Blog post

The regulation of genetic technologies: time for dialogue

There are two kinds of question that people ask about developments in life sciences and biotechnology. One is along the lines of: ‘what controls or limits should we place on technological innovation?’ There may be obvious answers to this question: threats to public safety, or risk of adverse environmental impact, for example, offer good reasons to control innovation in specific ways. The other is of the form: ‘what kind of technologies do we want?’

This question is harder, more open. Formulating a response requires us to feel our way towards it, taking trouble to explore what it means, what the context is, what the options are, what their implications and consequences might be, and for whom. In many cases of technological innovation, the second question is not heard at all, or posed only weakly, implicitly or abstractly. Some assume that the answer to the first question itself gives a sufficient answer to the second: that not interfering with innovation, other than to control risk and prevent harm, makes way for the ineffable wisdom of aggregated individual evaluations to shine through in the marketplace.[1]

In the first week of January, the UK Department for the Environment, Food and Rural Affairs (Defra) launched a consultation on the regulation of genetic technologies, focused on potential applications of genome editing in UK agriculture and aquaculture. Genome editing (the deliberate, targeted modification of a DNA sequence in a living cell) has been adopted enthusiastically in biological research and a number of agricultural applications have been explored. It was the subject of our report Genome editing: an ethical review, published in 2016. That report identified the use of genome editing in farmed animals as a priority area for further consideration. Among all the applications of genome editing it is one of the most advanced yet least discussed, despite the decisive impact public attitudes have had on earlier agricultural biotechnologies and the distinctive issues that surround their use in animals. For these reasons, it is currently the subject of a major Council inquiry that began in 2019 and will conclude later this year.

The gap into which the Defra consultation plays is an equivocation over whether genome editing, a subtle and precise range of techniques, should be subject to the same regulatory strictures as earlier generations of biotechnologies. The consultation is in two parts. The first concerns the use of genetic technologies to produce organisms that could have come about without deliberate intervention or using ‘traditional’ breeding methods, given a sufficient number of cases and a sufficient amount of time. This use of technology is appealing in the way that giving Shakespeare his head might seem preferable to waiting for the monkeys to do their thing with the typewriters. The consultation asks whether organisms produced in this way should be subject to less stringent regulation than the more radical and less controllable ‘old school’ transgenic approaches where, for example, a functional DNA sequence is taken from one kind of organism and inserted into another.

The UK is not alone in thinking that not all technologies are equal – other European countries and the European Commission’s own group of scientific advisors think that genome edited organisms could be regulated with a lighter touch than some GMOs. The sticking point is a judgment of the European Court of Justice from 2018 that says that they shouldn’t. This judgment is, of course, binding for the member states of the European Union.

The Defra consultation honours a promise made during the passage of the Agriculture Bill last year. But the circumstances – the indecent haste after the end of the Brexit transitional period, hiving off a class of applications as a potential ‘quick win’ and a short, ten-week consultation period – betoken a political exigency to find some tangible good that might come from Brexit.

The consultation itself follows the model of government written consultations that are designed to gather up the established views of key stakeholders (although it does encourage them to foster wider discussions). And early indications are that the battle lines familiar from earlier GMO debates are, indeed, being drawn up once more. While there are intimations that, as a result of what appears to be a mainly strategic capitulation, the gambit of hiving off some applications of genome editing may have persuaded some objectors to cross the floor, others have merely ‘doubled down’.

Whether the majority of people will be drawn into the trenches with the pro-biotech lobbyists or anti-GM NGOs is questionable, however. Taking the trouble to discover whether they will is important because we know that public attitudes have had a decisive (and chilling) effect on UK agricultural biotechnology in the past and that they can be mobilized effectively by interest groups. With the life sciences enjoying a boost in cultural approbation there have been suggestions that some scientists may see this as an opportunity for a land grab. By hiving off the most innocuous-sounding applications of genome editing for less stringent regulation they may be able to split the opposition. And with the political support to carry it through, why not get this in the bank?

I think this would be short sighted, and possibly self-defeating. In splitting the opposition to technological innovation it would, at the same time, also split the science. The second part of the Defra consultation relates to the wider framework for GMOs. It does not propose an imminent change but seeks information about how Defra should reform its approach to regulating novel organisms in the longer term. It then asks about the sufficiency of existing non-GM regulations to regulate GMOs in relation to a number of sectors (crop plants, farmed animals, human food, animal feed, medicines etc.). This is, potentially, where bigger potatoes are buried.

While these are important questions, the focus on the organisms themselves tends to shore up the old canard that the controversies are mainly about product safety. Certainly, factors such as ‘impacts on trade, consumer choice, intellectual property, regulatory, animal welfare” were mentioned in part one of the consultation. But there are a myriad of other interdependent dimensions including animal health, nutrition, zoonotic disease, ecosystems, biodiversity, climate, rural livelihoods, supply chains, industry structure and food security that comprise the sociotechnical imaginaries that are at stake. And these wider considerations apply equally where the biotechnology in question produces organisms that could have come about as a result of ‘traditional’ breeding and where it produces others that could not.

The internal and external challenges facing the food and farming system do not only affect us as food producers and consumers but as citizens and societies. And they are more complex and longer-term challenges than can be addressed by simply having an efficiently functioning marketplace.[2] Under the right circumstances, biotechnologies may have an important part to play. How they fit in is a question of the broader vision.

For over a year now we have been working to develop a significant public dialogue initiative in this area. We have been doing this in partnership with others who have an interest in responsible research and innovation, including major UK research funders, and with the help of Sciencewise, the programme funded by UK Research and Innovation, that aims to ensure policy is informed by the views and aspirations of the public. While our progress has been impeded by the pandemic and its shifting priorities, our hope remains that the dialogue will arrive at just the right time, borne by the growing salience of genome editing, to contribute to what should be an informed and nuanced debate on directions for future national policy. There is a distance to travel but it is important to get this right. This could be the defining moment for this generation of biotechnologies and for the direction of our future food and farming system.


[1] For example, F.A. Hayek: “Value indicates the potential capacities of an object or action to satisfy human needs, and can be ascertained only by the mutual adjustment through exchange of the respective (marginal) rates of substitution (or equivalence) which different goods and services have for various individuals.” The Fatal Conceit, the Errors of Socialism.

[2] On the ‘disembedding’ of markets see Polanyi, Karl (1944) The Great Transformation, the political and economic origins of our time.

Comments (3)

  • Andrew Woodfield   

    What are we to make of the exemption-condition proposed for GE crops and farm-animals ‘where their genetic changes could have been produced by traditional breeding’? These words (from page 6 of the Consultation Document) are sure to prove troublesome.
    1. DEFRA must specify the traditional breeding methods to which it refers. A previous commentator has rightly pointed out the irony if for instance, X-ray mutagenesis is on the list. The government would be awarding benchmark status to a terribly haphazard technique. Without it, however, the scope of the exemption is diminished.
    2. In DEFRA’s three published documents, there are seven different statements of the proposal. Three formulations, like the one above, focus upon ‘genetic changes’, while four speak of the organisms produced. There seem to be two distinguishable proposals.
    The ‘organism’ version says that an organism that has a phenotypic characteristic brought about by gene-editing is exempted from the GMO regulation provided that non-GE organisms of the same species having same phenotypic characteristic are possible.
    Take the example of a GE blight-resistant potato. We know it is possible to breed blight-resistant potatoes using traditional methods, as non-GE blight-resistant varieties actually exist. So the escape-condition is met.
    The ‘genetic changes’ version is more stringent. Assume that a bio-tech team directly alters the DNA of organism O which started life having a certain genome G, in such a way that O ends up with genome G*. Then they apply for permission to sell the variant to farmers. On the stricter interpretation, the exemption-condition is that it is possible for an organism like O to possess genome G* as a result of traditional breeding.
    The former version is laxer, because it does not insist on exact genetic similarity between the GE product and the non-GE product. All that matters is that they share the same relevant phenotypic trait.
    Which interpretation does DEFRA prefer?
    3. The verb ‘could’ signifies modality; the proposal speaks of a possibility. How might an applicant to DEFRA establish that the relevant possibility is real, in cases where no actual non-GE example exists?
    Let us construe the proposal strictly as requiring relevant genomic identity between the GE and the possible non-GE counterpart.
    If no organism with genome G* exists except for the edited variant, people might try to breed one by traditional methods, just to prove the possibility. That might take a while. And there is no guarantee they will succeed.
    In the absence of conclusive proof, the bio-tech researchers must supply evidence. Perhaps they might tell a story of how G* could be produced in a non-GE way through a series of incremental steps across several generations, where there is verifiable proof for each step.
    But let us consider the problem from a wider perspective. Many types of organisms (microbes, fungi, plants, animals… ) have already undergone gene-editing in labs around the world. In the UK, numerous agricultural and food-related GE projects are in the pipeline, and it is DEFRA’s job to monitor them. What will happen if the proposed change of regulation comes into force?
    It seems quite likely that a small proportion of the fast-track applications will satisfy the escape-condition. These will be cases where the alterations are relatively slight. A significant proportion will fail to pass, however, because the applicants - and DEFRA - do not know whether the new genome can brought about by traditional breeding methods. In some cases the issue will be objectively undecidable.
    A regulation whose proper domain of application is so uncertain must be bad law. If it comes into force, we may expect to see speculation, special pleading, disagreement, and fraud.

    • Pete Mills   

      Thanks for this comment, Andrew. Your point about undecidable criteria is a serious challenge to effective regulation. I would guess that the answer given will be to do with the scale of the variation (at a molecular level), and the fact that it is non-lethal. (Again, we should be wary of thinking that the scale of the genetic change will necessarily correlate with the significance of the phenotypic change.) I would add that the focus on the characteristics of the organism, whether genotypic or phenotypic, ignores wider considerations about the sustainability of the organism in the environment. Many genetic variants are possible and many that may occur ‘naturally’ in organisms will have been selected against because organisms with those variants are not accommodated (or not as well adapted as other organisms) to the prevailing environment. Some will have found an environmental niche. Others have been sustained by human environmental management (e.g. requiring inputs of chemicals, labour, etc.). Attention to the longer term implications and externalities of these scenarios is also important – not only whether the variations or organisms “could have been produced through traditional breeding” but what conditions would be required for them to thrive, and what living with those conditions would imply.

  • Theresa   

    Here is the GeneWatch UK submittance to DEFRA's consultation:
    http://www.genewatch.org/sub-507666 Dated 20 January 2021.

    • Pete Mills   

      Thanks for sharing this link. The response makes a number of important points many of which are around risk. These lead to questions about the definition, assessment, management and governance of risk, which can be debated. But I think they also bear out the need for a dialogue that is focussed not on individual technologies but on the challenges we face collectively, how we may arrive at a response to these challenges and what role biotechnologies may play. This leads us to debate our appetite for risks of different kinds and their distribution, and how, beyond estimable risks, we confront irreducible uncertainty.

  • Andrew Tylecote   

    Just as genome 'editing' has a reassuring buzz to it, so does 'traditional' breeding. Would it not be helpful to make clear that so far as regulation is concerned, 'traditional' breeding is taken to include random genome-smashing by the use of chemical and nuclear mutagenesis? In my experience rank and file members of 'environmental' organizations generally have no idea that they are, in effect, defending the unrestricted use of such methods.

    • Pete Mills   

      Thanks, for commenting, Andrew. It’s good to hear from you. In the 2016 report I referred to in the post, the chapter on 'Food' discusses this in a section that proceeds through ‘confused terms’, ‘contested concepts’, ‘inconsistent framings’ and ‘contending imaginaries’ (see para.5.28ff.). You might detect a resonance here with the concept of ‘ambiguity’, which I carried forward from the 2012 Emerging Biotechnologies report. Interestingly, I had a footnote in the draft of this blog post (cut for the sake of economy) which read as follows: “When translating between Whitehall Mandarin and demotic English, the term ‘traditional’ is something of a faux ami – in relation to plants it can encompass, for example, dousing them with toxic chemicals or bombarding them with radiation while, in animals, it can mean crossing animals based on QTLs and other molecular biomarkers. The rationale is inductive: we’ve been doing this for longer and have not yet come seriously unstuck, although it seems conceptually strange: it amounts to saying that a new technique (about which we have little prior evidence) is acceptable if its effect is (equivalent to a familiar technique, the purpose of which is) to cause random genetic mutations, the effects of which cannot be predicted. The difference may be in the scale of the change, although I don’t think it is a sound hypothesis in genetics that little changes have only little effects. I take this to explain why, from the point of view of product safety (but perhaps only from that point of view), the smart money favours the regulation of products in relation to the characteristics of the organism itself rather than how it was produced.”

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