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Biosafety Virtual Library Resources
(VLR)
published: 18 Aug 2011
last updated: 25 May 2012
Guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants
EN
- Inter-governmental organization (IGO)
Largo N. Palli 5/A
Parma,
I-43100, Italy
Phone: +39 0521 036111,
Fax: +39 0521 036110,
Website: http://www.efsa.europa.eu,
EFSA Panel on GMO; Scientific Opinion on guidance on the Post-Market Environmental Monitoring
(PMEM) of genetically modified plants. EFSA Journal 2011;9(8):2316. [40 pp.] doi:10.2903/j.efsa.2011.2316. Available
online: http://www.efsa.europa.eu/efsajournal
EN
2011-08
EN
EFSA Panel on GMO; Scientific Opinion on guidance on the Post-Market Environmental Monitoring
EN
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.
EN
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.
- GBF-T17. Strengthen biosafety and distribute benefits of biotechnology
No
No
No
Identifier (ISBN, ISSN, etc.)
Keywords and any other relevant information
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.