National Quality Infrastructure: The Metrology Perspective Alan Steele, PhD, FRSC Chief Metrologist Director General, NRC Metrology April 4, 2019
Introduction and Overview • Some background on NRC Metrology • An introduction to National Quality Infrastructure • Cannabis: emerging market NQI Case Study 2
NRC: By the numbers • Over 4,500 employees and visitors • 4 scientific divisions with 14 research centres • Industrial Research Assistance Program
NRC Metrology: Canada's National Metrology Institute We help when high-precision measurement is critical to success • Accurate, traceable measurements • Innovative technology and high-performance laboratories • Advisory and calibration services for high precision measurements 4
Organizational Structure NRC – Metrology Chief Metrologist Directors of Research and Development Metrology Sectors Metrology Teams NRC Initiatives Thermometry and Radiometry Inorganic Chemical Metrology Quality System PDF Program Radiation, Environment & Security Frequency & Time Challenge Program Measurement System Engagement Photometry & Spectrophotometry Electrical Standards Electrical Power Measurement Collaboration Centres Organic Chemical Metrology Assessment Services Dimensional Metrology Nanoscale Measurement Research & Development Supper Cluster Support Black Carbon Metrology Medical & Industrial Dosimetry Small Teams Nano Biotoxin Metrology Mass & Related Quanities New Beginnings Operations Common Services
Disseminating National Standards: Calibration and Technical Services NRC helps clients solve immediate problems • Calibrations • Certified reference materials • GD-MS analysis • Laboratory assessment services
National Quality Infrastructure “The system comprising the organizations (public and private) together with the policies , relevant legal and regulatory framework, and practices needed to support and enhance the quality, safety and environmental soundness of goods, services and processes. UNIDO Definition (2017)
National Quality Infrastructure The quality infrastructure is required for the effective operation of domestic markets , and its international recognition is important to enable access to foreign markets . It is a critical element in promoting and sustaining economic development, as well as environmental and social wellbeing. UNIDO Definition (2017)
National Quality Infrastructure NQI relies on: metrology , standardization , accreditation , c onformity assessment, and market surveillance .” UNIDO Definition (2017)
Disseminating National Standards: Accreditation In Canada, the accreditation of calibration laboratories is the shared responsibility of the Standards Council of Canada - Laboratory Accreditation Program , and the National Research Council of Canada - Calibration Laboratory Assessment Service 10
Certified Reference Materials (CRM) For decades, NRC has been developing and producing high-quality CRMs that laboratories around the world trust to provide: precise measurement values, traceable references, standards, valid process methodologies, and samples with correct concentrations. These materials relate to regulatory safeguards for food safety, and environmental health. NRC collaborates with industry, government departments, and other countries’ national metrology institutes (NMIs) for the development of materials. Currently 4 teams within MSS developing CRMs – Biotoxin Metrology, Inorganic Chemical Metrology, Organic Chemical Metrology, and Nanoscale Measurement. NRC sells approximately 10,000 certificates per year, to over 300 clients, in 55 countries. Our clients include government departments, inspection agencies, ISO-certified laboratories, and academic and private research teams. As of today NRC metrology has 73 materials available to clients, with close to an additional 20 in development.
Biotoxin Metrology Research 15 staff located in Halifax, NS Analytical chemistry, toxin identification, algal culture Certified Reference Materials >35 CRMs distributed in Canada and around the world Biotoxin CRM Distribution 8000 Engagement 7000 6000 Industry clients, OGDs, CCQM, etc. 5000 CRM units 4000 3000 2000 1000 0 1990 1995 2000 2005 2010 2015 -1000 FY
Cannabis: An Emerging Marketplace Medicinal cannabis has been available in Canada since 1999 under: Access to Cannabis for Medical Purposes Regulations (ACMPR)
Adult recreational cannabis was legalized in Canada on October 17 th , 2018 • Market is highly regulated, similar to previous medicinal market, or even more stringent • Federal regulations for testing include: • Major cannabinoids • Pesticides (current list of 95) • Heaving metals • Mycotoxins • Residual solvents • Bacteria 14
Cannabis testing frequently in the media • “….The samples were sent to an accredited lab to test for THC and CBD levels. • Testing showed that many of the labels were not accurate; only two of the labelled samples fell within one percentage point of what was listed. And many of the samples contained more THC than listed. • For example, one sample said it contained 13 per cent THC, but testing showed it contained 18 per cent. Another sample contained only half of what was promised. • None of the samples contained a detectable level of CBD.” 15
Pesticides have caused several recent cannabis recalls • Can be used relatively safely on most crops that are eaten myclobutanil • However, hydrogen cyanide is released upon smoking 16
“The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities” Nick Jikomes & Michael Zoorob (2018) 8:4519 17
NRC is addressing these challenges in cannabis testing though standards development Certified reference Documentary standards materials (CRMs) (Methods) • Standard methods are being developed with organizations such as ASTM, and US Pharmacopeia • While NRC is leading the development of standards, NRC is not a regulator. • NRC provides guidance and research to Health Canada for regulatory decisions. 18
Laboratory standards under development at ASTM (ASTM D37.03) • WK60319 Laboratory Test Method Validation and Method • WK64646 The Sampling of Cannabis Products for Subsequent Development Laboratory Analyses of Marijuana Process lots including, extracts, concentrates, and products in Support of Laboratory Analyses for • WK60479 Quality Assurance and Quality Control for Cannabis Regulatory and Quality Control Elements. Analytical Methods and Laboratories • WK65013 Determination of Cannabinoid Concentration in Cannabis • WK63913 Analytical Laboratory Operations Supporting the Cannabis Using High Performance Liquid Chromatography Industry • WK65014 Analyses of Terpenes in Cannabis using Gas • WK64333 Multiresidue Analysis of Pesticides in Cannabis Leaves and Chromatography-tandem Mass Spectrometry (GC-MS/MS) Oils using Gas Chromatography-Mass Spectroscopy (GC-MS) • WK65015 Analyses of Trace Elements in Cannabis by Inductively • WK64334 Multiresidue Analysis of Pesticides in Cannabis Leaves using Coupled Plasma-Mass Spectrometry (ICP-MS) Gas Chromatography-Tandem Mass Spectroscopy (GC-MS/MS) • WK65018 Analysis of Class 2 Residual Solvents in Cannabis Oil • WK64335 Multiresidue Analysis of Pesticides in Cannabis Leaves, Flowers, and Oil using HPLC-tandem mass spectroscopy (HPLC-MS/MS) • WK65194 Stability Testing Standard Guide for Cannabis Products WK64336 The Sampling of Cannabis Products for Subsequent WK65402 Determination of Cannabinoids in thermally prepared food • • Laboratory Analyses of Harvest Lots of Usable Marijuana in Support of products (edibles) using Thermal desorption Gas Regulatory and Quality Control Elements chromatography/mass spectrometry (TD-GC/MS) or Gas chromatography flame ionization detector (GC/FID) • WK66628 Assay for real-time stability of cannabis products for 19 inhalation.
Certified Reference Material Development Pure materials or calibration solutions: • Primary standards • Calibration of instruments and assays • Required for certifying matrix CRMs Matrix materials (representative): • Validation of entire methods • QA & QC • Verification of correct application of standardized methods 20
Metrology in Chemistry: ISO17034 Selection of material • Matrix CRMs are large-scale projects requiring multiple steps for Processing, homogenization production and certification Bottling/packaging Characterization (ie quantitation) Homogeneity study Stability study Value assignment and uncertainty estimation
Homogeneity is Key … Measurands Matter
We are putting the metrology in place
What’s Still Missing? The NQI Overlay • Social License • Business Confidence • Efficient Marketplace • Comprehensive Regulatory Framework • Standard test methods for Evidence • Laboratory Accreditation and Surveillance
Thanks for listening! • Alan Steele alan.steele@nrc-cnrc.gc.ca • Ralph Paroli ralph.paroli@nrc-cnrc.gc.ca • Georgette Macdonald georgette.macdonald@nrc.ca
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