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Regulation of GMOs: time to modify the law?

Posted: 26/08/2021


At an Environmental Audit Committee meeting in June 2020, the UK Secretary of State for Environment, Food and Rural Affairs, George Eustice, offered his support for gene editing after Brexit, saying that the UK Government disagrees with the EU’s stance on the matter.

The meeting, held by video link on 18 June 2020, raised a number of issues including conservation, biodiversity and chemical regulation, but significantly, the matter of selective breeding in the United Kingdom was also addressed. This follows on from an open letter sent by the All-Party Parliamentary Group (APPG) on Science and Technology in Agriculture to George Eustice the previous month, urging the Government to introduce an amendment to the Agriculture Bill 2019/2021 to alter the definition of a GMO (genetically modified organism), which would allow selective precision breeding in the United Kingdom.

The bill received Royal Assent without incorporating the APPG’s recommendations, which will be viewed by some as a missed opportunity to facilitate a more flexible approach to GMO regulation. Nevertheless, it remains to be seen what policy changes might be introduced following the end of the Brexit transition period, particularly given that the United Kingdom is currently seeking trade deals with a number of countries that uphold GMO cultivation.

Background

GMOs are organisms (usually plants, animals or micro-organisms such as bacteria and fungi) in which the genetic material (DNA or RNA) has been altered in a way that does not occur naturally. Often, the process involves detaching and removing the DNA encoding a single gene from an organism, manipulating it externally from the cell (frequently in a laboratory) and putting it back into the same organism or alternatively into another organism. Such modifications can then be replicated and/or transferred to other cells or organisms. The process is known as genetic engineering, and the resulting organism can be referred to as genetically modified, genetically engineered, or transgenic.

There is a notable distinction between gene editing and genetic modification, the latter being arguably subject to far greater controversy. As described by Lord Krebs during the House of Lords debate on the Agriculture Bill, gene editing involves changing the genes that already exist in the organism, much like adjusting one of the ingredients in a recipe to improve the flavour of the dish, whereas traditional genetic modification involves inserting new genes from a different organism. The latter is akin to the introduction of a new ingredient into the recipe to change the nature of the dish. Of course, there are much more complex issues to be considered on the subject, particularly around food safety and the possibility of unintended effects from gene flows occurring between crops and close wild relatives, many of which were discussed within the debate. Irrespective of their differences, both processes currently receive the same treatment under UK law.

The most common types of GMOs are genetically modified crops (such as maize, soybean, and cotton), but other genetically modified products include medicines and vaccines (such as insulin, blood factor VIII and human growth hormones).

Current law and current practice

Historically, the EU has adopted a cautious approach to the regulation of GMOs, which it considers necessary to protect individuals and the environment from any possible adverse effects arising from the release of GMOs. Its GMO regime has been recognised as one of the strictest frameworks across the world.

Despite the growing presence of GMO distribution outside the EU, the EU has maintained a stringent position. Conversely, the United States adopts a lighter touch approach involving less oversight from government agencies and regulations which focus on the standard of the finished product (whether that be a crop or medicine), rather than the underlying manufacturing process.

By virtue of their membership to the EU, member states are required to enact the provisions into their national systems and policies that implement the same restrictive approach to GMOs. This doctrine continued to apply to the United Kingdom until the end of the Brexit transition period on 31 December 2020. Therefore, in the United Kingdom, genetic engineering and precision breeding have been tightly regulated and subject to the significant restrictions derived from EU legislation.

The primary piece of UK legislation that applies to the use of GMOs is the Genetically Modified Organisms (Contained Use) Regulations 2014, which place tight restrictions on the use and dissemination of genetically modified plants and animals. Genetically modified (GM) crops are not currently being grown commercially in the United Kingdom, but certain GM commodities are imported for use in animal feed and in some food products.

In 2018, the Court of Justice of the European Union (CJEU) ruled in the Confédération paysanne case that organisms obtained by mutagenesis were GMOs within the meaning of the GMO Release Directive 2001 and were therefore subject to the obligations laid down by that directive.(1) This decision put the EU at odds with countries such as the United States, Australia and Japan, and has been criticised by George Eustice as being based on a ‘legal technicality rather than a science-based decision’.(2)  The UK Government’s position was, and still is, that if the products of gene editing could have been produced naturally or by using traditional breeding methods, they should not be regulated as GMOs.

The CJEU ruling does, however, go on to clarify that ‘only organisms obtained by means of techniques/methods of mutagenesis which had conventionally been used in a number of applications and had a long safety record were excluded from the scope [of the directive]’.(3) Although not expressly confirmed in legislation or otherwise, it is widely accepted that the exemption refers to ‘variation’ or ‘mutation breeding’, which is the process of exposing plants to chemicals or radiation in order to generate random mutations. Once a desirable mutation is achieved, these traits can be bred into other cultivated plants.

Recommendations of the All-Party Parliamentary Group

The APPG sought to change the EU derived definition of a GMO in the Agriculture Bill 2019/2021 for a more flexible term, such as ‘living modified organism’ or similar, which encompasses organisms with a novel combination of genetic material derived through modern biotechnology. It was argued that such a change would refocus GM regulation on the insertion of viable, heritable, foreign DNA, and would therefore remove around 90 per cent of current gene editing applications from the scope of GM regulation. The suggested amendments to the bill would have also provided new powers for ministers to make changes to the UK Environmental Protection Act 1990, which contains the current definition of a GMO. APPG argued that such changes are crucial in order to boost genetic innovation after Brexit.

After a lengthy debate in the House of Lords, the recommended amendments were withdrawn from the bill.

Environmental groups, who had been vigorously campaigning against relaxing the definition on GMOs, celebrated the withdrawal, taking the view that such an approach could open the floodgates to a broad range of genetic engineering techniques.

The future of GMOs post-Brexit

Eustice highlighted that ‘the UK disagreed with the judgment of the European Court of Justice on this, in that we think that gene editing techniques such as CRISPR and other similar ones are really a more targeted form of conventional plant breeding in that it is cisgenesis’. Cisgenesis is the genetic modification of a recipient plant with a natural gene from a crossable, compatible plant, and involves only genes from the plant itself or from a close relative, which could also be transferred by traditional breeding techniques.

Eustice went on to say that:

‘… gene editing is an area we ought to be considering because if we want to reduce our reliance on chemical pesticides, getting that improved genetic resistance to certain fungal diseases in particular will be quite important. Some of these techniques are really just an extension of conventional plant breeding.’

The move would give UK scientists, farmers, plant and animal breeders the same access to new gene editing technologies as countries outside the EU, and, it is argued, could lead to vital innovations in the response to climate change, food security and sustainable development. MPs say the techniques could present the United Kingdom with opportunities to keep pace with demands for increased agricultural productivity, resource-use efficiency and more durable pest and disease resistance.

However, Eustice did qualify this statement with: ‘We would not propose changing at all the regulatory framework on GMOs’.

In spite of Brexit, the laws around GMOs in the United Kingdom will continue in their current form until the relevant legislation is repealed or amended. There already exists a vast regime for regulating the acquisition, importation, release, and marketing of GMOs in the form of the Environmental Protection Act 1990. In addition, the European Union (Withdrawal Agreement) Act 2020 ensures that any existing EU laws are transformed into UK laws, and the Government has been creating Brexit statutory instruments to ensure that the existing regime on movement, release and marketing of GMOs will continue to operate at the end of the transition period.

Whilst there has been no confirmation that the United Kingdom will diverge from the EU position currently, DEFRA minister in the House of Lords, Lord Gardiner of Kimble, has confirmed the Government’s view that gene-edited products should not be regulated as GMOs where the DNA changes could have occurred naturally or through traditional breeding techniques, and he acknowledged there is a very strong case for removing simple gene-editing techniques from the scope of GMO regulation. He said:

‘The Government are committed to taking a more scientific approach to regulation. Many scientific institutes share our view that the current rules are unscientific. A solution is needed soon if we are to reap the benefits, such as more resilient crop varieties, reduced use of synthetic pesticides and more disease-resistant animals.’(4)

The Government opened a consultation in January 2021, inviting the public to share their views on the regulation of genetic technologies. With a focus on the regulation of gene edited organisms possessing genetic changes which could have been introduced by traditional breeding, Part 1 will guide any change to the meaning of a GMO in England. Part 2 sought opinions on the wider framework governing GMOs and will inform any wider reforms. The consultation closed on 17 March 2021 and the response is expected by the end of June 2021. Lord Gardiner of Kimble acknowledged there is a very strong case for removing simple gene-editing techniques from the scope of GMO regulation.

National Farmers’ Union (NFU) vice president Tom Bradshaw said:

‘The underlying principle of this consultation is that some new breeding techniques, such as gene editing, are not the same scientifically as genetic modification [GM] and should, therefore, not be regulated in the same way; an approach already used in several countries around the world and one the NFU supports.’(5)

 

1) Case C–528/16 Confédération paysanne and others.

2) George Eustice speaking at the meeting of the Environmental Audit Committee, 18 June 2020.

3) Note 1 above.

4) Lord Gardiner of Kimble, House of Lords, Tuesday 28 July 2020.

5) Agriland, 18 March 2021. In responding to the Government’s consultation on future regulation, the NFU said farmers should have the choice to access the best tools available to enable a resilient and innovative British farming industry.

 

This article was published in Bio-Science Law Review in August 2021.


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