In May, I set out my off-the-cuff reaction to what the Queen’s Speech had to say about an impending Genetic Technology (Precision Breeding) Bill, which was so general that it seemed merely to promise to duplicate regulations that had come into force the previous month on the release of genetically edited plants. The speech promised that the eventual Act would one day include animals, but otherwise it looked much the same. When the Bill emerged a fortnight later, it was swaddled in the inevitable boosterish blurb accompanying all government announcements on genetic technology. The media coverage was no less fevered. “Frankenfoods could be on supermarket shelves in the UK as soon as NEXT YEAR” the Mail needled, while the Telegraph stated that the Bill’s real aim is “to help guarantee British food supplies in the wake of the conflict in Ukraine”.
Genetics and brexit
We should not be surprised by this sort of political trumpeting. Genetics and politics have a notoriously troubled relationship, and the Bill is a child of a bitter political divorce. Its inspiration, an unintended gift to Brexiters from the EU Court of Justice (CJEU), was a decision so duff it seemed to confirm their claims about EU idiocy, scientific illiteracy and the opportunity to do things better. The UK’s advisory panel on the governance of synthetic biology, of which I was then a member, was summoned to Victoria Street to consider a UK response. We did not agree among ourselves, but by consensus recommended a change in the law on the basis that EU rules on genetic technologies had become absurd, people had voted to make their own rules in the 2016 referendum, and England and Wales now had the power to do so: i.e. that it was possible. In his first speech as Prime Minister a year later, Boris Johnson boasted that the power to make British genetic technology regulations was a clear example of the advantage of Brexit. Many Remainers, including distinguished scientists and science journalists, reluctantly agreed.
The 2018 CJEU decision that lead to this, Confédération Paysanne, was absurd, but not because organisms produced using gene editing technologies such as CRISPR were deemed to be GMOs. That should never have come as a surprise: you edit a gene and you modify it genetically. What was startling was that the Court held (against the advice of its own Advocate General) that despite the clear words of the GMO Directive in question, an exemption specific to organisms derived by mutagenesis did not apply to those derived by precision mutagenesis (i.e. genome edited organisms). By contrast, GMOs derived by random mutagenesis were exempt from the bureaucratic palaver required by the Directive. The result was not only eye-swivelling, but grated against the EU’s own sustainability goals: you don’t have to go far to hear about the potential of genetic technologies like base and prime editing to meet global challenges such as food security, energy production and climate change.
Confédération Paysanne caused a stink, not just because the Court had bent law, policy and common sense into a hairpin, but for its rationale: a galumphing scientific gaffe. The justices treated two radically different methods of genetic modification as equivalent. The first is the one that lead to the Directive in the first place: taking a DNA sequence from one organism and transferring it into another: for example, inserting bacterial genes conferring glyphosate resistance into soybean genomes, or transferring human genes into mouse genomes to study disease. This transfer of DNA from one species to another is known as transgenesis. Transgenesis became controversial after a graduate student told a meeting in 1971 of her plan to splice genes from a virus into that celebrity bacterial resident of our guts, E.coli. After someone mentioned that the virus in question, SV40, could induce cancer in hamsters, scientists organised a conference in Asilomar to draw up biosafety rules. To cut a long story short, these rules morphed into today’s EU Directives and British laws on the containment and release of such transgenic organisms.
The second type of modification is the one the Court was looking at: genome editing. It involved using a tool like CRISPR to prune DNA already present in an organism. This process is called cisgenesis, and nothing gets transferred at all: in fact, it’s equivalent to what happens in breeding. The CJEU treated it as exactly the same as transgenesis.
Such was the ire in response to Confédération Paysanne that the unique advantages of transgenesis were neglected in a campaign to protect the cisgenic potential of new genome editing tools. In this series of posts, I’ll show how this seems to have led, in the EU as well as in the UK, to an unhelpful polarisation of policy, with genome editing cast as hero and old-school transgenic approaches as something less. The title of the Precision Breeding Bill tells you that nothing has changed as regards the regulation of GMOs in the UK, other than to complete the reversal of Confédération Paysanne in England that had begun in the April plant regulations. As we will see, the foundations of the Bill comprise the cis-trans distinction itself. The way it keeps the two apart is pure magic. As a piece of conjuring, however, it ends up all Tommy Cooper. We’ll see quite how wonky things get in the Precision Breeding Magic Show, which you can reach via the link at the end of this warm up.
What the Bill does
The Precision Breeding Bill seeks to establish and govern a new regulatory class of organism, defined by reference to the process of their production: “Precision Bred Organisms” or “PBOs” and their gametes. PBOs may be either plant or animal. Additional “health or welfare” provisions apply in the case of “precision bred” animals. The Bill’s first objective is to regulate the release of PBOs from the highly controlled environment in which they are developed and studied as (sotto voce) GMOs. This is essentially an expansion of the April plant regulations. The second aim of the Bill is to regulate the marketing of products consisting of, or including, PBOs or their gametes. Making available for sale in England PBO-containing products (whether living or as food on a plate or feed in a trough) is an act of PBO marketing.
The most striking feature of the Bill is that it is less a set of rules than a statement of intent. Rather than providing details in Schedules, the proposed Act would empower the government to introduce future regulations to flesh out the detail. Fifteen of these thirty regulation-making powers avoid Parliament’s involvement altogether, including the power to “make supplementary, incidental or consequential provision in connection with any provision of or made under this Act”. Such proclamation-making powers are named after the autocrat who most used them. Dr Michael Edenborough QC voiced his unease to the Public Bills Committee: “there is also, in essence, a Henry VIII clause tucked away in clause 42, which is incredibly widely drafted. Those clauses always give rise to concern because, basically, you can do what you like, when you like, with very little scrutiny.”
The framework itself provides two mandatory PBO notification requirements: one for release and one for marketing. In order to get a “marketing notice” endorsed, an applicant has to secure a “precision bred confirmation” from the Department for the Environment, Food and Rural Affairs (DEFRA). This, in turn, is subject to DEFRA receiving confirmation from ACRE that the candidate PBO has, indeed, been “precision bred”. This term, “precision bred”, is the foundation stone upon which the Bill is built, but its meaning is so questionable that I have devoted an entire Magic Show to it. For now, let’s briefly note a few downstream issues. For example, if the PBO is an animal an additional “animal marketing authorisation” is required, which is only granted if a “welfare advisory body” is satisfied by the applicant’s “animal welfare declaration”: a statement, backed up by a methodology and evidence, that the applicant “does not expect the health or welfare of the relevant animal or its qualifying progeny to be adversely affected by any precision bred trait”. The cis-trans distinction emerges in the meaning of “qualifying progeny”, but note how it happens. If an organism has inherited any “functional” genes from a transgenic organism, it won’t qualify. By contrast, there is no limit on the number of cisgenic interventions an organism may have accumulated in the course of its family history. Nor is account taken of the effects of genomic interventions appearing at a rate far higher than in traditional breeding, including genetic material which did not previously give rise to functional protein, but does so as a result of an accumulation of edits made over numerous generations. Have you noticed the wiggle room afforded by that word, “or”? If the state values health over welfare, it can still provide a confirmation. Nor is it clear whether declarations and authorisations apply by class or on a case-by-case. These things are arguable, but that’s a problem. Regulations that leave room for argument invariably favour deep pockets, which is not a good look for a Bill purporting to unleash new enterprise.
But hush, the Precision Breeding Magic Show is about to begin!
|In the following series of posts, presented as a series of tricks in a magic show, Julian questions the meaning of the central term of the Precision Breeding Bill and reaches some rather unexpected conclusions about the meaning of “precision bred”.|