I am aware of recent concerns and media reports concerning the issue of genetically modified food. This is a very 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.
I will explain briefly the technique of genetic modification. Genetic modification, sometimes referred to as genetic engineering, uses a series of technologies which enable the genetic properties of living micro-organisms, bacteria, fungi and viruses, organisms, plants and animals, to be altered in a way that does not occur naturally. The techniques required to alter the genetic properties of an organism in a precise and controlled manner have only been discovered in the past 25 years and are still being developed. As a result, processes involving genetic modification are often referred to as modern biotechnology. Genetic modification techniques have opened up new possibilities for growth in sectors such as agriculture and industry and made a significant contribution to modern health care. Genetically modified organisms are referred to as GMOs.
The purpose of modifying the genetic properties of any organism is to make it capable of producing new substances or performing new functions. For example, the scientific knowledge and technology exists to produce crop plants, such as sugar beet, soya and maize, with resistance to specific herbicides and pests. GMOs and 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. Because of the recent emergence of this technology, we must approach the issues which it raises in a thorough, comprehensive and balanced manner. The technology has the potential to be of great benefit to humanity. However, its potential benefits must be weighed against any potential risks. Because of the wide range of issues to be considered in relation to genetic modification several Departments have responsibility for different aspects of it, including responsibility for different EU legislative instruments.
My colleague, the Minister for Enterprise, Trade and Employment, has responsibility for developments in the biotechnology industry while the Minister for Agriculture and Food has responsibility for EU legislation on seed varieties. I understand that this legislation is in the process of being amended to take account of developments in gene technology. The Minister for the Environment and Local Government, has responsibility for Directive 90/219 on the contained use of genetically modified organisms as well as Directive 90/220 on the deliberate release into the environment of genetically modified organisms. These directives cover the environmental risk assessment and release approval of all GMOs through the research and development stage, known as field trials, as well as the placing of products containing GMOs on the market. The Environmental Protection Agency enforces this directive on behalf of the Minister.
I am cognisant of public concern regarding the labelling of genetically modified foodstuffs. The EU, supported by member states, has drafted legislation in this regard. The purpose of measures taken by the EU on the labelling of GMOs and their derivatives is to give consumers clear, honest, neutral and scientifically sound information on products derived from a genetically modified source.
In July 1997 the European Commission adopted a general policy orientation on the labelling of genetically modified products which stated that it would develop legislation based on the following: labelling of products consisting of, containing or derived from GMOs throughout the food chain; labelling of products to give consumers clear, honest and neutral information about the GMO origin of products, facilitating choice for consumers without stigmatising modern biotechnology or raising doubts about the safety of products; a science-based approach implying mandatory labelling whenever the GMO origin can be scientifically proven in order to ensure enforceability and to limit the scope for fraud, through the possibility of verification; an approach which is simple and not unduly costly for operators to comply with and minimises uncertainty; an approach that is in accordance with the EU's international obligations and does not impose mandatory segregation of production, transport and distribution lines on operators, but only proportionate labelling requirements, and a coherent and flexible framework to determine the precise labelling rules with a clear proactive role for the EU.
My Department is the competent authority in Ireland for EU legislation pertaining to the genetic modification of foodstuffs intended for human consumption. There are two EU regulations is this regard. Regulation No. 258/97 came into force in all member states on 15 May 1997 and introduced a statutory pre-market approval system for novel foods throughout the EU. This regulation applies to the placing of novel foods and novel food ingredients on the market in the European Union.
Foods and food ingredients which have not, as of 15 May 1997, been used to a significant degree within the European Union and contain, or are produced from, a genetically modified organism fall, inter alia, within its scope. In essence, the regulation provides that novel foods and novel food ingredients, if not substantially equivalent to their non-novel counterparts, must be officially approved and authorised before being placed on the European market.
The regulation defines a novel food as a food which has not been used for human consumption to a significant degree within the Union and which falls under one of the following categories: foods and food ingredients consisting of or containing GMOs; foods and food ingredients produced from, but not containing GMOs; foods and food ingredients with a new or intentionally modified primary molecular structure; foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae; foods and food ingredients consisting of, or isolated from, plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagation or breeding practices and having a history of safe food use; foods and food ingredients to which has been applied a production process not currently used, where that gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.
The regulation provides that a person intending to place a novel food on the market must submit a request to the member state in which it is to be placed on the market for the first time. That member state must ensure an assessment is carried out within three months from receipt of the request. This initial assessment is forwarded to the European Commission which circulates the report to other member states, which have a period of 60 days to make comments or lodge reasoned objections to the marketing of the novel food. No product consisting of, containing or derived from GMOs can be authorised for marketing without first having undergone an appropriate safety assessment.
Labelling should make it possible for consumers to make choices, and the novel foods regulation states that there must be specific label ling to inform the consumer of any characteristic or food property, for example, composition, nutritional value, nutritional effects and intended use of the food, which renders a novel food or novel food ingredient no longer equivalent to an existing food or food ingredient. There must also be specific labelling to advise the consumer of the presence in the novel food or food ingredient of the following: material which is not present in an existing equivalent foodstuff and which may have implications for the health of certain sections of the population; material which is not present in an existing equivalent foodstuff and which gives rise to ethical concerns; or an organism genetically modified by techniques of genetic modification.
The controls as outlined provide protection for consumers and I assure the House that I am keeping the matter under continuing review to ensure this continues to be the case. I am aware that consumers wish to be in a position where they can decide whether they want to consume products either containing GMOs or produced using genetic modification techniques. I assure the House that I will continue to urge for maximum transparency on this issue. These labelling requirements for novel foods, as prescribed by the novel foods regulation, are additional to the general food labelling provisions which are the responsibility of my colleague, the Minister for Enterprise, Trade and Employment.
To assist my Department in this area, the newly established Food Safety Authority of Ireland's scientific committee has set up a GMO and novel foods sub-committee which advises my Department on issues in the area of genetic modification. 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. This sub-committee assesses applications made under Regulation 258/97. To date, no application for the placing of a novel food on the market has been made to my Department, which is the competent authority for this regulation. However, the GMO and novel foods sub-committee has commented on a number of applications which have been made to other member states. To date, no product has received approval in Europe under this regulation.
However, a genetically modified soya bean manufactured by Monsanto and a genetically modified maize manufactured by Novartis, formerly Ciba Geigy, were authorised under Directive 90/220 prior to the coming into force of Regulation 258/97. To address consumer concerns about the labelling of these two products, the Council published Regulation 1139/98, which came into effect on 1 September 1998. This ensures that the provisions of Regulation 258/97 apply to foods and food ingredients consisting of or derived from GMOs which were placed on the market before the entry into force of Regulation 258/97. The aim of this regulation is to ensure that the same labelling rules for the information of the final consumer apply to food and food ingredients consisting of or derived from GMOs which were placed on the market before the entry into force of Regulation 258/97.
Regulation 1139/98 lays down additional labelling requirements for the Monsanto genetically modified soya bean and the Novartis genetically modified maize. Such labelling ensures that the consumer is informed of any characteristic or food property, such as composition, nutritional value, nutritional effects or the intended use of the food, which renders a food or food ingredient no longer equivalent to existing ones. In essence, if genetically modified protein or DNA is present in a foodstuff, then it is subject to the additional labelling requirements. In the context of its legislative framework the European Union is currently examining developing proposals for food additives derived from a genetically modified source and the labelling thereof, as well as the use of labelling claims referring to the absence of use of genetic engineering techniques – so-called "GMO-free" labelling.
Last August the Minister for the Environment and Local Government published a consultation paper on genetically modified organisms and the environment. The three main aims of this consultation paper were to explain the regulatory process, identify key issues of concern and establish the views of all interested parties. I understand the Minister is currently in the final stages of consultation on this paper and that this will consist of consultation over two days with interested parties and will be chaired by an independent person. Arising from this, the independent chairperson will submit a report to the Minister and, having considered this, will arrive at a national position. I await the outcome of this consultation with interest.
I appreciate that it is a subject which is debated with intensity by those in favour of or against genetically modified foods, and I know the public can become confused and fearful with claims and counter-claims being bandied about. There is an onus on us to ensure the matter is evaluated in a calm and reasonable way, that we can put the proper safeguards in place and that a satisfactory and acceptable means of labelling can be agreed so that consumers are fully informed at all times 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 am determined to ensure that public health and the rights of consumers are fully protected in this regard.