Report from the EuropaBio workshop on Environmental Risk Assessment for the cultivation of genetically modified crops


Report from the EuropaBio workshop on Environmental Risk Assessment for the cultivation of genetically modified crops

A series of GM plant market authorisation applications for the cultivation of GM plants in the European Union have been submitted under Regulation (EC) No 1829/2003 and are being assessed for their potential effects on the environment by ‘rapporteur’ Member States and EFSA. Applicants highlighted that there is currently no possibility for a so-called technical meeting between applicants and Member States to share the rationale behind respectively preparing, presenting and reviewing the ERA. This workshop aimed at establishing a platform to facilitate communication between the different parties involved in the preparation and review of applications, and at gaining insight into the respective approaches and methodologies applied to ERA. Representatives from the different parties involved in this process were invited. A list of participants to the workshop is included as Annex 1.

Each of the selected topics -the agenda is included as Annex 2- was introduced in a short presentation. They served to generate discussion between the participants, maximizing the opportunity to exchange views and to gain a common understanding. The participants then explored ways in which the preparation and review of ERAs can be improved allowing for more transparent and effective science-based decision-making.

In order to allow an open and frank dialogue, participants were asked to observe the Chatham House Rule that governs the confidentiality of the source of information received at a meeting. Participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed. In the same spirit, this report reflects the presentations and discussions, but does not include any attribution to a particular person. Where required to reflect the discussion, a general reference to “applicant”, “risk assessor”, “authority” or “participant” is provided.

This report it is not a literal account of the presentations and the discussion of the workshop. As the discussion developed, certain themes were revisited at different moments and a literal reporting would have resulted in a high level of repetition and potential contradiction between sections of the report. Therefore, an attempt was made to organise the information around particular themes and to provide a view on the different elements of the discussion, indicating points of agreement, as well as on subjects that require further reflection.

Discussions were moderated by Dr. Patrick Rüdelsheim (Perseus) who also drafted the initial version of the workshop report. All participants received the draft and had an opportunity to comment. All comments were evaluated and integrated as much as possible to the extent that they related to the discussions during the Workshop. Inputs that provided additional information and references not discussed in the Workshop were not taken up. The final report remains the responsibility of the author.

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