What is the EPA’s attitude to Genetically Modified Organisms (GMOs)?
We examine each activity on a case-by-case basis to ensure that no harm will be caused to human health or the environment. We are also consulted in respect of all significant GMO activities in other European countries.
It is a matter for the Government to decide on national policy in respect of GMOs, for example whether they should be allowed in Ireland. The EPA has made recommendations about changes that were needed to the GMO regulations.
What is modern biotechnology?
In recent years, it has become possible to introduce changes to the DNA of living organisms in a precise and controlled manner in the laboratory, using recombinant DNA (rDNA) technology. This is often referred to as modern biotechnology, genetic modification, or genetic engineering.
In brief, the DNA encoding a specific property is isolated from one organism, purified, and introduced to the same, or a second, organism.
If the proper signals have been provided, the newly introduced DNA will be translated and the new property is conferred on the host. This new organism is referred to as a Genetically Modified Organism (GMO).
What are Genetically Modified Organisms (GMOs)?
These are defined as bacteria, viruses, fungi, plant and animal cells, plants and animals, 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 past 30 years, the development and use of genetic engineering techniques has brought many useful applications in agriculture, food processing, pharmaceuticals, environmental clean-up, forensic science and other areas.
What is the EU's role in regulating GMOs?
What is the EPA's role in regulating Genetically Modified Organisms (GMOs) in Ireland?
We are responsible for implementing the GMO regulations in Ireland on the contained use and deliberate release into the environment of GMOs and GMMs - genetically modified organisms and micro-organisms.
We regulate two areas of GMO activities:
(a) Contained uses - for example, in laboratories and in industry
(b) Deliberate release into the environment for
The regulations stipulate that GMM contained use activities must be classified into Class 1, Class 2, Class 3, or Class 4, as appropriate.
This classification is directly related to the containment level required to control the risk as identified on completion of the Risk Assessment.
All existing GMO contained users must be reclassified in accordance with the requirements of the 2001 regulations.
The EPA is required to provide and update a register of GMO users, consider notifications for first-time use of premises for the contained use of GMOs/GMMs and to evaluate notifications for field trials and the placing on the market of products containing GMOs for seed and animal feed use (until 18 April 2004).
Who is responsible for GMO policy in Ireland?
The Government has overall responsibility for policy matters in this area.
The Minister for the Environment, Heritage and Local Government has overall responsibility for policy matters in relation to Directives on the contained use of GMOs, and the deliberate release of GMOs into the environment.
The Department of the Environment, Heritage and Local Government is also responsible for certain functions under Directive 2001/18/EC, e.g., decisions to place GMOs on the market under Article 18 of this Directive.
The Department of Health and Children has responsibility for food safety aspects of GMOs and products derived from them.
The Department of Agriculture and Food is responsible for:
The Department of Enterprise, Trade & Employment is responsible for the protection of workers related to biological agents at work and for the transportation of certain GMOs. Under the auspices of BioResearch Ireland, it is also responsible for promoting and enhancing national biotechnology infrastructure.
What are the principles of environmental risk assessment?
The safety of GMOs depends on the characteristics of:
Environmental risk assessment (under Directive 2001/18/EC) aims to identify and evaluate potential adverse effects of GMOs, either direct or indirect, immediate or delayed, including possible cumulative and long-term effects on human health and the environment.
The assessment looks at how the GM product was developed, and examines potential risks associated with the gene products (for example toxic or allergenic proteins), and the possibility of gene transfer (for example transfer of antibiotic resistance genes).
The assessment procedure is as follows:
What are the new food and feed traceability and labelling requirements?
The following regulations came into force in EU member states in April 2004:
These regulations will provide a harmonised EU system to trace GMOs, introduce the labelling of GM feed, reinforce current labelling rules on GM food and establish a streamlined authorisation procedure for GMOs in food and feed and their deliberate release into the environment.
A strict safety assessment of GMOs will continue to assure a high level of health and environmental protection. The labelling of all GM food and feed products will allow consumers and farmers to decide whether or not to buy food or feed produced from a GMO.
In Ireland, the Food Safety Authority and Department of Agriculture and Food are the competent authorities for the food and feed legislation respectively.
Why do we need traceability of GMOs?
Traceability is about providing the means to trace products containing or produced from GMOs through the production and distribution chains. The objectives are to facilitate:
Differences between national laws, regulations and administrative provisions about traceability of GMOs - and of food and feed products produced from GMOs - may hinder the free movement of products and create conditions of unfair competition.
Therefore, the EU has developed a harmonised framework for traceability of these types of products to provide legal certainty and a coherent approach, and contribute to the effective functioning of the internal market.
What is the scope of the traceability legislation?
The new regulation sets specific traceability requirements for GM products. Traceability specifically for GMOs was introduced in general terms into EU legislation with Directive 2001/18/EC.
This requires Member States to ensure traceability at all stages of the placing on the market for GMOs. General traceability provisions have already been laid down in EU rules concerning food, feed and seed.
What are the new rules on traceability of GMOs?
Under Regulation 1830/2003 on traceability, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of placing them on the market.
In particular, they must have the following:
Transmission and keeping records of this information will reduce the need for sampling and testing of products.
How does traceability work in practice?
Traceability can be defined as the ability to trace products through the production and distribution line.
For example, where production starts with a genetically modified (GM) seed, the company selling the seed mustinform any purchaser that it is genetically modified, together with more specific information allowing the GMO to be precisely identified. The company must also keep a register of business operators who have bought the seed.
Equally a farmer must inform any purchaser of the harvest that it is GM and keep a register of operators to whom he/she has made the harvest available.
The new regulation covers all GMOs that have received EU authorisation for the placing on the market, that is all products, including food and feed, containing or consisting of GMOs.
Examples are GM seeds and bulk quantities or shipments of whole GM grain such as soybean and maize.
The new regulation also covers food and feed that are derived from a GMO. This includes tomato paste and ketchup produced from a GM tomato, or starch, oil or flour produced from a GM maize. However food and feed produced "with" a GMO is not covered.
What are the new labelling requirements?
These extend current labelling provisions to all genetically modified (GM) food or feed, irrespective of the detectability of GM DNA or protein.
All food and feed which consist of, contain or are produced from GMOs must be labelled as such. The purpose is to inform consumers and farmers about the exact nature and characteristics of the food or feed, so that they can make informed choices.
The labelling threshold for EU authorised GMOs for food and feed is 0.9%. A food or feed does not need to be labelled if it is below 0.9% and if it can be shown to be adventitious and technically unavoidable.
A tolerance level of 0.5% has been introduced, for a maximum of three years, for GMOs not yet authorised but with a positive risk assessment in the EU. Above 0.5%, products cannot be put on the market.
GM feed needs to be labelled along the same principles to give livestock farmers accurate information.
This means a large number of feedstuffs currently not subject to GM labelling requirements, such as GM soy meal in feed or compound feedstuffs and GM feed authorised under Directive 90/220/EEC will in future need to be labelled.
What are the new requirements on transboundary movement of GMOs?
The EU's Regulation 1946/2003 on transboundary movement of living modified organisms (LMOs or better known as GMOs) came into effect in 2003. It completes the EU regulatory framework for implementing the provisions of the Cartagena Protocol on Biosafety.
The Protocol is an international agreement on the cross-border movement and use of GMOs that may have potential risk to human health, the environment and biodiversity.
The Protocol provides a safety net for the protection of biodiversity in developing countries that do not have systems and resources in place to control trade in GMOs. It excludes GMOs used in pharmaceuticals that are covered by other international agreements.
Ireland became a party to the Protocol in 2004. Relevant provisions of the EU Regulatory framework on GMOs were transposed into Irish law as S.I. No. 54 of 2004 - Genetically Modified Organisms (Transboundary Movement) Regulations 2004.
The Environmental Protection Agency has been designated as the focal point for the purposes of the regulation and as the Competent Authority for both contained use and deliberate release of GMOs into the environment.
The Food Safety Authority and Department of Agriculture and Food are the competent authorities for food and processing and for feed and processing respectively.
What is the Register of GMO users in Ireland?
The Environmental Protection Agency maintains a Register of GMO users in Ireland.
Members of the public can inspect the Register, free of charge, during office hours at our headquarters in Wexford. At the end of March 2007, there were 233 registered GMO users in Ireland; 95% are contained users, the remainder are deliberate release users.
The vast majority of the contained use activities are carried out in third-level institutions and the remainder are by industrial users.
What is a deliberate release?
This is also known as a Part B release - a release of GMOs (plants, microbes or animals) into the environment for R&D purposes such as field trials/clinical trials. For example:
Between October 1991 and May 2006 there have been 2,121 notifications within the EU to carry out field trials with GM crops on greater than 70 plant species under Part B of Directive 90/220/EEC and Directive 2001/18/EC.
Greater than 90 trials have been carried out in the EU on GMOs other than plants (for example bacteria).
Part B releases are now regulated under Directive 2001/18/EC. This came into force in EU Member States in 2002. Implementing regulations were enacted in Ireland on 1 November 2003, giving rise to the GMO (Deliberate Release) Regulations 2003, S.I. No. 500 of 2003.
What is the role of the Advisory Committee on Genetically Modified Organisms?
The first Advisory Committee on GMOs was set up in 1995, under the GMO Regulations S.I. No 345 of 1994, to advise the Environmental Protection Agency on relevant GMO issues.
Each committee is appointed for a three-year term and meets quarterly. It consists of 14 members nominated by Government and non-Government organisations (NGOs). Nominating bodies include:
Who else advises the EPA in relation to GMOs?
The GMO and Novel Foods Working Group was set up by the Food Safety Advisory Board's Microbiology Committee in 1996 in response to a request from the Environmental Protection Agency for advice on safety issues concerning 'live' GMOs under the GMO Regulations.
This working group is now known as the GMO and Novel Foods Sub-Committee under the Food Safety Authority of Ireland Scientific Committee.
The Sub-Committee consists of 15 members nominated by Government Departments, State bodies, industry and academia. It has experts in areas including:
The EPA also consults Government Departments, State bodies and academic institutions for advice on GMO notifications and dossiers.
Who regulates GM foods and food ingredients derived from GMOs in Ireland?
Since April 2004, legislation on the authorisation and labelling of GM feed, "live" GMOs and feed derived from GMOs is covered by GM Food and Feed Regulation EC 1829/2003.
The Department of Agriculture and Food is responsible for implementing it.
Who regulates pesticides for use in the cultivation of GM crops in Ireland?
The Pesticide Control Service of the Department of Agriculture and Food is responsible for implementing Directive 91/414/EEC. This is the regulation on the use of plant protection products (for example, herbicides, insecticides & fungicides etc.) on crops including GM crops.
Visit the Pesticide Control Service website
What are the current rules on GM seeds in Ireland?
The Department of Agriculture and Food is responsible for implementing Directive 98/95/EC. This regulates the marketing of GM plant varieties and amends current Directives relating to seed.
EU Member State competent authorities must agree on the use of a seed in their territory and must notify their acceptance to the European Commission. It in turn examines the information they supply.
If the seeds comply with Community seeds legislation, the Commission includes the variety in the "Common Catalogue of varieties of Agricultural Plant Species", and the seed can be marketed throughout the EU.
GMO seed varieties also have to be authorised in accordance with Directive 2001/18/EC before they can be included in the Common Catalogue and marketed in the EU. If the seed is for use in food, it must also comply with the Novel Foods Regulation.
Legislation on the marketing of forestry reproductive material also requires prior authorisation of GM material in line with the requirements of Directive 2001/18/EC.
Further rules are proposed on growing conditions and other requirements for purity concerning the presence of GM seeds in seed lots of traditional varieties, as well as detailed labelling rules.
Who is responsible for inspection control and traceability of GMOs used in Ireland for cultivation, animal feed or human food?
Irish rules on the labelling, use and marketing of GMOs, and products derived from GMOs, are in line with the relevant EU Directives and regulations. This ensures that, based on the best available scientific knowledge, GM food, animal feed and seeds are as safe as their non-GM counterparts.
The Commission and EU Member States will soon adopt a technical guidance for sampling and detection of GMOs and material produced from GMOs as or in products in the context of Regulation 1830/2003 on traceability and labelling.
Under this regulation Member States must ensure that inspections and other control measures including sample checks and testing, as appropriate, are carried out to ensure compliance.
The Irish agencies with regulatory responsibilities in relation to GMOs have set up a working group on the issue. Of these agencies:
What is the role of the European Food Safety Authority?
The EFSA was established in January 2002. It provides independent scientific advice on all matters with a direct or indirect impact on food safety including applications sent by applicants under Regulation 1829/2003 on food and feed.
The EFSA has established a scientific panel to advise on GMO matters. Dr Patrick Wall, Adjunct Professor on Food Safety, University College Dublin, is the Irish representative on the 14-member board.
Find out more on the EFSA website
Are GMOs safe?
A fundamental objective of the GMO regulations is to ensure that all measures are taken to protect human health and the environment. The overriding concern of the Environmental Protection Agency in looking at notifications related to GMOs is to ensure that their use does not have an adverse effect on human health or the environment.
The Environmental Protection Agency regulates the environmental and animal feed aspects of 'live' GMOs under the GMO Regulations. Human food consumption aspects are controlled by Food Safety Authority.
Since April 2004, animal feed aspects pertaining to feed containing GMOs and feed derived from GMOs fall outside the remit of Directive 2001/18/EC and are regulated under Regulation 1829/2003 by the Department of Agriculture and Food.
