Dr. Thomas McLoughlin:

Dia dhaoibh, a Theachtaí Dála agus a Sheanadóirí. I wish to thank the committee for the kind invitation to come before it this evening. In particular, I wish to thank Senator Paul Daly for getting this important subject on the agenda.

Gene or genome editing is also referred to as new genomic techniques and new breeding techniques. I will use the acronym GE.

The world faces enormous challenges in producing sustainable food for its growing population, given the escalating pressures of climate change and biodiversity loss. There can be no doubt that the Covid-19 pandemic reminded us of our vulnerability and the need to be prepared for potential future pandemics. The same can be said of how we produce our food and the potential for food shortages due to drought, floods, forest fires, the advent of more aggressive plant and animal diseases or pests, and the threat due to war.

The EU’s farm to fork strategy is the cornerstone of its green deal. Its objective is to contribute to a more sustainable food production system by reducing, among other things, dependency on pesticides by 50%. The strategy refers to GE, which may play a role in increasing sustainability.

I shall turn now to mutation breeding. Over the past 70 years, mutations in plant genomes have been induced by plant breeders using ionizing radiation or chemicals to increase genetic variability. This method of modifying genetic material is called random mutagenesis and the resulting organisms are technically genetically modified organisms, GMOs, and are exempt from the scope of EU GMO legislation on the basis that they have a long history of safe use. Much of the food we eat today originated from the use of this technology.

What is gene editing? GE, which can be defined as all techniques to alter the genome of an organism developed after 2001 - when the EU's legislation on GMOs was adopted - has rapidly developed over the last two decades in many parts of the world, with some applications already on the market. The most recent addition to the breeder’s toolbox, discovered in 2012, is a GE technique called CRISPR-Cas9, which is what we are talking about this evening. It is described as a genetic scissors that can be used by scientists to change the DNA of animals, plants, and microbes with extremely high precision. Two scientists, Jennifer Doudna and Emmanuelle Charpentier, won the 2020 Nobel Prize in chemistry for discovering this technique.

In 2018 the European Union Court of Justice, ECJ, ruled that organisms obtained by induced or classical random mutagenesis constitute GMOs, and that these are exempt under the GMO directive. However, the ruling also stated that organisms obtained through techniques of directed mutagenesis involving techniques like CRISPR-Cas9 are not excluded from the scope of the directive. Since that ruling, there has been much debate about its implications. Industry, breeders, farmers and academia were alarmed at the court’s decision.

The ruling prompted many European plant and life science companies to submit a paper to the EU Commission outlining the negative consequences for agriculture if all organisms developed with GE will have to comply with EU rules on GMOs. This prompted the EU Council in November 2019 to request the Commission to submit a study in light of the ECJ ruling regarding the status of GE techniques under Union law.

Contributing towards this process, 12 legal and scientific experts - including myself - published an article in January 2021. In this article we analysed the court’s judgment and concluded that the ruling merely sheds light on the court’s general thinking but did not address the legal status of organisms developed through GE techniques in general, nor was it asked to do this. Also, the precise implications of the ECJ ruling are far from settled, as is also highlighted by the Council’s request to the Commission. Furthermore, in November 2021, the French authorities took a second case to the ECJ seeking further clarity on the 2018 judgment.

The EU study was published in April 2021, following stakeholder consultations. The main findings were that GE technology has the potential to contribute to sustainable food systems; and that the 2001 GMO legislation is not fit for purpose and needs updating. It is more than 20 years old and the science has moved on but the legislation has not moved on. Concerns were also raised over potential impacts on biodiversity, coexistence and labelling. The European Food Safety Authority, EFSA, concluded that targeted mutagenesis techniques that modify the DNA of plants, like some CRISPR technologies, do not pose more hazards than conventional breeding or techniques of GMO. The executive summary states that organisms obtained through GE are subject to the GMO legislation. In a submission to the Commission in May 2021, a number of EU regulatory experts, including myself, concluded that this statement was not substantiated by the report and we urged the Commission to elaborate on the points raised in our analysis in order to reduce the ambiguity in the regulatory status of organisms obtained with GE.

With regard to the next steps, the EU Commission is working on a targeted policy action on crop plants derived from targeted mutagenesis. This policy aims at a proportionate regulatory oversight to maintain a high level of protection of human and animal health and the environment, and to achieve the goals of the farm to fork strategy, which is of paramount importance. An impact assessment, including a public consultation, will be carried out by the Commission to examine potential policy options this year and a proposal for legislation by the middle of 2023.

We can ask whether EU attitudes are changing on GE. There is certainly an increasing interest in GE technology worldwide. This was driven by the part played by modern biotechnology in the identification of the vaccines, PCR and antigen tests, and genomic sequencing that are enabling the world to protect us against the Covid pandemic. These are all examples of advances in modern biotechnology over the past 40 years. I put it to the Chairman that these are of paramount importance. Science is taking us out of this terrible pandemic.

Will GE technology be used in the EU? GE technology has the propensity to revolutionise agriculture, environment and medicine for the benefit of people worldwide. It is of paramount importance that this technology is regulated in a proportionate manner at EU level and harmonised with other countries. We hope that the intransigence regarding GMO adoption in the EU for the past 30 years does not continue to blight the adoption of GE technologies like CRISPR into the future. This message needs to be communicated by the Irish Government at EU level. Gabhaim míle buíochas leis an gCathaoirleach.