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

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Article
Panel on Genetically Modified Organisms
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

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
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
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.

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.