UK Launches Consultation on the Regulation of Genetic Technologies

UK Launches Consultation on the Regulation of Genetic Technologies

January 13, 2021, Covington Alert

The EU legislation governing genetically modified organisms (“GMOs”) is over 30 years old. It states that an organism is classified as a GMO where its genetic material has been altered in a way that does not occur naturally. The 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 contain ingredients produced from GMOs.

As an EU Member State, the UK was bound by the EU legislation in this sector—legislation of which the UK was always somewhat critical. It is significant that one of the UK’s first legislative initiatives on leaving the EU is to launch a consultation on how it should regulate genetically edited/engineered (“GE”) technologies, with a particular focus on GE organisms that could have been produced with traditional breeding techniques (the “Consultation”). The UK is using the second part of this Consultation to reshape regulation of GE technologies more broadly, so as to assess the safety of a GE organism based on its characteristics and use, rather than on how it was produced.

Whilst many in the industry may welcome the up-dating of legislation in this sector to take account of scientific progress, there are areas for concern as well. This is a sector with significant potential environmental and human health implications and, consequently, a number of important safeguards and standards. Unilateral UK changes in this sector, including changes to those safeguards, could have an impact on access to EU markets for GE products originating in the UK. The result of the Consultation may also lead to legislative changes which may test the robustness of the non-regression, “level playing field” and balancing measures of the EU-UK Trade and Cooperation Agreement.

The EU GMO framework legislation has been in place in one form or another since the 1990s. Despite this, its key definitions and exemptions have been subject to uncertainty and debate, especially with regards to their application to newer, more precise GE techniques. This was until a landmark Court of Justice of the EU decision in 2018^[1] (the “mutagenesis decision”) advanced a very broad GMO definition and confirmed that the EU GMO legislation covers an extensive range of traditional and more recent technologies, including newer mutagenesis techniques. The general upshot of that decision is that now, save for very limited and narrowly interpreted exemptions, the EU GMO legislation is triggered by any genetic editing/engineering of organisms, irrespective of whether foreign genetic sequences are introduced and whether or not the organisms could have been produced by traditional breeding methods.

Whilst the mutagenesis decision was welcomed by those opposed to GE and GM as a matter of principle, as well as those in favour of strict controls and a precautionary approach to this technology, the decision highlighted a growing feeling that the GMO framework was beginning to creak, in particular given scientific innovations and advancements in safety controls, as well as changes in public attitudes compared to those of the early 1990s. Advocate General Bobek in his earlier Opinion to the Court on the mutagenesis decision, was clear that legislation should be dynamic and not “frozen”, relative to the state of the art at the point of its publication.

The culmination of this disquiet was a European Council request in 2019 to the Commission^[2] to submit a study regarding the status of novel genomic techniques under EU law, and a proposal, if appropriate, in view of the outcomes of the study. The study is to be submitted by 30 April 2021.

The UK however, now no-longer part of the EU, has stolen a march on the EU, with its own Consultation due to end in March 2021.

UK Consultation on GE Technologies

Significantly, and rather unusually, the UK’s Department for the Environment, Fisheries and Rural Affairs (“Defra”) has affirmed upfront its “view” that “organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods.”

Defra is also using this Consultation to explore how the UK should regulate GE organisms—in particular, whether to assess the safety of an organism according to a risk- and trait‑based approach. Notably, Defra states that “[its] position follows the science (…and…) that the safety of an organism is dependent on its characteristics and use rather than on how it was produced.”

Depending on the results of the Consultation, Defra may amend the definition of a GMO as it applies in England,[3] meaning that section 106 of the Environmental Protection Act 1990 would not apply to organisms produced by GE and other genetic technologies if they could have been developed using traditional breeding methods.

Amending the definition of a GMO in this way would also affect which food and animal feed products are regulated under GM legislation.

The Consultation seeks views on any safety or non-safety issues associated with this approach, including potential impacts on trade and animal welfare.

The Consultation closes at midnight on 17 March 2021.

Comment

On the expiry of the Brexit transitional period on 31 December 2020, the UK largely “lifted and shifted” the EU GMO legislation and its associated procedures and processes, into its national law. However, the UK has been a long-standing critic of the EU GE/GMO rules and Brexit has offered the UK an opportunity to proactively amend its laws in this area.

The EU-UK Trade and Cooperation Agreement, signed on 24 December 2020, contained mutual agreements “to maintain and improve” environmental and other standards; not to lower the overall level of environmental protection in a way that impacts trade or investment; and to continue to observe fundamental principles (including the precautionary principle) when regulating to protect the environment. Failure by either party to do so may be subject to counter‑measures, whilst the imposition of higher standards by one party may trigger rebalancing measures against the other.

A European Commission Q&A on the Agreement states that there will be no changes to high standards on matters such as the use of hormones or GMOs and that the Agreement will safeguard the EU's high levels of sanitary and phytosanitary requirements for imported food, animals and plants.

* * *