The German National Reference Laboratory for Genetically Modified Organisms at the Federal Office of Consumer Protection and Food Safety (BVL) Dr. Joachim Mankertz 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 1 Outline Organisation of the BVL Group 5 Analyses EURLs and NRLs Activities of the BVL The German NRL GMO 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 2 1
Welcome to the The BVL (www.bvl.bund.de) Federal Office of Consumer Protection and Food Safety (BVL) 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 3 Locations of the BVL Braunschweig Location Bundesallee Berlin Location Mauerstrasse Location Messeweg Location Marienfelde 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 4 2
Organisation Plan of the BVL 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 5 Group 5 Analyses Group Analyses Head: Dr. Petra Gowik Email: crlvetdrug@bvl.bund.de NRL-TAM@bvl.bund.de NRL-Kontaminanten@bvl.bund.de NRL-Pestizide@bvl.bund.de NRL-GVO@bvl.bund.de 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 6 3
Group 5 Analyses Location Berlin Group 5 Group 5 Analyses Unit 501 National Reference Laboratory for Pharmacologically Active Substances and Contaminants, Method Standardisation Unit 502 EU Reference Laboratory for Pharmacologically Active Substances www.bvl.bund.de E-Mail: 500@bvl.bund.de Unit 503 Biological Analyses, Resistance to Antibiotics, National Reference Laboratory for GMO 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 7 Responsibilities of Group 5 Analyses Reference laboratories 1 European Reference Laboratory for Residues of Veterinary Drugs (EURL) 8 National Reference Laboratories (NRLs) Method standardisation, coordinating office for 64 LFGB (Foods and Other Commodities Act)/ 35 Prelim. Tobacco Act/ 28b GenTG (Genetic Engineering Act) Coordinating office for proficiency tests for BÜp (=nationwide monitoring programme), monitoring of food, cosmetics and commodities German coordinating office for proficiency tests in the official food control sector (DKLL) Monitoring of resistance to antibiotics Quality management system (accredited since 2000 according to ISO 17025 ) Cooperation in committees, working groups (CCMAS, CCQM, Advisory Committees and COM WG, 64 LFGB WGs, national expert for COM, FVO, DIN, CEN) 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 8 4
Reference Laboratories (1) European Network EU Commission EURL EURL EURL EURL National Reference Laboratories 1 NRL per member state and substance / substance group Official Control Laboratories 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 9 Reference Laboratories (2) Aims Harmonisation of the performance of European control laboratories Comparability of measurement results Harmonisation of assessment criteria Coordination of national and European control laboratories Support to Third Countries 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 10 5
Legal Basis Article 32: Community reference laboratories Article 33: National reference laboratories 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 11 Reference Laboratories Appoinment In 2006/2007 appointment of National Reference Laboratories in Germany by the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) NRL for Pesticide Residues in Cereals and Feed in Fruits and Vegetables in Food of Animal Origin for Single Residue Methods NRL for Heavy Metals in Feed and Food NRL for PAH in Food and Feed NRL for GMO in Food and Feed 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 12 6
Responsibilities of German Federal Länder German Federal Länder are responsible for inspection and control of - contained use - deliberate releases - placing on the market of genetically modified organisms as well as the products derived from them 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 13 German Federal Länder Official Control Laboratories Official Control Laboratories with different responsibilities - food and/or feed - taxon-specific 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 14 7
Responsibilities of the BVL regarding Genetic Engineering 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 15 Unit 503 Activities of Unit 503 Biological Analyses, Resistance to Antibiotics, National Reference Laboratory for GMO Referatsgruppe Group 5 5 Untersuchungen Analyses Referat Unit 501 501 National Reference Nationale Referenzlaboratorien Laboratories for Contaminants für Kontaminanten und and Residues incl. Rückstände einschl. Pharmacologically Active pharmakologisch wirksamer Substances, Method Stoffe, Standardisation Methodenstandardiesierung Head of Unit: Dr. Joachim Mankertz Referat Unit 502 502 EU EU-Referenzlabor Reference Laboratory für for pharmakologisch Pharmacologically wirksame Active Stoffe Substances Referat Unit 503 503 Biological Biologische Analyses, Untersuc Resistance hungen, to Antibiotikaresistenz, Antibiotics, National Nationales Reference Referenzlaboratorium Laboratory for GMO für GVO 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 16 8
Responsibilities of the NRL GMO Responsibilities of the National Reference Laboratory for Genetically Modified Organisms (according to Regulation (EC) No. 882/2004) Contact with and support of the EURL and the national authorities Organisation of NRL workshops Support and coordination of the official GMO control laboratories Organisation of PTs (as needed) Collection of methods Transfer of information from the EURL to the official laboratories Collection and distribution of Reference materials to official laboratories Contact with the European Network of GMO Laboratories (ENGL) 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 17 Responsibilities of the NRL GMO New scientific Developments Trainings Novel Methods Workshops Reference Materials National Working Groups Support to national official Laboratories Proficiency Tests Boards NRL GMO Methods European Network of GMO Laboratories Reporting Advice in Elaboration of Directives Support to the Federal Ministry of Food, Agriculture and Consumer Protection Transfer of Information Cooperation with EU-RL Proficiency Tests Overview of Methods and Proficiencies Validation Studies Participation in Workshops 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 18 9
Activities of the NRL GMO in 2009/2010 Support/Coordination of official laboratories Collection / distribution of reference material (published on BVL Homepage) Collaboration in the development of screening-methods Preparing an overview about methods used by the official laboratories Organisation of workshops Method development Development of an event-specific method for linseed CDC Triffid FP967 Quality assurance Participation in Proficiency-Tests - GeMMA: Mixed flours MU12, Baked products MP07, Maize flour SU39 - EU-RL: Maize NK603, Maize MON810 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 19 Activities of the NRL GMO in 2009/2010 Boards European Network of GMO Laboratories - ENGL Plenary Sessions - ENGL-WG Method Verification 64 LFGB AG GMO Detection - Ring trial Tnos-spec (dfr) 64 LFGB UAG Methodenvalidierung - Test of robustness in a factorial design (Pnos-nptII) Collaboration EU-RL Establishment of GMO detection methods validated by the EU-RL EU-RL NRL-Working Group 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 20 10
Staff and Equipment NRL GMO Scientists Technicians Applied Biosystems ABI7500 FAST Roche LightCycler 480 Tecan Infinite F200 NanoQuant with fluorescence Eppendorf epmotion 5070 und 5075LH Qiagen QIAcube DNASTAR Lasergene Software-Module 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 21 Overview on selected activities - Screening Table - Unauthorized GMO: CDC Triffid - Survey on methods used by control laboratories - Workshop 2010 - Collection of reference materials - Communication platform 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 22 11
Screening table plant DNA nos 3 T CP4 EPSPS CTP CaMV 35S P plant DNA Screening construct-specific event-specific 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 23 Screening table Anal Bioanal Chem. 396 2065-72, 2010 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 24 12
CDC Triffid Development of an event-specific detection method for FP967 (CDC Triffid) transgenic Linseed 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 25 History FP967 (CDC Triffid) was developed in the 1980s in Canada. 1996-2001 cultivation was allowed in Canada. Since then no further cultivation known. Detection of FP967 (CDC Triffid) in September 2009 in linseed and products derived from linseed by CVUA-Freiburg (cdc Triffid) A construct specific method (Tnos dfr) is available since November 2009 (GeneticID) 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 26 13
CDC Triffid next steps - Analysis with samples from the market in different official labs - Ring trial for method validation 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 27 2010 Survey - Equipment - Reference material - Screening-methods - Event-specific methods - Reference genes 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 28 14
2010 NRL GMO Workshop 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 29 Further activities Collection of reference material Communication platform NRL GVO in the German FIS-VL 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 30 15
ENGL European Network of GMO Laboratories Development, harmonisation and standardisation of means and methods for sampling, detection, identification and quantification of Genetically Modified Organisms (GMOs) or derived products in a wide variety of matrices, covering seeds, grains, food, feed and environmental samples. Under Consortium Agreement II: Nearly all German official Laboratories Participation in different working groups (UGM, MPR, MV) 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 31 A(n) (inter)national network of control laboratories A network of control laboratories ensures analytical competence is the basis for harmonisation of analytical methods is the basis for risk management by the competent authorities to ensure consumer protection and food safety 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 32 16
Thank you for your Attention! 2 Workshop dei laboratori del controllo ufficiale di OGM Roma 1-2 Dicembre 2010 Dr. Joachim Mankertz Seite 33 17