National Policy, Regulatory and Institutional Support Mechanism/ Framework. Critical gaps in Testing, Standardization and Certification

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2 National Policy, Regulatory and Institutional Support Mechanism/ Framework and Critical gaps in Testing, Standardization and Certification of Nanomaterials and Nanoproducts July 23 rd, 2014 Manilla, Pjilippines

3 Outline Nanotechnology - the markets new hype Role of Nanotechnology in Developing countries Nanotechnology in Pakistan National Policy approaches Regulatory and Institutional support framework Critical gaps in testing, standardization and certification 3

4 Nanotechnology (NT) the markets new hype A new term that begins to invade the market since launching of first NT based product in market in It deals with all such materials, systems, structures and applications that have at least one dimension in the range of 1-100nm. physical and chemical properties at atomic and molecular level artificially prepared with provision of combining into larger structures 4

5 Nanotechnology the markets new hype NT with its very broad and transcending boundaries is touching almost every field of science and technology, hence gathered attention of scientists, engineers, businessman, industrialists, economists and so on. NT has the potential to benefit many areas of research which contributed to sustainable development. With the launching of new products in market and their commercialization the issues related to their testing, standardization and certification came into picture. 5

6 Certification Legislations/ Regulations Standardization Testing Commercialization Product Development Research 6

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8 Why nanotechnology in Pakistan? Capable of tackling the major issues that are being faced by Pakistan i.e. Cleaner water Abundant food Disease control and diagnostics Cheaper energy Less use of non-renewable resources Greener environment 22/08/2014 8

9 Nanotechnology Activities in Pakistan: Progress and Plan Launching of National Commission on Nano Science and Technology (NCNST) Inclusion of Nanotechnology as an integral part of current Government s manifesto Setup of National Nanotechnology Technical Committee Establishment of National Nanotechnology Directorate in MoST Launching of A National Nanotechnology Statement to drive further the nanotechnology initiatives in Pakistan Approval of an umbrella project worth almost Rs 2 billion to establish a National Center of Excellence in Nanotechnology. 22/08/2014 9

10 Focus on commercialization of viable nano-products Nanotechnology Activities in Pakistan: Progress and Plan Collection of database pertaining to identification of potential R&D and nanotechnological applications in Pakistan. Capacity and human resource building leads to almost 300 researchers in the field of nanotechnology PCSIR,NUST and CIIT have been identified to strengthen their current activities to meet new challenges Development of high tech labs as infrastructure restructuring promoting nanotechnology R&D culture Research collaboration of Pakistani researchers with foreign universities and other research groups 22/08/

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12 National Commission on Nano Science and Technology (NCNST) Development of NCNST in 2003 by MoST Nanotechnology policy is decided by NCNST Objectives Human resource development Infrastructure development Research and Development Dissemination of knowledge Industrial liaison 22/08/

13 National Nanotechnology Initiatives (NNI) Vision: Accomplishment of revolution in technology and industry by nanotechnology for ultimate benefit of the society Objectives: Improve Pakistan economic competitiveness to face global challenges Accelerate scientific breakthrough on selective beneficial nanotechnologies Enhance societal and environmental contribution. Functions: To integrate all existing local nanotechnology activities To coordinate and plan the R&D activities To prepare a platform for commercialization and transfer of new technology to generate economic return for the general public To develop educational resources, skilled labor, expertise and nanotechnology infrastructure To provide facilities and nanotechnology research support services 22/08/

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15 Testing Facilities Major facilities are available in Pakistan for basic characterization of nanomaterials and nanoproducts SEM/EDX AFM/STM/MFM TEM Optical microscopy Nano-indentation XRF Electrical and magnetic measurments 15

16 Need for Standardization To reduce the risk of safety and health hazards To ensure smooth and responsible development of nanotechnology market To support innovation Application of regulations Support industry and economic development 16

17 Pakistan Standards & Quality Control Authority (PSQCA) National standardization body working under the Ministry of Science and Technology. Major responsibilities Formulation of Pakistan Standards Promulgation of standards Conformity assessment Member of International Organization for Standardization (ISO), International Electro-technical Commission (IEC), and International Organization of Legal Metrology (OIML). 17

18 Pakistan Standards & Quality Control Authority (PSQCA) Mission Promote quality business culture through standards and conformity assessment to compete internationally Standards developed

19 Different departments dealing in multifarious sectors Pakistan Standards & Quality Control Authority (PSQCA) Textiles Mechanics Health care Agriculture And Food Chemicals Electronics ICT Nanotechnology Electrotechnical Weights and Measures 19

20 National Physical and Standards Laboratory Islamabad (NPSL) The laboratory is affiliated with Pakistan Council of Scientific and Industrial Research Centre (PCSIR) Complex. Objective: To maintain national reference-standards of measurements and materials in conformity with International Standards and their dissemination in the country. NPSL is the national custodian of all physical standards of measurements and materials. NPSL realizes, maintains & disseminate the standards of measurement. 20

21 National Physical and Standards Laboratory Islamabad (NPSL) ONLY certified link of the country to the international measurement system. NPSL also carries out inter comparison of its standards with the ones held internationally so that it can be certain that any measurement made with equipment tested by NPSL conforms to the same fact the essence of the international co-operation under the SI protocol, which requires all measurement worldwide to conform to one and the same standard. NPSL acts as the focal point for all calibration / standardization and testing needs of the country Working on building Nanometrology section 21

22 Need for Certification Gaining the confidence of consumer in commercial sector Evidence of the existence of agreements between manufacturers and national accreditation testing and certification organizations. Provision of guarantee and adequate quality of nanoproducts Encourage manufacturers to develop quality products for consumer acceptance Promote favorable public opinion concerning the reliability and safety of nanoproducts and nanotechnologies 22

23 Certification Bodies TÜV Austria Bureau of Inspection and Certification (Pvt.) Limited Bureau Veritas Certification SGS Pakistan (Pvt.) Limited, Systems & Services Certification Certification Services Pakistan (Pvt.) Limited 23

24 Pakistan National Accreditation Council (PNAC) Established under the administrative control of the Ministry of Science and Technology, GoP National apex agency to accredit conformity assessment bodies Testing laboratories Calibration laboratories Certification bodies Inspection bodies 24

25 Pakistan National Accreditation Council (PNAC) PNAC is having Mutual Recognition Arrangement (MRA) with International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) since 2009 PNAC achieved MLA status in 2013 Pakistan now is included in the list of countries having equivalent status for accreditation of testing & calibration laboratories and certification bodies for QMS & EMS all over the world. 25

26 Pakistan National Accreditation Council (PNAC) Vision: To become the most competent and reliable accreditation body of the region Mission: Pakistan National Accreditation Council (PNAC) strives for improvement, competence and integrity of conformity assessment bodies by providing them an internationally recognized accreditation service and also promotes quality culture, which ultimately benefits the consumers, producers, regulators and other stakeholders. 26

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28 Critical issues Internationally accepted definitions and nomenclature Standardized protocols for testing Validation of already existing methods Requirement of new test methods Analysis methods (Matrix effects) Degradation pattern (life cycle assessment) Toxicity studies Health impacts Effects on biotic system 28

29 Critical issues Requirement of measurement techniques New instruments for specific measurements Calibrated instruments Nano-Reference materials and Certified nano-reference materials (with predicted properties both chemical and physical) Metrological traceability Multifunctional nanomaterials new standards Nanometrology mass, conductivity, dimensions etc. 29

30 Properties (toxicological and other) are dependent on size, shape, surface area, etc. and variations in these properties could have a larger influence on the test results as compared to the composition changes within a batch or production. Different characterization techniques for measurement of one property giving varied results agreement needed on the relevancy of technique to property measured Provision of certified PT provider Suitability of existing regulations for manufacturing and marketing Critical issues Formulation of Database related to nanomaterials and their applications 30

31 Critical issues Lack of nanometrology certification bodies Skilled manpower with proper degrees 31

32 Flow Sheet of Critical gaps comparison Standard Validated Method PT provider Testing Accredited Scope Calibrated Instruments Certification Body Traceability to NIST Response Reference Material Response Homogenous Size Shape Area Chemical composition Physical properties etc. Representative Sample Variety of systems exists Variety of responses Quantitative Agreement on Relevancy of Qualitative technique for specific measurement Nanomaterial Sample 32

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34 Contact details Dr. Shahzad Alam Director General, PCSIR Laboratories Complex (LLC), Shahrah-e-Jalaluddin Roomi, Lahore-Pakistan. Ph: Cell: Fax: Web: 22/08/