Guidance on the environmental risk assessment of genetically modified animals

Tabs

Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2013;11(5):3200 [190 pp.].
doi
10.2903/j.efsa.2013.3200
Panel members at the time of adoption
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
Acknowledgements

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.

Contact
Type
Guidance of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00919
Adopted
18 aprile 2013
Published
23 maggio 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (2.31 MB)
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.

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 analysis, as well as explain how each type of identified uncertainty was treated throughout the ERA. This Guidance Document also addresses the assessment of long-term effects requiring specific information sources and techniques, including experimental or theoretical methodologies, as well as aspects of the health and welfare of GM animals.

The ERA should be carried out on a case-by-case basis, meaning that the required information may vary depending on the type of GM animal and the GM trait(s), the potential receiving environment(s) and the intended use(s). Some data already compiled for the comparative safety assessment of food and feed derived from GM animals, including data on the molecular characterisation, on the compositional analysis and on the phenotypic characterisation of the GM animal, will inform the initial steps of the ERA of GM animals and, in particular, the identification of possible unintended effects due to the transformation process and/or the trait. For the sake of a comprehensive ERA, information related to interactions between the GM animal and its receiving environments should be collected (e.g. desk and literature studies), assessed and, where appropriate, generated (e.g. experiments, modelling).

In conclusion, the ERA should be carried out in a scientifically sound manner based on available scientific and technical data and following the common methodology for the identification, gathering and interpretation of the relevant data. Tests, measurements and data generated should be clearly described as well as the assumptions made during the ERA. In addition, the use of scientifically sound modelling approaches could provide further useful information for the ERA. Thus, sufficient scientific data enabling qualitative/quantitative risk estimates must be available in order to draw a conclusion on the possible environmental risks posed by a given GM animal.

Keywords
Birds, Directive 2001/18/EC, environmental risk assessment (ERA), fish, genetically modified, insects, mammals
Print on demand
Themes
Medical and biological research, Environment policy and protection of the environment
ISBN number
978-92-9199-555-4
Catalogue number
TM-03-13-157-EN-C
Price
€ 8.00
Number of Pages
190
Order status
Available