COP28 Series: Genetic Technologies

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Food systems are responsible for a third of anthropogenic greenhouse gas emissions, and already half of the world's habitable land is devoted to agriculture.
United States Environment
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Food systems are responsible for a third of anthropogenic greenhouse gas emissions, and already half of the world's habitable land is devoted to agriculture. While crop land use has become more efficient over time, meaning that less land is theoretically needed to produce a given quantity of food, large-scale land clearance and deforestation continue apace. There is also concern that many modern farming methods are unsustainable. For example, as long ago as 2015 it was reported that a third of all arable land had already been lost to erosion and pollution, and algal blooms and watercourse pollution caused by nitrate runoff from fertilised fields are well-documented. It is perhaps surprising, therefore, that COP28 in 2023 was the first Conference of the Parties to devote a full day to food and agriculture. COP28 unveiled the UN Food and Agriculture Organisation food system roadmap, which highlights the role of technology and innovation in responding to challenges and creating a diverse arsenal of approaches to bolster food security.

It is sometimes said that we are entering the 'bio-age' of innovation: an evolution away from dependence on small molecule chemical solutions in agriculture and towards targeted solutions tailored to biological conditions. Promising agri-biotechnologies innovations which leverage this concept and offer potential to reduce agriculture's environmental impact include bio-inoculants, probiotics, indoor and vertical farming, lab-grown meat, precision fermentation and many more. However, some of the most powerful and agile tools – genetic technologies - are often downplayed in, or absent from, international dialogue.

Resistance to genetic technologies is often attributed in part to a history of high-profile demonstrations, media campaigns and lobbying from environmental groups as the technologies emerged. However, as a recent policy briefing from the UK Royal Society explains, it is now clear that these technologies are precise, predictable and effective. Years of data generated through field trials and global use of genetically altered crops can provide reassurance on the safety profile of genetic approaches and underscore the technologies' potential to benefit human nutrition, health and the natural world.

As highlighted by the Royal Society's briefing, use of genetic technologies in crops is well-understood, validated and scalable. Many genetically engineered crops are immediately deployable, and more are springing up all the time. Yet many are not, in practice, presently implementable in Europe due to high regulatory and practical hurdles.

The European legislative landscape may be about to change. 2023 saw some cautious moves towards implementation of some forms of genetic technologies in the UK and a proposal to alter genetic regulations was recently approved by the EU Parliament. So, what actually are genetic technologies, and how could they be leveraged in agriculture to provide environmental benefits?

What are genetic technologies?

In short, genetic technologies are methods that customise the genetic code of an organism. When applied to the plant space, genetic technologies allow researchers to go beyond or move faster than "conventional" crop breeding techniques. Multiple customisation techniques exist and terminology is often inconsistent, so it is always worth checking what exactly is being discussed. The following terms are frequently used:

  • Random mutagenesis: artificially increasing the rate at which mutations (changes) arise in DNA using UV or chemical mutagens, and then screening for plants with useful functional changes. This is the oldest of the genetic tools available and the resulting plants are not subject to the EU's stringent regulations for genetically modified organisms.
  • Genetic modification (GM):
    • Transgenesis (also often itself known as genetic modification): inserting a functional unit (gene) from a different species or organism to confer a new functionality. For example, inserting a glow-in-the-dark gene into petunias (you can actually pre-order these in the US). Alternatively, techniques such as RNAi and siRNA allow modulation of pre-existing functionalities in a plant.
    • Cisgenesis: inserting a functional unit (gene) from the same species. For example, introducing a disease resistance gene found in a wild potato cultivar into a commercial variety. Equally, genetic sequences that act as 'on' or 'off' switches can be moved about and duplicated within the genome to modulate gene activities.
  • Gene editing (also often known as targeted mutagenesis): making specific, intentional mutations to genetic material without inserting new genetic material. For example, the activity of some genes can be modulated in agronomically significant ways by changing even just one letter of DNA code (one 'base pair').

There are different ways in which to implement these changes. As with most techniques in the bio-sciences, nature was doing this long before we were and biotechnology has applied these biological principles to new contexts. For example, one 'older' method of gene insertion uses a bacterium (Agrobacterium tumefaciens) that naturally pastes genetic material into a plant's DNA. Scientists can replace the genetic material to be inserted with a gene conferring a desired function to generate a modified crop with new functionality. A 'newer' method also derives from bacteria: CRISPR/Cas9 is a protein-DNA machine which inserts or changes genetic material at a precise, specific location in the genome which can be deliberately selected by a scientist. Now that genome sequencing is a routine technique, resulting genomes can be readily sequenced to validate where exactly a gene has been inserted.

These technologies are methods that modulate functionality of an organism, but they do not fundamentally change the organism itself. A recent lecture by Prof Jonathon Jones of the Sainsbury Laboratory described genetic modification of a crop as equivalent to installing a new app on a phone: it's still the same phone, but now it can do something new.

What can genetic technologies do?

Resulting new functionalities can be powerful and wide-reaching. Already, genetic technologies have produced numerous crops with resistance to key pests. For example, crops have been modified to express a 'Bt' toxin naturally produced by a bacterium in the leaves. Traditionally, Bt toxin is applied by spraying onto crops – a fairly messy process which can 'contaminate' neighbouring plants. By genetically introducing the toxin sequence into the plants themselves, resistance can be constrained to just the crop itself without the need for spraying. Genetic technologies have also produced crops with the ability to metabolise alternative forms of minerals (like absorbing phosphite instead of phosphate), reducing the need to mass-spray fertilisers.

Genetic technologies can also be leveraged to reduce food waste, for example as developed by Tropic Biosciences, which uses gene editing to reduce browning in bananas. The non-browning banana may reduce waste and CO2 emissions from spoilage and is the first product to clear the Philippines' new gene edited regulatory determination process.

Other companies are focussing on increasing yields in the face of changing climates: UK spin-out Wild Bioscience is testing wheat genetically modified to have elevated photosynthetic efficiency, while Argentinian company Bioceres Crop Solutions has developed wheat with improved drought tolerance. The Centre for Novel Agricultural Products in York in the UK has shown that GM native grass species can mop up explosive residues from contaminated soil.

Most famously, 'Golden Rice' – into which beta carotene, the precursor of vitamin A, has been inserted - was developed for humanitarian use in tackling blindness and death caused by vitamin A deficiency, but has been stalled by anti-GM lobbying and regulatory and legal hold-ups around the world.

A 2014 meta-analysis concluded that adoption of GM technologies had – even ten years ago - reduced chemical pesticide use by 37%, increased yields by 22% and increased farmer profits by 68%, with improvements more marked in developing countries. And as well as the direct benefits that the engineered trait confers, there are potentially more subtle environmental benefits. Anything that increases the efficiency of a crop means that more land can be freed up for climate-friendly projects such as nature restoration.

However, without a permissive European regulatory landscape for these genetic technologies, they will not be deployable in Europe, and many would-be innovators may be dissuaded from taking their ideas forward at all.

Are genetic technologies safe?

Safety concerns generally fall into two camps: risks to the consumer, and risks to the environment.

Recourse is often made to the fact that we have altered the genetic content of our food throughout history by selective breeding. Less well-known is that some staple foods evolved through transgenesis themselves: genetic analysis has revealed that the sweet potato is the result of a natural gene transfer event. Moreover, modern genetic techniques can in some ways be seen as less 'risky' than chance breeding events in that they target and monitor the change (via a site-specific targeted introduction and/or via screening to sieve products having the desired change). This means that the resulting genetic change is smaller, more precise, and deliberately tracked and assessed. The changes can also be contained to the engineered plant itself: by the very definition of a species (as composed of organisms which can breed to give fertile offspring), traits cannot cross routinely into different species; engineered plants can also be made sterile in order that a trait cannot spread to other members of the same species. The Royal Society's briefing summarises that "risks are predictable and specific to the change being made."

At the moment, European legislation assesses 'risk' with a broad brush, carving out blanket risk assessments based on the method of production and not actual change or the resulting product. However, the Royal Society's briefing posits this this is the wrong way of looking at the problem, stating that "there is nothing risky about the technology per se" and that "risk and benefit are instead determined by the purpose for which the method is used," which is more appropriately assessed on a case-by-case basis. The briefing calls for outcome-based – not method-based - risk assessment.

Who will own the technology?

Many who argue against the roll-out of genetic technologies conflate the genetic technologies themselves with business practice. There are concerns that that use of the technologies might create a dependence on a handful of heavyweights in the agricultural sector and a lack of choice for farmers and consumers. However, this is not an argument against genetic technologies themselves; rather it's an argument against a lack of competition and transparency in the space.

The US Department of Agriculture recently introduced a new Regulatory review process which aimed to reduce the authorisation burden for some engineered plants, in the hope that this would encourage competition by allowing smaller innovators to enter the space. The new process has already led to regulatory exemptions for over 50 new crops from 30 companies, amongst which start-ups and SMEs like Norfolk Healthy Produce.

A huge amount of genetic innovation is already cropping up across the ag-bio space and the pace looks set to accelerate. Genetic technologies are relatively easy to use and apply to new research and ideas and lend themselves to start-up culture, so a gene-friendly regulatory environment should encourage innovation and commercialisation in the space. Moreover, many companies that currently operate by traditional breeding practices due to the EU's current restrictions on genetic methods are in a position to rapidly pivot to using genetic techniques to arrive at the similar outcomes in a more efficient manner. This would potentially cut crop development timelines by decades. All-in-all, genetic technologies could lend themselves to a competitive environment (which could sit comfortably alongside other sustainable methodologies like regenerative farming and organic approaches) if facilitated by proportional legislation and policy.

Just how to cultivate this type of competitive genetic environment is being hotly debated in the EU at the moment. The EU Parliament recently voted in favour of allowing engineered plants which could theoretically be arrived at via conventional breeding (so called 'NGT-1' category plants) to fall outside the current GMO legislation, alongside plants obtained by random mutagenesis. However, adoption of the NGT-1 proposal into regulation has stalled due to debate regarding whether the resulting plants should be exempt from patent protection.

Proponents of the exclusion argue that patents on engineered plants could price out farmers and distributors and place them in the line of litigation and infringement suits. However, others argue that without a promised period of exclusivity in which to recoup development costs, the genetic innovation which the legislation seeks to facilitate will be significantly stymied by a lack of investment. Moreover, without patent protection, small players may be vulnerable to being undercut by larger players, thereby hindering the development of a competitive landscape. Some have suggested that interests of small farmers and wholesalers could still be protected by other legal mechanisms which operate downstream of a patent, such as infringement exemptions (akin to the researchers' and breeders' exemptions which currently operate in many countries). We are likely to see uncertainty and movement in this policy space for a while to come.

What next?

Despite movement in the regulatory space, neither the UK or the EU has yet come close to loosening regulation for transgenic techniques, or indeed any technique which creates a plant which cannot be created via conventional breeding. Here, Europe is lagging behind other global regions.

However, there are signs that the perceived public antagonism to genetic technologies may actually be over-estimated. Scientific support for the technologies is certainly strong; a petition led by WePlanet in support of the EU's NGT proposal was signed by 35 Nobel Laureates and more than a thousand scientists, and thousands of scientists across the EU publicly placarded ahead of the vote. Public support also seems to be more favourable than many think: a paper by researchers at the Alliance for Science suggests that sentiment across both traditional and social media is now trending in favour of gene editing.

We are also beginning to see genetically modified plants aimed at consumer appeal, like the Big Purple Tomato from Norfolk Healthy Produce which was recently approved in the US, and a pink pineapple from Fresh Del Monte already on sale in the US. It is possible that these will improve the GM brand image. In a sentiment survey of 400 customers in the US, Norfolk Healthy Produce found that 80% were interested in the Big Purple Tomato, while only 5% were completely put off by the knowledge that it's a GMO.

It looks like we may be at a tipping point of the adoption curve for genetically altered food. It remains to be seen how Europe responds and how scientific capabilities will be leveraged in Europe in the future.

J A Kemp LLP acts for clients in the USA, Europe and globally, advising on UK and European patent practice and representing them before the European Patent Office, UKIPO and Unified Patent Court. We have in-depth expertise in a wide range of technologies, including Biotech and Life Sciences, Pharmaceuticals, Software and IT, Chemistry, Electronics and Engineering and many others. See our website to find out more.

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