Defra takes first steps toward deregulating gene editing in the UK – Beyond GM responds

September 29, 2021 by Staff Reporter

Late yesterday afternoon Defra emailed an embargoed press release to select members of the media outlining its agenda for the deregulation of genome editing in the UK.

Over-hyped and under-referenced, the headline proclaimed: ‘Eustice – Unlocking power of gene editing to protect the natural environment’.

It spoke of “plans to unlock potential benefits of gene editing”, of new technologies that “could help UK farmers grow more nutritious and resilient crops which need fewer chemicals to protect them” and rule changes “made possible by UK’s departure from the EU” that will “help deliver on our ambitious climate and biodiversity goals”.

The official version of the press release, published at midnight, has lost some of the hyperbole but retains the hollow promises which have now become part of Minister for the Environment George Eustice’s playbook.

In substance, the government’s plans represent an underwhelming and highly cautious box-ticking exercise destined to frustrate all sides for the GMO debate:

As a first step government will enact legislation to change the rules relating to gene editing to cut red tape and make research and development easier.
Research scientists will still need to notify Defra of any trials involving GE plants.
This first step applies to research and development only; for any products that are authorised for market, existing GMO rules would apply.
The government will also consider the appropriate measures needed to enable gene edited products to be brought to market safely and responsibly.
In the longer term, this will be followed by a review of the UK’s approach regulating all types of GMOs.

The initial plans relate only to England. Whether and when this might also extend to Scotland, Wales and Northern Ireland, remains to be seen. We believe it will.

Updates from Defra

The Defra consultation documents have now been published
(see links at the bottom of the page)

Of real importance and urgency is the intention to introduce
a statutory instrument by the end of this year which will
remove the requirement for researchers wishing to
conduct field trials of gene edited crops to apply
for a license. Instead, researchers and institutions
need only notify Defra of their intention to conduct a trial.

This will be followed by primary legislation to change
the definition of genetic modification to exclude
gene editing from current regulations.

“In the longer term” there will also be a review of how
the UK regulates other types of genetically modified
organisms. The timeframe for this is not specified.

There is some very troubling math in the consultation.
Defra appears to have excluded nearly half of the
responses based on the fact that it identified
them as coming from supporters of campaigns.

Of the remaining responses, 85% indicated no support
for deregulation – yet the government has
chosen to ignore these and pursue deregulation
anyway.

Don’t forget to check our twitter feed for more updates
as we get them.

Questions

There may be more to come this week (we will update this article as and when), but at the time of writing, there’s very little in the Defra statement that was not in the consultation document published in January.

That’s problematic. Our own internal analysis of around 40 publicly available responses to the consultation revealed that those who support and those who oppose or are neutral about deregulating gene editing raised numerous concerns and objections to the framing of the consultation, its lack of clear criteria and lack of meaningful analysis.

As a result, we are left with a number of unanswered questions.

What exactly is changing?

This is not at all clear. According to Beyond GM Director Pat Thomas, “Defra says it wants to cut the red tape and lift the regulatory burden on biotech research and development. But the process of, for example, applying for a field trial in the UK already has a very low burden of proof and takes only a couple of months from start to finish. Moreover, to our knowledge, few, if any, field trial applications have ever been refused in the UK, so it’s hard to imagine what the government can do to make what is essentially a rubber stamp process less burdensome, unless it is to remove sensible ‘safety-first’ measures like public notifications, requirements for buffer zones between the trial and other crops and procedures to stop trial material getting into the food chain and crop residues persisting in the field”.

Will the changes apply to all types of genetically engineered organisms?

Significantly and without comment, the plans sidestep livestock – at least for the time being. Perhaps the horror that lies behind gene editing animals was judged to be to much of a PR minefield (European regulators also consider it a scientific minefield, and have also put on hold regulatory decisions around gene-edited livestock).

Decisions around the regulation of microorganisms is also deferred for now.

Instead, according to Defra, the focus of any changes will be on plants produced by genetic technologies, where genetic changes could have occurred naturally or could have been a result of traditional breeding methods.

In our response to the consultation we were highly critical of this framing noting that, “The concept of gene editing events that ‘could have occurred naturally or through traditional breeding’, which is used throughout this consultation, is not defined in the consultation document, on the Citizen Space form or in any of Defra’s materials relating to this consultation.

We weren’t the only ones. The Institute of Food Science & Technology (IFST) for instance, called it “overly simplistic”; the Microbiology Society said it was “purely philosophical”, Nuffield Council on Bioethics said “not convinced that this is either the most proper or most popular framing”, the Roslin Institute found it “exceptionally challenging”, Royal Society called it “problematic” and quite rightly made reference to issues around how rare this phenomenon actually is. The Royal Society of Biology said it provided “no clear criteria” and further noted that “no clarity can be achieved using this principle” and “we would not recommend using it as the basis for regulation”.

In spite of all this Defra is persisting with this inadequate, poorly defined and unscientific framing.

When will the changes take place?

No timelines are given for any proposed regulatory changes. They could happen next week or over a period of years.

Recent reports suggest that the European Commission is now looking at a tentative 4-year horizon to change regulations in order to exempt organisms created using new gene editing technologies. A 10-year horizon is seen as the most likely option to regulate all other GMOs, based on a case-by-case risk assessment.

Will the UK follow this timeline or forge another path? Consumers and farmers have a right to know.

What kind of crops are we talking about?

According to Eustice, “Gene editing has the ability to harness the genetic resources that nature has provided. It is a tool that could help us in order to tackle some of the biggest challenges that we face – around food security, climate change and biodiversity loss”.

Indeed, a new and aggressive PR narrative around gene editing seeks to bolster support for deregulation of gene edited crops by framing them in the context of global emergencies like climate breakdown and the fragilities of the industrial food system.

But the degree to which plant breeding in general and agricultural genetic technologies in particular can address these overwhelming global challenges is highly contested and certainly not as straightforward as Defra and the pro-biotech lobby would have us believe.

According to Thomas, “For more than 30 years, biotechnology has been promising that environment-enhancing crops are just around the corner. They have never materialised because the genetics of disease- and pest-resistance, and drought and salt tolerance are complex and difficult to manipulate. What works in the lab all too often doesn’t work in the real world and it is that failure, rather than the regulatory landscape, which has stalled the progress of genome editing in farming”.

When can we expect gene edited crops to come to market?

Again, this is unclear. Defra says it will consider “appropriate measures” to bring gene editing products to market and will review its approach to the regulation of all genetically engineered crops and foods.

The Defra statement suggests we could soon be growing more nutritious crops thanks to gene editing, but the best example it can come up with for the near future in the UK is gene edited sugarbeet – a crop that has no nutritional value.

Where is the consultation report?

To us, this seems to be the most important question of all. Nearly 6,500 people responded to the public consultation and the government had an obligation to publish a report on the consultation, along with the public responses, in June. Four months later that report still has not been published.

The purpose of the public consultation was to inform and guide Defra’s decisions around the regulations of agricultural genome editing. It is inconceivable that the most pressing issue arising out of the canvassing of public views was a demand to make R&D of genetically engineered crops easier.

Continued delay in publishing the consultation findings stifles public debate and is wholly unacceptable.

“The outcome of the consultation has important implications for the future of food and farming in the UK,” said Thomas. “Before any changes in policy were announced, the government should have published the findings of the public consultation. Not doing so is a validation of our official complaint to Defra that, amongst other things, the government was breaking Cabinet Office Rules by consulting on a matter upon which it had already made a decision”.

She adds: “The vagueness of today’s announcement suggests that the government did not get the answers it was hoping for in its public consultation and that the public has expressed little appetite for deregulating an experimental technology that could heap more disruption on a food system already in crisis”.

UPDATES

See crucial updates in the box above
Read more about how Defra rolled out the consultation report in our latest newsletter
Listen to Beyond GM Director Pat Thomas on BBC Radio4’s Farming Today
You can now read the Defra consultation summary report here
You can now read a summary of Defra consultation responses here
Email us and let us know what you think of the UK Government’s plans