First EFSA experiences with monitoring plans

Authors: Detlef Bartsch A Gathmann S Hartley N B Hendriksen R Hails K Lheureux J Kiss S Mesdagh G Neemann J Perry S Renckens J Schiemann J Sweet

Publish Date: 2008/02/01

Volume: 2, Issue: 1, Pages: 33-36

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Abstract

A plan for Post Market Environmental Monitoring PMEM of genetically modified GM plants is mandatory in all applications for deliberate release submitted under EU Directive 2001/18/EC and EU Regulation 1829/2003 PMEM is composed of casespecific monitoring and general surveillance of GM plants The European Food Safety Authority EFSA is responsible for assessing the scientific quality of PMEM plans submitted with each application In a scientific opinion the EFSA GMO Panel presented specific guidance for applicants for developing PMEM plans In addition the EFSA GMO Panel explained the scientific rationale for this guidance and makes a number of recommendations for the management and conduct of PMEM by both applicants and risk managers Until the end of March 2007 the EFSA GMO Panel gave opinions on 11 PMEM plans submitted under EU Directive 2001/18/EC and another 11 plans submitted within applications under EU Regulation 1829/2003 Currently 27 applications for GM plants are still in the evaluation process and the EFSA GMO Panel sent 26 questions to the applicants for clarification and additional information during the evaluation process Sixteen of these questions were related to General Surveillance eg general structure farm operator questionnaires integrations of identity preservation systems use of existing surveillance systems feral plant surveillance Nine questions requested clarification on the environmental risk assessment which might effect whether casespecific monitoring is needed In one case an application for cultivation of a GM crop the GMO Panel recommended casespecific monitoring We explain in more detail how the environmental risk assessment of two Bt maize dossiers maize Bt11 and 1507 were considered by the GMO Panel in the evaluation of the PMEM plan and the consequences for the environmental monitoring plan As stated in the EFSA opinion on postmarket environmental monitoring the general surveillance plans shall when possible make use of existing monitoring systems in addition to more focused monitoring systems However the use of these national monitoring programmes is outside of the management and control of an individual applicant and thus it cannot be the task of an applicant alone to use modify or improve existing surveillance systems The availability of biodiversity monitoring programmes in the EU Member States should be evaluated by applicants in close liaison with risk managers

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