International Standards Creating CONFIDENCE for the Peoples and - - PowerPoint PPT Presentation

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International Standards Creating CONFIDENCE for the Peoples and - - PowerPoint PPT Presentation

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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

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SLIDE 1

S lide 1

International Standards

Creating CONFIDENCE for the Peoples and Nations

  • f the World

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 2

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)

S lide 2 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 3

Examples of Standards

  • A set of specifications (criteria) that

sellers and buyers agree to; usually a mix

  • f 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

S lide 3 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 4

Standards cover many activities

  • S

tandards cover a vast array of subj ects and topics.

  • Include products and

services of almost every description.

  • S
  • me libraries contain
  • ver half a million

standards!

S lide 4 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 5

S lide 5

Local Customs and Consumer Preferences Laws and Regulations Private S ector Competitive S trategies Enforcement Capacity S tandards As Applied

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

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SLIDE 6

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

S lide 6 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 7

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

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SLIDE 8

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

S lide 8 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 9

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

S lide 9 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 10

Codex has Guidelines Relevant to Ag. Biotech

S lide 10

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

  • f 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

  • f 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)

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 11

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

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SLIDE 12
  • 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
  • f 192 countries, one member per country
  • Has published more than 19 500 International

S tandards

12

ISO: International Standards Organization

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 13

ISO Member Countries

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 13

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SLIDE 14

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

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SLIDE 15

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

Secretariat: USA (ANSI) Participating Countries (25)

  • Argentina (IRAM)
  • Austria (AS

I)

  • Belgium (NBN)
  • Canada (S

CC)

  • Chile (INN)
  • China (S

AC)

  • Denmark (DS

)

  • Egypt (EOS

)

  • France (AFNOR)
  • Germany (DIN)
  • India (BIS

)

  • Iran, Islamic Republic of (IS

IRI)

  • Ireland (NS

AI)

  • Jamaica (BS

J)

  • Japan (JIS

C)

  • Korea, Republic of (KATS

)

  • Namibia (NS

I)

  • Netherlands (NEN)
  • Russian Federation (GOS

T R)

15

Participating Countries (continued)

  • S

lovenia (S IS T)

  • S

weden (S IS )

  • S

witzerland (S NV)

  • Thailand (TIS

I)

  • United Kingdom (BS

I)

  • United S

tates (ANS I) Observing Countries(10)

  • Croatia (HZN)
  • Cyprus (CYS)
  • Czech Republic (UNMZ)
  • Hungary (MSZT)
  • Italy (UNI)
  • Poland (PKN)
  • Romania (ASRO)
  • Serbia (ISS)
  • Slovakia (SOSMT)
  • Spain (AENOR)

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 16

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

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 16

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SLIDE 17

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
  • rganisms
  • 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

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SLIDE 18

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

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SLIDE 19

Standardization is Coordinated

CEN AACC ISO Method Development – Laboratory Validation

EURL

AOAC AOCS

Collaborative (Ring) Trials

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SLIDE 20

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

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 20

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SLIDE 21

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

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 21

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SLIDE 22

Sampling of Seed and Grain is Done to International Standards

ISTA sampling standards for seed ISO24333, ISO542

Photos courtesy of US DA, Bayer.

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SLIDE 23

Laboratory Accreditation

  • Laboratories may be accredited under official accreditation

schemes

– IS

O (17025) – not equally applied

– IS

TA

– National schemes (e.g. COFRAC, UKAS

, CNAL, QUACERT, S AC- S INGLAS )

  • Accredited laboratories validate/ verify methods for use in their
  • wn laboratory and participate in proficiency tests (check sample

programs organized by e.g. IS TA, GIPS A, FAPAS , AOCS , AACC...) as part of the accreditation maintenance scheme

  • Calibrate pipettes, instruments (temps) etc.
  • Use Rules, Methods and Procedures
  • Identify and Correct Deficiencies

S lide 23 Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015

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SLIDE 24

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

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 24

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SLIDE 25

S lide 25

Local Customs and Consumer Preferences Laws and Regulations Private S ector Competitive S trategies Enforcement Capacity S tandards As Applied

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

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SLIDE 26

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

Det ect ion Methods and Reference Materials S ymposium – Oct ober 2015 S lide 26