Slide 1

International Standards

Creating CONFIDENCE for the Peoples and Nations

of the World

Detection Methods and Reference Materials Symposium – October 2015

Definition of a Standard

• A published specification that establishes a common language, and contains a technical specification or other precise criteria and is designed to be used consistently, as a rule, a guideline, or a definition

(British Standards Institution)

Slide 2 Detection Methods and Reference Materials Symposium – October 2015

Examples of Standards

• A set of specifications (criteria) that sellers and buyers agree to; usually a mix of physical and chemical parameters

• Methods of analysis (technology and procedures) used to determine if the specifications have been met

• Buyers and Sellers use standards to facilitate equitable trade

Slide 3 Detection Methods and Reference Materials Symposium – October 2015

Standards cover many activities

• Standards cover a vast array of subjects and topics.

• Include products and services of almost every description.

• Some libraries contain over half a million standards!

Slide 4 Detection Methods and Reference Materials Symposium – October 2015

Slide 5

Local Customs and Consumer Preferences

Laws and

Regulations

Private Sector

Competitive Strategies

Enforcement Capacity

Standards As Applied

after Steven Jaffee - International Trade Department, World Bank 2005

Detection Methods and Reference Materials Symposium – October 2015

International and Regional Standards are set by….

• Codex Alimentarius Commission • International – ISO

– Regional – CEN, PASC, COPANT, ACCSQ, NASCF, etc. – National – SAC, JISC, ANSI, IRAM, UNIT, BSA, etc.

• Scientific organisations – AACCI, AOAC, AOCS, ICC (SDOs)

• Traders – FOFSA, etc. • National (or supranational) bodies

Slide 6 Detection Methods and Reference Materials Symposium – October 2015

AACC, AOCS and AOAC have Official Methods programs

• 11-10 -01 Bt Cry1Ab-Modified Corn in Corn Flour - ELISA Method • 11-20 -01 StarLink Corn in Corn Flour and Corn Meal - ELISA Method • 11-21-01 ELISA Method for StarLink Corn in Corn Flour and Corn

Meal • 11-30 -01 PCR method MON 810 Corn in Corn Flour by Real-Time

Polymerase Chain Reaction

• 1 PCR GM method included to determine characteristics and logistics.

• No other PCR methods in AACC. BAX methods in AOAC.

Detection Methods and Reference Materials Symposium – October 2015 Slide 7

Codex Alimentarius

• Commission created by FAO and WHO to develop food standards, guidelines and codes of practice

• Codex is a government led organization • Established 1963

Slide 8 Detection Methods and Reference Materials Symposium – October 2015

Codex Committee on Methods and Sampling (CCMAS) • Methods of analysis and sampling and

quality assurance systems for laboratories

• Reference Methods of Analysis and Sampling

• Procedures, protocols, guides for the assessment of food laboratory proficiency

Slide 9 Detection Methods and Reference Materials Symposium – October 2015

Codex has Guidelines Relevant to Ag. Biotech

Slide 10

Reference Title CAC/GL 27-1997 Guidelines for the Assessment of the Competence

of Testing Laboratories Involved in the Import and Export Control of Foods

2006

CAC/GL 50-2004 General guidelines on sampling 2004

CAC/GL 45-2003 Annex III

Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (LLP)

2008

CAC/GL 74-2010 Guidelines on performance criteria and validation of methods for detection, identification and quantification of specific DNA sequences and specific proteins in foods

2010

CAC/GL 54-2004 Guidelines on Measurement Uncertainty 2011 (Annex)

Detection Methods and Reference Materials Symposium – October 2015

Codex approach to methods

• Focused on performance requirements,

rather than specific methods • This is the case for all methods, not just

methods for DNA and Protein identification

• Government driven

Detection Methods and Reference Materials Symposium – October 2015 Slide 11

• Established in 1947 • Is a Non-governmental organization (NGO) that

has a membership made up of standard institutions advised by panels of experts in each country.

• Is network of the national standards institutes of 192 countries, one member per country

• Has published more than 19 500 International Standards

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ISO: International Standards Organization

Detection Methods and Reference Materials Symposium – October 2015

ISO Member Countries

Detection Methods and Reference Materials Symposium – October 2015 Slide 13

ISO and Food Biotechnology

• TC 34 Food products (75 countries + 60 observing) – TC 34/SC 16 Biomolecular testing (25 + 10)

• TC 47 Chemistry • TC 48 Laboratory equipment • TC 69 Applications of statistical methods • TC 93 Starch (including derivatives and by-products) • TC 134 Fertilizers and soil conditioners • TC 176 Quality management and quality assurance • TC 276 Biotechnology • ISO/REMCO Committee on reference materials

Detection Methods and Reference Materials Symposium – October 2015 Slide 14

TC 34/SC 16 - Horizontal methods for molecular biomarker analysis

Secretariat: USA (ANSI) Participating Countries (25) • Argentina (IRAM) • Austria (ASI) • Belgium (NBN) • Canada (SCC) • Chile (INN) • China (SAC) • Denmark (DS) • Egypt (EOS) • France (AFNOR) • Germany (DIN) • India (BIS) • Iran, Islamic Republic of (ISIRI) • Ireland (NSAI) • Jamaica (BSJ) • Japan (JISC) • Korea, Republic of (KATS) • Namibia (NSI) • Netherlands (NEN) • Russian Federation (GOST R)

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Participating Countries (continued) • Slovenia (SIST) • Sweden (SIS) • Switzerland (SNV) • Thailand (TISI) • United Kingdom (BSI) • United States (ANSI) Observing Countries(10) • Croatia (HZN) • Cyprus (CYS) • Czech Republic (UNMZ) • Hungary (MSZT) • Italy (UNI) • Poland (PKN) • Romania (ASRO) • Serbia (ISS) • Slovakia (SOSMT) • Spain (AENOR)

Detection Methods and Reference Materials Symposium – October 2015

ISO TC 34/SC 16

ISO committees in liaison: • ISO/TC 34/SC 9 • ISO/TC 69/SC 6 • ISO/TC 93 • ISO/TC 212 • ISO/TC 276

Organizations in liaison: • AACC • AOCS • EURL-GMFF • ECOS (Europe) • EPPO • IPPC

Detection Methods and Reference Materials Symposium – October 2015 Slide 16

Methods under ISO TC 34/SC 16 • ISO 24276:2006/Amd 1:2013 General requirements and definitions

• ISO 21569:2005/Amd 1:2013 Qualitative nucleic acid based methods • ISO/TS 21569-2:2012 Part 2: Construct-specific real-time PCR method

for detection of event FP967 in linseed and linseed products • ISO/TS 21569-3:2015 Part 3: Construct-specific real-time PCR method

for detection of P35S-pat-sequence for screening genetically modified organisms

• ISO 21570:2005/Amd 1:2013 Quantitative nucleic acid based methods

• ISO 21571:2005/Amd 1:2013 Nucleic acid extraction

• ISO 21572:2013 Protein-based methods

Detection Methods and Reference Materials Symposium – October 2015 Slide 17

ISO approach to methods

• General Standards focused on performance requirements

• Specific methods have been and can be appended to these methods guidelines

• Country driven (all stakeholders)

Detection Methods and Reference Materials Symposium – October 2015 Slide 18

Standardization is Coordinated

CEN

AACC

ISO

Method Development – Laboratory Validation

EURL

AOAC AOCS

Collaborative (Ring) Trials

Codex and ISO standards for PCR methods

Codex CAC/GL 74-2010 ISO 24276

Quantitative Qualitative Quantitative 21570 Qualitative

21569 Nucleic acid

21571

Trueness X Precision (RSDr) X Repeatability (RSDR) X Robustness X X LOD X X X X LOQ X X Specificity/Selectivity X Applicability / practicability X Dynamic Range X Sensitivity X Validation X

Detection Methods and Reference Materials Symposium – October 2015 Slide 20

Codex and ISO Performance Requirements for PCR Methods

Codex CAC/GL 74-2010 ISO 24276

Quantitative Qualitative Quantitative 21570 Qualitative

21569 Nucleic acid

21571

Specific Criteria Size of amplicon X Efficiency X Primers X X Reference material X X X Number of cycles X Temperatures (primers) X Amount of DNA X Quality of DNA X X Controls X X Replicates X X Agreement of replicates X Confirmation X Endogenous (taxon) reference X X X Calibration X Reporting X X X

Detection Methods and Reference Materials Symposium – October 2015 Slide 21

Sampling of Seed and Grain is Done to International Standards

ISTA sampling standards for seed

ISO24333, ISO542 Photos courtesy of USDA, Bayer.

Laboratory Accreditation • Laboratories may be accredited under official accreditation

schemes – ISO (17025) – not equally applied – ISTA – National schemes (e.g. COFRAC, UKAS, CNAL, QUACERT, SAC-

SINGLAS)

• Accredited laboratories validate/verify methods for use in their own laboratory and participate in proficiency tests (check sample programs organized by e.g. ISTA, GIPSA, FAPAS, AOCS, AACC...) as part of the accreditation maintenance scheme

• Calibrate pipettes, instruments (temps) etc.

• Use Rules, Methods and Procedures

• Identify and Correct Deficiencies

Slide 23 Detection Methods and Reference Materials Symposium – October 2015

Standards can contribute to Harmonisation by providing guidance

On • Method development best practices • Laboratory best practices • Validation of methods • Proficiency testing • Interpretation of Results • and by providing Analytical methods

Detection Methods and Reference Materials Symposium – October 2015 Slide 24

Slide 25

Local Customs and Consumer Preferences

Laws and

Regulations

Private Sector

Competitive Strategies

Enforcement Capacity

Standards As Applied

after Steven Jaffee - International Trade Department, World Bank 2005

Detection Methods and Reference Materials Symposium – October 2015

Standards help Harmonisation

• Guidance on operation of laboratories • Criteria for method performance • How to determine if methods are fit for

purpose • Measurement Uncertainty • Methods Goal of standards -> methods performing to the same criteria, and with the same results, globally

Detection Methods and Reference Materials Symposium – October 2015 Slide 26