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J. Verbr. Lebensm. 3 (2008) Supplement 2: 17 – 20 1661-5751/08/120017-4 DOI 10.1007/s00003-009-0366-8 © Birkhäuser Verlag, Basel, 2009
Journal für Verbraucherschutz und Lebensmittelsicherheit Journal of Consumer Protection and Food Safety
GMO monitoring data coordination and harmonisation at EU level – Outcomes of the European Commission Working Group on Guidance Notes supplementing Annex VII of Directive 2001/18/EC F. Graef1,2, A. De Schrijver3, and B. Murray4 In cooperation with the members of the European Commission Working Group on Guidance Notes supplementing Annex VII of Directive 2001/18/EC 1 Federal Agency for Nature Conservation (BfN), Bonn, Germany 2 Leibniz Centre for Agr. Landscape- and Land Use Research (ZALF), Müncheberg, Germany 3 Scientific Institute of Public Health, Brussels, Belgium 4 European Commission, DG Environment, Brussels, Belgium Correspondence to: F. Graef, Federal Agency for Nature Conservation (BfN), Bonn, Germany Eingegangen: 2. Dezember 2008
Key words: GMO, monitoring, data coordination, data harmonisation, environmental monitoring programmes, data infrastructure schemes. Abstract: A major objective of the European Commission Monitoring Working Group (MWG) on Guidance Notes supplementing Annex VII of Directive 2001/18/EC was to explore the possibility of European Union (EU)-wide coordination and harmonisation of data resulting from monitoring of genetically modified (GM) crops. Firstly, we present concepts for the coordination and harmonisation of monitoring data of cultivated GM crops. We argue that data coordination is necessary at both national and EU level and that data harmonisation is advisable at different technical levels of monitoring. Secondly, we explore the applicability of existing monitoring programmes and data infrastructure schemes run at EU level for monitoring of GM crops, and options for implementing data coordination and harmonisation. Our work identifies useful European monitoring programmes and data infrastructure schemes for the monitoring of GM crops. Their relevance, however, needs to be analysed in more depth.
1. Introduction In 2004, the European Commission set up a MWG to discuss the monitoring of genetically modified organisms (GMOs). Annex VII of the Directive 2001/18/EC and Council Decision 2002/811/EC establishing guidance notes supplementing
Annex VII to Directive 2001/18/EC recommend using existing agro-environmental monitoring systems, standardised GMO monitoring methodologies, standardised mechanisms for data collection and collation and statistical analyses. However, there is no guidance as to how existing monitoring programmes and data infrastructure schemes may support GMO monitoring. Furthermore, there is no legal framework to regulate the coordination and harmonisation of GMO monitoring data within and between EU member states (MS). A major objective of the MWG was to discuss coordination and harmonisation of data obtained through monitoring of GM crops. One of the outputs of these discussions was a general document on concepts for data coordination and harmonisation of GM crops (European Commission, 2007). This document sets out the existing state of GMO monitoring in the EU, defines data coordination and harmonisation, the purpose thereof and proposes options for central data coordination, harmonisation and analysis. The document on concepts for data coordination and harmonisation was endorsed by the Competent Authorities (CAs) under Directive 2001/18/EC. A second output was a conceptual document exploring the feasibility of coordination and harmonisation of GMO monitoring data at EU level. This document gives an overview of existing environmental monitoring programmes and data infrastructure schemes run at EU level and evaluates their relevance for monitoring of GM crops. This concept still needs to be discussed by the CAs in order to determine how to proceed. The present paper describes the main findings of the two conceptual documents elaborated by the MWG of the European Commission.
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2. Concepts for coordination and harmonisation of GMO monitoring data 2.1 Definitions Data coordination refers to the collection, reporting, storage and exchange of GMO monitoring data (including numerical data and reports) from different sources. Monitoring data can either be received from the applicants, third parties or from existing agro-environmental monitoring programmes, and may include case-specific monitoring and general surveillance data. Data harmonisation refers to the process of setting common standards for GMO monitoring, including methods (Fink et al., 2006), spatio-temporal data collection designs (Graef et al., 2005), data quality, and data storage, analysis and exchange. 2.2 Purpose of data coordination and harmonisation The main purpose of data coordination and harmonisation of EU-wide GMO monitoring data is to a) enhance availability of GMO monitoring data, b) manage data from different sources using certain standards and a common structure. An EU-wide coordinated GMO monitoring information and data analysis system as a central reporting office is the preferred option, c) provide a strong and reliable basis from which to extrapolate monitoring data to unsurveyed EU areas and a baseline for environmental factors, which may potentially be affected, and d) reduce the overall monitoring and analysis efforts.
Fig. 1 Interrelationships between existing EU-wide agro-environmental monitoring programmes (AEMP) and infrastructure schemes relevant to GMO monitoring and proposed structure for GMO monitoring data coordination.
2.3 Outcomes for central data coordination and harmonisation From the options proposed for central data coordination, harmonisation and analysis, the CAs indicated that they were in favour of integrating national monitoring in parallel with an EU-wide monitoring information system. Coordination and
harmonisation of monitoring data from applicants and agroenvironmental monitoring programmes will take time to implement at MS and EU level. National solutions are already needed in MS where GM crops are grown and are more likely to be functional in the short term. Setting up an EU-wide common structure will demand more time. The MWG is of the opinion that a common strategy and time schedule for the implementation of data coordination and harmonisation would help to move things forward. In addition, the MWG believes data harmonisation is crucial and therefore recommends that a) monitoring data provided by applicants, third parties or existing agro-environmental monitoring programmes include, if requested, standardised numerical raw data ready to be statistically analysed, b) if standard monitoring methods exist for specific species, habitats and geographical regions, they are used, c) data quality is standardised to enable advanced statistical analysis and d) the submission of monitoring data is based on certain standards, for example, for storage media, file types and processing.
3. Applicability of existing EU monitoring programmes and data infrastructure schemes for GMO monitoring 3.1 Current state of agro-environmental monitoring, data coordination and harmonisation in the MS and at EU level EU MS have various agro-environmental monitoring programmes in place – some of which have a long history of data collection – that are presently being considered in the context of general surveillance of GMOs. However, no programme identified to date, fully meets all the needs of GMO monitoring. National agro-environmental monitoring programmes are often driven by EU obligations (Directives and Regulations) with the result that environmental parameters are periodically monitored. In addition, NGOs in a voluntary capacity often monitor environmental parameters at EU level. The MWG considered that the monitoring programmes run in accordance with the following pieces of legislation were potentially relevant for GMO monitoring: the Habitats Directive1 on the conservation of natural habitats and of wild fauna and flora, the Water Framework Directive2 (WFD), the Birds Directive3 on the conservation of wild birds and Council Regulation 1698/ 2005/EEC on support for rural development by the European Agricultural Fund for Rural Development (EAFRD). In addition to these programmes, the Pan-European Common Bird Monitoring Scheme (PECBMS) was also considered. For some of the Directives mentioned, data infrastructure schemes – focal points, the purpose of which is to coordinate and/or harmonise the monitoring data – have been developed which could have potential relevance to GMO monitoring, including data coordination and harmonisation. These are namely, the European Environment Information and Observation NETwork (EIONET) and the Infrastructure for Spatial Information in the European Community (INSPIRE). Besides 1 2 3
Official Journal L 206 , 22/07/1992, P. 0007 – 0050 Official Journal L 327 , 22/12/2000, P. 0001 – 0073 Official Journal L 103 , 25/04/1979, P. 0001 – 0018
GMO monitoring data coordination Tab. 1 Evaluation criteria of agro-environmental monitoring programmes and infrastructure schemes in the EU*. General information
Data analysis
aim of programme/scheme commencement of programme/scheme implementation stage of programme/scheme
aim of data analysis type of data analysis baseline/threshold values
Observed features/indicators
Data harmonisation efforts/extent
type of features/indicators observed criteria for selection of features/indicators
sampling or observation methods data quality management data coordination
Observed areas
Data availability
land surface types biogeographic regions total area
public access to data host of data repository at EU level temporal availability of data
Sampling/observation design general approach of sampling/observation design frequency of sampling/observation no. of sampling/observation sites representativeness of sampling/observation sites * Criteria for sampling/observation design and data analysis are not applicable to infrastructure schemes
these infrastructure schemes, regulatory information systems in the context of GMOs and the research project on ’EU-wide monitoring methods and systems of surveillance for species and habitats of Community interest’ (EuMon) are also operative at EU level. While most of the infrastructure schemes are already fully operational at EU level, most of the EU monitoring programmes are still in the process of implementation. 3.2 Evaluation of EU monitoring activities The information on both EU monitoring programmes and data infrastructure schemes were evaluated with respect to their relevance to GMO monitoring (Table 1). At EU level the monitoring activities under the WFD, the Habitats Directive and the PECBMS have been identified as being the most relevant for GMO monitoring given their aim, indicators observed, methods and spatio-temporal design for data collection, data analysis, data storage and data exchange facilities. These three EU-wide agro-environmental monitoring programmes predominantly use specific national monitoring methodologies and designs, which make an intercalibration of the collected data at EU level difficult. However, at higher levels of data aggregation, an intercalibration of the collected data is still possible, since national monitoring methodologies are well described and the reported data are required to be comparable and compatible in order to allow analysis at EU scale. Furthermore, the process of data coordination under the WFD and Habitats Directive can be taken as an example of how monitoring activities at national level could be integrated within a monitoring design covering several or all EU MS. Be-
sides the obligation to report at national level, the nationally collected monitoring data are forwarded to a European infrastructure scheme. Under the PECBMS, data are collected and hosted by PECBMS itself. Data collected nationally under the WFD and the Habitats Directive are integrated into EIONET by the use of a standardised reporting format. EIONET is the central European focal point for a number of environmental monitoring reporting obligations and hosts the most developed data coordination scheme. More in depth evaluation is required to determine the overall value of these programmes for GMO monitoring purposes, since at present no agro-environmental monitoring programme is fully applicable for GMO monitoring. For instance, no raw environmental monitoring data are provided yet on a regular basis at EU level and the monitored areas of the agro-environmental monitoring programmes overlap only partially with areas cultivated with GMOs. Hence, in the EU there is an existing network of both agroenvironmental monitoring programmes and infrastructure schemes for coordinating monitoring data. This to some extent could be applicable for GMO monitoring (see Figure 1 for their interrelationship). While the EU-wide monitoring programmes and infrastructure schemes undertake individual efforts to harmonise their approaches, additional efforts are being undertaken at EU level to achieve harmonisation of monitoring data. In this context, EuMon and particularly the INSPIRE process are of importance. EuMon envisages harmonised approaches at the level of methods and data coordination to be used for longterm biodiversity indicator-based monitoring and access to data; INSPIRE aims at harmonising spatial data sets in the EU
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(including data collected under the WFD, the Habitats Directive and for the GMO monitoring). Spatial data harmonised under INSPIRE will also be coordinated and hosted by the EIONET. 3.3 Outcomes of the MWG for future coordinated activities On the basis of the study done, the MWG is of the opinion that an implementation of both national and EU-wide GMO monitoring activities in parallel is feasible, if monitoring is integrated into, or makes use of a similar approach as the existing EU-wide network of programmes and infrastructure schemes involved in agro-environmental monitoring. The current infrastructure scheme of EIONET is considered most appropriate for this aim. The setting up and implementation of such a GMO monitoring system (preferably, including monitoring activities carried out by the applicants as national and EU-wide agroenvironmental monitoring programmes only partly cover GMO monitoring features) will need further scientific consultation. For example, the applicability and potential adaptation of the existing national and EU-wide monitoring programmes (e.g. in terms of observed features/indicators and methods) to meet the requirements for GMO monitoring, will need some further thought. A scientific consultation process will also be required to discuss the coordination and harmonisation of GMO monitoring data, data collection methods, spatio-temporal design for data collection, data quality, data storage and analysis as well as reporting formats for data exchange within the EU with the aim of achieving EU-wide standards. This scientific consultation process could be largely integrated with and follow similar coordination and harmonisation procedures as those of INSPIRE, EIONET, WFD and Habitats Directive4.
When initiating this process, administrative aid, funding and legal matters such as obligations to use technical and scientific standards, would also need to be considered. For example, the data coordination approach of EIONET using national and EU focal points for storing the monitoring data could be evaluated with a view to adoption for GMO monitoring. National and/or European bodies could be given the responsibility for the collation of GMO monitoring data from the applicants, third parties and from existing monitoring programmes (Figure 1) and for reporting data to the EIONET. In conclusion, the MWG recommended that the CAs specify in greater depth the details of and the conditions to participate in or make use of the existing monitoring programmes and infrastructure schemes already operational in the EU.
4. Literature European Commission (2007) Concepts for the coordination and harmonisation of monitoring data exchange regarding GM crops. http://ec.europa.eu/environment/biotechnology/pdf/ concepts_coordinating_gmo_data.pdf Fink, M., Seitz, H., and Beismann, H. (2006) Concepts for General Surveillance: VDI proposals. Standardisation and harmonisation in the field of GMO monitoring. J Verbr Lebensm 1:11 – 14. Graef, F., Züghart, W., Hommel, B., Heinrich, U., Stachow, U., and Werner, A. (2005) Methodological scheme for designing the monitoring of genetically modified crops at the regional scale. Environ Monit Assess 111:1 – 26. Reuter, H., Verhoeven, R., Middelhoff, U., and Breckling, B. (2006) Information System for the Monitoring of Genetically Modified Organisms (GMO) – ISMO. J Verbr Lebensm 1:89 – 91.
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These coordination and harmonisation procedures established over the years required regular meetings of the Member States and the Commission responsible, the buildup of technical and staff infrastructure, and the drafting of documents providing common guidance to the stakeholders.
