Guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2011;9(8):2316
doi
10.2903/j.efsa.2011.2316
Panel members at the time of adoption
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal
Acknowledgements

The Panel wishes to thank the members of the Working Group on the Update of the 2006 PMEM Scientific Opinion: Salvatore Arpaia, Detlef Bartsch, Cristina Chueca, Rosie Hails, Antoine Messéan, Gerd Neemann, Joe Perry, Josef Soukup, Jeremy Sweet & the hearing expert Boet Glandorf for the preparation of this opinion and EFSA staff: Sylvie Mestdagh and Jane Richardson for the support provided to this scientific opinion

Contact
Type
Guidance of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2010-01253
Adopted
6 July 2011
Published
2 August 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The European Commission asked the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to update its 2006 scientific opinion on Post-Market Environmental Monitoring (PMEM) of Genetically Modified Plants (GMPs). For doing so, the EFSA GMO Panel made use of the experience gained from its assessment of applications on GMPs for cultivation and considered different sources of information such as the PMEM reports on cultivated GMPs, relevant scientific literature and stakeholders comments. This scientific opinion aims to clarify the objectives, tasks, tools and requirements for PMEM. Firsly, the present document explains the scientific rationale for PMEM, including the concept of developing management and monitoring strategies based on the overall conclusions and assumptions of the Environmental Risk Assessment. Secondly, it provides examples and guidance to applicants on how to develop and implement their plans for Case-Specific Monitoring (CSM), taking into account the case-by-case character of CSM. In addition, it provides guidance to applicants on the strategy, methodology and reporting of General Surveillance (GS). Different tools and approaches to implement a plan for GS are considered. The EFSA GMO Panel proposes a holistic and integrative approach for monitoring GMPs in the EU that considers GS within a framework of general environmental protection monitoring. Finally, the EFSA GMO Panel makes proposals to risk managers for the future conduct of PMEM in the EU and suggests that access to PMEM data could be facilitated by setting-up standardised and centralised reporting centres. This scientific opinion repeals the former 2006 scientific opinion of the EFSA GMO Panel on PMEM of GMPs.

Summary

The Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked by the European Commission to update its 2006 scientific opinion on the Post-Market Environmental Monitoring (PMEM) of Genetically Modified Plants (GMPs).

The EFSA GMO Panel made use of the experience gained from its assessment of applications on GMPs for cultivation and considered different sources of information such as the PMEM reports on cultivated GMPs, relevant scientific literature and stakeholders comments.

The EFSA GMO Panel firstly focused on the scientific rationale for PMEM. This scientific opinion shows how the overall conclusions and assumptions of the Environmental Risk Assessment (ERA), including the remaining uncertainties, determine the requirements for PMEM.

In second instance, the EFSA GMO Panel developed guidance to applicants on how to establish and implement their plans for Case-Specific Monitoring (CSM) in order to generate robust, scientifically-sound and statistically relevant data to further inform the ERA. Guidance on the statistical design and, when needed, the choice of appropriate non-GM comparators for CSM is provided. In addition, subject to the case-by-case character of CSM, examples of objectives for CSM are given in this scientific opinion.

In third instance, the EFSA GMO Panel discussed the concept and principles of General Surveillance (GS). It was recognised that GS is not hypothesis driven as it targets unanticipated effects. A plan for GS should be designed to identify the aspects of the environment that need to be protected from harm. In this respect, the EFSA GMO Panel provides a non-exhaustive list of examples of protection goals, assessment endpoints and indicators as well as of possible approaches for GS. The EFSA GMO Panel refers to three main approaches for GS of GMPs, namely (1) by monitoring the GMP and its cultivation sites (e.g. using a questionnaire to farmer), (2) by utilising the data collected by existing monitoring networks active in biodiversity surveys at local/regional/national scale and (3) by compiling and analysis data from scientific literature. Whereas the EFSA GMO Panel highlights the advantages and limitations of these approaches for GS, it also provides detailed guidance on how to use and to improve them.

In the present opinion, the EFSA GMO Panel proposes a holistic and integrative approach for monitoring GM plants in the EU that considers GS within a framework of general
environmental protection monitoring. In this context, the EFSA GMO Panel recognises that all parties (e.g. applicants, Member States) have to consider their roles in such an approach for environmental protection monitoring that embraces GS, both within countries and across the EU. In this wider context of monitoring GMPs as one component of the overall production system, the EFSA GMO Panel also suggests that standardised and centralised reporting centres for PMEM data be implemented. This would have the benefit of being able to harmonise and synchronise environmental monitoring, facilitate analysis and interpretation of PMEM reports.

Therefore, this scientific opinion repeals the former 2006 scientific opinion of the EFSA GMO Panel on PMEM of GMPs.

Keywords
Genetically Modified Plant (GMP), Environmental Risk Assessment (ERA), Post-Market Environmental Monitoring (PMEM), risk management strategies, Case-Specific Monitoring (CSM), General Surveillance (GS), protection goals, Directive 2001/18/EC.