New guidance from the European Food Safety Authority (EFSA) provides applicants and risk assessors with a clear framework to evaluate the potential adverse effects of living genetically modified (GM) animals on the environment, including those on human and animal health. While no applications for GM animals have yet been received in the European Union (EU), scientific developments suggest future submissions may be made for a number of species. Therefore, the European Commission requested that EFSA develop environmental risk assessment (ERA) guidance for GM fish, insects, mammals and birds.
The vast majority of the GM animal ERA guidance has been newly developed by EFSA’s GMO Panel, and its publication is the culmination of several years’ work. It was finalised following the consideration of more than 700 comments received from stakeholders and interested parties during a public consultation held last year. This work complements previous guidance by EFSA on the safety of food and feed from GM animals published in 2012 and completes the mandate from the Commission for comprehensive risk assessment guidelines on GM animals.
Data requirements and monitoring
Environmental risk assessments of GM animals must be carried out on a case-by-case basis which means the information required in applications may vary depending on aspects such as the animal type, the new trait being introduced and the intended use of the GM animal.
The guidance document lays down requirements for collecting, evaluating and generating key information to complete an ERA for a GM animal. These data would form an essential part of an application for a living GM animal to enter the EU market. The document also offers guidance for continuous post-market environmental monitoring (PMEM) and addresses animal health and welfare.
“The core of the guidance is that ERAs for GM animals must be carried out in a scientifically sound and transparent manner,” said Elisabeth Waigmann, head of EFSA’s GMO Unit. “They must be based on sufficient scientific and technical data that enable conclusions to be drawn on possible environmental risks posed by a living GM animal. The inclusion of a comprehensive uncertainty analysis is of central importance given the current limitations in the availability, relevance and quality of data relating to GM animals.”
The guidance details three broad aspects that should form part of a rigorous ERA of GM animals. The first is the mandatory six-step evaluation procedure enshrined in EU legislation that forms the basis of the GMO Panel’s approach to environmental risk assessment. This approach should be followed by an assessment of seven areas of potential risk from GM fish, insects, mammals or birds that applicants are legally obliged to consider. (See Notes to editors for further explanation of these processes.)
Thirdly, the GMO Panel has introduced a number of cross-cutting considerations that should be factored into the full GM animal ERA process. One of these is the use of so-called comparators – non-GM animals that serve as a baseline in the comparative risk assessment of GM animals. Another element is the use of appropriate surrogates, when this is considered necessary. A surrogate animal is one that does not bear the same genetic modification at issue but shares enough traits with the GM animal to act as its substitute in risk assessment tests and experiments. The guidance also describes methods for the identification and characterisation of environments into which GM animals might be released.
Crucially, EFSA specifies the methodology and reporting standards that should be observed in application data. The importance of clear guidance on experimental design, general statistical principles to be employed, the assessment of long-term effects and a detailed breakdown of several aspects of the uncertainty analysis are all emphasised.
In accordance with Directive 2001/18/EC, EFSA lists the six steps for the ERA of GM animals as: (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.
Under annex 2 of the same Directive, the seven areas of potential risk applicants must consider are: 1) persistence and invasiveness of the GM animal, including vertical gene transfer; (2) horizontal gene transfer; (3) interactions of the GM animal with target organisms; (4) interactions of the GM animal with non-target organisms; (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.