Gene editing consultation – Part 1
Answering the questions in Section 2 (Part 1) of the government’s gene editing consultation: the regulation of GMOs which could have been developed using traditional breeding methods
This is one of a series of linked pages on the UK Government’s gene editing consultation. Please see the main consultation page for more information and guidance on taking part.
Please choose one or all of the points below each question and try to use your own words to express your views as clearly and strongly as you are able.
- Part 1, Question 1 (Q10 on Citizen Space)
- Part 1, Question 2 (Q11 on Citizen Space)
- Part 1, Question 3 (Q12 on Citizen Space)
- Part 1, Question 4 (Q13 on Citizen Space)
Part 1, Question 1 (Q10 on Citizen Space)
Currently, organisms developed using genetic technologies such as GE are regulated as genetically modified organisms (GMOs) even if their genetic change(s) could have been produced through traditional breeding. Do you agree with this?
We recommend answering YES – these organisms should continue to be regulated as GMOs. You may also wish to make some of the points below.
Challenging the question
We consider this question to be biased, misleading and open to challenge. The possibility that gene editing can produce organisms that are identical to those produced naturally or by traditional breeding is entirely theoretical. The government should not change regulations or remove protections on the basis of unproven theories.
If such organisms do exist in nature or can be produced by traditional breeding then we do not need a poorly understood experimental technology like gene editing to create them.
Gene editing produces GMOs
Genetic technologies, including gene editing, are artificial laboratory-based genetic engineering procedures which, by definition, produce novel genetically modified organisms. This was the ruling of the European Court of Justice (ECJ) in 2018 which made it clear that scientifically and legally, gene editing is genetic engineering and that gene edited crops and animals are GMOs.
New gene editing techniques induce targeted mutations (DNA damage) in order to produce new traits in plants, animals and other living organisms. The ECJ ruling – which was the result of a two-year long review of the most up-to-date science – was that organisms produced by gene editing (referred to in the ruling as “new techniques of mutagenesis” or “directed mutagenesis”) are GMOs. This means that they fall within the scope of the EU GMO Directive 2001/18, which seeks to protect human health and the environment by ensuring GMOs are subjected to a full risk assessment and must be labelled. There is no reason for the UK to override this thorough, carefully considered and scientifically-based judgement.
Gene editing is very different from traditional breeding
Conventional breeding uses sexual reproduction to create offspring with desirable traits such as higher yields or resistance to drought, pests and diseases. It has been used by farmers and breeders for eons to produce both crops and livestock. With genetic engineering, including newer gene editing techniques, researchers directly alter the genetic material of an organism using laboratory techniques. It is this direct alteration at the genetic level that defines ‘genetic engineering’, underpinning the definition of a GMO in the United Nations and the European Union.
Implications of deregulation
Current GM regulations ensure that when genetic engineering is used, the crop or animal cannot be farmed, imported or eaten until checks are made to ensure that the process has not altered the organism in a way that poses risks to human health or the environment. This is often referred to as ‘process-based regulation’.
Process-based regulation acknowledges that how an organism is produced is relevant. It recognises that direct intervention at the genetic level is different from traditional breeding and can result in multiple and unexpected errors across the genome, some of which may pose a threat to people, animals or the environment.
Shifting to ‘product- based regulation’ means that regulators will no longer have to consider how a plant or animal was created. This amounts to taking the genetic engineer’s word for it that they have only made the DNA changes that they intended to make. Any unexpected effects, such as new allergens or toxins, may go unnoticed.
The safety net of process-based regulation
It’s important to recognise that gene editing isn’t a single process but a collection of processes that can be used singly or in combination. Complex traits such as pest or drought resistance, improvements in yield or resilience in the face of climate change, cannot be achieved through simple genetic ‘edits’ or ‘tweaks’ but are likely to involve multiple interventions at the genetic level. With each intervention the risk of unintended effects multiplies.
The type of deregulation being proposed by the UK government ignores the unintended genetic changes that are common with gene editing. New gene editing techniques give biotech developers access to parts of the genome that are generally ‘protected’ against mutations (DNA damage) and thus not accessible to traditional breeders. This creates a higher risk of unintended changes occurring both at the intended edit site (on-target effects) and at other locations in the genome (off-target effects).These unintended changes are considered by researchers to be both a major challenge and a major concern, not least because they can affect genes with completely different, often vital, functions.
Process-based regulation looks at how an organism was created and whether the genetic engineering process has introduced any unintended changes in the organism. It is an essential safety net where new and/or experimental technologies are concerned.
Part 1, Question 2 (Q11 on Citizen Space)
Do organisms produced by GE or other genetic technologies pose a similar, lesser or greater risk of harm to human health or the environment compared with their traditionally bred counterparts as a result of how they were produced?
We recommend answering that organisms produced by gene editing or other genetic technologies pose a GREATER risk of harm to human health or the environment compared with their traditionally bred counterparts as a result of how they were produced. You may also wish to make some of the points below.
No history of safe use
Traditional breeding is generally accepted to have a history of safe use stretching back millennia. In stark contrast, genetic engineering (and especially gene editing) is so new that we are only just beginning to understand what can go wrong.
The European Court of Justice (ECJ) judgement of 2018 supported this view. It argued that newer techniques (most of which have yet to reach the marketplace) do not have a history of safe use and therefore “the risks linked to the use of those new techniques/methods of mutagenesis might prove to be similar to those that result from the production and release of a GMO through transgenesis”.
In 2017 a statement published by the European Network of Scientists for Social and Environmental Responsibility (ENSSER) was signed by scientists throughout the world. It recommended that, because of our lack of knowledge and the possibility of unintended errors, the products of new genetic modification techniques should be strictly regulated as GMOs.
Claims that gene editing only produces small or very few changes in the genome ignore the reality of how these techniques can and will be used.
Gene editing isn’t a single process but a collection of processes. For example, it can include Agrobacterium insertion of the gene-editing tool, the use of plasmids containing foreign genes, encoding the gene-editing tool, tissue culture, and the use of antibiotic marker genes. Each of these processes can produce unintended changes or genetic errors so each should be evaluated for the specific risks that it entails.
Gene editing tools make it possible to make more ‘precise’ cuts in DNA, but however precisely targeted the initial cut is, the subsequent ‘repair’ process is not under the control of the genetic engineer but is carried out by the cell’s own repair processes. This repair is often not precise or clean, but results in many genetic errors.
In addition, although gene editing can be used to target a single gene, it can also be used to target several genes, either at once or successively. Because gene editing produces unintended effects, each additional edit made in this approach multiplies the risk of unintended effects.
While the government claims that gene editing does not involve the use of ‘transgenes’ (genetic material from unrelated species), it has been shown that this can happen by accident. For example, gene-edited mice can end up carrying bovine and goat DNA as a result of the use of standard culture medium for mouse cells, which can be derived from body fluids extracted from cattle and goats.
Genetic engineering of plants poses a greater risk of harm
The types of traits proposed in the widespread promotion of gene editing include similar claims to those made when the first generation of genetically modified organisms emerged in the 1990s. Such traits, if they were ever to be achieved, involve fundamental changes to the biochemistry of crop-producing plants. This is why they must be assessed for potential new allergens or toxins, higher levels of existing allergens or toxins, or other changes that could impact the health of people or animals consuming the plants, and the wider ecosystem.
Cibus’s oilseed rape brings with it the same risks from increased herbicide use as the older-style GM herbicide-tolerant crops, including biodiversity reduction, devastating impacts on particular wildlife species and the evolution of herbicide-tolerant ‘superweeds’.
Calyxt’s soybean oil is largely intended for use in fast food restaurants where, according to the manufacturers, it gives a 3-fold greater fry life compared to conventional soybean oil. In other words, you can keep frying food in the same quantity of gene-edited for even longer than other oils. The growth of the fast-food sector represents a direct threat to human health.
Genetic engineering of animals poses a greater risk of harm
Nobody knows if eating genetically engineered animals or their products (milk, meat, eggs) is safe as there have not been any animal feeding studies to prove or disprove this. There is, however, sufficient uncertainty about gene editing in animals to justify robust regulation based on the Precautionary Principle.
Genetic engineering of farm animals is largely intended to address the problems of industrial factory farms. It also supports livestock systems that have been shown to have multiple negative impacts on human health and the environment including soil, water and air pollution and the spread of antibiotic resistance.
In a 2019 a study by the US Food and Drug Administration (FDA) found numerous irregularities in gene-edited ‘hornless’ cattle, including the unintended incorporation of antibiotic resistance genes in the genomes of the cattle. The FDA said that its findings “demonstrate that there is good reason for regulators to analyse data on intentional genomic alterations in animals to determine whether there are any unintended results, either on- or off-target and, if so, to determine whether they present any cause for regulatory concern.”
Concerns about the impact of gene editing on animal welfare are covered below.
Genetic engineering of plants or animals disrupts the environment
Releasing genetically novel organisms into the environment disrupts the delicate balance of nature and risks a range of unpredictable harms.
Altered genes can spread to wild relatives, changing or polluting the natural ecosystem in ways that are very difficult to predict, control or repair. If plants or animals are genetically altered to make them resistant to pests or diseases, it does not take long for those pests or diseases to evolve in response. This has been widely seen with herbicide tolerant and insect-killing GM crops around the world: weeds and pests have quickly adapted and new problems of herbicide-resistant weeds and insecticide-resistant pests have emerged.
Are there any non-safety issues to consider (e.g. impacts on trade, consumer choice, intellectual property, regulatory, animal welfare or others), if organisms produced by GE or other genetic technologies, which could have been produced naturally or through traditional breeding methods, were not regulated as GMOs?
We recommend answering YES – there are many non-safety issues that must be considered when choosing how to regulate genetic technologies. You may also wish to make some of the points below.
Damage to our trading relationship with the EU
No EU country will accept food products, commodities, seed or other imports from the UK that might include unauthorised GMOs. If gene edited organisms are not regulated as GMOs in England, English farmers, food producers and exporters will not know whether or not they are using GMOs. It will be impossible for them to prove that their goods are acceptable for import into the EU.
Even where GMOs are approved for import into the EU, they must be labelled (making them traceable) and subjected to post-market monitoring to check for any problems and allow for unsafe products to be recalled. When GMOs are used in foods for human consumption the end products must be labelled. If gene edited organisms are not regulated as GMOs in England, English farmers, food producers and exporters will not be able to meet these requirements. And if anything goes wrong, for example, if a gene-edited food is found to cause allergic reactions, the cause will not be traced.
Undermining the UK’s devolved nations
Food and agriculture are devolved areas of competency, meaning that Scotland, Wales and Northern Ireland are responsible for GM regulation in their own countries. All three of the UK’s devolved countries have sceptical policies on GM and in 2015 all three used a new EU Directive (2015/412) to ban the cultivation of GM crops on their territory.
This consultation is said to only apply to England, but if Defra changes the definition of a GMO it will affect Scotland, Wales and Northern Ireland. The Internal Market Act could force Scotland and Wales to allow English food producers to sell unchecked, unlabelled gene edited foods, whatever the rules at home. Food businesses in Northern Ireland could be prevented from selling or handling any food produced in England because it might include GMOs that breach EU rules.
Conventional breeding has been shown to push farmed animals beyond their physiological limits leading to poor health and welfare, including bone and metabolic diseases, lameness, reproductive issues, breathing problems and mastitis. However, claims that gene editing can bring improved animal welfare are unconvincing.
The process of gene editing animals usually involves a cloning step which, according to both the RSPCA and Compassion in World Farming inflicts very severe or lasting pain on animals, violates their integrity and reduces them to a mere instrument or tool.
Cloning is typically only successful 10-25% of the time, meaning that most embryos transferred into hosts’ wombs do not result in a full-term pregnancy and are aborted. For those cloned animals that survive, birth defects are common. Defects include premature death, pneumonia, liver failure and obesity. For example, a study on cloned mice found that up to 4% of the genes were malfunctioning during pregnancy.
Regardless of whether cloning is used or not, genetic engineering (including gene editing) raises multiple other ethical and welfare concerns. For instance, using microinjection instead of cloning requires a large number of animals to act as ‘mothers’ for the implantation of genetically engineered embryos. On average, 24 embryos are needed to produce one gene-edited pig.
Using genetic engineering as a sticking plaster for disease and injuries that result from over-crowding can both perpetuate and cover up poor animal management, particularly in intensive farming operations. For instance, gene editing pigs for disease resistance could lead to the animals being raised in less hygienic conditions. Similarly, gene editing cows without horns could lead to animals being kept in more crowded enclosures.
Genetic errors created by the gene-editing process can occur as an unintended consequence of genetic engineering, even if new genes are not inserted into the animal. For example, gene editing for super-muscly animals resulted in rabbits, pigs and goats with enlarged tongues and pigs having an extra spinal vertebra, even though no DNA had been inserted.
Co-existence with non-GM crops and livestock
Most farming in the UK – and most of the food produced and sold here – does not involve the use of genetic engineering. This will continue to be the case in the future, whatever the potential of gene editing. Additionally, there are significant markets, in the UK and abroad, for certified non-GM products. In the EU, retailers are already reaping the commercial benefits of selling certified non-GMO food products.
Many consumers will not wish to buy products produced using genetic engineering, including gene editing technologies, and many farmers will not wish to use such methods.
The right to choose is a long-established part of UK farming and food policy. It recognises that conventional, organic and genetically engineered crops and animals can only ‘coexist’ if one system of production does not negatively impact the others.
Regulation, transparency and labelling are necessary if we are to achieve fair coexistence. At present there are no proposals for how coexistence will work at farm level, within the supply chain and at the consumer interface. Farmers, food producers and consumers should all have a say in the development and implementation of effective coexistence rules.
Social and ethical considerations
All technological advances bring new risks and raise ethical questions, such as, “Why are we doing this?”, “How will it be used?” and “What will its impact on society be?”. This is particularly true with gene editing, where what is being created could outlast us and be passed on to future generations. In addition to assessing risk to health and the environment, the government has a duty to consider and assess, on a case-by-case basis, the value and ethics of adopting each new application of gene editing. This kind of assessment should take place as early as possible in the research and development phase.
If we don’t allow for the possibility of saying no to proposed technological interventions, or allow ourselves to place rational limits on them, we lose the ability to shape our world, as well as our accountability for the things we shape.
Undermining consumer choice and confidence
UK consumers do not want to grow, buy or eat genetically engineered foods.
A 2020 survey by Food Standards Scotland found that, next to chlorinated chicken, genetically engineered foods are a top issue of concern for 57% of consumers. Another 2020 study conducted by the National Centre for Social Research, which focused on Brexit-related issues, found that 59% wish to maintain the de-facto ban on genetically engineered crops. A 2021 survey by the UK’s National Economic and Social Research Council found that 64% of those who took part were opposed to the cultivation of genetically engineered food.
British food is associated with high standards, but this perception will be quickly undermined once people know that new, experimental products of genetic engineering are being distributed, unlabelled and without any traceability or accountability, throughout our food system.
A distraction from key sustainability issues
Gene editing is promoted with a long list of boasts and promises that have almost no foundation in science. Many of the same claims were made for the first generation of GMOs when they emerged in the 1990s and yet these older style GMOs have not resulted in higher yields, lower pesticide use, better profits for farmers, or lower seed prices. GMOs have also failed to ‘feed the world’. Around 40% of GM crops are turned into biofuels, the rest are used as animal feed or as ingredients – mostly oils and sugars from corn, soya and cottonseed – for unhealthy highly-processed human food.
An understanding of genetics can greatly assist with both plant and animal breeding. Nevertheless, it is widely recognised that there are limits to what can be achieved solely through genetics in terms of improvement in plant variety/performance and in terms of the bigger picture of ‘feeding the world’.
To frame gene editing as the answer to all farming’s problems is not just unproven and misleading, it distracts attention from meaningful actions which are likely to have a greater and more immediate beneficial impact. Instead of deregulating gene editing the government should be addressing the real problems, such as soil health and waste in the food system.
What criteria should be used to determine whether an organism produced by gene editing or another genetic technology, could have been produced by traditional breeding or not?
We recommend that you use your own words to challenge the idea that any gene edited organisms could have been produced by traditional breeding (see page 6 for more details). You may also wish to make some of the points below.
A commitment to transparency
In order to ensure ongoing environmental and health monitoring, as well as farmer and consumer choice, criteria enabling transparency at all levels (including product labelling) should be developed.
Development of scientific criteria
There are no agreed scientific criteria to determine whether an organism produced by gene editing or another genetic technology could have been produced by traditional breeding. We know that genetic engineering technologies (including gene editing) can create many unintended genetic changes, so even if the intended trait could have been produced by traditional breeding, the overall genetic makeup of the gene edited organism will not be the same.
To scientifically determine that a gene-edited organism is the same as one produced by traditional breeding it would be necessary to examine the sequence of the entire genome and the detailed composition of the gene-edited organism, including the proteins and metabolites – as revealed in analytical methods known as ’omics. The technologies to do this are available and have been recommended for inclusion in GMO risk assessments.
Gene editing methods vary. This has not been recognised in the information accompanying this consultation but any rational discussion of regulation and evaluation criteria must take this into account.
Although gene editing is often described as using a process of ‘tweaking’ or making a ‘simple cut’ in the DNA of an organism, in most cases it involves much more invasive processes including the insertion of a genetic repair ‘template’ containing instructions for how the organism should repair itself after it has been damaged by the initial cut. It can also involve the insertion of ‘foreign’ or ‘trans’ genes.
Even the few countries that have deregulated gene editing have only done so with one type of gene editing (known as SDN-1) which does not use a repair template. The other methods continue to be regulated as GMOs.
However, these (SDN-1) procedures should not be assumed to lead to effects that could be found in nature or through traditional breeding. Even SDN-1 procedures have been found to lead to unwanted mutations. A recent study on rice found that SDN-1 gene editing using CRISPR unexpectedly caused large insertions, deletions, and rearrangements of DNA. This raises the possibility that the function of genes other than the one being targeted could have been altered. The researchers warned that “Understanding of uncertainties and risks regarding genome editing is necessary and critical before a new global policy for the new biotechnology is established”.
Record keeping and audit trail criteria
As some impacts of the gene editing process may not be immediately identifiable, we need an international public register of gene editing events used in the specific product (crop or animal) that will enable tracing and monitoring over time. This register would form the basis of a supply chain audit and product labelling of the type already used in farming and food from the Red Tractor Scheme through to organic certification. The methods and protocols of such schemes are well developed and could be readily adapted.
Social, ethical and values-based criteria
The national and international discussion over gene editing has recognised that, with such a far-reaching technology, assessment criteria must go beyond narrow scientific and technical aspects. Social, ethical and values-based criteria have been put forward and some countries, such as Norway, have begun to use them in their legal and regulatory frameworks for genetic engineering technologies.
It has also been acknowledged that citizens; specialists in the social sciences and ethics; and members of civil society all have a key role to play in developing and implementing such criteria. Citizen panels and assemblies are likely to be an important part of this process at all levels of decision making.
Please submit your response well before the deadline of 17 March 2021 and share this page with others who may want to have their say.