Genetic modification of an animal involves altering its genetic material by adding, changing or removing certain DNA sequences in a way that does not occur naturally. It aims to modify specific characteristics of an animal or introduce a new trait, such as disease resistance or enhanced growth. 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.
While this technology has so far been used in plants for agriculture and in micro-organisms to produce enzymes, the potential application of genetic modification techniques to animals is also 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.
EU Regulatory Framework
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 derived products as well as the release of living 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 and to propose appropriate measures to mitigate the risks. While it acknowledges the broader societal, political and economic concerns over GM animals, EFSA does not consider these aspects when carrying out its scientific assessments. 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.
EFSA’s remit regarding GM animals
Currently, no GM animals or derived products are on the EU market, nor have any applications for GM animals been received in the EU. However, scientific developments suggest submissions may be made in future across a range of species. Therefore, as a proactive measure, the European Commission has asked EFSA to develop comprehensive risk assessment guidelines that would be used by companies and risk assessment bodies to evaluate the possible risks for food and feed safety, the environment as well as related animal health and welfare aspects. These will help possible future applicants when submitting their applications to EFSA.
Acting on the Commission’s request, EFSA has developed two separate guidance documents for the risk assessment of GM animals.
- Food, feed and animal welfare risk assessment
This guidance document, published in January 2012, outlines specific data requirements and the methodology to be followed for risk assessment should applications for food and feed derived from GM animals be submitted for market authorisation in the EU.
The risk assessment approach compares GM animals and derived food and feed with their respective conventional counterparts, integrating food and feed safety as well as animal health and welfare aspects. The basic assumption of this type of comparative assessment, which is required under current EU legislation for all GMOs submitted for market authorisation, is that food and feed from conventionally-bred animals have a history of safe use and therefore can serve as a baseline for the risk assessment of food and feed derived from GM animals.
The guidance gives recommendations for the post-market monitoring and surveillance (PMM) of GM animals and derived food and feed. PMM seeks to identify any potential unintended effects related to the genetic modification which might arise after the product has been authorised for placement on the market.
- Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects
- Environmental risk assessment of GM animals
In May 2013, EFSA published its guidance on the environmental risk assessment (ERA) of GM animals. The document provides guidance to applicants and risk assessors on how to conduct an ERA of living GM animals to be placed on the EU market according to Regulation (EC) No 1829/2003 (EC, 2003) or Directive 2001/18/EC (EC, 2001). This guidance document also includes health and welfare aspects of the GM animals.
Based on the wide range of GM research thought to be currently underway related to several different animal species, the European Commission requested that EFSA develop environmental risk assessment guidance for GM fish, insects, mammals and birds.
EFSA concluded that a risk assessment of GM animals should include three major aspects. Firstly, a six-stage assessment procedure should be completed. This step-by-step process, laid down in EU legislation, should begin with identifying potential hazards and the extent of human, animal and environmental exposure to them. The next three stages are characterising the hazard, exposure and risk. Finally applicants must outline risk management strategies and provide an overall risk evaluation.
Secondly, applicants must address seven areas of potential risk for GM fish, insects, mammals or birds: (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.
Thirdly, the guidance highlights a number of cross-cutting considerations that should be factored into the full ERA process. These include which non-GM animals to use as comparators, the use of appropriate surrogates if necessary, and recommendations on identifying environments into which GM animals are likely to be released.
Cooperation and consultation
EFSA’s Panel on Genetically Modified Organisms (GMO) and Panel on Animal Health and Welfare (AHAW) worked in close co-operation to develop both guidance documents. Separate public consultations were launched on the guidance documents to ensure that the broadest possible range of comments and opinions from consumers, Member States, and stakeholders were taken into account before being finalised. Hundreds of comments made during these consultations by interested parties and stakeholders were assessed by EFSA and, where appropriate, incorporated into the final guidance documents.
EFSA’s work on GM animals builds upon the work carried out thus far at international level, including that of the Codex Alimentarius.