Public consultation on the draft Opinion by the EFSA GMO Panel providing guidance on Post-Market Environmental Monitoring (PMEM) of genetically modified plants

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The EFSA GMO Panel has launched an open consultation on a draft scientific opinion providing guidance on Post-Market Environmental Monitoring (PMEM) of GM plants.

The aim of this draft opinion is to update the previous opinion providing guidance on PMEM that the EFSA GMO Panel adopted in 2006. This initiative was undertaken in response to a mandate received from the European Commission and carried by a need from a wide range of stakeholders.

Following the recent update of the EFSA Guidance Document on the Environmental Risk Assessment of GM plants, this draft opinion shows how the conclusions of risk assessments determine the requirements for PMEM and provides guidance for the development of PMEM plans. The draft opinion provides the scientific rationale for the different types of monitoring (Case-Specific Monitoring and General Surveillance) as well as draft guidelines and recommendations to applicants and, where appropriate, to risk managers on monitoring strategy, methodology and reporting.

The EFSA GMO Panel considered a broad range of information, including comments from Member States on PMEM plans and references from scientific literature, during the development phase of the current draft opinion. EFSA is of the opinion that PMEM of GM plants is a challenging area that needs in-depth discussions on the approach of PMEM as set by the regulatory framework as well as on the methodology. A scientifically-sound basis for PMEM data collection and analysis is very important for risk assessors and risk managers so that the results can inform a comprehensive environmental risk assessment of GM plants.

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and all stakeholders, EFSA has launched a public consultation on the draft opinion providing guidance on PMEM of GM plants updated by the EFSA GMO Panel.

Interested parties are invited to submit written comments by 22 May 2011. Please use exclusively the electronic template provided with the documents to submit comments and refer to the line and page numbers. Please note that comments submitted by e-mail or by post cannot be taken into account and that a submission will not be considered if it is:

• submitted after the deadline set out in the call,
• presented in any form other than what is provided for in the instructions and template,
• not related to the contents of the document,
• contains complaints against institutions, personal accusations, irrelevant or offensive statements or material,
• is related to policy which is out of the scope of EFSA's activity.

EFSA will assess all relevant comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the EFSA GMO Panel and taken into consideration if found to be relevant.