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
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The BVL (www.bvl.bund.de)
Welcome to the
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
Berlin
Braunschweig
Location Mauerstrasse
Location Bundesallee
Location Messeweg
Location Marienfelde
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Organisation Plan of the BVL
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Group 5 ‚Analyses‘
Group ‘Analyses’
Head: Dr. Petra Gowik
Email:
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
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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
Unit 503
www.bvl.bund.de
E-Mail: [email protected]
Biological Analyses, Resistance
to Antibiotics, National Reference
Laboratory for GMO
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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)
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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
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Reference Laboratories (2) – Aims
¾ Harmonisation of the performance of European
control laboratories
¾ Comparability of measurement results
¾ Harmonisation of assessment criteria
¾ Coordination of national and European control
laboratories
¾ Support to Third Countries
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Legal Basis
Article 32: Community reference laboratories
Article 33: National reference laboratories
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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
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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
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German Federal Länder – Official Control Laboratories
Official Control Laboratories
with different responsibilities
- food and/or feed
- taxon-specific
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Responsibilities of the BVL regarding Genetic Engineering
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Unit 503
Referatsgruppe
Group 5
5
Untersuchungen
Analyses
Activities of Unit 503
Biological Analyses, Resistance to
Antibiotics, National Reference Laboratory
for GMO
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
Referat
Unit 502
502
Head of Unit: Dr. Joachim Mankertz
EU EU-Referenzlabor
Reference Laboratory
für for
pharmakologisch
Pharmacologically
wirksame
Active
Stoffe
Substances
Referat
Unit 503
503
Biological
Biologische
Analyses,
Untersuc
Resistance
hungen,
toAntibiotikaresistenz,
Antibiotics, NationalNationales
Reference
Referenzlaboratorium
Laboratory for GMO
für GVO
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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)
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Responsibilities of the NRL GMO
National
Working
Groups
European
Network of GMO
Laboratories
Advice in
Elaboration
of Directives
Boards
New scientific
Developments
Support to the
Federal Ministry of
Food, Agriculture and
Consumer Protection
Novel
Methods
Overview of
Methods and
Proficiencies
NRL GMO
Transfer of
Information
Workshops
Trainings
Reference
Materials
Support to
national official
Laboratories
Methods
Proficiency
Tests
Reporting
Cooperation
with EU-RL
Proficiency
Tests
Validation
Studies
Participation in
Workshops
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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
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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
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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
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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
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Screening table
plant DNA
nos 3‘T
CP4 EPSPS
CTP
CaMV 35S P
plant DNA
Screening
construct-specific
event-specific
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Screening table
Anal Bioanal Chem. 396
2065-72, 2010
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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)
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CDC Triffid – next steps
- Analysis with samples from the market in different official labs
- Ring trial for method validation
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2010 Survey
- Equipment
- Reference material
- Screening-methods
- Event-specific methods
- Reference genes
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2010 NRL GMO Workshop
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Further activities
Collection of reference material
Communication platform NRL GVO in the German FIS-VL
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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)
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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
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Thank you for your
Attention!
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