Dr. Thomas McLoughlin:

Ar an chéad dul síos, ba maith liom buíochas a tabhairt duith a Chathaoirleach for inviting the Environmental Protection Agency to discuss COM (2015) 177 pertaining to GM food and feed. At the end of this opening statement, I would be happy to answer any questions that members might have and if I am unable to provide answers today, I will arrange for the relevant information to be forwarded to the committee.

The EPA is the competent authority in Ireland for the implementation of the genetically modified organisms, GMO, regulations on the contained use in laboratories and the deliberate release of GMOs into the environment. This could be for a field trial or a clinical trial in hospital. The agency was nominated as the competent authority to administer the regulations in Ireland and the commencement date for implementation was 1 January 1995. The Minister for the Environment, Heritage and Local Government is responsible for national policy for GMOs and the environment. I think one of the previous papers said that it is the EPA which gives consent for both contained use and field trials. Other regulatory agencies involved in the regulation of GMOs in Ireland include the Food Safety Authority of Ireland; the Department of Agriculture, Food and the Marine; and the Health Products Regulatory Authority, HPRA, which is the body for GM medicines and medicines derived from GMOs.

What are GMOs? GMOs are defined as bacteria, viruses, fungi, plant and animal cells, plants and animals that are capable of replication or of transferring genetic material in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination. In the last 39 years, the development and use of GMO or genetic engineering, GE, technology has brought many useful applications in health care in the form of new pharmaceuticals, vaccines and new methods of diagnosing disease. An example is insulin which has saved millions of lives over the past 30 years. Insulin is important for people who suffer from diabetes and 100% of it is now made using GM technology. This technology is also making a major impact in the investigation of crime, waste treatment, environmental clean up and other areas.

The EPA's remit is to implement the GMO regulations in Ireland pertaining to the contained use and deliberate release into the environment. What does the licensing of GMO users in Ireland mean? In practice, what this means is that anyone who wants to use a GMO in a laboratory or in a field or clinical trial, which involves deliberate release into the environment, must first obtain a licence from the EPA. By 1 June 2015, there were 579 entries on the register of GMO users in Ireland, more than 95% of which are contained users. A total of 98% of this use relates to genetically modified micro-organisms, GMMs, that are used in laboratories and are categorised as low- risk categories - class 1-2 GMM - and GM animals which are used for medical research. Quite a number of researchers in Ireland use GM mice. Class 1 encompasses researchers looking at bacteria that produce antibiotics.

The class 2 category includes the use of genetically modified viruses for the production of vaccines.

Currently, there is one GM field trial that has been ongoing since 2012. This relates to a GM potato which is tolerant to the late potato blight fungus. This has been planted for the past four years and next year will be the last year of planting. This work is being conducted at Oak Park by Teagasc and is part of a larger European-funded project called AMIGA to assess the impacts of GM crops on the agro-ecosystems. Dr. Ewen Mullins from Teagasc was a speaker at our 2013 conference, details of which I will outline presently. He has updated the relevant slide. Committee members can see the slide on the right, which shows the position after two years of planting. On the left side members can see the devastation caused by the late potato blight fungus. To combat this disease Irish farmers would have to use approximately 15 to 20 sprays of fungicide per year. The slide on the right shows the GM plant. It has a single gene from a wild potato. I imagine committee members can see the potential of this technology. Every picture tells a story, mar a deirtear.

The EPA has no remit for GM food and feed in Ireland and, therefore, the agency has no comment to make on this proposal. However, I wish to inform the committee of some of the outcomes of a conference held by the EPA in 2013. The outcomes are still pertinent to this day. The aim of the conference was to emphasise the relevance and importance of GM technology to Irish research, industry and the economy. An EPA report, "Synopsis of issues arising from the conference - Regulation and Use of Genetically Modified Organisms (GMOs) in technology in Ireland" was sent electronically to all Members in January this year for information purposes. No doubt all committee members have read the document. I re-sent it to the committee last week in electronic form.

What were the main outcomes? We had several international speakers from the European Food Safety Authority and the Advisory Committee on Releases to the Environment in the United Kingdom. From the United States we had an NGO speaker and we had a speaker from the IFA as well and so on. I will summarise the main points. It was evident that Irish farmers rely on the importation of animal feed derived from GM soya and corn. In 2012 more than 50% of imported grain was derived from GM soya and GM maize. In fact, the EU is only 35% sufficient in animal protein and the remainder must be imported. This means approximately 1,800 million ha must be planted outside the European Union to provide vegetable protein, an incredible area of land. Irish farmers were concerned that they might become less competitive because they had to pay a higher price for imported commodity crops. This is still pertinent for the current proposal before the committee.

Another outcome of the conference was the evidence that the use of GM technology is helping to drive Ireland's exports. GM technology has the propensity to create more jobs in the bio-pharma sector. For the first time Irish researchers now have the capability to carry out clinical trials on patients in hospitals using GM vaccines and other medicinal products. Basically, this derives from Government policies in recent years. The money has been spent on research and much of this has now been transferred to hospitals to determine whether those vaccines or drugs have any efficacy.

Nine of the top ten global pharmaceutical companies are located in Ireland and this has created over 24,000 jobs. Fully 50% of our exports derive from the life sciences, including the bio-pharma sector. The sector is very important. Many companies are moving away from chemical synthesis of drugs in favour of biologics. This is more efficacious and environmentally friendly because the companies are not using chemicals.

A further outcome was the general agreement that the EU regulatory system pertaining to GM crops is cumbersome, expensive, not proportionate to the risks and not functioning properly for the workings of the Internal Market. Already there is evidence that this dysfunctional regulatory system is responsible for bio-tech job losses in the European Union. Two multinational companies have already given up on the EU regulatory regime for cultivation purposes. In 2012, the German giant, BASF, announced that it had halted the development of commercialisation of GM crops in Europe and moved its bio-tech research and development operations lock, stock and barrel, including growth chambers, greenhouses and laboratories, to the United States.

The firm cited consumer and political resistance to transgenic plants or GM crops in Europe for its decision. Two weeks ago I heard from my German colleagues that Bayer and KWS have moved from Germany over the past year and a half. KWS is a more traditional plant breeding company and it moved half of its research and development facilities to the United States. The German authorities did say they were very concerned about the potential for job losses.

I will outline another conclusion. There was a discussion on why Ireland should support a product and phenotype-based regulatory system, rather than the current process-based regulatory system. It was felt the former might better serve EU farmers and SMEs. Such an initiative would make sense, bearing in mind that there are herbicide tolerant crops in the EU at present that are unregulated even though they have the same potential concerns as their GM counterparts. These conventional herbicide tolerant crops are now available to Irish farmers. They are also called clearfield crops. Basically, it means one can select herbicide tolerance using traditional plant breeding. However, they have the same potential concerns with the fallout from the GMO regulations. Canada uses a product-based regulatory which regulates everything, if one knows what I mean.

The word "proportionality" is key when it comes to the implementation of the GMO deliberate release directive 2001/18/EC. It was the opinion of some of the speakers at the conference that the EU is overly concerned about the potential risks from using GM crops and is not sufficiently concerned about the environmental harm that invasive species do to ecosystems. The two species of Gunnera or wild rhubarb and Japanese knotweed are a huge problem. I have no doubt that they have caused environmental harm. They have adversely affected biodiversity by affecting whole ecosystems and habitats, especially in some parts of the west of Ireland. If one drives from Achill Island, which is my own part of the woods, up to Bangor Erris and south to Clifden, one will see that wild rhubarb has completely taken over ecosystems. Japanese knotweed has done the same in Kerry, Wexford and other counties and is very dangerous. Unfortunately, it appears that no one is doing anything to eradicate these invasive species. Twenty years ago people were concerned that GM crops would be released into the ecosystem. Ireland has a problem with invasive species and we seem to have taken our eye off the ball.

Another matter of paramount importance is how the new techniques for plant-breeding and the genetic modification of microbes will be regulated at EU level. The relevant EU directives are 25 years old but GM technology has come on in leaps and bounds. At present scientists can turn a gene on or off in a plant or microbe without the insertion of new DNA or protein in the plant. The big question in Europe is how can we regulate such products. If we regulate them as GMOs then other jurisdictions, such as the United States, will probably deregulate. Such a scenario would leave SMEs in the European Union with huge concerns, as I alluded to previously.

It is likely that some of the new techniques currently under scrutiny will not be regulated as GMOs in other jurisdictions. The product or phenotype-based regulatory system might overcome the problem of how to regulate the new techniques. Changing to a product-based system would bring the EU regulatory system in line with our main trading partners and would not distort trade.

In conclusion, I hope I have given the committee an overview of GMO regulation in Ireland. I am happy to answer any questions from committee members. Míle buíochas daoibh go léir.