Reform of Regulation of Gene-Edited Organisms – An update

A re-evaluation of the way in which gene edited crops are regulated is ongoing in both the UK and the EU, with both territories pushing forward with their plans for reform.

England

We reported earlier this year on the UK government’s public consultation on reducing regulation for gene edited organisms. A summary of the results of this consultation has now been published as well as the government’s initial response to the findings. As mentioned in our previous report, environmental protection is a devolved matter for the four nations of the United Kingdom and the UK government can only legislate to amend the law for England. Demonstrating the considerable interest around the issue of relaxation of the rules for new genomic techniques (NGTs), the government reported that it received 6,440 responses to its consultation.

Of the respondents, the majority of academic institutions (63%) and public sector bodies (82%) considered that there was a similar level of risk of harm to human health or the environment from gene editing compared with naturally bred counterparts. On the other hand, most individuals (87%) and businesses (64%) considered that gene edited crops posed a greater risk.

On the question of whether the products of gene editing should continue to be regulated as GMOs, even where the resulting genetic changes are similar to those found naturally in organisms, 55% of public bodies and 58% of academic institutions did not support continued regulation. However, most individuals (88%) and businesses (64%) supported continuing to regulate the products of gene editing as GMOs.

Non-governmental organisations (NGOs) were evenly split in their positions.

Taking these results into account, the government has concluded that the current legislation should be relaxed but has decided to take a stepwise approach to reform, perhaps reflecting the wide range of opinions garnered from the consultation.

As a first step, scientists will be able to carry out field trials in England and test the safety and benefits of new gene edited crops that could have been developed through traditional breeding methods, without requiring any consents.

There will still be a requirement to notify the Department of Environment, Food and Rural Affairs (DEFRA) of these trials. The current requirements regarding authorisation of GMOs for commercial cultivation and for any food or animal feed will continue to apply.

The report highlights that this change is an attempt to ease burdens on research and development work involving plants developed using new genetic technologies:

We will use existing powers in the Environmental Protection Act 1990 to lay a Statutory Instrument^[1], by the end of this year, which will help free up gene editing of plants at the research and development stage, to be more in line with those developed using traditional breeding methods.

The government’s second step towards reform will:

1. review the regulatory definitions of a GMO with a view to excluding certain organisms produced by gene editing and other genetic technologies if they could have been developed by traditional breeding; and
2. consider what measures would be appropriate to enable gene edited products to be brought to market, taking account of consumer choice and traceability.

The government has specifically confirmed that research involving gene edited animals will continue to be governed by existing GM ‘contained use’ regulations.

The government’s announcement represents a cautious initial relaxation of current rules, enabling scientists and plant breeders to evaluate new traits under field conditions. Some will consider the approach does not go far enough, particularly in terms of setting out potential timescales for the government to adopt a position on making gene edited crops available to consumers. However, in view of the potential controversy in any formally-adopted government position on NGT regulation, the recently announced relaxation will potentially provide a fast initial route to boost development of new beneficial crops.

European Union

We have also reported on the publication by the European Commission of results from its study of new genomic techniques, published on 29 April 2021.

The study concluded that NGTs can promote sustainability of agricultural production, identifying both a desire to update the way in which NGTs are regulated, as well as significant potential benefits in more widespread use of NGTs. The Commission announced that publication of the report would be followed by an EU-wide public consultation.

That consultation has now been launched with the Commission seeking feedback on their proposed Roadmap, which is open for responses until 22 October 2021.

Individuals and entities both inside and outside the EU are able to make their views known through the consultation website. Nearly 8000 feedback responses were submitted within the first two weeks of the consultation launch. The announcement of the consultation process was accompanied by the publication of an inception impact assessment indicating that the adoption of a Commission position is planned for the second quarter of 2023. It will be interesting to see whether the UK government position on step two of the reform plan will be finalised ahead of the Commission’s predicted date in 2023.

^[1] A form of secondary legislation allowing the government to amend aspects of the law without new parliamentary scrutiny.