Guidance on the environmental risk assessment of genetically modified plants

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2010;8(11):1879
doi
10.2903/j.efsa.2010.1879
Panel members at the time of adoption
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal.
Acknowledgements

The Panel wishes to thank the members of the Working Groups on (1) “sub ERA Guidance Document” Detlef Bartsch (chair), Cristina Chueca, Adinda De Schrijver, Achim Gathmann, Rosie Hails, Antoine Messéan, Joe Perry, Lucia Roda, Angela Sessitsch, Geoff Squire, Jeremy Sweet (vice-chair); (2) “Self-task on Non Target Organisms” Salvatore Arpaia (chair), Detlef Bartsch, Marc Delos, Achim Gathmann, Rosie Hails, Jozsef Kiss (vice-chair), Paul Hening Krogh, Barbara Manachini, Joe Perry, Jeremy Sweet, Claudia Zwahlen and (3) “Statistics ERA guidance” Marco Acutis, Detlef Bartsch, Rosie Hails, Antoine Messéan, Joe Perry (chair), Jeremy Sweet, Hilko Van Der Voet for the preparation of this opinion and EFSA staff members Yann Devos, Karine Lheureux, Sylvie Mestdagh and Claudia Paoletti for the support provided to this scientific opinion.

Contact
Type
Guidance of the Scientific Committee/Scientific Panel
On request from
European Commission and EFSA
Question Number
EFSA-Q-2008-262
EFSA-Q-2008-089
Adopted
21 October 2010
Published in the EFSA Journal
12 November 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six steps for the ERA of GM plants, as indicated in Directive 2001/18/EC, starting with (1) problem formulation including hazard identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible relatives, including plant-to-plant gene transfer ; (2) plant-to-micro-organism gene transfer; (3) interaction of the GM plant with target organisms and (4) interaction of the GM plant with non-target organisms, including criteria for selection of appropriate species and relevant functional groups for risk assessment; (5) impact of the specific cultivation, management and harvesting techniques; including consideration of the production systems and the receiving environment(s); (6) effects on biogeochemical processes; and (7) effects on human and animal health. Each specific area of concern is considered in a structured and systematic way following the above-mentioned steps (1 to 6). In addition, the guidance document is supplemented with several general cross-cutting considerations (e.g. choice of comparator, receiving environment(s), general statistical principles, long-term effects) that need to be considered in the ERA.

Keywords
GM plant, GMO, guidance document, environmental risk assessment, environmental safety, import, processing, cultivation, Regulation (EC) No. 1829/2003, Directive 2001/18/EC.