The European Food Safety Authority has launched a public consultation on its draft guidance for the environmental risk assessment of GM animals.

The document, which focuses on GM fish, insects, mammals and birds, outlines the specific data requirements and methodology for the risk assessment of GM animals, in case any such animals are submitted for market authorisation in the EU. The draft guidance was created in response to a request from the European Commission last year and follows on from health and welfare guidance already published by the Authority.

EFSA said its risk assessment is based on a comparative approach between GM and non-GM animals, in which non-GM animals serve as a baseline with respect to animal safety. The agency invited “all stakeholders and interested parties” to contribute through an online consultation, which will run until 31st August.

GM animals have been approved for use in other global regions, though there are significant animal welfare implications with the process and European consumers have strongly rejected more commonplace transgenic crop plants. Nevertheless, in 2010, Canadian authorities authorised production of GM ‘Enviropigs’ which excrete between 30 and 70 per cent less phosphorus and scientists in Argentina and China have created cows with human genes to render their milk more similar to human breast milk.   

EFSA risk assessment

According to EFSA scientists, different areas of potential risk will be examined specific to fish, birds, mammals and insects. Risks which will be examined include:

• interactions of the GM animal with target and non-target organisms
• environmental impacts of the techniques used to rear or keep the GM animal;
• the impact of the GM animal on human and animal health, including potential risks to farmers, other workers or the general public which may come into contact with the animal.

Risk assessments will be based on a six-step approach and EFSA’s draft guidance also includes recommendations for ‘post-market environmental monitoring’ (PMEM) of GM animals, which is required under EU law. PMEM covers ways in which any “potential unanticipated adverse effects on the environment” will be monitored.

Although there have currently been no applications to approve GM animals for import or production in the EU, in global regions where genetic modification of animals takes place, mostly the Americas, the technology has become more commonplace in recent years.

The Commission also requested EFSA develop guidance for the safety assessment of food and feed derived from GM animals and the animals’ health and welfare, which the authority completed in January. The EFSA said that, following its consultation on draft guidance for environmental considerations, it will publish final guidelines later in the year.

Controversy persists

However, the genetic modification of animals is an acutely controversial area of science. The EFSA said that its risk assessment is based purely on the scientific process and does not factor in “the broader societal, political and economic debates about GMOs and GM animals.”

Critics of the process have said it violates animal rights as, by manipulating animals for human ends, creating GM animals gives the impression that they are nothing more than human property, rather than beings in their own right; this is also reflected in moves to patent animals produced by the process of genetic modification.

Furthermore, the impetus for creating GM animals is almost exclusively economic, and welfare organisations including the RSPCA have raised concerns about the process. Currently, only between one and three per cent of experiments aimed at creating GM animals are successful and cloning is often used with the genetic modification, which often creates oversized, weak animals, that are more susceptible to disease.

The EFSA said its welfare guidance would measure any animals produced through genetic modification against their non-GM comparators to establish whether there is a difference in welfare, however, it said it is not responsible for ethical concerns.

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