Gene editing consultation – Part 1

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.

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.

Gene editing raises animal welfare concerns

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.