GM Freeze’s Leonie Nimmo reports on a disturbing meeting
The committee that advises the UK government on new Genetically Modified Organisms (GMOs) met in July for the first time since the Genetic Technology (Precision Breeding) Regulations (GenTech Regulations) were signed into law. The UK is now poised to open up our environment, health and borders to a likely influx of newer forms of genetically engineered organisms, but it was clear during the meeting that there are problems and disagreement at the committee with key decision-making powers.
The Advisory Committee on Releases to the Environment (ACRE) have been tasked with deciding whether or not certain GMOs should be granted “precision bred organism” (PBO) status, which means they will be exempted from labelling, risk assessment and traceability requirements. But the Committee is divided on key issues, including the presence or otherwise of transgenes; that is, genes introduced from another organism. According to their own guidance and repeated claims by politicians, transgenes are not permitted in PBOs. There is also a clear contradiction between there being no upper limits on the number of changes that are permitted in the genomes and the claim – in fact the legal definition of PBOs – that the organisms “could have” been produced through traditional reproductive processes.
The Committee is in a bit of a bind because the GenTech Act, which was signed into law in 2023 and which the GenTech Regulations implement, provides a definition of PBOs which is scientifically meaningless. Furthermore, the Regulations have been constructed in such a way as to critically undermine foundational aspects of scientific enquiry: the assessment of risks and probabilities, and the testing of hypothesis.
Although it’s very much a British mess that we’ve gotten ourselves into with the GenTech Act and Regulations, it was clear during the meeting that it’s a mess the government fully intends to export.
The July ACRE meeting was open to the public, and though my train to Euston arrived late and I walked in after it had started, somebody kindly provided me with coffee.
International ramifications
A representative from the Department for Environment, Food and Rural Affairs (DEFRA) provided the meeting with an update on “EU Reset work”. A commitment has been made to further talks on regulatory alignment, and there is recognition that there are “certain areas that we want to retain our own rules.” Although it is still subject to negotiation, “we remain committed to taking forward the PB (legislation) actively,” said the DEFRA representative.
It would appear from this update that the UK-EU reset deal could be used as a lever to push the EU into adopting similarly terrible – “aligned” – legislation with regard to newer forms of GMOs. If Europe capitulates there are even more serious implications for global trade.
“Risk is not in our remit”
ACRE has already decided that GM-PBOs are no riskier than traditionally bred organisms, and it’s an opinion that is regularly repeated by DEFRA and the Food Standards Agency (FSA). The trouble is, because it’s already decided this, it has tied its own hands in terms of looking at risk when it assesses individual applications for PBO designation.
“In determining whether or not something is a PBO we are not assessing risk,” one attendee reminded the room. “It’s just this strict role we’ve been given in law.”
But one scientist was clearly uncomfortable: “The spirit of the Act is that the inherent risks are equivalent. I think we may be pushing the envelope.” It was a lone voice in the room.
The next time risk was mentioned the response was immediate and unequivocal: “Risk is not in our remit.” And the conversation moved on.
For someone that’s followed the passage of the GenTech legislation, it’s a bit of a shock to hear someone at ACRE make this statement. ACRE is exactly the advisory body that has been tasked with assessing the risks of new GMOs. But now they can’t talk about it?
Furthermore, the GenTech Regulations forbid government regulators from ever finding out that a “precision bred” GMO is different from, and more risky than, conventionally bred organisms.
The shutting down of debate on risk is deeply worrying in terms of public health and the environment. It’s also an anathema to scientific enquiry, and makes a mockery of DEFRA’s claims to be “led by the science”.
What are the chances?
The GenTech Act defines PBOs as those that “could have resulted from traditional processes”, but with changes to the genome having been made using “modern biotechnology”. There is no requirement for scientists to assess the likelihood of this happening.
Throwing any assessment of probability out the window would also be problematic for some self-respecting scientists.
One aspect of an application that was the focus of considerable attention during the meeting was the insertion of a hairpin – a genetic structure that involves part of a gene folding back on itself. The papers for the meeting were not shared with the audience and therefore this element of the discussion was difficult to follow. But here are some snippets, captured as accurately as my coffee-fuelled typing would allow.
“If we say that the applicant can rearrange all the…
“At what point do you draw the line and…
“Tricky.
“The more intragenic [referring to a mutation/DNA damage brought about by GM processes that occurs within a gene]…
“This hairpin is a cisgene [GM gene from the same species] at the moment…
“But the fact that they are planning to flank it with other species…
“An inverse repeat or inverse repeat and then gluing bits on then that becomes more and more ridiculous…
“Single step mutation…
“I don’t think we can write a formal decision on that…
“Likelihood is not in the Act.”
“…if it exists it doesn’t take it outside of the scope of a PBO – similar genetic formulation could be found in plants… are found in plants… something with that level… any hairpin…
“Should we be concerned that that makes it transgenic [referring to a GM gene that is introduced from another organism, from another species or the same species – the speaker here intends it to mean from another species]?
“It could have been done by traditional breeding.”
At one point someone Googled hairpins and apparently found that there are loads of them. As the meeting closed for lunch the lonely voice of integrity could be heard saying “I don’t know what a transgene is any more if these things aren’t transgenes.”
Testing hypothesis
The definition of a PBO is a stroke of legal genius. It could have happened by another (traditional) process – OK, it’s possible to test and prove this (although proof is not required).
But how is it possible to test and prove that something couldn’t have happened? It’s impossible, because it hasn’t and won’t happen. So there will never be any solid legal grounds for rejecting PBO applications. The scientists have got themselves a non-sensical hypothesis.
However, the Committee did come up with one case where it should be possible to exclude an organism from PBO designation, and that was where a synthetic gene had been inserted. “Could you introduce it by conventional breeding? No because it doesn’t exist.”
An entirely new, man-made gene: a reminder of the power of the type of technology we are talking about.
No limits
It became apparent during the meeting that ACRE’s hands were also tied with regard to setting any limits on the number of genetic changes that will be permitted. “If the Act says the number is not relevant we can’t reimpose after the event,” someone commented.
“There must be a cut off somewhere at some point because what happens if you change every amino acid in a protein?” asked another.
One attendee outlined a scenario in which DNA from one or more crossable species were re-arranged in vitro (in a laboratory using genetic engineering). “Is there any limit to what that rearrangement can be as long as it’s a species that could be crossed?” they asked. One person mentioned a boundary but another queried how that could work. “There are no limits,” said another.
ACRE’s inability to set any limits means that the rationale for granting PBO status can only be applied on a case-by-case basis. “That doesn’t make any scientific sense,” protested one attendee. “It might make legal sense,” replied another.
The chilling prospect of court challenges
Legal issues were very much in the minds of the committee members during the meeting. When the voice of integrity raised once again the spirit of the Act, the response was simply “I’m not a lawyer.”
One asked about what will happen if an applicant appeals a decision not to grant PBO status. They were told that there will be a tribunal to test whether there has been an error in law which will be made up of a combination of scientists and lawyers.
Some people stand to make a lot of money out of this legislation and it’s not the Government.
Help on the horizon?
The prospect of commissioning a study that might help with some of these issues was raised. Someone pointed out that DEFRA’s new Chief Scientific Advisor started at the department that week. More would become clear after that, such as establishing whether they have “an opinion with ACRE’s opinion”. I understood this to mean “in alignment with” ACRE’s opinion.
What next?
After ACRE agrees that something has been “precision bred” there’s a couple more regulatory steps before a company can get on with producing the organism. But what then? Various questions and issues arise:
“If an applicant moves an edit into a new species by conventional breeding…?”
“Plant breeding rights come into it later on.
“…See what the real-life world brings us next year.
“The half-life of new varieties is finite anyway…
“Everything will become redundant in 10 years because of the passage of time….
“It will apply to all the progeny.
“…prove how it all works is going to be something.
“Don’t envy Richard and his associates [at DEFRA]…”
In that moment, though, it was the attendee with the lonely voice of integrity that I didn’t envy. Whilst on paper PBO decision-making lies with ACRE, in reality they’ve had their hands and feet tied and their teeth extracted. Some members don’t appear to mind it like that, but I would certainly be uncomfortable.
There was still enough coffee for me to fill my cup for the journey home. Thank you, DEFRA.
Consideration of consequences is crucial
Commenting on the proceedings as reported above, London-based molecular geneticist Professor Michael Antoniou said: “Although DEFRA claims to be led by the science, its scientific advisory body ACRE appears to be ignoring the science that underpins genetic technologies, including gene editing. It is incomprehensible how they can ignore not only the numbers of genetic changes made, but also – crucially – their consequences.
“To take the position that there are no special risks associated with the potentially large number of genetic alterations that could be present in a PBO neglects the fact that these could lead to major changes in its biochemistry and composition, which could include the production of novel toxins and allergens. Can we rely on the Food Standards Agency, which is entrusted to evaluate the safety of food PBOs, to acknowledge this possibility?
“It is my sincere hope that the warnings expressed by the ‘voice of integrity’ on the committee are heeded. Otherwise public and environmental health are at risk.”
Leonie Nimmo is the Executive Director of GM Freeze. This article was first published by GM Freeze and is reproduced on GMWatch with kind permission of the author. For clarity, GMWatch has added some definitions of technical terms in square brackets [ ].