National Quality Infrastructure: The Metrology PerspectiveAlan Steele, PhD, FRSCChief MetrologistDirector General, NRC MetrologyApril 4, 2019

Introduction and Overview

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• Some background on NRC Metrology

• An introduction to National Quality Infrastructure

• Cannabis: emerging market NQI Case Study

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

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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

Organizational Structure

NRC – Metrology

Biotoxin Metrology

Black Carbon Metrology

Dimensional Metrology

Electrical Power Measurement

Electrical Standards

Inorganic Chemical Metrology

Mass & Related Quanities

Medical & Industrial Dosimetry

Nanoscale Measurement

Organic Chemical Metrology

Photometry & Spectrophotometry

Radiation, Environment & Security Frequency & Time

Directors of Research and Development

Operations

Chief Metrologist

Thermometry and Radiometry Quality System

Measurement System Engagement

Assessment Services

Research & Development

Nano

Metrology TeamsMetrology Sectors NRC Initiatives

PDF Program

Common Services

Challenge Program

Collaboration Centres

Supper Cluster Support

Small Teams New Beginnings

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, conformity assessment, and market surveillance.”

UNIDO Definition (2017)

Disseminating National Standards: Accreditation

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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

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.

ResearchAnalytical chemistry, toxin identification,

algal culture

Certified Reference Materials>35 CRMs distributed in Canada and

around the world

EngagementIndustry clients, OGDs, CCQM, etc.

15 staff located in Halifax, NS

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Biotoxin CRM Distribution

Biotoxin Metrology

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 17th, 2018

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• 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

Cannabis testing frequently in the media

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• “….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.”

Pesticides have caused several recent cannabis recalls

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myclobutanil

• Can be used relatively safely on most crops that are eaten

• However, hydrogen cyanide is released upon smoking

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“The Cannabinoid Content of Legal Cannabis in Washington State Varies Systematically Across Testing Facilities”

Nick Jikomes & Michael Zoorob(2018) 8:4519

NRC is addressing these challenges in cannabis testing though standards development

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• While NRC is leading the development of standards, NRC is not a regulator.• NRC provides guidance and research to Health Canada for regulatory decisions.

Documentary standards(Methods)

• Standard methods are being developed with organizations such as ASTM, and US Pharmacopeia

Certified reference materials (CRMs)

Laboratory standards under development at ASTM (ASTM D37.03)

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• WK60319 Laboratory Test Method Validation and Method Development

• WK60479 Quality Assurance and Quality Control for Cannabis Analytical Methods and Laboratories

• WK63913 Analytical Laboratory Operations Supporting the Cannabis Industry

• WK64333 Multiresidue Analysis of Pesticides in Cannabis Leaves and Oils using Gas Chromatography-Mass Spectroscopy (GC-MS)

• WK64334 Multiresidue Analysis of Pesticides in Cannabis Leaves using Gas Chromatography-Tandem Mass Spectroscopy (GC-MS/MS)

• WK64335 Multiresidue Analysis of Pesticides in Cannabis Leaves, Flowers, and Oil using HPLC-tandem mass spectroscopy (HPLC-MS/MS)

• WK64336 The Sampling of Cannabis Products for Subsequent Laboratory Analyses of Harvest Lots of Usable Marijuana in Support of Regulatory and Quality Control Elements

• WK64646 The Sampling of Cannabis Products for Subsequent Laboratory Analyses of Marijuana Process lots including, extracts, concentrates, and products in Support of Laboratory Analyses for Regulatory and Quality Control Elements.

• WK65013 Determination of Cannabinoid Concentration in Cannabis Using High Performance Liquid Chromatography

• WK65014 Analyses of Terpenes in Cannabis using Gas Chromatography-tandem Mass Spectrometry (GC-MS/MS)

• WK65015 Analyses of Trace Elements in Cannabis by Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)

• WK65018 Analysis of Class 2 Residual Solvents in Cannabis Oil

• WK65194 Stability Testing Standard Guide for Cannabis Products

• WK65402 Determination of Cannabinoids in thermally prepared food products (edibles) using Thermal desorption Gas chromatography/mass spectrometry (TD-GC/MS) or Gas chromatography flame ionization detector (GC/FID)

• WK66628 Assay for real-time stability of cannabis products for inhalation.

Certified Reference Material Development

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Pure materials or calibration solutions:• Primary standards• Calibration of instruments and assays• Required for certifying matrix CRMsMatrix materials (representative):• Validation of entire methods• QA & QC• Verification of correct application of standardized

methods

Metrology in Chemistry: ISO17034

• Matrix CRMs are large-scale projects requiring multiple steps for production and certification

Selection of material

Processing, homogenization

Bottling/packaging

Stability study

Characterization (ie quantitation)

Homogeneity 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 Steelealan.steele@nrc-cnrc.gc.ca

• Ralph Paroliralph.paroli@nrc-cnrc.gc.ca

• Georgette Macdonaldgeorgette.macdonald@nrc.ca