1. To produce certified reference materials for at least all GMOs approved in Europe. To attempt to provide reference materials for GMOs released outside of the EU. To further optimise production methods and types of reference materials with regard to their use in collaboration with expert laboratories and authorities of the Member States, Candidate Countries and with international partners;
2. To demonstrate fitness for purpose of these materials and to support international ring trials to validate methods to be used in international trade. To investigate the impact of food processing and the applicability of certain types of reference materials;
3. To collaborate with relevant expert networks and professional organisations for efficient measurement standardisation and implementation of reference measurement systems;
4. To help develop concepts for reference systems, by addressing the issue of uncertainty calculation for quantitative measurements and by developing certified reference materials for biological and biochemical analysis. This action will participate in, and, where appropriate, organise, BIPM and EUROMET Pilot Studies and Key Comparisons dedicated to important bioanalytical issues;
5. To train scientists from the EU and Candidate Countries on the production of GMO certified reference materials and to promote metrology in biochemical measurements. Anticipated milestones and schedule Completion of a feasibility study for the production of rapeseed reference materials which cannot be produced the same way as the GMO CRMs produced so far: 07/2003 Completion of certification campaign of newly produced Bt-11 and Bt-176 CRMs: 04/2003 Completion of certification campaign of 3 to 5 other GMO CRMs in average 6 months after delivery of the raw materials Completion of the first BIPM pilot study on quantitative PCR: 09/2003
1.1 Possibly, production of maize GMO (GA21; NK-603, T25) and rape seed (Topas 19/2, Falcon GC40/90, Liberator). Other GMOs expected to enter or to complete the approval process and then consequently to be considered for reference material production are e.g. MON 809 maize, GA 21 maize, MON810xT25 maize, A5/15 beat, TGt-F tomato and IEH 92-527-1 potato. Priorities and number of materials may be revised for the above mentioned reasons;
1.2 MON810 will be delivered for an international collaborative study on the event-specific quantification of MON810 DNA in Maize flour by real-time PCR;
1.3 Grinding and homogenisation of soybean lots for the KeLDA (Kernel Lot Distribution Assessment) project in collaboration with IHCP;
2.1 Development of alternative reference materials such as plasmid DNA and evaluate fitness for purpose;
2.2 Cloning vector as a common vector for the cloning of relevant plant targets;
2.3 Plasmids will be constructed and produced for the event-specific detection of different maize and soya within legal or IP limitations;
3.1 Contribution to a plasmid GMO database accessible via the web. Compilation of databases ("molecular register") of GMO markers and sequences for rapid exchange and distribution of information on such GMO sequences in collaboration with IHE;
3.2 If genomic DNA reference materials turn out to be the optimal solution the extraction of plants, cultivated within the legal and IP issue limitations, would offer the highest yields and quality. The cultivation could be done in collaboration with partners. If such collaborations are not be possible for legal or intellectual property reasons, own facilities have to be set up;
3.3 Contibution to the "European Network of Competent Authorities".
4.1 Introduction of metrological principles and identification of critical aspects in biochemical analysis in order to achieve comparability of measurement results on an international level;
4.2 Identification of generic metrological aspects in biotechnology related measurements within the BIPM working group on bioanalysis;
4.3 Performance of a first pilot study comparing the measurement capability of metrology institutes for quantitative DNA based methods using an artificial plasmid based model;
5.1 XX scientists trained.
Summary of the Action:
This action will focus on providing certified reference materials for those GMOs having been approved or going to be approved in the EU. Within the limitations created by legal and intellectual property issues, it will also attempt to provide reference materials for GMOs released outside of the EU in order to allow control of imports. The action will demonstrate fitness for purpose of these materials and will support international ring trials to validate methods to be used in international trade. The impact of food processing and the applicability of certain types of reference material will be further investigated. In the area of biometrology, this action will collaborate with relevant expert networks and professional organisations, which are indispensable for efficient measurement standardisation and implementation of reference measurement systems. The JRC is a founding member in the Bioanalysis Working Group set up by the Bureau International des Poids et Measures (BIPM) where it represents the European Commission. This group comprises the world's leading metrology institutes. The major issue to be addressed by this Working Group is how to achieve a satisfactory degree of measurement equivalence and comparability of data worldwide to support free trade and consumer protection. The JRC contributes in particular by developing concepts for reference systems, by addressing the issue of uncertainty calculation for quantitative measurements and by developing certified reference materials for biological and biochemical analysis.
This action will participate in, and, where appropriate, organise, BIPM and EUROMET Pilot Studies and Key Comparisons dedicated to important bioanalytical issues. It will also produce certified reference materials by using innovative concepts making use of the rapid advances in biotechnology. This action offers training possibilities since IRMM is the leading institute producing GMO certified reference materials and is promoting metrology also in biochemical measurements. Rationale The availability of reference materials for GMOs is of utmost importance for the performance of quantitative GMO measurements and consequently for the implementation of EU legislation related to GMO. This requires the development of production methods and proper means for the characterisation of various types of GMOs and reference materials. However, the production of any GMO certified reference material in the future will depend on the provision of suitable raw materials and on the clarification of the legal implication related to its distribution. So far, the production of new materials and the replacement of exhausted batches were delayed or made impossible by the non- availability of raw materials. In addition, some GMO producers have started to link the provision of raw materials and/or the signature of distribution agreements to the pending approval of GMO in Europe. This situation is absolutely not under JRC's control.
Biometrology is the application of metrological principles and the development of reference systems for biological and biochemical measurements. It now relies on newly described biomarkers explored by functional genomics and proteomics techniques. The Bureau International des Poids et Mesures (BIPM) has set up a Working Group on Bioanalysis comprising the world's leading metrology institutes, where JRC has been a founding member and represents the European Commission.