Regulatory chicanery – Biotech lobby quietly hijacks the UK’s Agriculture Bill to change the definition of ‘GMOs’

May 28, 2020 by Pat Thomas and Lawrence Woodward

MPs, peers and the research establishment are urging the government to introduce genome editing into UK food and farming by sidestepping parliamentary and public scrutiny.

A cross-party group of MPs and Lords has written to George Eustice, Secretary of State for Environment, Food and Rural Affairs, urging the government to table an amendment to the Agriculture Bill which would circumvent and undermine the Environmental Protection Act by changing the way the UK defines a genetically modified organism (GMO).

If adopted the amendment would open the door to the deregulation of genetically engineered crops and animals produced using gene-editing technologies such as CRISPR.

The letter from MP Julian Sturdy, on behalf of the All Party Parliamentary Group on Science and Technology in Agriculture, has been backed by further letters from the heads of various GMO research establishments and from the British Society of Plant Breeders (BSPB). It also has the support of the National Farmers Union (NFU).

What’s it all about?

The proposal is a blatant attempt to sidestep rigorous parliamentary scrutiny and avoid transparent debate on a crucial issue which has widespread implications for the farming and food sector and consumer choice.

Sturdy acknowledges that the changes being proposed would normally require primary legislation but as “this opportunity may not arise again for some considerable time” he suggests the underhanded tactic of using an House of Lords amendment to give Ministers the power to make such far-reaching changes themselves without the need for parliamentary approval.

The Agriculture Bill is now very advanced in its passage through Parliament. At this stage, it is heading for its second reading in the House of Lords (likely before mid-June) – a stage where it is very unusual for substantive issues which have not been debated in the House of Commons to be introduced. This amendment proposes significant changes to a Bill which has not addressed genetic engineering, or gene editing or GMOs or the biosciences in either principle or detail.

Furthermore, it proposes to give Ministers power through one Act (Agriculture) to deal with issues which are within the ambit of another Act (Environmental Protection). This seems to be spectacularly unwise way to proceed and is certainly not the best way to achieve sensible and workable laws.

Avoiding democratic scrutiny is such a breathtakingly cynical tactic it is difficult to believe the MPs and Lords who are members of this group have actually signed up to it. That the heads of taxpayer-funded institutions support such an underhanded attempt to sneak under the radar of public attention a technology they hail as a powerful ‘gamechanger’ also beggars belief.

Weasel Words? In reporting on Sturdy’s letter Farming UK says Sturdy and colleagues are looking to boost ‘”precision breeding” post Brexit.The NFU also uses this term, though neither Sturdy’s letter nor those of his other supporters do. Precision breeding has no formal or legal definition and is part of a lexicon of weasel words used to describe new genome editing technologies such as CRISPR. Others include ‘bioengineered’, ‘new plant breeding techniques’, ‘plant breeding innovations’, ‘innovative breeding techniques’ and ‘new genomic techniques’. Such terms are used to suggest that these technologies are not genetic engineering.Their use has become more common since the 2018 European Court of Justice ruling that these technologies, in fact, do produce genetically modified organisms and therefore the products of these technologies should be regulated in the same way as older style genetic engineering technologies.

Surely, if this technology is as powerful and as far reaching and as important as they claim – and if the issue of a new definition of a GMO is so important to UK agriculture – then shouldn’t it have been included in the Agriculture Bill from the beginning and given the benefit of a full debate in the House of Commons – not quietly slipped in after the fact?

Don’t the heads of these institutions and parliamentarians have the responsibility to openly present and discuss the pros and cons of a proposed change of law rather than sneak it around the corridors of Westminster like a dirty, little secret?

Erroneous claims and misunderstandings lead to bad laws

Sturdy and his supporters want the UK to adopt a regulatory definition of GMO compatible with that of Cartagena Protocol (which the UK is a signatory to) which, they argue, would exempt what they refer to as “simple gene editing applications” from the scope of GM regulation.

This, they argue, would align the UK with other countries which have given genome editing a free pass. They are obviously frustrated that transparent debate about the technology would have to involve all stakeholders – including citizens – and a reasoned consideration of evidence. But that is no excuse for such a bizarre and misleading proposal.

Firstly, the definition of GMOs in the Cartagena Proposal doesn’t do what they say it does. Secondly, genome editing covers a range of applications and even “simple” gene editing techniques are not “simple” either biologically or in terms of their impacts on trade and the market. Thirdly, other countries have not treated genome editing uniformly and, in fact, many have sought to recognise the issue is far from straightforward and have sought to address its complexity in differentiated regulations.

Grasping at semantic straws

The Cartagena Protocol refers to genetically engineered plants and animals as Living Modified Organisms (LMOs) produced by “modern biotechnology” and states:

“Living modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;

(h) “Living organism” means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;

(i) “Modern biotechnology” means the application of:

In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or

Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;

It appears that Sturdy et al are grasping at semantic straws and engaging in verbal acrobatics to argue either that gene-edited organisms don’t have a “novel combination of genetic material” obtained through the GM process, and/or that “natural physiological reproductive or recombination barriers” are not overcome, whilst conveniently ignoring the fact that genome editing is not a technique traditionally used in plant breeding and selection.

Given that many researchers, civil society bodies and government signatories to the Cartagena Protocol believe genome editing clearly does not fall outside of this GMO definition, Sturdy and colleagues view is somewhat idiosyncratic.

In any event, invoking a highly debated definition as the basis of regulation does not seem to be a rational or sensible way to make laws. It certainly is not the simple, stroke-of-a-pen process it is being presented as.

Not a straight forward issue

Through our A Bigger Conversation initiative, which involves discussion with a range of different types of plant and animal breeders, we are aware that many scientists working with gene-editing technologies do believe that, as BSPB state in its letter of support, “genome edited products whose DNA changes could have occurred naturally or through traditional breeding methods should not be subject to GMO regulation.”

They are referring here to a type of genome editing known as SDN-1 where technologies like CRISPR are used to make a double stranded cut at a single location on the genome and the organism’s own repair mechanism is then left to fix the damage. Some see this as radically different enough from older style technologies to justify deregulation.

There are, however, other increasingly invasive techniques used in gene editing classified as SDN-2 and SDN-3 – and for the most part it is accepted that these do produce GMOs and require regulation.

But even in the territory of SDN-1 techniques there is controversy because even small changes can have big effects. GM Watch has pointed out that:

“On-target or off-target effects can result from modifications that are described as small; that is, where one or a few nucleotides of a gene have been altered. Even changing a single nucleotide within a gene sequence can induce drastic changes in the gene’s function and/or its expression. Such changes can be brought about in SDN1, SDN2, and SDN3 procedures. For example, a change in the function of an enzyme through alteration of its active site can lead to its being able to carry out unintended biochemical reactions.

“In addition, genes and their RNA or protein products work in networks.Thus an apparently small change in one gene can affect the function of other members of the network in which the edited gene functions.

“Thus even the “small” genetic modifications brought about by genome editing, which are claimed to mimic what may occur in nature and thus not to require regulation, can affect the function of the targeted gene and other gene functions in addition.”

If the technical issues are far from straightforward, the market, labelling and transparency issues are a minefield.

Some proponents of genome editing might not like it, but all the indications are that even consumers who are sympathetic to the technology believe it should be regulated to some degree and that the products arising from genome editing should be labelled. Many others – probably the majority – remain sceptical or opposed and certainly demand labelling.

These are not issues that can – or should be – swept under the carpet or magicked away by with some parliamentary conjuring trick.

Different countries, different regulations

This is why many countries – including those that look more favourably to genome editing – are taking a more cautious and responsible approach than that advocated by Sturdy and his supporters – and why the assertions Sturdy makes in his letter about widespread deregulation are so misleading.

Throughout the world some countries are regulating gene editing, some are not and some are applying an ad hoc approach.

Australia has deregulated the products of SDN-1 genome editing technologies but those that result from SDN-2 and SDN-3 techniques are considered GMOs and remain regulated.

Australia’s closest neighbour, New Zealand takes a different view and considers all gene-edited organisms as GMOs and they are, therefore, regulated. Japan is currently considering deregulation of SDN-1 but not SDN-2 and -3.

Canada follows a regulatory approach which means some gene edited products may, and others may not, be regulated while Brazil, Argentina and Paraguay require no special regulations for the products of gene editing.

While the US has deregulated SDN-1 plant products it is proposing much tougher regulations on gene edited animals.

This recently became a hot topic when Brazil’s plans to breed hornless dairy cattle gene-edited with TALENs were abandoned after a study by the US Food and Drug Administration (FDA), published in Nature Biotechnology, revealed that one of the experimental animals contained a sequence of bacterial DNA, including a gene conferring antibiotic resistance.

Commenting on the study on its website FDA stated that “both scientists and regulators need to be alert to the potential for such unintended alterations to take place.” In a frank editorial accompanying the study it further underscored why regulation of gene-edited animals was important. It notes:

“At this early stage, as genome-editing technology is continuing to develop and the science is evolving, bringing products with unknown risks to market without adequate oversight to ensure they are safe and that they produce the promised effects will undermine consumer confidence and, ultimately, set back the progress of the entire field.”

Russia, the Ukraine, China, the whole of Europe and Mexico agree and in these countries strict regulations apply on genome edited plants – and, like the US, even stricter regulations on genome edited animals.

Not a decision to be taken quickly – or lightly

Sturdy and colleagues say that the cost of regulation is crippling innovation. How this might be is unclear. Certainly there is no evidence that cost is a prohibitive factor at the research and development stage.

In the UK a substantial proportion of biotech innovation is funded with public money. In line with UK the policy of “public money for public good” we believe that a participatory process for assessing technological innovations needs to involve citizen stakeholders and a precautionary approach should be consistently applied. This is the direction of travel for governments and regulations worldwide.

How the products of genetic engineering in food and farming should be regulated and labelled is not a decision that should be taken behind closed doors by procedural chicanery in order to avoid full and open debate. It is an issue of concern and consequence to every UK citizen as well as to our farmers and growers and any attempt to change the law should be taken in a considered, open and transparent way.

Beyond GM will be making these points to George Eustice. Watch this space for developments.
We urge anyone amongst you who is also concerned to express that concern in a short email to the Secretary of State and ask him not to table this amendment – the arguments in the article above may be helpful in framing your response.