Gene editing consultation – what does it mean for agri-tech?

What are genetic technologies?

Genetic technologies are ways of understanding, making or adapting genetic material. This can be achieved by a number of methods and there are differing opinions over how these can be regulated.

The two key categories are:

• Genetic modification – is when genetic material is introduced from a different organism to achieve a preferred characteristic.
• Gene editing – involves changing or altering the original base pair arrangements within the genome of an organism so there is no introduction of foreign genetic material. Techniques include CRISPR/Cas-9.

The key debate here is whether the new characteristic or trait could have been achieved eventually through natural selection.

Traditional breeding selects plants or animals with perceived benefits and breeds from these to produce offspring with the desired traits. This process can take many generations to perfect.

Advanced breeding techniques have been developed to speed up this process by making it possible to identify at a molecular or genetic level the genes that code for these characteristics. As knowledge of the genome for each species increases then the opportunities for making changes is greater.

The scientific community is proposing that a distinction is made between the types of Novel Genomic Techniques (NGTs) to reflect advances in this field that have been made since the EU regulation in 2001.

Why is a review of legislation happening now?

There are a number of drivers:

New technologies emerging
Researchers have found new ways to increase the resilience of staple crop plants to disease and also to improve the nutritional value of foods. Other work has shown the potential to use plants as factories to create new types of medicine. The potential of these advances to improve the quality and quantity of food, reduce the use of artificial fertilisers and pesticides, and overcome chronic health conditions is limited as the regulations currently prevent their exploitation in the UK and Europe.

Divergence from European legislation
As the Transition Period ends, the UK has an opportunity to review how genomic technologies are regulated. The EU regulation was created in 2001 and is considered in need of review. However, any new legislation will need to adhere to global treaties, such as the Cartagena Protocol, as well as international safety standards.

Use of genetic technologies in other industries
Gene editing techniques are being explored in medicine and a number of treatments are in clinical trials, such as a cure for eye disease which is using CRISPR/Cas.

Another example that may create a precedent is the Covid-19 vaccine developed by Oxford/AstraZeneca, which uses genomic technologies to create a ‘viral vector’, by modifying the common cold virus, to deliver the vaccine into the body. The European Parliament suspended its existing GM laws to enable the vaccine to be developed and used.

Two genetically modified foods plants – maize and soy are authorised for use in foods in the EU, as they were introduced prior to the ‘novel foods’ regulation, which includes foods developed through cell culture. Applications for nine foods containing live GMOs are currently pending categorisation as novel foods.

Another example that may create a precedent is the Covid-19 vaccine developed by Oxford/AstraZeneca, which uses genomic technologies to create a ‘viral vector’, by modifying the common cold virus, to deliver the vaccine into the body. The European Parliament suspended its existing GM laws to enable the vaccine to be developed and used.

Two genetically modified foods plants – maize and soy are authorised for use in foods in the EU, as they were introduced prior to the ‘novel foods’ regulation, which includes foods developed through cell culture. Applications for nine foods containing live GMOs are currently pending categorisation as novel foods.

How could legislation be changed?

Currently the basis for the EU safety assessment for Novel Food Regulation is based on scientific principles developed through international consultation with agencies including the World Health Organisation (WHO), and the Food and Agriculture Organisation (FAO) and the Organisation for Economic Co-operation and Development (OECD).

The safety assessment takes into account how the plant was developed and examines the risk associated with the products of the plant. The concept of ‘substantial equivalence’ allows for comparison of the novel food that is being assessed with one that has a long history of safety. Parameters compared include levels of sugars, proteins, minerals and possible toxins.

Process based – The current EU legislation takes a ‘process-based’ approach that focusses on the technology used to develop the product. This could potentially be refined to make a distinction between GM and gene editing approaches. Moves towards this re-classification have come with the recent (April 2021) European Commission study into the regulatory status of Novel Genomic Techniques (NGTs) such as gene editing.

Product based – An alternative could be a ‘product-based’ approach that looks at the properties of the end product and is agnostic about the technology used. This product approach could be used to expand the existing system used to regulate non-GM plant varieties and seeds. This system is focussed on the attributes of each variety, not how it was bred. It provides a proven vehicle and could embrace the new technologies.

1. Clarity – the current legislation has not kept up with scientific advances and there is a concern over damage to reputation for commercial organisations wanting to invest in the development of these techniques. Legislation that is fit for purpose would enable greater investment in technologies that have the potential for huge societal benefit.
2. Public confidence – consensus on labelling would enable informed choices and also ensure that farmers would be able to maintain their organic status or meet the certification requirements of their customers in the value chain as appropriate.
3. Ensuring safety and traceability – one concern is the unregulated release of genetically engineered organisms into the environment. A workable regulatory system would enable appropriate safety measures to be implemented.
4. Competitive advantage – the UK has particular capabilities in genetic engineering that positions it as a leader in this field. The tools and techniques under development have great potential to make a contribution to sustainable food systems through the development of crop plants with more resistant to diseases, environmental conditions and climate change effects and by reducing the need for agricultural inputs such as pesticides. Also, Novel Genomic Techniques offer the opportunity to create food products with higher nutritional qualities and to provide novel approaches for therapeutics.