The UK government has proposed legislation to open the way for gene‑edited food products in England.  The Genetic Technology (Precision Breeding) Bill (“Precision Breeding Bill”) sets out a new regulatory regime that may provide a faster and easier path to market for certain gene-edited plants, animals and derived products.

Overview of the Precision Breeding Bill

The Precision Breeding Bill applies to “precision bred organisms”.  These are defined in the Precision Breeding Bill as plants and animals that have been genetically modified through the use of “modern biotechnology”, where that genetic modification is of a type that could have been produced using “traditional processes” (i.e. selective breeding, grafting, embryo transfer, spontaneous mutation, etc.).  The definition of “modern biotechnology”, for the purposes of the Precision Breeding Bill, aligns with the set of techniques listed in regulation 5(1)(a) or (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443).  Ultimately, the effect of the Precision Breeding Bill is to create a distinction in law between ‘precision bred organisms’ and all other ‘genetically modified organisms’ (“GMOs”) where the genetic modification could only have been produced using genetic modification technologies (e.g. introducing genes from one species into another, entirely unrelated, species).

The Precision Breeding Bill provides that a person wishing to use precision bred organisms for research or for marketing must first notify and register the precision bred organism.  Once notified and registered for research and development, the precision bred organisms can be released i.e. planted, bred or cultivated.  No specific authorisation is required.  Before marketing the precision bred organism, a person must apply for a ‘precision bred confirmation’, which indicates that the Secretary of State is satisfied, on the basis of information provided by the person, and scientific advice, that the organism qualifies as a precision bred organism.  The UK government will maintain a public register of all notified information. 

The Precision Breeding Bill also provides for an authorisation system for food and feed derived from precision bred organisms.  The UK Food Standards Agency (“FSA”) will have the power to conduct a risk assessment on food and feed derived from precision bred organisms, and recommend that the food and feed receive a marketing authorisation.  The FSA states that “[p]recision bred foods will only be permitted if our risk assessment judges them… not to present a risk to health, not to mislead consumers, and not to be nutritionally disadvantageous.

The Precision Breeding Bill does not provide for any specific labelling or information requirements for precision bred organisms or products.  The FSA states that it is working on a relevant ‘consumer education project’, although it has not provided details.  

Initially, the government will open the new system to precision bred plants only.  It will not open the system to precision bred animals until it has established “a proportionate regulatory system for precision bred animals to ensure animal welfare is safeguarded”.

Legal and policy background

The Precision Breeding Bill would modify existing UK GMO regulation, which is derived from EU legislation.  The EU legislation provides that an organism is classed as a GMO where its genetic material has been altered in way that does not occur naturally.  It does not distinguish between instances where the genetic modification could have been produced using traditional processes and instances where the genetic modification could only have been produced using genetic modification technologies i.e. EU law does not provide for a separate category of precision bred organisms or similar.

The EU‑derived rules around “contained use” of GMOs (essentially in laboratory settings) are relatively straightforward.  The “deliberate release” GMO rules are more complicated, with complex risk assessments and authorization processes, and strict mandatory traceability and labelling requirements, including for food and feed which contains ingredients produced from GMOs.  Products produced using GMOs must be assessed and authorised on a case-by-case basis before they may be placed on the market. 

The UK government considers that the current, EU-derived “requirement for onerous and expensive authorisation processes for all products of genetic technology has stifled innovation in the UK”.  In contrast, the UK government argue that the Precision Breeding Bill will “cut red tape… [and] remove unnecessary barriers…”.  The proposals in the Precision Breeding Bill are based on advice from the Advisory Committee on Releases to the Environment (“ACRE”).  ACRE argues that the fact that an organism is produced through gene‑editing (or other genetic technologies) does not mean that it necessarily poses a greater safety risk than a traditionally bred or naturally occurring version of that organism.  Rather, ACRE argues, the final characteristics of an organism must be examined to determine whether it presents any safety risks.

Claimed benefits

Defra’s Factsheet on the Precision Breeding Bill claims that the change to the law will bring a number of potential benefits.  The Factsheet notes that precision breeding could enable “the development of crops that are more nutritious, resistant to pests and disease, resilient to climate change and more beneficial to the environment.  This in turn could reduce the need for pesticides, increase food production and reduce costs to English farmers.  Precision breeding can also enhance the health and welfare of animals through greater resistance to diseases and reduced use of antibiotics, and improved resilience to the impacts of climate change.”  The Factsheet also notes that permitting precision breeding “could help facilitate greater trade with countries that currently, or are planning to, make use of precision breeding technologies… [could] enable the creation of potential new export markets for UK-based producers… [and could] also lead to a greater willingness of companies to invest and sell products in the UK relative to the EU due to the creation of a more favourable regulatory environment.

Territorial application

The territorial scope of the Precision Breeding Bill is limited to England only.  GMOs are regulated by the devolved powers in Wales and Scotland and, currently, neither administration appears willing to follow England’s lead and carve out precision bred organisms from the existing regime.  However, due to the mutual recognition principle in the UK internal market, it will be possible to place food and feed products derived from precision bred organisms on the market in Wales and Scotland, if they can be marketed lawfully in England.  In Northern Ireland, the existing restrictions in EU law on GMOs will continue to apply, and products produced using GMOs must be assessed and authorised on a case-by-case basis.

Timeline

Secretary for the Environment and Conservative MP, George Eustice, sponsored the Genetic Technology (Precision Breeding) Bill (the “Precision Breeding Bill”), and introduced it to the House of Commons on 25 May 2022.  Defra published a full impact assessment on 26 May 2022.  UK Members of Parliament will consider the Precision Breeding Bill again at a second reading on 14 June 2022.  It is not clear when the Precision Breeding Bill will be finalised but it may be before the end of 2022.

Meanwhile, the EU are also reviewing their GMO regime.  The European Commission has opened a public consultation on the regulation of plants produced through certain gene editing techniques, as well as food and feed products derived from those plants.  The consultation will close on 22 July 2022.

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Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the London Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Mr. Kelly’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law, and product liability…

Brian Kelly is a partner in the London Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Mr. Kelly’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Mr. Kelly as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Mr. Kelly’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Mr. Kelly has also been advising on UK and European “Brexit” related issues including tariffs.

Mr. Kelly has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Mr. Kelly is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Mr. Kelly is an honorary lecturer at University College London.

Photo of Seán Finan Seán Finan

Seán Finan advises clients in the life sciences sector on a broad range of regulatory and commercial matters, including MDD/MDR classification, due diligence on life sciences regulatory matters and policy implementation.

Seán is a member of the firm’s Disability and Mental Health affinity group.