Genetically modified animals

EFSA’s role is to independently assess and provide scientific advice to risk managers on any possible risks that genetically modified organisms (GMOs) pose 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.

Acting on a request from the European Commission, EFSA developed comprehensive guidance for the risk assessment of food and feed derived from GM animals, including an evaluation of animal health and welfare and environmental safety. The Authority has also developed a guidance document on the environmental risk assessment (ERA) of GM animals, which covers GM fish, insects, mammals and birds.

No GM animals, or food or feed from GM animals, have been authorised for placement on the market in the EU, nor have any applications been made by industry for approval.

Scientific developments suggest future submissions for GM animals may be made for a number of species. In some countries outside the EU, regulators are already assessing the safety of GM animal products developed for food and feed purposes. For example, in the US the Food and Drug Administration (FDA) is considering an application from industry for placement on the market of a growth-enhanced GM salmon.

Based on these considerations, and as a proactive measure to assure consumer safety, the European Commission requested that EFSA develop comprehensive risk assessment guidance for GM animals. They provide clear guidance to risk assessors and biotech companies. In the event of making any future application for market approval, applicants would be obliged to use.

EFSA has developed two guidance documents that outline specific data requirements and the methodology for the risk assessment of GM animals.

• The first relates to the safety assessment of food and feed derived from GM animals and includes considerations on animal health and welfare aspects.
• The second document provides guidance on how to conduct an environmental risk assessment (ERA) of living GM animals to be placed on the EU market and includes health and welfare aspects.

This guidance document, published in January 2012, relates to the safety assessment of food and feed derived from genetically modified animals and on animal health and welfare aspects. The document 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 guidance document outlines a risk assessment approach to compare GM animals and derived food and feed with their respective conventional counterparts. The basic assumption of this type of comparative assessment Required in law, an assessment designed to compare the safety of a genetically modified (GM) organism against its non-GM bred counterpart. 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. Important components of the risk assessment include molecular characterisation, compositional analysis and assessment of toxicity The potential of a substance to cause harm to a living organism., nutritional aspects and potential allergenicity The ability to trigger an abnormal immune response that leads to an allergic reaction in a person.. For example, experts will assess whether food and feed from GM animals are as nutritious to humans and animals as those from conventionally-bred animals.

The guidance document also outlines the methodology required for the comparative assessment of health and welfare aspects of GM animals. This assessment is applied in two ways: firstly, in relation to the GM animal itself, where the assessment should focus on the effective functioning of the animal’s body systems (e.g. disease resistance); and secondly, in relation to the food and feed risk assessment, as the health and welfare status of animals is seen as an important indicator of the safety of animal-derived products. (For further information on animal health and welfare aspects, see question 10).

The guidance also includes recommendations for the post-market monitoring and surveillance of food and feed derived from GM animals on a case-by case basis.

EFSA published guidance on the environmental risk assessment (ERA) of GM animals in May 2013. 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).

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 Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to them. The next three stages are characterising the hazard A substance or activity which has the potential to cause adverse effects to living organisms or environments. and exposure and - from the combination of both - the potential risk. Finally applicants must outline risk management The management of risks which have been identified by risk assessment. It includes the planning, implementation and evaluation of any resulting actions taken to protect consumers, animals and the environment. strategies and provide an overall risk evaluation.

Secondly, applicants should address seven areas of potential risk for GM fish, insects, mammals or birds; (1) persistence Persistence refers to the ability of harmful organisms like bacteria to survive and thrive despite regular cleaning and disinfection efforts, potentially lingering in hidden places for months or even years. 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.

The guidance also 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 this is considered necessary, and recommendations for the assessment of potential long-term effects of GM animals as well as for the uncertainty analysis A method of identifying the sources of uncertainty in a risk assessment calculation and estimating their size and direction so that errors can be taken into account..

EFSA recognises that there are concerns about animal health and welfare related to the development of GM animals for food and feed purposes. Requirements for the assessment of animal health and welfare are integrated in both its guidance documents on GM animals.

The guidance of food and feed derived from GM animals highlights the need for extensive comparative analysis of the characteristics and traits of GM animals, including physiological parameters, with those of their conventional counterparts. It also proposes that health and welfare should be assessed at all stages of development of the GM animal. The recommended assessment strategy covers the laboratory setting where the GM animal is initially developed, experimental field trials outside the laboratory involving a higher number of animals and trials with large numbers of animals carried out in a commercial setting (prior to authorisation).

The ERA guidance also covers GM animals for non-food/feed uses, such as ornamental fish. In these cases, the document provides guidance on data requirements and outlines the obligation for applicants to show the health and welfare of the animals are not significantly affected compared to an appropriate comparator – a non-GM counterpart that is used as a baseline against which to assess the GM animal. Where no comparator can be identified, the health and welfare of the GM animal itself should be considered. If experiments need to be carried out to generate data, these should comply with EU legislation regarding the use of animals for scientific purposes.

Post-market monitoring and surveillance is also considered necessary to identify unintended effects of the genetic modification on the health and welfare of the GM animal arising after it has been authorised for placement on the market.

EFSA is only responsible for evaluating the food and feed safety, environmental safety and health and welfare aspects of GM animals. While EFSA acknowledges the broader societal, political and economic debates about GMOs and GM animals, these considerations are not taken into account in the scientific process of risk assessment.

Genetic modification involves the altering of the genetic material of an animal. In a genetically modified animal, DNA sequences have been inserted, removed or modified in order to introduce a new trait or change a characteristic such as the disease resistance of an animal. The technology used is known as recombinant-DNA technology and was first applied in the 1970s.

Animal cloning A technique used to make an exact genetic copy of an animal. results in the production of an animal that is a genetically identical copy of the original.

• Further information on cloning