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.