DOI: https://doi.org/10.58248/PB50
Genome editing creates the possibility of making more precise alterations in the DNA of animals than existing genetic modification approaches. Much of the research and development on genome-edited animals is on farmed vertebrate animals, including on developing animals with faster growth, shorter hair, disease resistance and without horns. Traditional breeding selects desirable traits that have occurred by natural mutation during reproduction and uses individuals with those traits for further breeding, whereas genome editing is a deliberate genetic change. Researchers have highlighted that all genetic changes that occur by natural mutation and adopted by traditional breeding are unexpected. However, some genetic alterations that occur by genome editing are unlikely to occur naturally. The genome of edited animals can be sequenced and analysed for undesirable changes, and the animal can be observed over many generations so that any adverse developmental effects could be removed before commercialisation (as would occur with traditional breeding programmes).
Overview of key points
This POSTbrief complements the Commons and Lords Library briefings on the Bill. The Bill proposes that plants and animals that are produced by some forms of genome editing, and other genetic technologies, are regulated as Precision-Bred Organisms (PBOs). This regulatory definition applies if the PBO could have been developed by traditional breeding methods or may have occurred naturally. These plants and animals are currently regulated as Genetically Modified Organisms (GMO). Secondary legislation would be required before livestock and other animals classified as PBOs can be released into the environment.
In the Bill, the term precision breeding is presented as a scientific term, but some commentators question whether this is appropriate. Others suggest that an imprecise definition may not provide public reassurance that these techniques have the same risk profile as traditional breeding.
Globally, genome editing to alter traits in animals, such as disease resistance, growth rates or reproductive efficacy, is at different stages of development. This ranges from the initial ‘discovery’ phase to commercialisation and marketing of genome-edited animals.
An important aspect of the debate focuses on the animal welfare implications of the technology. Animal welfare concerns include possible unintended effects of the genome editing process, as well as the intended development of some traits such as faster growth. These concerns exist alongside potential improvements to animal welfare from the development of beneficial traits.
Stakeholders disagree on the extent to which the Bill should also consider any social and ethical implications. Market authorisation of genome-edited animals could have implications for the wider food system, society and trade. Public perceptions of the benefits of genome-edited animals are tied to how this technology will change the food and farming system, such as whether it further intensifies food and farming.
Concerns have also been expressed over transparency for consumers. The Bill does not require food labelling to state whether genome editing was used.
Public perspectives depend on what the applications of genome editing are used for. Stakeholders differ in their opinions on genome editing and many key issues are interrelated:
- Animal Welfare. Some proponents highlight that genome-edited animals will be held to the same welfare standard as traditionally bred animals, whereas other commentators have highlighted concerns about the protection of embryos and the reporting of off-target effects throughout the development of the genome-edited animal. There are also disagreements about the current welfare standards in livestock farming that go beyond genome editing (Section 3.1).
- Trust and transparency in the food system. Proponents suggest genome editing will help address challenges in the food and agricultural systems but is a standalone issue. Other commentators suggest genome editing cannot be separated from wider debates about farming systems, and that consumer attitudes to genome-edited animals are tightly bound to trust and transparency in the food system, and who realises the tangible benefits of technological changes (Section 3.2).
- Risks and benefits. The UK Government does not consider genome-edited animals to pose greater risks to human health or the environment than traditionally bred animals. However, some studies have explored other points of consideration (Section 3.3).
- Co-existence. While proponents of genome editing suggest the technology could be adopted in any type of farming system, organic farming has principles that do not permit the use of genome-edited animals, and relies on their labelling as GMOs to avoid growing or trading with them, suggesting co-existence challenges (Section 3.4).
- Responsible research and innovation. Researchers are encouraged to consider the wider implications of innovations, such as genome editing, on broader economic, societal, and environmental implications through application of the responsible research and innovation framework (Section 3.5).
Acknowledgements
POSTbriefs are based on literature reviews and interviews with a range of stakeholders and are externally peer reviewed. POST would like to thank interviewees and peer reviewers for kindly giving up their time during the preparation of this briefing, including:
- Professor Gideon Henderson, Department for Environment, Food & Rural Affairs (Defra)
- Dr Helen Ferrier, National Farmers’ Union (NFU)*
- Dr Craig Lewis, European Forum of Farm Animal Breeders (EFFAB) / Genus PLC
- Professor Sarah Hartley, University of Exeter*
- Dr Adrian Ely, University of Sussex*
- Professor Bruce Whitelaw, The University of Edinburgh / The Roslin Institute*
- Professor Guy Poppy, University of Southampton
- Professor Kate Millar, The University of Nottingham
- Professor Alison Van Eenennaam, The University of California, Davis
- Professor John Dupré, University of Exeter
- Professor Madeleine Campbell, British Veterinary Association (BVA)
* denotes people and organisations who acted as external reviewers of the briefing
Correction [02/12/2022]: P25 Original text: 'PBO status may only apply to genome-edited vertebrate animals. The Bill describes an animal as ‘any animal that consists of more than one cell, excluding humans’, and limits its scope to ‘relevant animal’, which covers all vertebrate animals, (those that contain a backbone such as mammals, birds, fish, amphibians, and reptiles), which require consideration of animal welfare. It is not yet clear whether invertebrates such as insects, will be exempted by the Bill from the GMO regulation. The Government stated that the definition of a “relevant animal” could be extended to include invertebrates if the Animal Welfare Act 2006 definition of “animal” was changed to include invertebrates.'
Amended text: 'The Bill as introduced seeks to remove plants and animals produced through precision breeding technologies, including certain types of genome editing, from regulatory requirements applicable to the environmental release and marketing of GMOs. The Bill describes an animal as ‘any animal that consists of more than one cell, excluding humans’. The Bill describes ‘relevant animal’ as all vertebrate animals, (those that contain a backbone such as mammals, birds, fish, amphibians, and reptiles), which require consideration of animal welfare. The Government stated that the definition of a “relevant animal” could be extended to include invertebrates if the Animal Welfare Act 2006 definition of “animal” was changed to include invertebrates. As introduced, the Bill may exempt other types of organisms from GMO regulation, such as insects, but no information has been provided on this in the guidance. Commentators have raised concerns that the Bill will allow any genome-edited animal (vertebrates and non-vertebrates) to be exempted from GMO regulation if classified as a PBO, with no provision for the secondary legislation of non-vertebrates.'
Correction [02/12/2022]: P42 Original text: 'The UK Government, considering committee evidence that precision-bred animals (and plants) do not present a greater risk to human health or the environment, state that the Genetic Technology Bill does not need to introduce additional environmental risk assessments beyond those outlined in the Environmental Protection Act 1990. Some commentators raise issue with this decision on the grounds that evidence should be provided to support this. The Regulatory Policy Committee has recommended that the impact assessment of the Genetic Technology Bill should include a detailed assessment of environmental impacts. The Bill sets out guidance on carrying out an assessment of risks of damage to the environment from the importing or the acquiring of a precision bred organism. It is unclear from the Bill whether the Advisory Committee on Releases to the Environment will provide detail on an environmental risk assessment.
Amended text: 'The UK Government, considering committee evidence that precision-bred animals (and plants) do not present a greater risk to human health or the environment, state that the Genetic Technology Bill does not need to introduce additional environmental risk assessments beyond those outlined in the Environmental Protection Act 1990. Some commentators raise issue with this decision on the grounds that evidence should be provided to support this. The Regulatory Policy Committee has recommended that the impact assessment of the Genetic Technology Bill should include a detailed assessment of environmental impacts. The Bill sets out guidance on carrying out an assessment of risks of damage to the environment from the importing or the acquiring of a precision bred organism, obtained for the purpose of their use in contained conditions such as in laboratories. This risk assessment does not apply to release of precision bred organisms into the environment. The Bill provides that regulations may be made to secure that the production of food or feed from a precision bred organism will not have adverse effects on the environment. However, commentators raise concerns that there is no commitment to do so, and raise further concerns that there is no provision to consider an environmental assessment for the release of precision bred organisms that are not food and feed (e.g. insects, algae, jellyfish). It is unclear from the Bill whether the Advisory Committee on Releases to the Environment will provide detail on an environmental risk assessment.'