EFSA has not yet received any applications for the introduction of GM animals in the EU, but in the United States, the Food and Drug Administration (FDA) gave provisional approval in December to introduce a GM salmon that reaches maturity twice as fast as traditional salmon and consumes 25% less feed. Following the end of a public consultation last month, which attracted more than 30,000 comments, the FDA is expected to provide its final assessment shortly.
Now, EFSA has issued a framework for risk assessors and potential applicants for assessing the potential adverse effects of living GM animals on the environment, including on human and animal health.
The culmination of several years’ work, it was finalised following consideration of more than 700 comments from interested parties during a public consultation period last year.
“The core of the guidance is that ERAs [environmental risk assessments] for GM animals must be carried out in a scientifically sound and transparent manner,” Elisabeth Waigmann, head of EFSA’s GMO Unit, sid in a statement.
“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 says that assessments would need to be carried out on a case by case basis, depending on animal type, the GM trait or traits, and the animal’s intended use.
There are three main parts to an ERA for GM animals, starting with a mandatory six-step evaluation process that forms the basis of the GMO Panel’s ERA approach. This would be followed by a mandatory assessment of seven areas of potential risk from GM animals, including fish, mammals, insects or birds.
Thirdly, the Panel has developed broad considerations to take into account, including using non-GM animals as a baseline in comparative risk assessment, and guidelines on how to characterise the environments into which the animals could be released.
“Crucially, EFSA specifies the methodology and reporting standards that should be observed in application data,” the food safety body said. “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.”
The framework is available online here.