Mr. Eoin Deegan:

I thank the Chair and members of the committee for inviting my colleague and I to assist the committee in its discussion on the issue of CRISPR-Cas9 gene editing. I am principal officer of the environment policy division in the Department of the Environment, Climate and Communications. I am joined by my colleague, Ms Susan Fleming, assistant principal officer. In my role as principal officer, I lead the division with responsibility for environmental policy matters, including in relation to the deliberate release of genetically modified organisms, GMOs, into the environment, the transboundary movement of GMOs and the contained use of GMOs. The Environmental Protection Agency, EPA, is the competent authority in this area. Responsibility for regulating seed for cultivation and animal feed in relation to GMOs falls under the Department of Agriculture, Food and the Marine. The Department of Health has responsibility for policy matters concerning food safety with respect to genetically modified food.

A GMO is any organism whose genetic material has been modified using genetic engineering or transgenic technology, for example, by insertion of genetic material from another living organism or through gene editing. This modification confers certain traits that are considered advantageous, such as increased productivity for crops or resistance to disease. No genetically modified crops are commercially cultivated anywhere on the island of Ireland and the only GMOs approved for cultivation in the EU are not suitable or relevant to Irish agricultural conditions. International policy on GMOs is governed by the Cartagena Protocol on Biosafety. The protocol is an international treaty governing the movements of GMOs from one country to another. The treaty is an agreement under the UN Convention on Biological Diversity, which is the main international instrument for addressing biodiversity issues. The protocol recognises that modern biotechnology and the cultivation of GMOs presents the potential to enhance human well-being while also recognising the need to protect human health and the environment from the potentially harmful impacts of GMOs. The protocol also sets out how risk assessment and risk management procedures should be conducted, to assess and control any potential risks arising from the importation of GMOs. All EU member states and the Union itself are parties to this protocol.

To implement the provisions of the protocol, the EU has put in place a comprehensive legal framework to deal with all aspects of the cultivation, transportation, labelling and use of GMOs, including the assessment and authorisation of genetically modified crops for cultivation; the assessment and authorisation of genetically modified products for use in food and animal feed; the cultivation of authorised genetically modified crops alongside conventional and organic crops; and the transboundary movement of genetically modified crops. The main aim of this legislation is to protect the environment from potential harm arising from the cultivation of genetically modified crops or other genetically modified organisms, as well as giving the consumer a clear choice, through labelling, between genetically modified and non-genetically modified products, and the confidence that all genetically modified products can be traced back to source.

Given the multifaceted nature of GMOs, an inter-agency meeting is held yearly between relevant bodies to support inter-agency working and policy positions while a statutory EPA advisory committee on GMOs is in place, providing advice to the EPA board on GMO matters. This committee has a broad remit and may be consulted on any aspects of its functions in relation to GMOs which the EPA considers appropriate.

I return to the Department's two main policy areas. The deliberate release of a GMO means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used. Deliberate release includes the placing on the market of genetically modified products or cultivation of genetically modified crops, including, for example, field trials in the case of genetically modified plants or any experimental release into the environment and clinical trials involving human medicinal products containing or consisting of GMOs. Deliberate release is governed by Directive 2001/18/EC at EU level and regulated at national level through SI 500 of 2003 - Genetically Modified Organisms (Deliberate Release) Regulations 2003. The EPA is the competent authority.

Contained use refers to the use of GMOs or genetically modified micro-organisms in a controlled setting and for which specific containment measures are used in order to limit their contact with, and provide a high level of safety for, the general population and the environment. As well as being physical, barriers can be chemical and-or biological. In Ireland, the contained use of GMOs is predominantly carried out in laboratories in colleges, universities and hospitals and by industry, for example, by biopharmaceutical companies. Contained use is governed by Directive 2009/41/EC at EU level and regulated at national level through SI 73 of 2001 - Genetically Modified Organisms (Contained Use) Regulations 2001, as amended. The EPA is the competent authority.

On this evening’s discussions on CRISPR-Cas9, CRISPR stands for clustered regularly interspaced short palindromic repeats. It differs from traditional genetic modification methods as CRISPR is able to resequence an organism's DNA without the insertion of DNA from another organism. This technique, in the main, does not involve the transfer of genes or DNA from another variety or species but alters the existing DNA sequence of the organism. These new mutagenesis techniques are referred to as new genomic techniques, NGTs.

In July 2018, the European Court of Justice ruled that organisms obtained using NGTs are GMOs and are subject to the full rigour of GMO legislation. In the EU this is likely to slow the development of GM crops produced using these techniques and make research using CRISPR more costly to undertake.

In particular, for member states, difficulties arise with the identification and quantification of the products produced using these techniques making enforcement more difficult. Many of these new mutagenesis techniques have been developed since the introduction of the GMO legislation.

The EU will need to address this matter through inter alia revising EU GMO legislation. The 2018 ruling prevents the EU from benefiting from the technological advances and competitiveness available to societies elsewhere, for example in the USA, China, Canada and in post-Brexit UK. This ruling has been also criticised by industry and a number of breeding companies are considering relocating their advanced mutagenesis breeding programs outside the EU.

Subsequent to the European Court of Justice ruling, a number of member states expressed a desire to amend EU legislation to facilitate the registration of NGTs for possible cultivation and use in the EU. As a result, the EU commissioned a study on the regulation of NGTs, which was published on 29 April 2021. There were a number of expert contributors to the study and some of the main conclusions included the following.

Many NGT products have been developed over the past 20 years with some already on the market in third countries and many more expected in the coming years. Regulation at trade level is problematic as detection and differentiation of NGT products that do not contain foreign genetic material is extremely difficult. A different regulatory regime for NGTs in the EU versus third countries will lead to disruption in trade between member states and their trading partners, potentially leading to trade disputes. The current regulatory regime in the EU, where NGTs are regulated in the same way as GMOs, restricts research and development and has a particularly negative impact on research and development work emanating from research institutions and SMEs.

The study concludes that NGTs can contribute to the objectives of the European Union Green Deal and the farm-to-fork strategy by developing plants more resistant to diseases, improved tolerances to environmental stress due to climate change, improved agronomic and nutritional traits, reduced toxins and allergens and reduced use of inputs such as fertiliser and plant protection products. In the pharmaceutical sector, NGTs would afford faster development of medicinal products, including vaccines, which could address unmet medical needs.

Negative aspects are identified, such as concerns regarding potential safety, potential negative impact on biodiversity, concerns regarding cross-contamination when cultivated beside conventional and organic crops, as well as regulation of labelling and consumers' right to information and freedom of choice. Stakeholders have different and often opposing views on these aspects.

The European Food Safety Authority concluded that plant products derived by conventional breeding techniques, which are not currently classed as GMOs and which target mutagenesis and cisgenesis, can have similar risk profiles. Thus, a different regulatory oversight for products with similar levels of risk would not be justified. The current risk-assessment procedures are rigid and not open to adaptation to evolving scientific progress, as will inevitably occur with further development of NGTs. The study indicates that the risk-assessment procedure employed for traditional GMOs is not fit for purpose for NGTs and their products and it needs adaptation to scientific and technological progress. Any new legislation needs to be resilient, future proof and uniformly applied, as well as contribute to sustainability objectives.

Following the publication of the study in April last year, the European Commission proposes to develop a policy action on NGTs which will facilitate a proportionate regulatory oversight, while at the same time maintaining a high level of protection of human and animal health and the environment and, allow the Community to reap the benefits from innovation.

Inception impact assessments aim to inform citizens and stakeholders about the Commission's plans in order to allow it to provide feedback on an intended initiative and to participate effectively in future consultation activities. In this regard, the Commission published an inception impact assessment on a proposal on the introduction of legislation for plants produced by certain new genomic techniques in September 2021 and received more than 70,000 responses.

The Commission is currently carrying out an impact assessment, including a public consultation, to examine potential policy options and a wide-ranging communication effort to share the results of the study and to discuss its outcome and next steps with the EU institutions and stakeholders. The impact assessment will also ensure policy consistency with other initiatives, for example food sustainability. It is expected that the legislative proposal will be available for public consultation in the second quarter of 2022 with a final adoption in 2023 and aims to tackle the issues I have highlighted.

GMO crops are not commercially cultivated anywhere on the island of Ireland. In addition, there was a Government decision in 2018 to transpose Directive 2015/412, which has been completed and enables Ireland to prohibit or restrict the cultivation of GMOs, and to change Ireland's voting stance from abstention to voting against the cultivation of GMOs. This currently sets the direction of GMO cultivation policy in Ireland. However, it is important that the GMO area be kept under review as it is ever evolving and has potentially wide-reaching socioeconomic and environmental implications. The legislative proposal which is due from the European committee in the second quarter of this year will be carefully examined by the Department of Environment, Climate and Communications and the Environmental Protection Agency, as well as other relevant Departments, Government agencies and stakeholders once published.