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Guidance on the Environmental Risk Assessment of Genetically Modified 1 3 Animals EFSA Journal 20YY;volume(issue):NNNN 1 SCIENTIFIC OPINION 2 Guidance on the environmental risk assessment of genetically modified 1 3 animals 4 EFSA Panel on Genetically Modified Organisms (GMO)2, 3 5 European Food Safety Authority (EFSA), Parma, Italy 6 ABSTRACT 7 This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) 8 animals to be released into the environment and placed on the EU market according to Regulation (EC) No 9 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on 10 animal and human health and the environment and the rationales for data requirements for a comprehensive 11 ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. 12 This document describes the six steps for the ERA of GM animals, as indicated in Directive 2001/18/EC, 13 starting with (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; 14 (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk 15 evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority 16 follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and 17 risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is 18 considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance 19 Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM 20 surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted 21 for throughout the whole ERA. 22 © European Food Safety Authority, 2012 23 24 KEY WORDS 25 Birds, Directive 2001/18/EC, Environmental Risk Assessment (ERA), fish, genetically modified, insects, 26 mammals, release. 27 1 On request from the European Commission, Question No EFSA-Q-2007-069, approved on DD Month YYYY. 2 Panel members: 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. Correspondence: [email protected] 3 Acknowledgement: EFSA wishes to thank the members of the following Working Groups: Working Group on GM Fish: Anne Kapuscinsky, Philip McGinnity, Audun Nerland, Kaare Magne Nielsen, Joe Perry, Fulvio Salati, Joachim Schiemann, Fredrik Sundstrom, Jeremy Sweet and the hearing experts: Ian Cowx and Edmund Peeler; 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 and the hearing experts: Luke Alphey, Michael Eckerstorfer, Bart Knols and Ernest Wimmer; Working Group on GM Mammals and Birds: Philip 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 and the hearing expert: Helen Sang for the preparatory work on this scientific output 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: European Food Safety Authority; Title of the guidance. EFSA Journal 20YY;volume(issue):NNNN. [175 pp.] doi:10.2903/j.efsa.20YY.NNNN. Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 2012 Guidance Document on the ERA of GM animals 28 SUMMARY 29 This Guidance Document (GD) provides guidance for the environmental risk assessment (ERA) of 30 GM animals to be released into the environment and placed on the EU market according to Regulation 31 (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance to risk assessors for assessing 32 potential adverse effects of GM animals on the environment and the rationales for data requirements 33 for a comprehensive ERA. It also provides general guidance for drawing conclusions on the post- 34 market environmental monitoring (PMEM). 35 The ERA of GM animals involves collecting, assessing and, where appropriate, generating 36 information on a GM animal in order to determine its impact on the environment, human and animal 37 health compared with non-GM animals or appropriate comparators. 38 The ERA should follow a step-by-step assessment approach. In accordance with Directive 39 2001/18/EC, the EFSA Panel on Genetically Modified Organisms (GMO Panel) describes the six steps 40 for the ERA of GM animals: (1) problem formulation including hazard and exposure identification; (2) 41 hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management 42 strategies; and (6) overall risk evaluation. As a general principle, the use of a step-by-step approach 43 beginning with problem formulation is required whereby scientifically reliable evidence, based on 44 qualitative and, whenever possible, quantitative analyses, is combined with an explicit uncertainty 45 analysis in order to support the final conclusions of the ERA. 46 In accordance with Annex II of Directive 2001/18/EC, the EFSA GMO Panel considers specific areas 47 of risk that applicants should address following systematically the six steps of the ERA. This GD 48 addresses for GM fish, GM insects and GM mammals and birds the following areas of risk: (1) 49 persistence and invasiveness of the GM animal, including vertical gene transfer; (2) horizontal gene 50 transfer; (3) interactions of the GM animal with target organisms; (4) interactions of the GM animal 51 with non-target organisms; (5) environmental impacts of the specific techniques used for the 52 management of the GM animal; (6) impacts of the GM animal on biogeochemical processes; and (7) 53 impacts of the GM animal on human and animal health. 54 In addition, this GD describes several generic cross-cutting considerations (e.g. choice of comparators, 55 use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) 56 that need to be accounted for throughout the whole ERA. The EFSA GMO Panel provides guidance to 57 applicants on the selection of relevant receiving environments in which the GM animal is likely to be 58 released, the choice of adequate comparators and, where appropriate, the use of non-GM surrogates 59 with similar characteristics that can inform the ERA of the GM animal. Applicants should follow the 60 experimental design, the general statistical principles outlined in this document such as specification 61 of effect size, limits of concern, power analysis and the reporting recommendations. If experimental 62 studies are being used they should allow testing for difference and equivalence. Moreover, applicants 63 should communicate results and conclusions from the uncertainty analyses, as well as communicate 64 how each type of uncertainty was treated, eliminated at a specific step, or further assessed and carried 65 throughout the ERA. This GD also addresses the assessment of long-term effects requiring specific 66 information sources and techniques, including experimental or theoretical methodologies, as well as 67 aspects of the health and welfare of GM animals to be released into the environment. 68 The ERA should be carried out on a case-by-case basis, meaning that the required information may 69 vary depending on the type of GM animals and trait(s), the potential receiving environments and their 70 intended use(s). The ERA may benefit from the comparative safety assessment of food and feed 71 derived from GM animals, including data on the molecular characterisation, on the compositional 72 analysis and on the phenotypic characterisation of the GM animal. The outcome of this comparative 73 assessment will inform the initial steps of the ERA of GM animals and, in particular, the identification 74 of possible unintended effects due to the transformation process and/or the trait. For the sake of a 75 comprehensive ERA, information related to interactions between the GM animal and its receiving EFSA Journal 20YY;volume(issue):NNNN 2 Guidance Document on the ERA of GM animals 76 environments should be collected (e.g. desk and literature studies), assessed and, where appropriate, 77 generated (e.g. studies, modelling). 78 Therefore, the ERA should be carried out in a scientifically sound manner based on available scientific 79 and technical data and on common methodology for the identification, gathering and interpretation of 80 the relevant data. Tests, measurements, and data generated should be clearly described as well as the 81 assumptions made during the ERA. In addition, the use of scientifically sound modelling approaches 82 could provide further useful information for the ERA. Thus, sufficient scientific data enabling 83 qualitative/quantitative risk estimates, must be available in order to draw a conclusion on the possible 84 environmental risk posed by a given GM animal. EFSA Journal 20YY;volume(issue):NNNN 3 Guidance Document on the ERA of GM animals 85 TABLE OF CONTENTS 86 Abstract ...................................................................................................................................................
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