Genetically modified animals
What are GM animals?
Genetic modification (GM), also known as “recombinant-DNA technology”, was first applied in the 1970s. It is one of the newest methods to introduce novel traits to micro-organisms, plants and animals. This technology has so far primarily been used in plants for agriculture and in micro-organisms to produce enzymes. The possible application of genetic modification techniques to animals is being researched. Several international organisations, including FAO/WHO and the United States Food and Drug Administration, have already published guidelines for the safety assessment of these animals and their derived products.
Within the European Union (EU), the application of GM technology is strictly regulated for domestic and imported goods. The EU has established a legal framework regulating GM food and feed as well as the release of GMOs into the environment in order to ensure a high level of protection of human and animal health, and the environment.
EFSA’s role is to independently assess and provide scientific advice to risk managers on any possible risks of GMOs for human and animal health and the environment. In Europe, it is the role of risk managers such as the European Commission and the Member States to decide whether a GMO or a derived product can be placed on the EU market.
Currently, no GM animals or derived products are on the EU market. In a proactive measure, the European Commission has asked EFSA to develop a risk assessment approach that would be used to assess the possible risks for food and feed safety and the environment as well as related animal health and welfare aspects. This will help possible future applicants to submit their applications to EFSA.
Genetic modification of an animal
Genetic modification of an animal involves the modification of its genetic material by adding, changing or removing certain DNA sequences to modify the characteristics of the animal or introduce a new trait, such as disease resistance or enhanced growth, in a predetermined way. DNA is the genetic material of an organism and carries the instructions for all the characteristics that an organism inherits. Changes introduced in an animal’s genetic make-up can therefore be transmitted to the next generation.
EFSA’s remit regarding GM animals
EFSA has agreed with the Commission to develop two separate guidance documents for the risk assessment of GM animals, covering the following areas:
- safety of food and feed derived from GM animals and related animal health and welfare aspects
- safety of releasing GM animals bred for food and feed purposes into the environment (yet to be published)
EFSA’s work on GM animals builds upon the work carried out thus far at international level, including that of the Codex Alimentarius
.
The guidance document for the risk assessment of food and feed derived from GM animals and related animal health and welfare aspects outlines the specific data requirements to be provided by applicants as well as the methodology for the food/feed risk assessment of GM animals should future applications be submitted for market authorisation in the EU. The upcoming guidance on environmental risk assessment of GM animals will broadly follow a similar structure.
In the EU regulatory system for GMOs, EFSA is responsible only for evaluating the food and feed and environmental safety of GMOs. Whilst it acknowledges the broader societal, political and economic concerns over GM animals, EFSA does not consider these aspects when carrying out its scientific assessments.
EFSA’s work on GM animals
Special Working Groups of EFSA’s Panel on Genetically Modified Organisms (GMO) and Panel on Animal Health and Welfare (AHAW) have worked in close co-operation to develop the guidance for the food/feed risk assessment of GM animals and continue to do so for the upcoming guidance on environmental risk assessment. As with all EFSA guidance documents on GMOs, the Authority consults Member States and relevant stakeholders as they are being developed. In addition, separate public consultations arelaunched on the guidance documents to ensure that the broadest possible range of comments and opinions are taken into account before they are finalised.
Working groups
To address the broad scope of this request from the Commission, dedicated Working Groups were created by the EFSA GMO and AHAW Panels:
1. Food and feed safety
EFSA’s GMO Panel established a Working Group to address the food and feed safety risk assessment of products derived from GM animals.
2. Health and welfare aspects of GM animals
EFSA’s AHAW Panel established a Working Group to address the assessment of possible health and welfare implications on GM animals bred for food and feed purposes.
The Working Groups from the GMO and AHAW Panels worked in close co-operation to develop a draft, integrated guidance document on the risk assessment of food and feed safety from GM animals including related animal health and welfare aspects.
3. Safety for the environment
The GMO Panel set up three dedicated Working Groups to enable them to effectively address the environmental safety of GM animals on a species-by-species basis. These groups will draft specific guidance for GM fish, GM insects, and GM mammals and birds.
In order to gather the necessary background information for this environmental risk assessment guidance document, EFSA launched three external calls for tenders with the aim of identifying available information and defining the risk assessment criteria for GM fish, GM insects and GM birds and mammals. The external reports produced by the selected contractors, available below, are being taken into consideration in the development of the guidance on environmental risk assessment.
Public consultation and finalisation of the guidance
The draft guidance document for the risk assessment of food and feed from GM animals and related animal health and welfare aspects was launched for public consultation between August and September 2011. Comments made during the consultation by interested parties and stakeholders were assessed by EFSA’s GMO and AHAW Panels and, where appropriate, incorporated into the final guidance document which was adopted at the end of 2011.
The guidance document on the environmental risk assessment of GM animals bred for food and feed purposes is expected to be launched for public consultation and subsequently adopted in 2012.
All EFSA public consultations are announced on the EFSA website and in EFSA’s weekly email newsletter (EFSA highlights).
