Scientist-turned-lawyer Dr Michael Edenborough QC says "there might be risk" to health from gene-edited GMOs. Report by Claire Robinson

Last week the House of Commons Public Bill Committee heard oral evidence on the Genetic Technology (Precision Breeding) Bill, which aims to deregulate gene editing in the UK on the supposed grounds that "precision bred" GMOs could arise through natural processes such as breeding.

Not a single critical or dissenting scientist was invited to speak, even though qualified candidates were suggested to the committee. However, some honest science snuck into the discussion by the back door, in the form of testimony from barrister Dr Michael Edenborough QC, an expert on patents who started out as a scientist before going into law.

Dr Edenborough spoke about the lack of precision in the Bill's language and its legal ramifications. He criticised the definition of a "precision bred" organism as one in which "every feature of its genome could have resulted from… traditional processes… or… natural transformation”. He said, "'could have resulted from' is staggeringly imprecise. Is that 'likely'? Is that 'very possible'? What level of probability is it?" Also, he said, "traditional processes" are not precisely defined.

He also highlighted a so-called "Henry VIII clause", which means "basically, you can do what you like, when you like, with very little scrutiny".

Dr Edenborough said that the vagueness of the Bill's definition of a "precision bred organism" will make it difficult for GMO developers to know whether their GMO fits into the category and therefore qualifies for light-touch regulation: "You have uncertainty built on uncertainty. If a particular set of facts were presented to me and I was asked the simple question, 'Is this within or without this particular Bill?' the answer would be simply, 'Maybe.'" The question could only be answered by "a mass of expert evidence" on each point of description of the GMO.

The lack of clarity in the definition could, he said, "introduce greater uncertainty into the commercial field". This is ironic, since the entire purpose of the Bill is to make it easier and quicker for GMO developers to commercialise their products.

Dr Edenborough's criticisms reflect concerns raised in a scientific and legal briefing commissioned by the sustainability group ARROW and written with the assistance of law firm Leigh Day. That briefing said the Bill’s definition of a “precision bred organism” is wide and could be misleading, as “A large number of genetic changes could, in theory, ‘have resulted from’ either traditional processes or natural transformation: but it is somewhat artificial to say that this is the case if (for example) the mutation is a 1 in a million chance, or would only have occurred very slowly – say over the course of a million years. Nevertheless, the absence of appropriate qualifiers in the Bill means that genetic changes that fall within either of those two extreme examples would still meet the definition in the Bill.”

Attempts to salvage the situation

The pro-GMO Conservative MP Katherine Fletcher attempted to salvage the proceedings by questioning Dr Edenborough, but without success, as he gave trenchant replies that further exposed the Bill's lack of legal and scientific rigour.

Fletcher asked about the possible consequences of the uncertainty in the drafting of the Bill. She said she couldn't understand "why someone would want to say that something has been genetically edited when it has not been, and... why someone would want to say that something has not been genetically edited when it has been".

Dr Edenborough answered, "The long and the short of it is that a single entity can say different things to different people in different contexts and therefore, in essence, confuse and confound people. You can secure rights in a place by saying one thing and then perhaps avoid liability in another place by saying the opposite."

This answer reflects the GMO industry tactic of telling the public and regulators that their products are nature-identical or nature-similar, while telling the patent offices that they are unique and novel organisms that involve an "inventive step" and could not occur naturally.

"There might be risk"

Fletcher then made the unevidenced claim, "But there is no risk to humans, no risk to health." Dr Edenborough immediately corrected her: "No, there might be risk." He pointed out that Fletcher's argument is an example of circular reasoning, as the assumption is that you do not need to regulate these organisms because they can result from a traditional process, or natural transformation, but in fact, "you do not actually know" whether the organism really could have arisen naturally.

Clearly aware that the discussion had entered into dangerous territory, Fletcher interrupted him before he could finish his statement. She mentioned Belgian Blue cattle, super-muscly animals obtained through conventional breeding that proved to have serious welfare issues. Dr Edenborough agreed that naturally bred organisms aren't always risk free, yet he pointed out that the Bill falls victim to the false notion that they are, since it deregulates GMOs on the basis of the assumption that they could have resulted from natural processes and thus are unlikely to be harmful. He called this assumption "a fallacy".

Fletcher then tried to argue that gene editing just speeds up what can happen naturally. But Dr Edenborough corrected her: "It is not just a speeding up, in the sense that the way in which it would occur naturally is probably one step at a time. Here you are allowed to take many steps, so what might have been stopped at step 1, you suddenly get to step 5. Therefore, that could be a fundamentally different thing that you are releasing into nature."

He added that the Bill provides no clarity on the extent of genetic changes that developers are allowed to make to an organism before it would trigger more careful oversight. He said, "You are going from a regime that is quite tightly controlled, and therefore every step is controlled, to one where you are allowed to jump through many hoops in one go, because the regulation allows for that in a discretionary sort of way. By having the discretion, you introduce greater uncertainty and therefore greater risk."

Dr Edenborough also noted the "very minimal safeguards" against GMO contamination for organic farmers and the difficulty of proving damage in the courts: "The larger manufacturers will have much greater power than the small farmers".

Commenting on the exchanges, Pat Thomas of Beyond GM, who was present and also gave evidence, said, "You could have heard a pin drop in the room as he spoke, and his testimony was met with some very sober faces."

GMWatch notes that it is testament to the UK government's fear of objective science that the most incisive scientific comments in the debate had to come from a patent lawyer. Yet perhaps it is not so much of a surprise. Patent lawyers, like independent scientists, are trained to look at the evidence and ignore the hype. So Dr Edenborough was in an excellent position to expose the unscientific assumptions underlying the government's GMO deregulation Bill.