follow

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Fate of International Standards

• Voluntary standards can be referenced by a government/ jurisdiction which may make it mandatory in that jurisdiction.

• Voluntary standards can be used as is, or customised by a jurisdiction to meet local needs

• Voluntary standards provide guidance for users, can act as best practices, or help in due diligence with buyer/seller transactions.

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First In-Canada ISO/TC229 WG3 nano-standard adoption – now available

• CSA Z12885-12 is based on ISO/TR 12885:2008 – the first WG3 OHS standard from ISO/TC229

• uses CAN/CSA Z1000, Occupational Health and Safety (OHS) Management framework

• added Canada-generated content, related to OHS nano-research in Canada

• CSA Technical Committee has balanced membership from government, industry, labour, and users in Canada

• English published Oct 2012

• French available Dec 2012

CSA standards are available at http://shop.csa.ca/ search “Z12885”

Canada: Current Acts and Regulations*

• Canadian Environmental Protection Act (CEPA, 1999)– New Substances Notification Regulations

• Canada Consumer Product Safety Act (CCPSA) formerly Hazardous Products Act (HPA) – June 20, 2011

– Controlled Products Regulations– Ingredients Disclosure List– Consumer Chemicals and Containers Regulations

• Food & Drugs Act (F&DA)– Food & Drugs Regulations – Medical Devices Regulations– Cosmetics Regulations– Natural Health Products Regulations– Safety of Human Cells, Tissues and Organs for Transplantation Regulations

• Pest Control Products Act– Pest Control Products Regulations

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* Extracted from “Health Canada’s Mandate and Responsibilities in Regulating Nanomaterials” Nanotechnologies Workshop, May 23, 2012

Regulations in Canada – more information

• Refer to Canada’s Nano Portal at: http://nanoportal.gc.ca for more information

• Canada’s government participates in OECD’s Working Party for Nanotechnology (WPN) and Working Party for Manufactured Nanomaterials (WPMN), to promote international co-operation with other nations on the human health and environmental safety of manufactured nanomaterials

• Canada and the U.S. have recently finalized a Work Plan for Nanotechnology under the Canada-United States Regulatory Cooperation Council (RCC)

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International Developments for Nanotechnology Standardization: SUMMARY

•The process of international voluntary standards development is transparent which uses the best global brains

• Adoption of ISO/IEC standards helps in safe commercialization and buyer/seller/import/export relationships

• Standards are voluntary, unless referenced in legislation; some regions have started to use ISO TC229

•Canada’s voice in international, Nano-standards is strong

• Regulations in Canada are emerging in sync with advances in global developments

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Further information and acknowledgments

• Interested in being involved in standards development for nanotechnologies? • In Canada contact Brian Haydon; at brian.haydon@csagroup.org• In other countries, contact your ISO or IEC National

Standards Body

• CSA Group acknowledges funding to support standards development for nanotechnologies in Canada from:

• Alberta Innovates Technology Futures – nanoAlberta;• Health Canada;• MDEIE (Développement économique, Innovation et Exportation - Gouvernement du Québec); • NRC-IRAP (National Research Council Canada – Industrial Research Assistance Program);• And in-kind contribution from volunteer committee members and experts

• Nanotechnology standards-setting groups share great information. Here are a few leading nanotechnology committees:

• ISO - http://www.iso.org/iso/iso_technical_committee?commid=381983

• IEC - http://www.iec.ch/dyn/www/f?p=103:22:0::::FSP_ORG_ID:1315

• OECD - www.oecd.org/env/nanosafety