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Taiwan’s Position on Nano Risk
                          Governance

                                 Tsing-Tang SONG
                                 ttsong@itri.org.tw
                       Industrial Technology Research Institute
                                       Taiwan


                                            CICN, Montreal, Canada, Nov 1, 2012

                                                                                  1
Copyright ITRI
Outline

             National nanotechnology program in Taiwan
             Survey of nanomaterials applications/revenues
             Status of nano risk governance in Taiwan




                                                              2
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Distribution of Fund on Taiwan
                 National Nanotechnology Program
                     •Phase Ⅰ(2003~2008) budget:USD 554 M
                     •Phase Ⅱ(2009~2014) proposed : USD 689M




                                                               3
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Budget Execution of Taiwan National
                    Nanotechnology Program 2012

    Final Accounts: USD 95 million (Fiscal Year 2012)
                                   Advanced Research
                                                      19%
                                            10%
            Strategic Projects                                          71%

         • EHS ~45 %
         • Education ~24 %
         • Nano Standardization ~ 14%
         • nanoMark and Industry Promotion ~18 %

                                  Industrialization of Nanotechnology
                                       • Biomedical and Agriculture ~14%
                                       • Electronics & Optoeletronics ~24%
                                       • Energy & Environment ~7%
                                       • Instrument Development ~28%
                                       • Traditional Industry ~26%
  ※ USD : NTD = 1 : 30
                                                                              4
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Survey of Nanomaterials Application
            Category of nanoproducts                        Nanomaterials for industrial applications

                          Product                                   Nanomaterials            Product number
          Category                         Ratio
                          number
                                                                          Ag                        517
            Textile         390            22.3%                         TiO2                       181
        Paint & resin       30             1.7%                          SiO2                       577
                                                                      C materials                   200
      Home appliance        301            17.2%
                                                                IR emission materials                67
       Metal/machine        11             0.6%
          Building                                                       ZnO                         64
                            883            50.6%                    Mineral powder                   36
          materials
                                                                        Anion                        35
      Rubber & plastic      132            7.5%
                                                                        Others                       70
             Total         1747            100%                          Total                      1747

      Most of the nanoproducts are applied to the building materials, textile and home appliance.
      The major nanomaterials for industrial applications are SiO2, Ag, TiO2, and C materials.

                                                                                                                   5
Copyright ITRI                    Ref. The report of IEK, ITRI, sponsored by IDB, in [奈米技術在我國傳統產業發展現況調查], 2012/2
Input Resource for Nanotechnology in Taiwan
                       -Traditional Industry
   Survey of the input resource to the traditional industries in the field of home appliance/building
   materials, metal/machine equipment, textile, paint & resin, rubber & plastic from 2007 to 2012.
                                                                                             USD:NTD=1:29.5


            Major Traditional Industry       2007      2008      2009      2010      2011       2012(e)


            Engaged R&D personnel            284        288       366       398       409         478


         Input Amount on R&D (M, USD)        11.5       9.7       13.7      15        17.5        19.5

                  R&D projects               105        112       108       135       155         171

      Input Amount on Investment (M, USD)    6.5        10.3       11       11.4      14.8        23.7

                    Products                  69         87       117       235       249         271

           Sales in Products(M, USD)         48.2       77.9     125.4     229.5     317.9       371.5



                                                                                                              6
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Traditional Products for Nanotechnology in Taiwan
                               - Revenue




    The revenues of nanoproducts are continually increasing year by year from 2007 to 2012, the revenue has reached 317.9 M
     USD in 2011, increased to 38% compared to the year of 2010, the products are applied to the home appliance/building
     materials with the highest revenue in 55%, textile and metal/machine equipment contribute in 22% and 14% respectively.
                                                                                                                               7
Copyright ITRI                         Ref. The report of IEK, ITRI, sponsored by IDB, in [奈米技術在我國傳統產業發展現況調查], 2012/11
Status of Nano Risk Governance in Taiwan


                     Opportunity                               Risk


                         Responsible Development of Nanotechnology

                  Strategy:Creating industrial good practices
                 Action plans:
                 (a) creating a common platform for environment, health and safety
                 (b) allocating resources for risk assessment, management and
                     communication and focus areas

                                                                                     8
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Governance Approach to Nano Risk
                        International                                        International
      ISO/TC229         Collaboration                                        Collaboration
                                                 Nano risk
                                                                                              OECD/WPMN, WPN
                                           Governance in Taiwan
     IEC/TC113


                                                                                             Consumer
            Standardization                       EHS issues
                                                                                             Protection
                (MOEA)                          (CLA/EPA/DOH)
                                                                                              (MOEA)
 Taiwan Nanotechnology                                                                   •The nanoMark System
 Standard Council (2009)                                                                  (2004)
                                        Inter-ministerial Collaborations

                     Workplace                    Environment                        Health
                      (CLA)                          (EPA)                           (DOH)

  • Occupational exposure assessment      • The risk perception and policy   • Set up standardized evaluation
    and epidemiological study               strategy (regulation)              platform
                                          • Nanoparticles monitoring and     • in vivo and in vitro toxicological
  • Fire and explosion hazard limit
                                                                               research
  • Hierarchical process management in      measurement in air               • Epidemiological studies
    workplace                             • The fate and transformation of   • Nano regulation on biomedical
                                            nanoparticles in water             aspect
Copyright ITRI                                                                                                      9
Budget Allocation of EHS/Standardization
    Investment (Million USD)




                                                                          Percentage of Total Budget
                                                 Year
※ USD : NTD = 1 : 30
                                                                                                       10
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Taiwan nanoMark System
                 -Labeling Consumer Products




                                               11
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Why Labeling

   • Protect Consumers         :Avoid waste money
   • Protect Good Companies:Eliminate unfair competitions
                            between good and bad
                            products
   • Increase Public Trust     :Facilitate healthy development
                                of nanotechnology
   • Facilitate Trade          :Stimulate economic growth


                 Accelerate Good Nanoproduct Development

                                                                 12
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What to Label
         Focus on Consumer Products
          Impossible to Certify All Commercial Nanoproducts
           ․ Criteria/Test Methods are not all ready
          Select Criteria
           ․ Market Size
           ․ Available Test Methods/Labs
              for Nanoscale & Unique Properties
           ․ Companies’ Interest
           ․ Prudent with Risk Potential Products

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Requirements

          Basic Requirements
                 ─ Nano Scale (in principle, < 100nm)

                 ─ Unique Properties

          Quality System Installed

          Safety Issues being taken care/Traceable Products

          Contract to use “ nanoMark”


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Copyright ITRI
Status of NanoMark System in Taiwan
                           – Certified Products
    • As of Oct. 2012, established 41 certification guidelines, and 12 certification testing labs.
    • A totally of 1196 products made by 39 firms have received the nanoMark, and 1150
      products made by 34 firms still had valid nanoMarks.




                                                                                                     15
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Revenues from nanoMark Companies

                                                                                                  2011




            The ratio of revenues from nanoMark companies to total revenues is
             21%, and nanoMark companies has reached 67 M USD in 2011.
                                                                                                              16
Copyright ITRI               Ref. The report of IEK, ITRI, sponsored by IDB, in [奈米技術在我國傳統產業發展現況調查], 2012/9
Taiwan Nanotechnology Standard Council
         Taiwan Nanotechnology Standard Council (TNSC), under
         the steering of National Nanotechnology Program and
         Bureau of Standards, Metrology & Inspection, MOEA,
         was established in June, 2009.

          The TNSC will consist of four technical working areas,
           focusing separately on particular aspects of
           (1)Terminology, (2)Measurement and
           Characterization, (3)Health, Safety and
           Environmental issue of Nanotechnologies,
           (4)Material/Component/Product Performance and
           Specifications.                                            Inauguration of TNSC

          The four groups will work cooperatively to develop standards and
           formulate proposals on behalf of the nation with response to ISO/IEC
           standardization activities. ITRI is entrusted to be the Secretariat of
           TNSC.
                                                                                             17
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TNSC Activities
  Standard developments in Taiwan
  1. Method of dimensional measurement of nanoparticles on surface - scanning
       electron microscope) (Published in 2012)
  2. Traditional Chinese version of ISO/TS 27687:2008, Nanotechnologies -
       Terminology and definitions for nano-objects - Nanoparticle, nanofibre and
       nanoplate. (Published in 2012)
  3. Traditional Chinese version of ISO/TS 80004-3:2010, Nanotechnologies -
       Vocabulary - Part 3: Carbon nano-objects (committee draft)
  4. 「Guideline of quality and risk assessment for nano electrotechnical products
       」(1st working draft stage), IEC TC 113 PT-113 working project (through ANF
       liaison)
  5. Potential working items: Nanoindentation measurement standards、Nano-
       particle measurement standards for TEM、Cosmetics containing nano-
       material label
  6. Other standards: 12 CNS standards (1 terminology, 11 photo catalyst)
                                                                                  18
Copyright ITRI           41 Nano Mark standards
Regulation Studies
       The IOSH drafted two safety guidelines in 2009
      • 奈米物質作業環境控制策略指引(Guidelines for Nanomaterials at
        the Workplace)
      • 奈米技術實驗室暴露控制手冊( Guidelines for Nanomaterials
        Exposure at the Laboratory
     Throughout the guidelines, low exposure limit were proposed and
     appropriate personal protective equipments were recommended
     such as mask, protective clothing, gloves, and exhaust hood in
     the workplace.

       The DOH is working 30 drafts which are related to
        registration, examination, assessment, technique, and
        laboratory, especially in the drug, cosmetics, and medical
        devices area.
                                                                     19
Copyright ITRI
Epidemiological Studies

      Institute of Safety Health (IOSH), CLA
       cooperated with The National Health
       Research Institute (NHRI) initiated the
       epidemiological study on nano risk
       among workers exposed to
       nanoparticles in 2009. The objective of
       this study was to investigate the
       health hazards following exposure to
       nanoparticles.


     There are thirteen factories and one R&D institute to join together, a
      total of 277 participants including exposure group (142 people) and
      control group (135 people) in 2011.


                                                                                     20
Copyright ITRI                                                    Source:IOSH/NHRI
Taiwan’s Position on Nano Risk Governance

                           Objectives :
                            Analyze the status of nanotechnology risk
                             management, and evaluate the direction and major
                             topics in Taiwan.
                            Statistical data analyses and offer recommendations
                             to government policy makers, including:
                              – Establishing an empowered nanotechnology risk
                                management unit
                              – Focusing on nanopowder risk management
                              – Life cycle risk assessment of nanotechnology products
                              – Promoting occupational exposure limits for
                                nanomaterials
                              – Providing systematic assistance for the collection of
                                available information
                              – Tracking and assuring compliance with internation
                                regulations
                              – Exploring the ethical, legal, and social implications
                                issues to establish public trust
                                                                                        21
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Thank You Very Much
                   for Your Attention




                                        22
Copyright ITRI

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Tsing Tang Song_Taiwan’s position on nano risk governance

  • 1. Taiwan’s Position on Nano Risk Governance Tsing-Tang SONG ttsong@itri.org.tw Industrial Technology Research Institute Taiwan CICN, Montreal, Canada, Nov 1, 2012 1 Copyright ITRI
  • 2. Outline  National nanotechnology program in Taiwan  Survey of nanomaterials applications/revenues  Status of nano risk governance in Taiwan 2 Copyright ITRI
  • 3. Distribution of Fund on Taiwan National Nanotechnology Program •Phase Ⅰ(2003~2008) budget:USD 554 M •Phase Ⅱ(2009~2014) proposed : USD 689M 3 Copyright ITRI
  • 4. Budget Execution of Taiwan National Nanotechnology Program 2012 Final Accounts: USD 95 million (Fiscal Year 2012) Advanced Research 19% 10% Strategic Projects 71% • EHS ~45 % • Education ~24 % • Nano Standardization ~ 14% • nanoMark and Industry Promotion ~18 % Industrialization of Nanotechnology • Biomedical and Agriculture ~14% • Electronics & Optoeletronics ~24% • Energy & Environment ~7% • Instrument Development ~28% • Traditional Industry ~26% ※ USD : NTD = 1 : 30 4 Copyright ITRI
  • 5. Survey of Nanomaterials Application Category of nanoproducts Nanomaterials for industrial applications Product Nanomaterials Product number Category Ratio number Ag 517 Textile 390 22.3% TiO2 181 Paint & resin 30 1.7% SiO2 577 C materials 200 Home appliance 301 17.2% IR emission materials 67 Metal/machine 11 0.6% Building ZnO 64 883 50.6% Mineral powder 36 materials Anion 35 Rubber & plastic 132 7.5% Others 70 Total 1747 100% Total 1747  Most of the nanoproducts are applied to the building materials, textile and home appliance.  The major nanomaterials for industrial applications are SiO2, Ag, TiO2, and C materials. 5 Copyright ITRI Ref. The report of IEK, ITRI, sponsored by IDB, in [奈米技術在我國傳統產業發展現況調查], 2012/2
  • 6. Input Resource for Nanotechnology in Taiwan -Traditional Industry Survey of the input resource to the traditional industries in the field of home appliance/building materials, metal/machine equipment, textile, paint & resin, rubber & plastic from 2007 to 2012. USD:NTD=1:29.5 Major Traditional Industry 2007 2008 2009 2010 2011 2012(e) Engaged R&D personnel 284 288 366 398 409 478 Input Amount on R&D (M, USD) 11.5 9.7 13.7 15 17.5 19.5 R&D projects 105 112 108 135 155 171 Input Amount on Investment (M, USD) 6.5 10.3 11 11.4 14.8 23.7 Products 69 87 117 235 249 271 Sales in Products(M, USD) 48.2 77.9 125.4 229.5 317.9 371.5 6 Copyright ITRI
  • 7. Traditional Products for Nanotechnology in Taiwan - Revenue  The revenues of nanoproducts are continually increasing year by year from 2007 to 2012, the revenue has reached 317.9 M USD in 2011, increased to 38% compared to the year of 2010, the products are applied to the home appliance/building materials with the highest revenue in 55%, textile and metal/machine equipment contribute in 22% and 14% respectively. 7 Copyright ITRI Ref. The report of IEK, ITRI, sponsored by IDB, in [奈米技術在我國傳統產業發展現況調查], 2012/11
  • 8. Status of Nano Risk Governance in Taiwan Opportunity Risk Responsible Development of Nanotechnology  Strategy:Creating industrial good practices Action plans: (a) creating a common platform for environment, health and safety (b) allocating resources for risk assessment, management and communication and focus areas 8 Copyright ITRI
  • 9. Governance Approach to Nano Risk International International ISO/TC229 Collaboration Collaboration Nano risk OECD/WPMN, WPN Governance in Taiwan IEC/TC113 Consumer Standardization EHS issues Protection (MOEA) (CLA/EPA/DOH) (MOEA) Taiwan Nanotechnology •The nanoMark System Standard Council (2009) (2004) Inter-ministerial Collaborations Workplace Environment Health (CLA) (EPA) (DOH) • Occupational exposure assessment • The risk perception and policy • Set up standardized evaluation and epidemiological study strategy (regulation) platform • Nanoparticles monitoring and • in vivo and in vitro toxicological • Fire and explosion hazard limit research • Hierarchical process management in measurement in air • Epidemiological studies workplace • The fate and transformation of • Nano regulation on biomedical nanoparticles in water aspect Copyright ITRI 9
  • 10. Budget Allocation of EHS/Standardization Investment (Million USD) Percentage of Total Budget Year ※ USD : NTD = 1 : 30 10 Copyright ITRI
  • 11. Taiwan nanoMark System -Labeling Consumer Products 11 Copyright ITRI
  • 12. Why Labeling • Protect Consumers :Avoid waste money • Protect Good Companies:Eliminate unfair competitions between good and bad products • Increase Public Trust :Facilitate healthy development of nanotechnology • Facilitate Trade :Stimulate economic growth Accelerate Good Nanoproduct Development 12 Copyright ITRI
  • 13. What to Label Focus on Consumer Products  Impossible to Certify All Commercial Nanoproducts ․ Criteria/Test Methods are not all ready  Select Criteria ․ Market Size ․ Available Test Methods/Labs for Nanoscale & Unique Properties ․ Companies’ Interest ․ Prudent with Risk Potential Products 13 Copyright ITRI
  • 14. Requirements  Basic Requirements ─ Nano Scale (in principle, < 100nm) ─ Unique Properties  Quality System Installed  Safety Issues being taken care/Traceable Products  Contract to use “ nanoMark” 14 Copyright ITRI
  • 15. Status of NanoMark System in Taiwan – Certified Products • As of Oct. 2012, established 41 certification guidelines, and 12 certification testing labs. • A totally of 1196 products made by 39 firms have received the nanoMark, and 1150 products made by 34 firms still had valid nanoMarks. 15 Copyright ITRI
  • 16. Revenues from nanoMark Companies 2011  The ratio of revenues from nanoMark companies to total revenues is 21%, and nanoMark companies has reached 67 M USD in 2011. 16 Copyright ITRI Ref. The report of IEK, ITRI, sponsored by IDB, in [奈米技術在我國傳統產業發展現況調查], 2012/9
  • 17. Taiwan Nanotechnology Standard Council Taiwan Nanotechnology Standard Council (TNSC), under the steering of National Nanotechnology Program and Bureau of Standards, Metrology & Inspection, MOEA, was established in June, 2009.  The TNSC will consist of four technical working areas, focusing separately on particular aspects of (1)Terminology, (2)Measurement and Characterization, (3)Health, Safety and Environmental issue of Nanotechnologies, (4)Material/Component/Product Performance and Specifications. Inauguration of TNSC  The four groups will work cooperatively to develop standards and formulate proposals on behalf of the nation with response to ISO/IEC standardization activities. ITRI is entrusted to be the Secretariat of TNSC. 17 Copyright ITRI
  • 18. TNSC Activities Standard developments in Taiwan 1. Method of dimensional measurement of nanoparticles on surface - scanning electron microscope) (Published in 2012) 2. Traditional Chinese version of ISO/TS 27687:2008, Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate. (Published in 2012) 3. Traditional Chinese version of ISO/TS 80004-3:2010, Nanotechnologies - Vocabulary - Part 3: Carbon nano-objects (committee draft) 4. 「Guideline of quality and risk assessment for nano electrotechnical products 」(1st working draft stage), IEC TC 113 PT-113 working project (through ANF liaison) 5. Potential working items: Nanoindentation measurement standards、Nano- particle measurement standards for TEM、Cosmetics containing nano- material label 6. Other standards: 12 CNS standards (1 terminology, 11 photo catalyst) 18 Copyright ITRI 41 Nano Mark standards
  • 19. Regulation Studies  The IOSH drafted two safety guidelines in 2009 • 奈米物質作業環境控制策略指引(Guidelines for Nanomaterials at the Workplace) • 奈米技術實驗室暴露控制手冊( Guidelines for Nanomaterials Exposure at the Laboratory Throughout the guidelines, low exposure limit were proposed and appropriate personal protective equipments were recommended such as mask, protective clothing, gloves, and exhaust hood in the workplace.  The DOH is working 30 drafts which are related to registration, examination, assessment, technique, and laboratory, especially in the drug, cosmetics, and medical devices area. 19 Copyright ITRI
  • 20. Epidemiological Studies  Institute of Safety Health (IOSH), CLA cooperated with The National Health Research Institute (NHRI) initiated the epidemiological study on nano risk among workers exposed to nanoparticles in 2009. The objective of this study was to investigate the health hazards following exposure to nanoparticles.  There are thirteen factories and one R&D institute to join together, a total of 277 participants including exposure group (142 people) and control group (135 people) in 2011. 20 Copyright ITRI Source:IOSH/NHRI
  • 21. Taiwan’s Position on Nano Risk Governance Objectives :  Analyze the status of nanotechnology risk management, and evaluate the direction and major topics in Taiwan.  Statistical data analyses and offer recommendations to government policy makers, including: – Establishing an empowered nanotechnology risk management unit – Focusing on nanopowder risk management – Life cycle risk assessment of nanotechnology products – Promoting occupational exposure limits for nanomaterials – Providing systematic assistance for the collection of available information – Tracking and assuring compliance with internation regulations – Exploring the ethical, legal, and social implications issues to establish public trust 21 Copyright ITRI
  • 22. Thank You Very Much for Your Attention 22 Copyright ITRI