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Guidance on the Environmental Risk Assessment of Genetically Modified Animals Guidance on the Environmental Risk Assessment of Genetically Modified Animals [May 2013]

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Guidance on the Environmental Risk Assessment of Genetically Modified Animals Guidance on the Environmental Risk Assessment of Genetically Modified Animals [May 2013] [2013] TM-03-13-157-EN-C Guidance of the GMO Panel Scientific Opinion of the EFSA Panel on Genetically Modified Organisms (GMO) Guidance on Guidance Guidance on the environmental risk assessment of genetically modified animals the environmental risk assessment of genetically modified animals risk assessment the environmental [May 2013] Via Carlo Magno 1A Tel: +39 0521 036 111 43126 Parma Fax: +39 0521 036 110 ITALY www.efsa.europa.eu doi:10.2805/49649 The EFSA Journal is an open-access, online scientific journal that publishes the scientific outputs of the European Food Safety Authority (EFSA). EFSA’s scientific publications are devoted to the HOW TO OBTAIN EU PUBLICATIONS field of risk assessment in relation to food and feed, and cover topics including nutrition, animal health and welfare, plant health and plant protection. EU Bookshop’s ‘print on demand’ service Free publications: enables you to order a paper copy of selected scientific publications from the EFSA Journal: http://bookshop.europa.eu • one copy: via EU Bookshop (http://bookshop.europa.eu); • more than one copy or posters/maps: from the European Union’s representations (http://ec.europa.eu/represent_en.htm); from the delegations in non-EU countries (http://eeas.europa.eu/delegations/index_en.htm); by contacting the Europe Direct service (http://europa.eu/europedirect/index_en.htm) or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) (*). (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you). Priced publications: • via EU Bookshop (http://bookshop.europa.eu). Priced subscriptions: • via one of the sales agents of the Publications Office of the European Union (http://publications.europa.eu/others/agents/index_en.htm). Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed. More information on the European Union is available on the Internet (http://europa.eu). Luxembourg: Publications Office of the European Union, 2013 © European Food Safety Authority Printed in Luxembourg PRINTED ON ELEMENTAL CHLORINE-FREE BLEACHED PAPER (ECF) EFSA Journal 2013;11(5):3200 SCIENTIFIC OPINION Guidance on the environmental risk assessment of genetically modified 1 animals EFSA Panel on Genetically Modified Organisms (GMO)2,3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure 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 follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA. © European Food Safety Authority, 2013 KEY WORDS Birds, Directive 2001/18/EC, environmental risk assessment (ERA), fish, genetically modified, insects, mammals 1 On request from the European Commission, Question No EFSA-Q-2011-00919, adopted on 18 April 2013. 2 Panel members: Salvatore Arpaia, Nicholas Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe. Correspondence: [email protected] 3 Acknowledgement: EFSA wishes to thank the members of the following Working Groups: Working Group on GM Fish: Anne Kapuscinski, Philip McGinnity, Audun Nerland, Kaare Magne Nielsen, Joe Perry, Fulvio Salati, Joachim Schiemann, Fredrik Sundström, Jeremy Sweet; Working Group on GM Insects: Jeffrey Bale, Romeo Bellini, Michael Bonsall, George Christophides, Patrick du Jardin, Achim Gathmann, Marc Kenis, Jozsef Kiss, Esther Kok, Anna Malacrida, John Mumford, Kaare Magne Nielsen, Steve Sait, Jeremy Sweet; Working Group on GM Mammals and Birds: Phillip Cassey, Flavio Forabosco, Jonathan Jeschke, Jozsef Kiss, David Morton, Kaare Magne Nielsen, Michel Pascal, Joe Perry, Angelika Schnieke, Mike Sharp, Jan Arend Stegeman, Martin Wierup for the preparatory work on this scientific output; and the hearing experts: Ian Cowx, Michael Eckerstorfer, Edmund Peeler, Luke Alphey, Helen Sang and EFSA staff: Yann Devos, Christina Ehlert, Yi Liu, Sylvie Mestdagh, Nancy Podevin, Stefano Rodighiero and Elisabeth Waigmann for the support provided to this scientific output. Suggested citation: EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2013. Guidance on the environmental risk assessment of genetically modified animals. EFSA Journal 2013;11(5):3200, 190 pp. doi:10.2903/j.efsa.2013.3200 Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 2013 Guidance Document on the ERA of GM animals SUMMARY Following a request from European Commission, the EFSA Panel on Genetically Modified Organisms (GMO Panel) was asked to deliver a scientific opinion providing guidance on the environmental risk assessment of genetically modified (GM) animals. This Guidance Document provides guidance for the environmental risk assessment (ERA) of living GM animals to be placed on the EU market according to Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance to applicants and risk assessors for assessing potential adverse effects of GM animals on the environment, human and animal health and the rationales for data requirements for a comprehensive ERA. It also provides general guidance for drawing conclusions on the post-market environmental monitoring (PMEM). The ERA of GM animals involves collecting, assessing and, where appropriate, generating information on a GM animal in order to determine its impact on the environment and human and animal health compared with non-GM animals or appropriate comparators. The ERA should follow a step-by-step assessment approach. In accordance with Directive 2001/18/EC, the EFSA Panel on Genetically Modified Organisms (GMO Panel) describes the six steps for the ERA of GM animals: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) overall risk evaluation. As a general principle, the use of a step-by-step approach beginning with problem formulation is required whereby scientifically reliable evidence, based on qualitative and, whenever possible, quantitative analyses, is combined with an explicit uncertainty analysis in order to support the final conclusions of the ERA. In accordance with Annex II of Directive 2001/18/EC, the EFSA GMO Panel considers specific areas of risk that should be addressed systematically following the six steps of the ERA. This Guidance Document addresses for GM fish, GM insects and GM mammals and birds the following areas of risk: (1) persistence and invasiveness of the GM animal, including vertical gene transfer (VGT); (2) horizontal gene transfer; (3) interactions of the GM animal with target organisms; (4) interactions of the GM animal with non-target organisms (NTOs); (5) environmental impacts of the specific techniques used for the management of the GM animal; (6) impacts of the GM animal on biogeochemical processes; and (7) impacts of the GM animal on human and animal health. In addition, this Guidance Document describes several generic cross-cutting considerations that need to be accounted for throughout the whole ERA. The EFSA GMO Panel provides guidance to applicants on the identification and characterisation of relevant receiving environments in which the GM animal is likely to be released, the choice of adequate comparators and, where appropriate, the use of non-GM surrogates with similar characteristics that can inform the ERA of the GM animal. Applicants should follow the requirements for proper experimental design, modelling as well as the general statistical principles outlined in this document, such as the specification of the effect size and the power analysis. If experimental studies are being used, they should allow testing for difference and equivalence. Moreover, applicants should communicate results and conclusions of the uncertainty
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