Source: European Food Safety Authority

Opinion of the Scientific Panel on Genetically Modified Organisms on the Post Market Environmental Monitoring (PMEM) of genetically modified plants
(Question No EFSA-Q-2004-061)
Opinion adopted on 25 January 2006

SUMMARY

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 aims at identifying possible unanticipated adverse effects on human health or the environment which could arise directly or indirectly from GM plants. PMEM is composed of case-specific monitoring and general surveillance of GM plants. Case-specific monitoring is not obligatory but may be required to verify the environmental risk assessment, whereas a general surveillance plan must be part of the application. The European Food Safety Authority (EFSA) is responsible for assessing the scientific quality of PMEM plans submitted with each application. In this opinion, the GMO Panel presents more specific guidance for applicants for developing PMEM plans. The GMO Panel concludes that general surveillance can not be hypothesis driven, but should, when possible, make use of existing monitoring systems in addition to more focused monitoring systems (e.g. farm questionnaires). Data quality, management and statistical analysis are of high importance in the design of general surveillance plans and comparison should be made with baseline data. In addition the EFSA GMO Panel explains 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.

Full report in PDF format:
http://www.efsa.eu.int/science/gmo/gmo_opinions/1381/gmo_op_ej319_pmem_en1.pdf

1 For citation purposes: Opinion of the Scientific Panel on Genetically Modified Organisms on the Post Market Environmental Monitoring (PMEM) of genetically modified plants, The EFSA Journal (2006) 319, 1-27.