Activities of the GMO Technical Committee

Cheryl Dollard (Canada)

Christoph Haldeman (Switzerland)

Committee Members

Chair Cheryl Dollard Canada (Christoph Haldemann, Switzerland until Nov. 2011)

Vice-chair TBD

Members Clara Alarcon USA Charlotte Leonhardt Austria

Elizabeth Bates Belgium René Mathis France

Sofia Ben Tahar France Enrico Noli Italy

Tajinder Grewal Canada Elena Perri Italy

David Grothaus USA Kirk Remund USA

Lutz Grohmann Germany Guy van Den Eede Italy

Jean-Louis Laffont France Ana Laura Vicario Argentina

Mihael Cristin Ichim Romania Ruojing Wang Canada

Andrea Jonitz Germany Bruno Zaccomer France Benjamin Kaufman USA Dabing Zhang China

One application for committee membership received, one notice of pending resignation

Organization

• Work of the GMO Technical Committee is distributed among 8 Working Groups (WGs)

• Each WG has between 4-10 members, and the work is coordinated by the WG Lead

• Members often work in several groups at a given time.

• The work of the past 12 months will be presented

Permanent Work• Proficiency tests

– WG leader: Cheryl Dollard– Members: Elizabeth Bates, Andrea Jonitz, René Mathis, Bruno Zaccomer, Christoph Haldemann

• Accreditation programme (performance based approach)– WG leader: Elizabeth Bates– Members: Sofia Ben Tahar, Lutz Grohmann, David Grothaus, Enrico Noli, Elena Perri, Ana Laura

Vicario

• Information exchange: workshops– WG leader: Beni Kaufman– Members: Clara Alarcon, Cheryl Dollard, Enrico Noli, Guy Van den Eede, Bruno Zaccomer, Dabing

Zhang, Christoph Haldemann

• Information exchange: webpage ‘Info Platform for GM seed‘ – WG leader: Charlotte Leonhardt– Members: Clara Alarcon, Tajinder Grewal, Mihael Cristin Ichim, Benjamin Kaufman, Enrico Noli,

Guy Van den Eede, Ruojing Wang, Dabing Zhang

Temporary Work• Identification of stacked genes

– WG leader: Kirk Remund– Members: Jean-Louis Laffont, Bruno Zaccomer, Christoph Haldemann

• Publication of the results of the Proficiency Test– WG leader: Bruno Zaccomer– Members: Elizabeth Bates, Cheryl Dollard, Beni Kaufman, Jean-Louis Laffont, Enrico Noli, Kirk

Remund, Christoph Haldemann

• Establishment of an audit check list for GMO testing laboratories– WG leader: Elena Perri– Members: Elizabeth Bates, Sofia Ben Tahar, René Mathis, Ruojing Wang

• Rules - Handbook– WG leader: René Mathis– Members: Elizabeth Bates, Cheryl Dollard, Beni Kaufman, Kirk Remund, Bruno Zaccomer,

Christoph Haldemann

Progress Report: Proficiency Testpresented by Cheryl Dollard

• Delivery of PT15 and PT16– PT15: Flax – completed 2011– PT16: Maize – spring 2012 (in progress)

• Maize round was unavoidably delayed due to source issues for the conventional seed required to prepare samples

– PT17: Soybean – fall 2012• test plan drafted; awaiting confirmation of seed Events and delivery

• Improved administration of the GMO PT Program • SOP: Administration of GMO PT program - finalized• SOP: Sample preparation for GMO PT program – summer 2012

• Future – Significant challenges

GMO PT15 - Flax

Spiking level 0% 0.13% 0.2% 0.8%

Event None FP967 FP967 FP967

Lot No. 1, 2 3, 4 5, 6 7, 8

Number of samples 2 2 2 2

Number of non-GM seeds 1500 1498 1497 1488

Number of GM seeds 0 2 3 12

Rating Misclassified samples Number of laboratories

A 0% - 5% 27

B >5% - 10% -

C >10% - 20% 1

BMP >20% 1

Rating Number of laboratories

A 11

B 1

C 1

BMP 2

Each participant received 8 numbered Flax seed samples, containing approximately 1500 seeds (~8.2 gram) based on the 1000 seed weight. 3 spiking levels were used following the test plan below:

Sample sets were sent to 31 laboratories. 29 participants submitted their results, 15 provided qualitative and quantitative results, 14 provided qualitative results only.

Qualitative Results: Overall

Quantitative Results: Overall

ISTA GMO PT Program:Future Challenges

• Funding for the program: – Current funding available will end in 2013

• Seed purity testing and sample preparation– Service not guaranteed available beyond spring 2013.– Alternative delivery must be considered and is being

investigated

ISTA GMO PT Program:Thanks!

• The ISTA Secretariat– With special thanks to Agnes Hegedüs, Christof Neuhaus, Nadine Ettel, Michael Muschick, and

Patricia Muschick

• Our ECOM representative: Rita Zecchinelli• Co-members of the GMOTcom PTWG and all GMOTcom Colleagues• Industry

– Special thanks to Elizabeth Bates, Benoit Mayes, and Bayer CropScience during PT16

• German Government• LTZ-Agustenberg

– particular thanks to Andrea Jonitz and Uwe Bertrand

• Members of the Expert Team: Christoph Haldemann and Jean-Louis Laffont

Statistical Aspects of GMO Detection July 25th – 29th, 2011 Location:

Universidad Autónoma Metropolitana Iztapalapa, México, DF

Progress Report:ISTA Workshops:presented by Beni Kaufman

Organizers & Lecturers:A collaboration between:

•The National Institute of Ecology (INE) •SEMARNAT, Mexico•Autonomous Metropolitan University•ISTA

National Institute of EcologyMartha Rocha Munive, Deputy Director of Genetic Analysis,

National Institute of Ecology, SEMARNATAdriana Otero Arnaiz, Coordinator of the Biosafety Program, National Institute of EcologyBerenice Zúñiga, GMO Analysis Department, chief. National Institute of Ecology

Autonomous Metropolitan University (UAM) Beatriz Rendón

ISTAJean-Louis Laffont Chair ISTA Statistics CommitteeKirk Remund, Vice chair ISTA Statistics Committee,

ISTA GMO CommitteeBenjamin (Beni) Kaufman, ISTA GMO Committee

Twenty-two participants representing regulating bodies,

academia, and industry:• Mexican Secretariat of Environment and Natural Resources (SEMARNAT) • Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA) • The National Metrology Center (CENAM)• The Inter Ministerial Commission on Biosafety of Genetically Modified (CIBIOGEM)• The National Institute for Forestry, Agriculture and Livestock (INIFAP) • The National Center for Genetic Resources • The Center for Scientific Research of Yucatan (CICY)• Researches from UAM campus Xochimilco

International participants came from:• The National Seed Institute of Uruguay • ANSES GEVES - Plant Health Laboratory in France, and from • The Saskatchewan Research Council, Canada

The private sector was represented by attendees from: Pioneer Hi Bred International, Monsanto, BASF Plant Science, Bayer Crop Science Canada & Kenya Seed

Company.

Program:

Monday, July 25, 2011. Introduction to GMO testing. Opening & Introductions . Qualitative GMO testing methods. Quantitative GMO testing methods. The non statistical aspects of testing plans. The challenges for GMO testing. Assay and process validation

. GMO testing rules and activities at ISTA

Tuesday, July 26, 2011Basic statistical tools used in GMO testingProbability distributions: binomial, multinomial, hypergeometric, normalTools for exploring distributionsUncertainties, Linear modeling Repeatability/Reproducibility

Wednesday, July 27, 201Acceptance samplingPool testingTesting plans; Estimation; Stack assessmentLocal tour: Floating gardens of Xochimilco

Thursday, July 28, 2011Quantitative testingTesting plans, Estimation, Outlier detectionMeasurement of uncertaintyOfficial Dinner: Restaurant Fonda del Recuerdo

Friday, July 29, 2011. Measurement of uncertainty in GMO testing

LOD/LOQ. Workshop evaluation, Workshop wrap-up

SIMPOSIUM INTERNACIONAL SOBRE DETECCIÓN DE ORGANISMOS

GENÉTICAMENTE MODIFICADOS 201125 y 26 de octubre 2011

HOTEL MARQUIS REFORMA, PASEO DE LA REFORMA 465, CD. DE MÉXICO.27de octubre 2011

INSTALACIONES DEL CNRDOGM SENASICA-TÈCAMAC, ESTADO DE MÉXICO.

Objetivo: Que el asistente conozca y se actualice sobre los criterios de calidad utilizados internacionalmente y vigentes a nivel

nacional para la validación de métodos de análisis de OGM, así como la aplicación de las nuevas herramientas tecnológicas, los retos y perspectivas

en la materia.

Two of the organizers and many of the speakers and participants… “graduates “ of the Statistical Aspects of GMO Testing ISTA workshop

FOUR MONTHS LATER….

AIEC Meeting Wednesday, October 5th, 2011

Technical Presentations• 3:00 The GIPSA Rapid Test Kit Evaluation Program

Update. Gregory J. Giese, USDA

• 3:35 Genomics Assisted Breeding for Sunflower Hybrid Development. Pegadaraju Venkatramana, BioDiagnostics Inc.

• 4:10 Overview of ILSI International Food Biotechnology Committee and Workshops.David Grothaus, Monsanto

• 4:35 ISTA’s Biotechnology Trait Detection Workshops, Past and Future. Beni Kaufman, Pioneer Hi-Bred

• 6:30 Group Dinner

Biotechnology Trait Detection Workshop

December 5th- 9th, 2011

Shanghai, China

Prof. Dr. Dabing ZhangSchool of Life Science & BiotechnologyShanghai Jiao Tong Universityzhangdb@sjtu.edu.cnDr. Litao YangSchool of Life Science & BiotechnologyShanghai Jiao Tong Universityyylltt@gmail.comBenjamin (Beni) Kaufman, PhDPioneer Hi-Bred a DuPont BusinessJohnston, IA, USAben.kaufman@biodiagnostics.netCheryl Dollard, MSc.Ottawa Plant LaboratoryCanadian Food Inspection Agencycheryl.dollard@inspection.gc.caBruno Zaccomer, PhDMonsantoPeyrehorade, Francebruno.zaccomer@monsanto.comKirk Remund, PhDMonsanto,St. Louis, MO, USAkirk.m.remund@monsanto.com

Organizers & Lecturers:

21 participants from 7 different countries:Including China, India,

South Korea, USA, Croatia, Taiwan, and Brazil

Last name First name Position CompanyLi Yin 中国农业科学院北京畜牧兽医研究所

Peng Dan LongPing High technology companyBabu P Mahesh Research Executive Bioseed Research India Pvt. Ltd.Chen Xiaoyun 浙江省农科院

Wang Dong 农业部转基因植物环境安全监督检验测试中心（成都）Eunheui So senior researcher Korea Seed & Variety Service

Guo RongTechnology Coordination

Asia/Pacific Bayer Crop Science

Hanzer RenataHead of Biotechnological

Analyses DivisionCroatian Centre for Agriculture, Food and Rural

Affairs, Institute for Seed and SeedlingsHongli Hou 深圳市农业科技促进中心

Kamogae Kuwahara Marcia Lab Technician Embrapa - SoybeanSun Linyu SGS company

Oliveira Tatiane laboratory technician Embrapa Food TechnologyPan Chao-Chi Product Development Ti-Shiue Biotech Inc.Qian Lili 中国农业科学院北京畜牧兽医研究所

Shu-Jiau Chiou Researcher Industrial Technology Research InstituteShujing Nie Shujing SGS companySunyoung An senior researcher Korea Seed & Variety Service

Wen Hongtao 黑龙江省农科院农产品质量安全研究所Wu Fan 杜邦先锋种子公司 - Pioneer Hi-Bred

Wang Xuelin 深圳市农业科技促进中心Ye Jingsong Senior Scientist J R Simplot Company

PROGRAMMonday, 5th December, 2011 (Dazhiju, Academic activities center, SJTU)08:30 Opening and introductions Beni Kaufman•09:00 Introduction to GMO testing & work-shop overview10:00 Coffee break

TESTING PLANS Kirk Remund10:30 Theory I: Basic statistical concepts11:15 Qualitative testing plans – Introduction to SeedCalc12:00 Lunch 13:00 Theory: Testing plans II: Quantitative testing plans. 14:30 Computer exercises16:00 End of the day 118:00 Welcome Dinner hosted and sponsored by The National Canter of Molecular

Characterization of GMOs (NCMCG), Shanghai Jiao Tong University (LiuYuan Restaurant, SJTU)

Tuesday, 6th December, 2011 (4-106, Biological Pharmacy Building, SJTU)FROM SEED TO DNA Beni Kaufman8:30 Theory: Sample Preparation: I. DNA Extractions9:30 Introduction to the Hand-On laboratory procedure and design 10:00 Coffee break10:30 Hands-On Laboratory: DNA extraction using NucleoSpin method 12:00 Lunch 13:00 Theory: Sample Preparation: II. DNA quantification, normalization, and sample tracking14:30 Hands-On Laboratory: DNA visualization, quantification and normalization16:00 End of day 2

PROGRAM (Cont.)Wednesday, 7th December, 2011 (4-106 Biological Pharmacy Building, SJTU)

THE POLYMERASE CHAIN REACTIONCheryl Dollard/Bruno Zaccomer/ Kirk Remund

08:30 Theory: Introduction to PCR Cheryl Dollard09:30 Hands-On Laboratory: Qualitative PCR set -up10:00 Coffee break11:00 Theory: PCR for GMO testing: Definitions and practices Bruno Zaccomer12:00 Lunch13:30 Group picture13:45 Visit to Chenghuang Temple, YU Park, the Huangpu River

& Official Dinner sponsored by Pioneer Hi- Bred a DuPont Business at Xiqo- Nan-Guo restaurant

overlooking the Huangpu river .

PROGRAM (Cont.)Thursday, 8th December, 2011REAL-TIME PCR Bruno Zaccomer/ Beni Kaufman/Cheryl Dollard/ Kirk Remund

Morning (4-106, Biological Pharmacy Building, SJTU)08:30 Theory: Real-time PCR for GMO quantification Bruno Zaccomer09:30 Hands-On Laboratory: Real-time PCR set –up10:00 Coffee break10:30 Hands-On Laboratory: PCR results visualization & and documentation12:00 LunchAfternoon (Floor 2 meeting room, Dazhiju, Academic activities center, SJTU)13:00 Theory: Protein based methods Cheryl Dollard14:00 Theory: ISTA rules for GMO detection Cheryl Dollard15:00 Theory: GMOs analysis in China, an update Dabing Zhang16:00 End of day 4

Friday, 9th December, 2011 (4-106, Biological Pharmacy Building, SJTU)

LABORATORY BEST PRACTICES Beni Kaufman/Bruno Zaccomer/Cheryl Dollard8:30 Assay and Process validation: Beni Kaufman09:30 Theory/Hands-On Laboratory: Data analysis and interpretation Kirk Remund10:00 Coffee break10:30 Theory & discussion: Results analysis continued

Stacked traits new challenges and solutions Kirk RemundManagement and practices unique to the GMO testing lab

Beni Kaufman/Bruno Zaccomer/Cheryl Dollard12:00 Conclusion

THANK YOU’s:

Martina Haefeli, ISTA Secretariat and OUR SPONSORS!

Biotechnology Trait Detection Workshop

Dec. 5th- 9th, 2011

Shanghai, China

• Objectives– Write a new chapter for ISTA rules about GMO testing– As a technical committee of ISTA, GMO Technical

Committee will need a rules chapter to refer to.– This chapter will contain general principle and guidance on

commonly used techniques to test for GMO on seeds• no protocol since PBA is the implemented process for evaluation

– This work is in the charge of a new temporary task of the GMO Technical Committee

Progress Report: RULES

presented by René Mathis

Rules – GMO Working GroupFirst steps

• Initial steps– Establish the composition of the group members

– Set up a first work plan

– Organize the new working group and start the work

Rules – GMO Working GroupMembers

• Members: – Elizabeth Bates

– Cheryl Dollard,

– Beni Kaufman

– Kirk Remund

– Bruno Zaccomer

– Christoph Haldemann

– René Mathis

Rules – GMO Working Group

Work done

• Work done:– A first draft established (main structure, scope)

• Covers different aspects of GMO testing

• Trying to fit with architecture of other rule chapter

– + General and specific questions addressed

– From collective discussions and individual inputs (4 phone conferences + email exchanges)

– Still quite a lot to do...

• Many thanks to each group memberElizabeth Bates, Cheryl Dollard, Beni Kaufman, Kirk Remund, Bruno Zaccomer, Christoph Haldemann

• THANK YOU FOR YOUR ATTENTION

Progress Report: Establishment of an audit

check listfor GMO testing laboratories

presented by R. Mathis for Elena Perri

Members: Elena Perri, Elisabeth Bates, Sofia Ben Tahar, René Mathis, Ruojing Wang

Aims of the WG:• to discuss the “minimum requirements” for GMO Accreditation by ISTA: • how the theoretical requirements should be implemented by the lab• to cooperate with the ISTA Accreditation Department in order to provide a

useful aid to the ISTA auditors

Main Topics discussed

• Management Requirements and QA system control

• Staff

• Methods• Technical requirements:

Controls, sample handling and environmental conditions, equipment and goods (relevant for the quality of the tests), testing.

Future work

• to complete and link the GMO check list with the relevant ISTA Laboratory Accreditation Standard

• to identify the minimum requirements for each topic of the check list (where applicable)

• It could be useful to discuss the draft check list with the ISTA auditors already asked to audit GMO laboratories (system and technical)

• to provide the ISTA Accreditation Department with the final draft check list and ask for a feedback

Working group goals• Provide support to the WG for continuation of the GMOPT

• Regularly review info/data around the performance-based approach and provide information and support on this subject to ISTA members when required

• Review the process for accreditation for GMO labs in the ISTA PBA and make a preliminary proposal to the GMO TCOM before the next ISTA meeting

• Provide support to the working group on the ISTA rules for GMO testing

Progress Report: Accreditation Programpresented by C. Dollard for L. Bates

•Regular exchanges on the ISTA PT programs and support in finding seed and events

•Suggestion for alignment of accreditation standards to be discussed at the next TCOM meeting (this week)

•ISTA rules for GMO testing under discussion

•In 2012 will continue to support efforts for performance – based GMO testing, as this is endorsed by this team

Working group achievements :

Progress Report: Publication of the Results of

the Proficiency Testpresented by C. Dollard for B. Zaccomer

• A draft paper is written focusing on identification of the main factors influencing the reliability of GMO quantification

• Most statisical analysis complete for rounds 1 to 9 – plan to include all rounds to date

• Hard copy data from previous PTs has been entered in the new GMO DB administrated by the Secretariat

• Next steps: Additional data must be queried and analyzed

Thanks• Many thanks go to ISTA, colleagues and Industry for their

ongoing support for this work:

• All leaders of the Working Groups and members of the GMO TCOM

• Jean-Louis Laffont, Chair, ISTA Statistics TCOM

• Berta Killerman, Chair, ISTA Variety TCOM

• Landwirtschaftliches Technologiezentrum Karlsruhe, D and Uwe Bertrand: GMO PT program

• The German Government (Bundesanstalt für Landwirtschaft und Ernährung) for financial support

• The seed companies for providing the PT program with seed for the PT program and for financial support for the GM Workshops

• The ISTA secretariat, with special thanks to Michael Muschick, Patricia Muschick, Martina Haefeli, Agnes Hegedüs and Nadine Ettel and Christof Neuhaus

• Members of the ECOM, especially Rita Zecchinelli, our ECOM representative.

Big Shoes to fill…

Many thanks to Christoph!

Side Meeting

Please feel free to join the GMO Technical Committee Side meeting:

June 12, 201217:00-18:30

Foyer, Meeting Venue