Instruments drawn to the special attention of the House
Draft Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022
Date laid: 20 January 2022
Parliamentary procedure: affirmative
This instrument proposes to remove the current legal requirement in England to submit a risk assessment and seek consent from the Secretary of State before releasing plants with genetic modifications, which could have occurred naturally or been produced by traditional breeding, for non-marketing purposes. Under the proposed new arrangements, a notice will have to be given to the Secretary of State and published before the seed/other propagating plant material is placed into the ground for germination/onward growth. The Department for Environment, Food and Rural Affairs says that this policy change is to be a first step of a wider reform programme in the area of genetic technologies and gene editing which is to “unleash the potential of these technologies” and drive innovation. The proposals are of significant public interest, as indicated by a large number of responses to the Government’s consultation and three submissions we have received which raise a range of concerns. This report looks at some of these concerns, including how relevant plants will be assessed as qualifying for release and whether there will be safeguards and containment measures. The House may wish to explore these issues further with the Minister.
The draft Regulations are drawn to the special attention of the House on the ground that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.
1.These draft Regulations have been laid by the Department for Environment, Food and Rural Affairs (Defra) with an Explanatory Memorandum (EM) and an Impact Assessment (IA). The instrument proposes to remove current requirements in England to submit a risk assessment and seek consent from the Secretary of State before releasing genetically modified (GM) plants, which could have occurred naturally or been produced by traditional breeding methods, for non-marketing purposes. According to Defra, this is to remove a regulatory burden for research and development trials involving such plants, as a first step of a wider reform programme in this area.
2.We have received submissions from Beyond GM, GM Freeze and Organic Farmer & Growers (OF&G) which raise a range of concerns about the proposals. We are publishing the submissions in full on our website.1 We are also publishing at Appendix 1 the Department’s response to our questions which were informed by the submissions.
Background
3.Defra explains that a case before the Court of Justice of the European Union (CJEU)2 confirmed in July 2018 that in EU law all organisms produced by biotechnology are Genetically Modified Organisms (GMOs), and that they need to be regulated as such, even if they cannot be distinguished from organisms occurring naturally or produced by traditional breeding methods. According to Defra, the Government disagreed with this view and intervened in the case at the time “to present a different view based on scientific evidence and to argue that the regulatory regime should be proportionate to risk”.
4.Defra explains that in the Government’s view, where genetic alterations and combinations are of the type that are selected for in traditional breeding, the environmental release of these plants should not be regulated in the same way as the environmental release of GMOs. According to Defra, this is “because it is the characteristics of the end-product that determines its risk to human health and the environment–not how they were made”. Following Brexit, the Government now intend to change the law in England to allow GM plants that could have occurred naturally or through traditional breeding methods for release for non-marketing purposes. This is to enable the bioscience sector to test the benefits and safety of relevant new products “without the burden of unnecessary regulatory processes”.
5.Defra states in the IA that the changes will “send a signal that the UK Government wants to unleash the potential of these technologies and that this is the initial step of a wider reform programme”, adding that it “will have a positive impact on investment to drive innovation and generate wider spill over benefits into the UK economy from this increased investment”. Regrettably, the EM does not provide any further information on the Government’s plans for wider reform.
6.The Department says that the Advisory Committee on Releases to the Environment (ACRE)3 has advised on the safety aspects of the changes, concluding that where genetic alterations and combinations are of the type that are selected in traditional breeding, any associated health and environmental risks would be comparable, so the environmental release of these organisms should not be regulated in the same way as the environmental release of GMOs. According to Defra, this view is supported by the Royal Society.
Changes proposed by this instrument
7.Under current law, each GMO has to be assessed and authorised on a case-by-case basis before it can be used and released into the environment. This involves a risk assessment, a public consultation, and the publication of details of when and where its research trial will take place. In addition, consent must be sought from the Secretary of State.
8.Under the proposed new arrangements, any individual or organisation intending to release a “qualifying higher plant” into the environment will have to notify the Secretary of State. The draft regulations define “qualifying higher plant” as a higher plant which is a GMO, but which has not been genetically modified other than to make modifications that could have occurred naturally or could have been made using traditional breeding methods.4 The notice will need to be submitted to Defra before the seed or other propagating plant material is placed into the ground for germination or onward growth. The notice can be given by email and will be published on the gov.uk website/public register. These changes will apply only to relevant plants and not to animals.
Further use of qualifying higher plants
9.Asked whether qualifying higher plants could be used for food or animal feed and whether the labelling of such products would have to state their GM nature, Defra explained that:
“The instrument deals with plants released for non-marketing purposes, meaning developers are able to carry out research and development of such plants. However, the marketing of these plants will not be possible without consent from the Secretary of State, as they would still be GMOs. For this to be possible, developers would need to follow the GMO regulations and therefore would need to be labelled under the GMO Food and Feed Regulations.”
Criteria to be used to assess whether a plant qualifies as a qualifying higher plant
10.While the draft Regulations provide a definition of the term “qualifying higher plant”, they do not include criteria to assess whether the modifications of a relevant plant could have occurred naturally or could have been produced by traditional breeding methods. This is an issue that Beyond GM, GM Freeze and OF&G raised in their submissions.
11.Beyond GM stated that “neither the Instrument nor its Explanatory Memorandum provides a basis on which to justify creating a new subclass of exempted organisms. In addition, this subclass of genetically modified organisms is not defined or recognised in current scientific literature, in UK regulations [Environmental Protection Acts 1990 and 2002 and 2019 amendments], in international definitions (e.g., Cartagena Protocol) or the regulations of many other countries. The definition of a GMO is not minor theoretical point but a foundational concept in the regulation of agricultural genetic technologies and we therefore believe that the regulatory change presented in this Instrument is problematic”.
12.GM Freeze argued that the consultation suggested “significant uncertainty about such criteria” and that there is “clearly a high level of uncertainty about how and by whom the new category of ‘qualifying higher plant’ will be determined”. OF&G questioned the term “to occur naturally”, suggesting that it is not one they would “recognise in any way that would align with the techniques involved in altering genetic material by the invasive practice [ … ] in what is often referred to as ‘genetic editing’”.
13.We asked the Department about the scientific and regulatory criteria that will be used to determine whether a genetic change could have occurred naturally or through traditional breeding methods, and when these would be published. The Department told us that:
“ACRE is in the process of developing guidance for developers to determine if the genetic change could have occurred naturally or by using one of the techniques in the Genetically Modified Organisms (Deliberate Release) Regulations 2002 5(2). The guidance will be available shortly.”
14.We regret that the guidance has not yet been published, especially as the Department would have been aware of the concerns which were raised during consultation. The House may wish to press the Minister for an explanation why the guidance has not been made available in time for it to be taken into account by Parliament in its consideration of these draft Regulations. We urge the Department to ensure that the guidance is published in good time before the new rules come into effect and that this guidance is communicated effectively, in order to provide clarity to researchers and those who have concerns about the new policy.
Safeguards and containment measures
15.Under the current rules, an individual risk assessment and consent by the Secretary of State are required before any GMOs may be released. The instrument removes these requirements for qualifying higher plants. The submissions we received raised concerns about the safeguards that will apply to the release of such plants into the environment.
16.Beyond GM argued that the new approach in effect relies on “GMO developers to self-declare whether their product is a GMO or not [ … ] which is not appropriate for the deliberate environmental release of any kind of GMO”. OF&G suggested that “Risk assessments must have been in place and checks properly made in all situations with plant breeding especially in the field where escape does pose a significant risk.” GM Freeze raised concerns that “Non-marketing releases of experimental GMOs have, in many instances, led to the escape of pollen, seed and other plant material capable of reproduction”, and that “With no mandatory containment measures, farmers, food producers and distributers will be vulnerable to significant business disruption and potentially catastrophic costs in the event that ‘qualifying higher plants’ contaminate conventional or organic crops of the same, or a closely related species. Such contamination could lead to lost business, the loss of organic status (where relevant) and legal action.”
17.Asked about these concerns, Defra explained that:
“For GM plant research and development, where the changes could have been produced by traditional breeding methods, we will be moving to a self-declaration system. This approach is informed by advice from ACRE our independent scientific advisers and is more in step with approaches developed using traditional breeding methods. ACRE’s view is that an organism produced by gene-editing, or another genetic technology would not pose a greater safety risk than a traditionally bred or naturally occurring version of that organism, as a result of how it was produced. Researchers will still be required to notify Defra of these trials and commercial cultivation of these plants, food and animal feed derived from them will still need to be authorised in accordance with existing GM rules.
This SI will allow plants produced using genetic technologies that produce changes that could have occurred through traditional breeding, to be treated in the same way as their traditionally bred counterparts at the field trial stage. Underpinning this approach is the key principle that it is the final characteristics of an organism which determine whether it presents any safety risks, regardless of the method used to produce that organism. ACRE’s view is that where [Genome Editing] introduces genetic alterations and combinations that are of the type that are selected for in traditional breeding, the environmental release of these organisms should not be regulated in the same way as the environmental release of [GMOs].”
18.While the instrument establishes a notification requirement for the release of the qualifying higher plants, the information that must be notified to the Secretary of State for each release does not include the location or scale of any release, or details of the containment measures that will be employed to ensure that the GMOs do not affect either commercial crops or the wider environment. This is a particular concern for organic farmers. We asked how the Department could be sure that adequate containment measures have been put in place. Defra said that:
“[A]s GM plant material cannot be marketed without being authorised, researchers carrying out field trials that could lead to the marketing of the plant material (either directly or indirectly) may need to put measures in place to minimise gene flow to any sexually compatible commercial crops in the vicinity and/or minimise persistence of reproductive material at the site if there is the possibility of material entering the human food or animal feed chain. Any measures will depend on the plant species involved and on the characteristics of the trial site. Defra will not be specifying these measures; it will be the responsibility of researchers to abide by the law and gain authorisation for GM plants that are grown, or if material from them is present, in commercial products.”
19.Defra also highlighted that:
“The qualifying GM plants, covered by this SI do not pose a greater risk to human health or to the environment than their traditionally bred counterparts. We have more than thirty years of experience of GM field trials in England and none of these have affected commercial crops or the wider environment.”
20.Asked about who would be liable for any potential environmental or economic damage following the release of qualifying higher plants, Defra told us that:
“On the basis of the scientific advice provided to us by ACRE we do not believe that field trials involving these qualifying higher plants will lead to any more risk of environmental or economic damage than traditionally bred plants would. ACRE’s view is that an organism produced by gene-editing, or another genetic technology would not pose a greater safety risk than a traditionally bred or naturally occurring version of that organism, as a result of how it was produced.”
21.Defra added that:
“[R]esponsibility to follow all regulations is on the developer or whoever is releasing a GMO/GE. If they do not and there is subsequent economic or environmental impact it is likely that they would bear responsibility for it, but obviously this would have to be proven by the claimant.”
22.We also asked whether, in the context of public concerns about GMOs, a lack of clarity as to what constitutes qualifying higher plants and the lack of safeguards risk undermining trust in the research community in this sensitive area, a concern raised by Beyond GM. Defra responded that:
“ACRE is in the process of developing non-statutory guidance for developers [ … ]. Additionally, established Safeguards already exist based on the risk posed by these plants at the development stage in laboratory glasshouses, where they will be fully assessed under contained use rules. This includes approval of the safe working systems within the laboratory by the competent authority (jointly HSE/Defra). Therefore, we do not think this will affect the trust in the research community.”
23.Defra says that it will “monitor and review the impact of the instrument as part of its standard policymaking procedures and ensure that the provisions are adhered to”. Given the public interest in the new rules and that they rely on self-declaration, the Department should consider conducting and publishing an evaluation of the practical application of the new rules and of any environmental or economic damage, to inform the wider reforms that the Government intend to take forward in this area.
Devolution
24.The new rules only apply to England. We asked the Department about the views of the Devolved Administrations (DAs) and whether it was concerned about a different regulatory approach in different parts of the UK, an issue raised by OF&G. Defra responded that:
“We have engaged with the DAs to establish whether there was appetite to make corresponding changes in respect to Scotland and Wales. This included ministerial engagement at the Inter-Ministerial Group [Environment, Food and Rural Affairs] meetings in June and September. Our [Secretary of State] also wrote to DA ministers after the release of the Government Response clearly stating our intention to bring forward [a statutory instrument] on GE plant research and development. Welsh Government and Scottish Government have made clear that they do not currently wish to pursue equivalent changes in Scotland and Wales. [ … ] this regulatory divergence should not cause any issues for researchers, developers or the public.”
25.We note the Department’s response but remain concerned about what the new rules in England will mean for collaboration between researchers in different parts of the UK.
Consultation
26.Defra conducted a public consultation from 7 January to 17 March 2021 to seek views on whether the products of genetic technologies should continue to be regulated as GMOs if they could have been produced by traditional breeding methods, and on longer-term reform of legislation governing GMOs. The consultation received 6,440 responses,5 of which the Department attributed 3,904 to a coordinated campaign. While 55% of public sector bodies and 58% of academic institutions supported the Government’s approach, most individuals (88%) and businesses (64%) who responded were opposed. Non-governmental organisations (NGOs) were evenly split (50%).
27.The Department concludes that the consultation did not receive any scientific evidence indicating that GE organisms should be regulated as GMOs; and that a number of responses expressed the view that GMOs are demonstrably different to the products of gene editing. In its submission, Beyond GM criticised this conclusion, arguing that “Responses from all sides of the spectrum gave scientific perspectives–backed up by evidence–that gene edited organisms should continue to be regulated as GMOs”, adding that the EM “fails to reveal [ … ] the extent to which scientific opinion on all sides of the spectrum questioned and criticised the scientific basis of Defra’s proposals”.
28.Asked about this criticism, Defra responded that:
“The consultation, which included views from scientific experts including ACRE and the Royal Society, received no new scientific evidence indicating that gene edited organisms should be regulated as GMOs. The ACRE advice on the consultation6 was supported by the Royal Society which stated that “genome editing is likely to involve fewer such changes than traditional breeding techniques” and that “these are no more likely to pose a risk to human health or the environment than non-editing derived mutations, which occur spontaneously in each new generation”.7
Defra did receive responses which questioned the scientific basis of some aspects of our proposal. For example, concerns were expressed that Defra had failed to define or scientifically document what was meant by the term “could have been produced by traditional breeding”. The independent Advisory Committee on Releases to the Environment (ACRE) addressed this question in their advice on the consultation. They said: “Traditional breeding relies on the dynamic nature of genetic material and makes use of a range of genetic changes, including major structural variations which occur naturally within species and their close relatives that are used in breeding programmes. Examples of these are exchanges, rearrangements and duplications of extensive stretches of DNA containing potentially hundreds of genes that have taken place during breeding for disease resistance in tomato and wheat and during the domestication of peach varieties.”8
Some respondents also questioned the assertion that gene editing techniques can be targeted more precisely, countering that, like GM, the process can involve random events potentially leading to unanticipated or off-target effects. In response to the question regarding unanticipated or off-target effects, ACRE has stated that where gene editing introduces genetic alterations and combinations that are of the type that are selected for in traditional breeding, any associated health and environmental risks would be comparable.
All concerns that were raised have been considered as part of Defra’s step by step policy development process to develop a science-based proportionate approach to the regulation of gene edited organisms.”
29.Defra added that consumer research published by the Food Standards Agency in July 20219 found that “after being informed about GE [Genome Editing], 57% of participants were ‘not at all’ or ‘not very concerned’ about GE. Consumers tended to find genome edited food more acceptable than GM food, typically because they perceived it as safer and more natural.”
Use of secondary legislation
30.This instrument proposes a change in policy and regulation away from the current approach in retained EU law. Beyond GM argued that the “fundamental and far-reaching redefinition” of GMOs should have been taken forward through primary, rather than secondary legislation. The critical submissions we received, and the number of consultation responses indicate a significant interest amongst producers, consumers and the wider public in the issues. We therefore asked the Department whether it would have been more appropriate to take forward the policy changes through primary, rather than secondary legislation, thereby allowing for greater transparency and more robust scrutiny. Defra responded that:
“The public consultation on genetic technologies enabled Defra officials to capture the views of a wide range of individuals and organisations. We received a total of 6,440 responses (including ~3,900 campaign responses) with contributions from individuals, businesses, NGOs, academia, scientific community and public sector bodies. Respondents shared a wide variety of views with varying degrees of support for gene editing technologies. We considered all these views in establishing our approach.
After considering the wide range of views captured in the consultation, we outlined in the Government Response to the Consultation that we will be taking a cautious step-by-step approach.
The SI is our first step, which will focus on freeing up research on plants to enable scientists to develop our knowledge base and drive innovation in farming. Research scientists will be able to carry out field trials more easily for plants produced by genetic technologies where the resulting genetic changes could have been developed using traditional breeding methods.
We want to make changes carefully. Research scientists will continue to be required to notify Defra of these plant research trials. The commercial cultivation of these plants, and any food products derived from them, will still need to be authorised in accordance with existing GMO rules.
Our next step will be to review the regulatory definitions of a GMO to exclude organisms produced by gene editing and other genetic technologies if they could have been developed by traditional breeding. We will also consider the appropriate measures needed to enable gene edited products to be brought to market. This will be followed by a review of our approach to GMO regulation more broadly.”
31.In our recent report, Government by Diktat: A call to return power to Parliament, we expressed our concern about the use of secondary legislation to make significant policy change.10 We said: “It cannot be emphasised strongly enough that the critical problem about relegating significant policy change to secondary legislation is that parliamentary scrutiny of secondary legislation is far less robust than that afforded to primary legislation” (paragraph 18). And we set out the three ways in which it is less robust: it cannot be amended so the Houses have only an “all or nothing” choice; it is not subject to line-by-line scrutiny, with hours and days of consideration in each House; and, rejection of secondary legislation is very rare, with the legacy of the Strathclyde Review still casting a shadow.
32.We share the view of the Delegated Powers and Regulatory Reform Committee, set out in its report, Democracy Denied? The urgent need to rebalance power between Parliament and the Executive,11 in its revised Guidance to Departments, that “[t]he appropriate threshold between primary and secondary legislation should … be founded on the overarching principle that the principal aspects of policy should be on the face of a bill and only its detailed implementation left to delegated legislation” (page 57). Given the interest in, and concerns about, policy relating to GMOs, including in the House during the passage of the Agriculture Bill, and the number of issues that this instrument in particular has raised, in part caused by the absence of the associated guidance, we see strength in the argument that primary, rather than secondary, legislation would have been more appropriate in this case.
Conclusion
33.The intention is for the changes proposed by this instrument to be a first step of a wider reform programme. The proposals are of significant public interest, as indicated by critical submissions we have received and the large number of consultation responses. With guidance on the new rules still under development, the draft Regulations raise questions about the practical implementation of the policy, including how qualifying higher plants will be assessed, the reliance of self-declaration and the absence of prescribed safeguards and containment measures. These are issues which the House may wish to explore further with the Minister. The draft Regulations are drawn to the special attention of the House on the ground that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.
1 https://committees.parliament.uk/committee/255/secondary-legislation-scrutiny-committee/publications/8/scrutiny-evidence/.
2 Court of Justice of the European Union, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, Case C-528/16, (25 July 2018).
3 ACRE is an advisory non-departmental public body, sponsored by Defra, which provides statutory advice to ministers on the risks to human health and the environment from the release of GMOs. Advisory Committee on Releases to the Environment, ‘About Us’, https://www.gov.uk/government/organisations/advisory-committee-on-releases-to-the-environment/about [accessed 8 February 2022].
4 As set out in regulation 5(2) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (SI 2002/2443).
5 Defra, ‘Genetic technologies regulation: government response’: https://www.gov.uk/government/consultations/genetic-technologies-regulation/outcome/genetic-technologies-regulation-government-response [accessed 8 February 2022].
6 ACRE, ‘ACRE advice concerning Defra’s consultation on the regulation of genetic technologies’: https://www.gov.uk/government/publications/acre-advice-the-regulation-of-genetic-technologies/acre-advice-concerning-defras-consultation-on-the-regulation-of-genetic-technologies [accessed 8 February 2022].
7 Defra, ‘Genetic technologies regulation: government response’: https://www.gov.uk/government/publications/acre-advice-the-regulation-of-genetic-technologies/acre-advice-concerning-defras-consultation-on-the-regulation-of-genetic-technologies [accessed 8 February 2022].
8 ACRE, ‘ACRE advice concerning Defra’s consultation on the regulation of genetic technologies’: https://www.gov.uk/government/publications/acre-advice-the-regulation-of-genetic-technologies/acre-advice-concerning-defras-consultation-on-the-regulation-of-genetic-technologies [accessed 8 February 2022].
9 Food Standards Agency, ‘Consumer perceptions of genome edited food’: https://www.food.gov.uk/research/research-projects/consumer-perceptions-of-genome-edited-food [accessed 8 February 2022].
10 SLSC, 20th Report (Session 2021–22, HL Paper 105).
11 Delegated Powers and Regulatory Reform Committee, 12th Report (Session 2021–22, HL Paper 106).