Biometrology: Challenges and Opportunities – the INMS Perspective

1. Biometrology: Challenges and Opportunities – the INMS Perspective Presented by Janusz Lusztyk Director General, Institute for National Measurement Standards National Research Council of Canada SIM Meeting, November 2002 Santiago, Chile

2. Changing Context for National and International Metrology • Globalization of trade, investment and manufacturing • Development of international standards for goods and services • Explosive growth of high technology in almost every sector of the economy

3. INMS Metrology: at the center of Canada’sinnovation system and its international trade • Lowering TBTs, dispute resolution • Market access • Interoperability • World class science NRC/INMS is mandated by Parliament through the NRC Act (1917) and the Weights and Measures Act (1952) to maintain and disseminate standards and methods of measurement in Canada.

4. INMS Core Functions • development and maintenance of primary measurement standards • development of new measurement capabilities, and means for their dissemination • dissemination of calibration and measurement services • participation in international metrology activities • leadership in the national measurement system • measurement science outreach and education

6. Challenges for National Metrology • Role and scope of the NMIs – priority setting • Roles of government vis à vis private enterprises • Function of foreign/international services • Quantification of socio-economic impacts

7. New Challenges • Health • Nutraceuticals and functional foods • Genetic testing and in-vitro diagnosis • Environment and Energy • Electric power de-regulation • Climate change and greenhouse gas emissions (Kyoto agreement) • Biotechnology • Genetically Modified Organisms (GMOs) • Nanotechnology

8. Biometrology - Measurement Science for Biotechnology Cell Biology • counting techniques (manual and automatic) • biochemical techniques for selective quantification • DNA profiling Biochemistry • wide range of methods to study molecular structure and dynamics

9. Biometrology - Measurement Science for Biotechnology Protein Chemistry • separation techniques (e.g., electrophoresis) • mass spectrometry (for protein identification) • X-ray diffraction analysis (for determination of conformation) • immunoassay techniques • enzyme-linked assays (e.g., ELISA) Molecular Biology • DNA fingerprinting (qualitative analysis) • quantitative DNA measurements

10. Biometrology Activities at other NMIs USA - National Institute of Standards and Technology (NIST) • CSTL Biotechnology Division • strong capability for DNA analysis • CRMs for DNA profiling UK - Laboratory of the Government Chemist (LGC) • strong program in biometrology • emphasis on DNA analysis EC - Institute for Reference Materials and Measurements (IRMM) • CRMs for quantification of GMO soy, maize

11. “The effective implementation of labelling provisions…, is severely limited by lack of objective internationally-accepted standards for verifying the presence or absence of a GMO food in a food product.” Canadian Biotechnology Advisory Committee Report, August 2001 • Current EU embargo on GM canola • 750 M$ of Canadian agricultural exports to the EU at risk Risk/Benefit Assessment for Canada Metrology Needs for Genetically Modified Foods

12. The Need for Measurement Standards “Considering the potential economic impact of GMO co-mingling in the supply and marketing chain, it appears to be of paramount importance that analytical determinations on GMO presence/absence in food and agricultural products are being made by the use of internationally validated and approved methodologies and standards.” Scenarios for co-existence of genetically modified, conventional and organic crops in European agriculture, EC/JRC Report, May 2002

13. INMS Approach Consult with other government departments and agencies and industry stakeholders for information on measurement needs (a) Regulation-driven needs (b) Trade-driven needs

14. New Partners NRC/INMS Industry Canada (MC) Environment Canada SCC Foreign Affairs and International Trade Health Canada CFIA Agriculture Canada National Defence CGC

15. National Research Council Research Institutes and Facilities across Canada 17 research institutes 4 innovation centres 3,300 employees, 1000 guest workers National science facilities S&T information for industry and scientific community CISTI Network of technology advisors supporting SME IRAP

16. INMS Approach Access expertise in molecular biology in other NRC institutes as a means to eventually have adequate “in-house” expertise Institute for Marine Biosciences - aquaculture Biotechnology Research Institute - pharmaceuticals, environmental biotechnology Institute for Biological Sciences - pharmaceuticals, vaccines Institute for Biodiagnostics - biodiagnostics Plant Biology Institute - transgenic plants

17. INMS Approach Develop expertise in conventional methods of DNA analysis, i.e., methods involving the use of polymerase chain reaction (PCR) amplification followed by detection by fluorescence spectroscopy or time-of-flight mass spectrometry to assess limitations of current methodology, especially with respect to quantitative DNA analysis to use as benchmarks for new methods, e.g., “microarray” or “DNA chip” methods

18. Natural Health Products and Functional Foods • Industry Data • nutraceuticals and functional foods: $70 billion in North America • ($500 billion by 2010) • nutraceuticals: $44.5 billion in North America in 1999 • NHP industry in Canada: $1.5-2 billion in 1997 • mostly small and medium sized companies • 3000 varieties of nutraceuticals • 450 raw materials; 1700 finished products • 56% of Canadians reported taking one or more • NHPs in the past six months.

19. Natural Health Products and Functional Foods • Safety / Quality / Efficacy • used to support label claims • truth in advertising • enforce regulatory control • guaranteeing public health and safety • providing basis for contractual obligations which may arise • from trade agreements

20. Natural Health Products and Functional Foods To support future compliance/quality assurance requirements requires studies of • trace element bio-availability • detection of potential health hazards • development of standardized analytical methods • development of matrix reference materials

21. Natural Health Products and Functional Foods • The need for quality…. • blind study to determine the concentration of • chondroitin sulfate in 12 commercial bulk samples • conducted by the Institute for Nutraceutical • Advancement • undertaken by 14 laboratories / 8 different methodologies • The relative standard deviation of the results varied • amongst the samples and ranged from 7% to an • unacceptable 143% !

22. Valerian valerenic acid Conc. (%) Sample I. Khan, University of Mississippi

23. Feverfew I. Khan, University of Mississippi, 2001

24. INMS Approach New Investment in Natural Health Product Project in Chemical Metrology Group in Collaboration with other Government Departments, Industrial Partners and NRC’s Research Institutes

25. New Opportunities • CIPM MRA – global inter-changeability • Metrology research co-operations • Leveraging of resources

27. NRC Organisational Chart

28. INMS Approach Development of: • core competency in molecular biology • facilities and expertise for DNA analysis • increased flexibility by expanding the size of the INMS Chemical Metrology Group

29. The need for quality... Ginseng I. Khan, University of Mississippi

30. NMI Calibration Laboratories Routine Measurements The Traceability Pyramid Links “routine” measurements to national measurement standards NRC/INMS is Canada’s national metrology institute (NMI)