International Standards Creating CONFIDENCE for the Peoples and Nations of the World Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 1
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 S tandards Institution) Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 2
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 S ellers use standards to facilitate equitable trade Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 3
Standards cover many activities • S tandards cover a vast array of subj ects and topics. • Include products and services of almost every description. • S ome libraries contain over half a million standards! Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 4
Local Customs and Consumer Preferences Private Laws S ector and S tandards Competitive Regulations As Applied S trategies Enforcement Capacity aft er S t even Jaffee - Int ernat ional Trade Depart ment , World Bank 2005 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 5
International and Regional Standards are set by… . • Codex Alimentarius Commission • International – IS O – Regional – CEN, PAS C, COPANT, ACCS Q, NAS CF, etc. – National – S AC, JIS C, ANS I, IRAM, UNIT, BS A, etc. • S cientific organisations – AACCI, AOAC, AOCS , ICC (S DOs) • Traders – FOFS A, etc. • National (or supranational) bodies Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 6
AACC, AOCS and AOAC have Official Methods programs • 11-10 -01 Bt Cry1Ab-Modified Corn in Corn Flour - ELIS A Method • 11-20 -01 S tarLink Corn in Corn Flour and Corn Meal - ELIS A Method • 11-21-01 ELIS A Method for S tarLink 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. Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 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 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 8
Codex Committee on Methods and Sampling (CCMAS) • Methods of analysis and sampling and quality assurance systems for laboratories • Reference Methods of Analysis and S ampling • Procedures, protocols, guides for the assessment of food laboratory proficiency Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 9
Codex has Guidelines Relevant to Ag. Biotech Reference Title CAC/GL 27-1997 Guidelines for the Assessment of the Competence 2006 of Testing Laboratories Involved in the Import and Export Control of Foods CAC/GL 50-2004 General guidelines on sampling 2004 CAC/GL 45-2003 Guideline for the Conduct of Food Safety 2008 Annex III Assessment of Foods Derived from Recombinant- DNA Plants (LLP) CAC/GL 74-2010 Guidelines on performance criteria and validation 2010 of methods for detection, identification and quantification of specific DNA sequences and specific proteins in foods CAC/GL 54-2004 Guidelines on Measurement Uncertainty 2011 (Annex) Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 10
Codex approach to methods • Focused on performance requirements, rather than specific methods • This is the case for all methods, not j ust methods for DNA and Protein identification • Government driven Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 11
ISO: International Standards Organization • 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 S tandards 12 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015
ISO Member Countries Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 13
ISO and Food Biotechnology • TC 34 Food products (75 countries + 60 observing) – TC 34/ S C 16 Biomolecular testing (25 + 10) • TC 47 Chemistry • TC 48 Laboratory equipment • TC 69 Applications of statistical methods • TC 93 S tarch (including derivatives and by-products) • TC 134 Fertilizers and soil conditioners • TC 176 Quality management and quality assurance • TC 276 Biotechnology • IS O/ REMCO Committee on reference materials Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 14
TC 34/SC 16 - Horizontal methods for molecular biomarker analysis Secretariat: USA (ANSI) Participating Countries (25) Participating Countries (continued) • Argentina (IRAM) • S lovenia (S IS T) • Austria (AS I) • S weden (S IS ) • Belgium (NBN) • S witzerland (S NV) • Canada (S CC) • Thailand (TIS I) • Chile (INN) • United Kingdom (BS I) • China (S AC) • United S tates (ANS I) • Denmark (DS ) • Egypt (EOS ) • France (AFNOR) Observing Countries(10) • Germany (DIN) • Croatia (HZN) • India (BIS ) • Cyprus (CYS) • Iran, Islamic Republic of (IS IRI) • Czech Republic (UNMZ) • Ireland (NS AI) • Hungary (MSZT) • Jamaica (BS J) • Italy (UNI) • Japan (JIS C) • Poland (PKN) • Korea, Republic of (KATS ) • Romania (ASRO) • Namibia (NS I ) • Serbia (ISS) • Netherlands (NEN) • Slovakia (SOSMT) • Russian Federation (GOS T R) • Spain (AENOR) 15 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015
ISO TC 34/SC 16 ISO committees in liaison: Organizations in liaison: • • ISO/TC 34/SC 9 AACC • • ISO/TC 69/SC 6 AOCS • • ISO/TC 93 EURL-GMFF • • ISO/TC 212 ECOS (Europe) • • ISO/TC 276 EPPO • IPPC Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 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 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 17
ISO approach to methods • General S tandards focused on performance requirements • S pecific methods have been and can be appended to these methods guidelines • Country driven (all stakeholders) Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 18
Standardization is Coordinated CEN ISO AACC AOAC AOCS EURL Collaborative (Ring) Trials Method Development – Laboratory Validation
Codex and ISO standards for PCR methods Codex CAC/GL 74-2010 ISO 24276 Qualitative Quantitative Qualitative Nucleic acid Quantitative 21570 21569 21571 X Trueness X Precision (RSDr) X Repeatability (RSDR) X X Robustness X X X X LOD X X LOQ X Specificity/Selectivity X Applicability / practicability Dynamic Range X X Sensitivity X Validation Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 20
Codex and ISO Performance Requirements for PCR Methods Codex CAC/GL 74- ISO 24276 2010 Quantitative Qualitative Quantitative Qualitative Nucleic acid 21570 21569 21571 Specific Criteria Size of amplicon X Efficiency X Primers X X Reference material X X X Number of cycles X X Temperatures (primers) X Amount of DNA X X Quality of DNA X X Controls X X Replicates X Agreement of replicates X Confirmation X X X Endogenous (taxon) reference X Calibration Reporting X X X Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 21
Sampling of Seed and Grain is Done to International Standards ISTA sampling standards for seed Photos courtesy of US DA, Bayer. ISO24333, ISO542
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