Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2013

Question Number
EFSA-Q-2013-00329
Issued
15 January 2014
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Abstract

In accordance with EFSA’s strategy for cooperation and networking with Member States, the EFSA Scientific Network for Risk Assessment of GMOs (GMO Network) was launched in 2010. The overall goals of the GMO Network are to: improve dialogue among participants; build mutual understanding of risk assessment principles; enhance knowledge on and confidence in the scientific assessments carried out in the EU; and increase the transparency of the process among Member States and EFSA. The Annual reports of the GMO Network inform the public and the EFSA Advisory Forum about its specific activities and achievements. During its meeting in 2013, the GMO Network discussed the principles of statistical relevance and biological significance, the use of animal feeding trials in the risk assessment of GMOs, the development of environmental protection goals and the EFSA Guidance on the environmental risk assessment of GM animals. Following requests from EFSA, the GMO Network provided input to EFSA’s scientific report “Considerations on the applicability of OECD TG 453 to whole food/feed testing” and to the project “Review of statistical methods and data requirements to support post market environmental monitoring of agroecosystems”.

Summary

Developing networking and stronger cooperation with the Member States and strengthening EFSA’s relationship with its institutional partners (European Union and international) and stakeholders are among the key recommendations formulated by EFSA’s Management Board. In accordance with EFSA’s strategy for cooperation and networking with Member States, the EFSA Scientific Network for Risk Assessment of GMOs (genetically modified organisms—hereafter referred to as “the GMO Network”) was launched in 2010. The GMO Network had its inaugural meeting in November 2010 and since then it has met once per year.

The overall goals of the GMO Network are to: improve dialogue among participants; build mutual understanding of risk assessment principles; enhance knowledge on and confidence in the scientific assessments carried out in the EU; and increase the transparency of the process among Member States and EFSA. It aims to raise the level of harmonisation of the risk assessments developed in the EU.

Currently 24 Member States and Norway are members of the GMO Network. Each country was allowed to nominate two Member Organisations: one for competence in molecular characterisation and food/feed safety (MC/FF) and one for competence in environmental risk assessment (ERA). These Member Organisations have appointed in total 60 selected scientific experts (and substitutes) to attend the yearly meetings in the light of the topics on the agenda. A maximum of two experts per country are invited to the yearly meetings.

The fourth meeting, held in May 2013, was attended by 36 scientific experts from Member States, Norway and EU Candidate Countries (Bosnia and Herzegovina, Croatia (became a Member State on 1 July 2013), the Former Yugoslav Republic of Macedonia, Montenegro, Serbia and Kosovo) as observers, one representative of the European Commission (Directorate General for Health and Consumers) as an observer, five EFSA GMO Panel members, one EFSA Food Additives and Nutrient Sources Added to Food (ANS) Panel member, one EFSA Scientific Committee (SC) member, one external expert as invited speaker, and 12 EFSA scientific staff from the GMO, Scientific Committee and Emerging Risks, and Pesticides Units.

At the fourth meeting, the appointed experts were informed about active mandates of the EFSA GMO Panel, including GMO applications, risk assessment guideline development, requests for scientific advice, procurements, etc. This was followed by a discussion on statistical significance and biological relevance, debating the advantages and limitations of the tests of difference and equivalence used in the risk assessment of GMOs. As in 2012, two breakout sessions were organised according to the expertise of the two groups of experts to allow in-depth discussion of specific topics. The experts in the field of MC/FF discussed animal feeding trials and their role in the risk assessment of GMOs. The experts in the ERA field discussed the development of protection goals and their importance in the context of a harmonised environmental risk assessment. At the following joint plenary session, one of the topics discussed by the GMO Network members and EFSA was the design of protocols for long-term animal feeding trials and the added value of data obtained from such trials was debated. Related to this item, EFSA informed GMO Network members of its draft Scientific Report on the applicability of the OECD (Organisation for Economic Co-operation and Development) guideline for two-year animal feeding studies and invited them to provide input to this draft. The third topic discussed during the joint plenary sessions was the recently adopted EFSA Guidance on the environmental risk assessment of GM animals, its structure and applicability. Finally, EFSA reminded the Network members about activities requiring involvement from Member States and about ongoing calls for participation in procurement and grants.

All details of the meeting are recorded in the minutes. [1]

Published
17 January 2014