A Genetic Technology (Precision Breeding) Bill [PDF] was introduced to the House of Commons on 25 May 2022 and received Royal Assent on 23 March 2023.
TIMELINE:
Commons Stages: Second Reading, 15 June 2022. Committee Stage, 28 June to 7 July 2022. Report Stage and Third Reading, 31 October 2022.
The Bill completed its Commons stages unamended.
Lords Stages: First Reading, 1 November 2022. Second Reading, 21 November 2022. Committee Stage, 12 and 14 December 2022. Report Stage, 25 January 2023, when a number of Government amendments were agreed to. King's Consent and Third Reading, 1 February 2023.
Commons consideration of Lords amendments: 6 March 2023. All the Lords' amendments were accepted.
Royal Assent, 23 March 2023
Neither the Scottish nor Welsh Parliaments have granted legislative consent to the Bill. The Scottish and Welsh Governments have indicated they do not plan to change regulation of GE technologies for food and feed. The Scottish Government said it would block the application of this Bill in Scotland.
What does the Act do?
The May 2022 Queen’s Speech [PDF] said the measures aims were to “encourage agricultural and scientific innovation” in the UK” and that “legislation will unlock the potential of new technologies to promote sustainable and efficient farming and food production.”
The Act applies to precision bred plants and vertebrate animals (excluding humans), meaning they are gene edited, and would remove them from the regulatory system for genetically modified organisms (GMOs).
What is precision breeding?
The Government’s Genetic Technology fact sheet published with the Bill [PDF] describes precision breeding as a range of breeding technologies, such as gene editing (GE), that enable DNA to be edited “much more efficiently and precisely than current breeding techniques”.
Precision breeding technologies can make targeted genetic changes to produce beneficial traits that can also occur through traditional breeding and natural processes. This makes it different to genetic modification (GM) where modern techniques are used to insert functional DNA from an unrelated species into another species.
Scientists consider that precision breeding will allow a range of foods with health, environmental or commercial benefits to be developed more quickly than traditional breeding methods. Policy makers hope these will help to tackle global food security, climate change and human health challenges. GE crops may currently be cultivated in several countries including Canada, China, the US, Australia, and Brazil (with varying regulation).
Examples of current GE products include soybean oil with reduced saturated fat sold in the USA and a tomato sold in Japan that accumulates a chemical that lowers blood pressure. For the future, a range of wheat, chickpea, and peanut products with health benefits are in development, alongside products aimed at consumer convenience such as seedless fruits and corn that is higher in thickening starch.
How will the Act change the regulation of precision breeding?
The Government said the primary policy objective of the legislation was to ensure plants, animals and food and feed products developed using precision breeding technologies are “regulated proportionately to risk” [PDF]. The Bill will “introduce simpler regulatory measures to enable these products to be authorised and brought to market more easily.”
GE and other new precision breeding techniques are currently regulated under the complex regime that applies to all genetically modified organisms (GMOs). EU rules on GMOs currently continue to apply in the UK, (although 2022 regulations amended the rules in England for certain GE plants used for research and development).
Regulations define a GMO as an organism in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination, or both. The European Court of Justice in 2018 determined that the GMO regulations should include new breeding technologies such as GE developed in the last 30 years. This ruling was contentious and the EU is currently consulting on possible loosening of restrictions for plants resulting from GE technology.
The Government has said leaving the EU provides the UK with the opportunity to adopt a “more science based and proportionate approach to the regulation” of precision bred organisms [PDF]. This could “drive innovation and investment” in the UK.
According to the Government, it should cost less to take a precision-bred crop to market, compared to under the current GMO process. These savings would predominantly benefit the plant breeding sector, but also, indirectly, the rest of the food chain. The overall time taken to comply with existing regulation for getting precision bred crops to market will be reduced from an estimated 10 years to 12 months.
The main policy changes in the Bill [PDF] as set out by Defra, are to:
- Remove plants and [vertebrate] animals [excluding humans at any developmental stage] produced through precision breeding technologies from regulatory requirements applicable to the environmental release and marketing of GMOs.
- Introduce two notification systems; one for precision bred organisms used for research purposes and the other for marketing purposes. The information collected will be published on a public register on GOV.UK.
- Establish a proportionate regulatory system for precision bred animals to ensure animal welfare is safeguarded. The Government said it would not introduce changes to the regulations for animals until this system is in place.
- Establish a new science-based authorisation process for food and feed products developed using precision bred organisms.
The Government said the changes mean the level of regulatory scrutiny for precision bred organisms is “somewhere between that of GMOs and traditionally bred organisms” [PDF].
The Government has said the application of the measures to precision breeding of animals will not take place until an appropriate regulatory regime is in place. Nevertheless, the Bill provides powers for the Secretary of State to introduce the measures by secondary regulation.
The inclusion of animals in the proposed changes raises issues about the health and welfare of animals. GE could be used for breeding disease-resistant animals for example, but some stakeholders warn of the need to ensure animal welfare is not compromised by breeding to select certain traits. The legislation is drafted to apply to all animals, not just those used in agriculture. It includes a provision for animal welfare to be considered but does not include any specific restrictions on what can be marketed.
Several Government amendments were made in the House of Lords and accepted by the Commons. These were principally to change the scrutiny procedure for some secondary legislation made under the Act from negative to affirmative; and to clarify which kinds of genetic features are permissible in a precision-bred organism, and the techniques by which they may be introduced. There were no successful opposition amendments.
Issues raised during scrutiny of the Bill in both Houses focused on animal welfare implications, the regulatory framework and the lack of any requirement for labelling GE products for consumers.
Stakeholder reactions
The Government said the independent Advisory Committee on Releases to the Environment (ACRE) considered that precision bred organisms “posed no greater risk than their traditionally bred or naturally arising counterparts” [PDF]. However, stakeholders have divided views on regulatory changes.
Health and animal welfare
In 2021, Defra consulted on possible broad changes to GE regulation [PDF]. Most individuals (88%) and nearly two-thirds of businesses responding wanted GE regulation to continue as now, under the GMO regime. However, more than half of academic institutions (58%) and non-governmental organisations supported change.
Similarly, views were divided on the risks posed by GE organisms. Some 87% of individuals and 64% of businesses considered they posed a greater risk to human health and the environment compared to traditionally bred counterparts. In contrast, 63% of academic institutions and 82% of public sector bodies considered they posed the same level of risk.
Scientists are broadly in favour of removing GE from wider GMO regulation, as are many food producers and farmers including the National Farmers’ Union and livestock producers. However, some groups such as the Soil Association, GM Freeze and Beyond GM are concerned that there is insufficient knowledge about the effect on organisms and the environment, and that claims about benefits for tackling food supply and health issues are overstated. Others, such as the RSPCA, are concerned that changes could lead to lower animal welfare standards.
Marketing and labelling
There are also concerns about transparency for consumers. Ministers have said food and feed from precision bred organisms are unlikely to need to be labelled as such. This could be an issue for products authorised under this legislation in England which are sold in other UK nations.
Although regulation of genetic technologies is a devolved matter, under the UK Internal Market Act 2020, precision bred products legally marketed in one nation may be marketed in the other UK nations.