Group that advises on new GMOs tied in multiple knots
GM Freeze’s Leonie Nimmo reports on a disturbing meeting
The UK is poised to open up our environment, health and borders to a likely influx of newer forms of genetically engineered organisms – despite disagreements and unresolved issues at the committee with key decision-making powers.
The Advisory Committee on Releases to the Environment (ACRE) met in July for the first time since the Genetic Technology (Precision Breeding) Regulations (GenTech Regulations) were signed into law. The Committee is tasked with deciding whether or not certain Genetically Modified Organisms (GMOs) should be granted “Precision Bred Organism” (PBO) status. This would exempt them from labelling, risk assessment and traceability requirements.
The committee was clearly divided on key issues, including whether or not there were genes from other species present in the organisms they were assessing. According to their own guidance and repeated claims by politicians, such genes are not permitted in so-called PBOs. There is also a clear contradiction between there being no upper limits to 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 bind because the GenTech Act, signed into law in 2023 and implemented through the GenTech Regulations, provides a definition of PBOs which is scientifically meaningless. The Regulations have also been constructed so that they critically undermine foundational aspects of scientific enquiry: the assessment of risks and probabilities, and the testing of hypotheses.
Although this is very much a British-made mess, it was clear during the meeting that it’s a mess the government fully intends to export.
ACRE’s meeting at a London hotel was open to the public to attend.
International ramifications
A representative from the Department for Environment, Food and Rural Affairs (DEFRA) updated the meeting on “EU Reset work”. Following a summit in May, a commitment has been made to further talks on “regulatory alignment”, and there is recognition that there are “certain areas [in which] we want to retain our own rules”. Although it’s still subject to negotiation, the DEFRA representative said: “We remain committed to taking forward the PB (legislation) actively.”
It would appear that the UK-EU reset deal could be used as a lever to push the EU into adopting similarly terrible – “aligned” – legislation for 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). This means 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 who’s followed the passage of the GenTech legislation, it’s a shock to hear someone at ACRE make this statement. ACRE is exactly the advisory body tasked with assessing the risks of new GMOs. And now they can’t talk about it?
What’s more, 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 precision breeding as the application of modern biotechnology to achieve genetic changes that “could have” resulted from traditional reproductive processes. However, there is no requirement for ACRE to assess the likelihood of this happening. Throwing out any assessment of probability would be problematic for many self-respecting scientists.
The term transgene usually refers to genetic material from other species.[i] According to ACRE guidance, an organism can be classified as a PBO if inserted gene sequences “could have been crossed from within the existing gene pool of the organism”.
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…
“This hairpin is a cisgene 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?
“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 lone voice of integrity could be heard saying “I don’t know what a transgene is any more if these things aren’t transgenes”.
A nonsensical hypotheses
The definition of a PBO is a stroke of legal genius. Whilst it is possible to test and prove that something could have happened by another process (although proof is not required) it’s impossible to prove that something couldn’t have happened. This means that there will never be any solid legal grounds for rejecting PBO applications. The scientists have a hypothesis that is impossible to disprove, so in scientific terms, it’s meaningless.
However, the Committee did come up with one case in which it should be possible to exclude an organism from PBO designation: when a synthetic gene has been inserted. “Could you introduce it by conventional breeding?” The question was rhetorical. “No because it doesn’t exist.”
This would be 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 regarding setting any limits on the number of permitted genetic changes. “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 was 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 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 attendee asked what would happen if an applicant appealed a decision not to grant PBO status. They were told there would be a tribunal, made up of scientists and lawyers, to test whether there had been an error in law.
Some people stand to make a lot of money out of this legislation; taxpayers could lose.
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 had “an opinion with ACRE’s opinion” – a comment I understood to mean “in alignment with” ACRE’s opinion.
What next?
After ACRE agrees that something has been “precision bred”, there are a couple more regulatory steps before a company can produce the organism. But what then? Various questions and issues arose:
“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 that lone attendee with evident integrity I didn’t envy. 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, and to some extent they are responsible for the position they are in. But I would certainly be uncomfortable.
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.
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[i] This definition is not universally accepted as transgenic material can also refer to genes from other organisms. It is the author’s understanding that when members of the Committee used transgenes and related terms they were referring to genetic material from non-crossable species.
