Tim O'Malley (Limerick East, Progressive Democrats)

As Minister of State with responsibility for food safety, my primary concern is public health and the safety of food consumed by the public. I, therefore, welcome this debate on genetically modified foods and I intend to clarify the position taken by the Government in respect of GM foods.

Since taking office, the Government has attached great importance to the issue of food safety in general and to the concerns of consumers in particular. It recognises the need for uncompromised and independently verifiable assurances on food safety to ensure consumer confidence. This is particularly the case in the approach taken to GM foods.

I wish to preface my comments by setting out that the independent scientific advice made available to my Department provides no evidence that the GM foods authorised within the EU pose a risk to human health. It must be stressed that no product consisting of, containing or derived from GMOs can be authorised for marketing without first having undergone appropriate safety assessment. Under new EU legislation, this safety assessment is carried out by the European Food Safety Authority. In addition, measures to allow post-release monitoring of GM foods are provided for in the legislation. Consequently, I am satisfied that appropriate arrangements are in place to ensure the safety of authorised GM foods or foods containing GM ingredients placed on the market in Ireland.

Government policy on biotechnology is positive but precautionary in accordance with the recommendations of the report of the interdepartmental group on modern biotechnology which was published in October 2000. One of the inputs to this report was the public consultation process carried out by the then Department of the Environment and Local Government in 1999 in respect of GMOs and the environment. Consumer safety and consumer choice are paramount in the approach taken to GM foods, as reflected in the extent of the legislation developed to deal with this sensitive area. Government policy on GM foods is based on the advice that no credible evidence has yet been provided to show that GM foods pose a risk to human health.

Genetically modified organisms can be defined as organisms in which the genetic material, DNA, has been altered in a way that does not occur naturally. The technology is often called modem biotechnology or gene technology. It is sometimes also known as recombinant DNA technology or genetic engineering. It allows selected individual genes to be transferred from one organism into another and also between non-related species. Genetic modification techniques have opened up new possibilities for growth in sectors such as agriculture and industry and have made a significant contribution to modern health care. Genetic modification techniques are widely used in the pharmaceutical and chemical industries, including the production of valuable medicines such as human insulin for use by diabetics. Genetic modification is also central to the development of new gene therapy treatments to combat serious disease and disability. The benefits from these developments, particularly in the medical area, are well documented and widely accepted as a significant benefit for those requiring such treatment.

I am aware of public concerns and media reports regarding the issue of genetically modified food. This is a complex issue involving, inter alia, technical, scientific, ethical and economic aspects. Within the scientific aspect there are ecological, environmental, nutritional, human health and veterinary concerns. Due to the recent emergence of this technology, we must approach the issues it raises in a thorough, comprehensive and balanced manner. The technology has the potential to be of great benefit. However, the Government is aware of its responsibility to be alert not only to potential benefits but also to any potential risks.

Given the wide range of issues to be considered in respect of genetic modification, several Departments have responsibility for different aspects thereof, including responsibility for different EU legislative instruments. The Department of Health and Children has responsibility for food safety and consumer protection. The Department of Enterprise, Trade and Employment has responsibility for developments in the biotechnology industry. The Department of Agriculture and Food has responsibility for EU legislation on genetically modified animal feed and seed. The Department of the Environment, Heritage and Local Government is responsible for legislation relating to the deliberate release into the environment of GMOs. The EPA is the national competent authority in this area.

As the motion specifically addresses genetically modified foods, I will restrict my comments to that area. For generations, plant and livestock breeders have been breeding crops and animals to improve yields for disease resistance and for composition. The crops and livestock we consume today bear little resemblance to those our forefathers consumed in that plants and animals have been selectively bred to produce certain desirable traits. For example, we now have high-yield cereals, fruit and vegetables, faster maturing poultry, hens that lay more eggs, cows that give more milk, pigs with leaner meat and a range of cattle varieties selectively bred for beef production.

Scientists are now capable of identifying the genes responsible for some of these desired traits and are able to manipulate them. This technique is known as genetic engineering or genetic modification and a number of foods have been produced using this method. A wide variety of such foods are already on the market in the USA but in Europe there are only a small number of genetically engineered food ingredients on the shelves, mostly those derived from maize and soya. Consumers have, however, expressed concerns about GM food products. These concerns cover a wide range of issues and are best addressed by providing a strict regulatory framework to provide controls which ensure that consumer protection is paramount.

Ireland, in common with other member states and as required by European Union rules, applies EU legislation on GM foods. Such legislation comes in the form of EU regulations which are directly applicable to and binding on each member state. My Department is currently working on introducing measures into national legislation which will allow for enforcement measures, including penalties in the case of non-compliance.

Under EU rules, only products from 17 authorised GM foods or foods containing ingredients thereof can be imported and placed on the market. These include soya, maize and oil derived from oilseed rape, cottonseeds, maize and soya. These are produced from GM crops which have been engineered to be resistant to certain herbicides and-or resist attack by certain pests. GM foods have been consumed in some countries for approximately a decade and no credible evidence is available to suggest that any GM food has ever caused harm to human health. Should any problems arise out of the consumption of GM foods, EU legislation provides for the immediate removal from the market of the suspected product pending a full investigation. The Food Safety Authority of Ireland is the competent authority for the enforcement of EU legislation regarding genetic modification of foodstuffs. The FSAI is an independent science-based consumer protection body that utilises the expertise of the best scientific advice available in the country. It is involved on the international scene with CODEX Alimentarius and OECD task forces in developing guidelines for risk analysis and food safety assessments of food derived from biotechnology. The FSAI does not give blanket approval to genetically modified, GM foods, but individually evaluates, on its own merits, each application to place a new GM food on the EU market. The FSAI is satisfied that, based on the best scientific evidence available, all of the GM foods and ingredients currently on the EU market are as safe as those derived from their non-GM counterparts. The FSAI carries out checks on the marketplace for compliance with GM legislation.

Trace levels of GM ingredients can and do occur in non-GM food due to mixing during cultivation, harvest, transport and processing and this phenomenon is not particular to GM foods. Against this background, the EU objective is to ensure legal certainty and establish certain thresholds above which conventional foods have to be labelled as consisting of, or containing, or being produced from a genetically modified organism. With regard to future implications for the domestic food chain and the food industry in general, it must be noted that any further authorisations of GM foods will only occur following full independent safety assessment by the European Food Safety Authority and will also be subject to the latest European regulations with regard to traceability and labelling.

The EU has, following the recent adoption of new legislation, one of the most rigorous regimes for the assessment of GMOs as well as food and feed derived from GMOs. In this regard, only GM foods which satisfy the highest standards of safety are allowed on the market. This is combined with comprehensive safeguard measures on traceability and labelling. EU legislation on GMOs has been in place since the late 1980s and has within the last year been considerably reinforced to increase consumer protection and consumer choice. These updated regulations were introduced as it was acknowledged that previous Community legislation on GMOs was fragmented and that this was making it difficult to adopt cohesive provisions and to apply unequivocal Community rules. This situation, in conjunction with concerns about the ability to monitor the rapid developments in biotechnology and the production of GMOs and their products, led to reservations and to a de facto moratorium. During the so-called moratorium, no new GM applications, be they food, feed or the deliberate release of crops, were approved within the EU.

The new EU regulations establish a harmonised Community system to trace GMOs, introduce the labelling of GM feed, reinforce the current labelling rules on GM food and establish a streamlined authorisation procedure for GMOs in food and feed. New regulations on deliberate release into the environment were introduced in 2001. These regulations address the legitimate concerns of citizens, consumer organisations and economic operators. A strict safety assessment of GMOs will continue to ensure the highest level of health and environmental protection, while the labelling of all GM food and feed products will allow consumers and farmers to decide if they want to buy food or feed produced from a GMO.

For consumers, clear labelling is a key issue. Since 18 April 2004, obligations are placed on suppliers to forward the information to purchasers that a food is, consists of or is produced from a genetically modified organism and must give the unique identifiers for the GMOs. Also, the label must state, "This product contains genetically modified organisms" or "produced from genetically modified (name of organism)". For example, a biscuit containing soya flour derived from GM soya must be labelled "contains soya flour from genetically modified soya " and vegetable oils containing rapeseed oil produced from genetically modified rape must be labelled "contains rapeseed oil from genetically modified oilseed rape". Consequently, the labelling provided on a product will make it possible for consumers to make informed choices. The purpose of the specific labelling measures introduced by these regulations for GMOs and their derivatives is to give consumers clear, honest, neutral and scientifically sound information on products derived from a genetically modified source.

No food or drink can ever be guaranteed as 100% risk free. With this in mind, while the technology of genetic modification-engineering used in food production may not be inherently dangerous to human health, what is intended and achieved with the technology will always require close scrutiny. For example, the FSAI is keeping a watching brief on research and development of crops that are being engineered to produce non-nutritional products such as vaccines, pharmaceuticals and other products not necessary for human nutrition. While this bio-pharming may present many benefits for the industry and consumers in the future, the potential for the contamination of the general food supply by these "pharma crops" is a cause for some concern as large scale food crops like maize and rice are being targeted. Additionally, genetic engineering of certain food animals and fish is being progressed at research level in a number of countries and will bring a potentially new dimension to the food supply. The FSAI is watching developments closely.

The controls within the legislation provide protection to consumers and I wish to assure the House that I am keeping the matter under review to ensure this continues to be the case. To assist my Department in this area, the FSAI's scientific committee has set up a GMO sub-committee which advises my Department on GM issues. This sub-committee also affords a forum for the exchange of expert scientific opinion and advice on this new technology and its application to food. In addition, this sub-committee assesses each application for approval of a new GM food and provides my Department, on a case by case basis, with its opinion in terms of the human health aspects, particularly toxicity and allergenicity.

Following the adoption and introduction of the new EU rules on authorisation, labelling and traceability of GM food and feed, the European Commission recently approved the placing on the market of GM sweetcorn known as Bt-11. This decision has caused concerns in terms of the approval itself and the procedures under which the decision was taken. Therefore I would like to give Members some background on this decision.

On 11 February 1999, a request was submitted under Article 4 of the Novel Food Regulation (EC) No. 258/97 to the competent authorities of The Netherlands for placing sweet maize-corn from GM maize line Bt-11, referred to as Bt-11 sweetcorn, on the market as a novel food or as a novel food ingredient. A novel food is defined as any food or food ingredient that does not have a significant history of consumption within the European Community prior to May 1997.

During the assessment process by member states, objections to the marketing of the product within the EU were raised. Consequently, a Community decision requiring the support of a qualified majority was necessary to approve the application. The EU Scientific Committee on Food delivered an opinion in April 2002 stating that the Bt-11 sweetcorn was as safe for human food use as its conventional counterparts.

In order to grant Community authorisation, a draft Commission decision was submitted for vote to the Standing Committee on the Food Chain and Animal Health on 8 December 2003. This is a regulatory committee comprised of representatives of each of the member states which assists the European Commission in the development of food safety measures at all stages of the food chain in a process known as comitology. As the necessary qualified majority was not achieved, under comitology rules it was then necessary for the Commission to put forward a proposal to Council for a vote on the application. The Commission put forward the necessary proposal at the end of January 2004. If Council were to fail to come to a decision or fail to act on the proposal before 30 April 2004, that is, within three months of having received it, the proposal would then revert back to the Commission for a decision. The proposal was put on the agenda of the Agriculture Council on 26 April to allow the Council to meet its obligation to act before 30 April 2004. The Agriculture Council did not achieve a qualified majority either for or against the proposal, with most member states maintaining the positions adopted at the Standing Committee on the Food Chain and Animal Health.

Authority for the adoption of the proposal reverted to the Commission. On 19 May, the Commission duly authorised the placing on the market of sweetcorn from GM maize line Bt-11. This decision is valid for ten years. The granting of an approval in this case has ended an almost six year de facto moratorium. Irish representation at the aforementioned Standing Committee on the Food Chain and Animal Health was by the Department of Health and Children, while representation at the Council on 26 April was by the Department of Agriculture and Food. Ireland supported this proposal following consultation with the FSAI and based on the scientific risk assessment undertaken on this product, initially by The Netherlands' food assessment body and subsequently by the EU Scientific Committee on Food, which concluded that Bt-11 sweet maize is as safe for human food use as conventional sweet maize. There are currently applications for eight GM foods awaiting decision upon authorisation in the EU, including one soya bean, one sugar beet and six maize lines.

The FSAI has published a leaflet entitled, Food Safety and Genetically Modified Foods, which is currently being updated to take account of new legislation. In addition, the FSAI, in conjunction with Departments and industry organisations, is currently formulating a guidance note for industry which will highlight the legislation with regard to GMOs. The public has access to unbiased information on GM foods from the FSAI and can also access information from the Departments of Health and Children, Agriculture and Food and the Environment, Heritage and Local Government on any aspects of GMOs within their remits. This has resulted in requests for information from concerned individuals and groups, either directly or through their local representatives in the Dáil.

The GM food issue is debated with intensity, both by those in favour and those against genetically modified food, and the public can become confused and fearful with the claims and counter-claims being made. There is an onus on us to ensure the matter is evaluated in a calm and reasonable way. I am aware consumers wish to be in a position where they can decide whether they want to consume products containing GMOs or those produced using genetic modification techniques. I assure the House that I will continue to urge for maximum transparency on this issue.

I am satisfied proper safeguards are in place and the labelling requirements provide a satisfactory and acceptable means to allow consumers become fully informed of the content of the food they are purchasing. In this context, I reassure the House that I am keeping the matter of genetic modification of foodstuffs under continuing review and I am determined to ensure public health and the rights of consumers are fully protected in this regard. I welcome this discussion as the start of what will probably be a long debate and thank Members for their contributions to it.