Parallel session 5

1. International Developments for
Nanotechnology Standardization
Nov 1, 2012
Ne3LS Network International Conference 2012
Session V: Risk management and regulation in nanotechnology
Roland Hosein PhD
Chair, Standards Council Canada Mirror Committee (SMC)
for ISO TC 229, Nanotechnology,
facilitated by CSA Group (Canadian Standards Association)

2. 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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3. 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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4. 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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5. 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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6. 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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7. 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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8. ISO and IEC nano-standards, begun in 2005
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9. 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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10. Hierarchical Relationship
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11. 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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12. 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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13. Important ISO/TC229 WG3 standards completed
and near completion
• 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
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14. Other important ISO/TC229 WG3 work item
re-starting and under consideration
• 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
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15. 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
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16. Nano-Standards Participation and Progress
ISO/TC229 IEC/TC113 Canada’s CSA Nano
(international) (international) SMC / CSA TC
(national)
Number of Countries P: 34 P: 16 Members:
Participating / O: 12 O: 16 SMC: 89
Observer TC: 26
Number of delegates 180 (8 from Canada) 20 (2 from Canada) 29
at last international (14th Plenary at (7th Plenary at (22nd SMC at
meeting Stresa, Italy; Milpitas, USA; Montreal; Mar 2012)
Jun 2012) Oct 2012)
Number of standards 26 4 1 (Oct. 11, 2012)
published
Number of 17 underway 10 underway 1 (at TC ballot);
standards in-progress and 5+ pre- and new and 11 pre- and new others to follow
work items work items
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17. 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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18. 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” 18

19. 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
* Extracted from “Health Canada’s Mandate and Responsibilities in Regulating Nanomaterials” Nanotechnologies Workshop, May 23, 2012
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20. 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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21. 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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22. 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
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