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RESOURCES
DOCUMENTS:
GOVERNMENT OF IRELAND DOCUMENTS
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Important notice: All the information on this page was downloaded from Ireland's Environmental Protection Agency (EPA) web page at www.epa.ie/GMO%20Licensing/default.htm on 7 October 2003. This copy is provided here for information purposes only, without warrant of accuracy. Please refer to the original web page which may have been updated.
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GMO LICENSING
WHO REGULATES MODERN BIOTECHNOLOGY (GMOS) IN IRELAND?
Regulation of Genetically Modified Organisms
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GUIDANCE NOTE FOR USERS OF GMOs (CONTAINED USE) IN IRELAND [live links to EPA web site]
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Example of a Risk Assessment for Class 1 GMMs (30KB)
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Example of a Risk Assessment for Class 2 GMMs (30KB)
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Guidelines [live links to EPA web site]
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Q. |
What is biotechnology?
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Q. |
What is modern biotechnology?
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Q. |
What are Genetically Modified Organisms (GMOs)?
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What is the role of the EU Commission in regulating GMOs?
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Who is responsible for GMO policy in Ireland?
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What is the role of the IDG?
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Who regulates GM foods and food ingredients derived from GMOs in Ireland?
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Q. |
Who regulates pesticides for use in the cultivation of GM crops in Ireland?
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What are the current rules on genetically modified seeds in Ireland?
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What is the role of the EPA in the regulation of Genetically Modified Organisms (GMOs) in Ireland?
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What is the role of the Advisory Committee on Genetically Modified Organisms (GMOs)?
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Who else advises the EPA in relation to GMOs?
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Q. |
What is the Register of GMO users in Ireland?
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Q. |
What is a deliberate release into the environment for research & development purposes - also known as a Part B release?
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What is the placing on the market of products containing GMOs under Part C of Directive 90/220/EEC?
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What is the EPA position in relation to labelling of GMOs?
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Are GMOs safe?
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Who is responsible for inspection control and traceability of GMOs that are used in Ireland for cultivation, animal feed or human food.
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What are the main changes under 2001/18/EC - on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC?
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What other regulatory authorities are responsible for regulating GMOs in Ireland apart from the EPA?
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What is the role fo the European Food Safety Authority (EFSA)?
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Links to Other National and International Organisations.
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What is biotechnology?
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Biotechnology can be defined as the application of biological systems in industrial processes. This involves harnessing the natural biological processes of microbes, plant and animal cells for the benefit of mankind. It has been practiced in agriculture for thousands of years, examples of such genetic manipulation include:
* farmers select seed from their best plants for next yearís planting
* plants are cross bred to produce valuable new hybrids
* food processors select the best microbial strains for food fermentations
While these examples involve heritable changes in the genetic material of living organisms, none of the products derived in this manner are subject to regulatory control since they are deemed to be natural processes.
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What is modern biotechnology?
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In recent years, it has become possible to introduce changes to the DNA of living organisms in a precise manner and a controlled manner in the laboratory, using recombinant DNA (rDNA) technology (often referred to as modern biotechnology, genetic modification , or genetic engineering). In brief, 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).
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What are Genetically Modified Organisms (GMOs)?
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GMOs 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 last 28 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.
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What is the role of the EU Commission in regulating GMOs?
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The Communityís regulatory framework on modern biotechnology was designed about 13 years ago for the dual purpose of providing legislation necessary to ensure adequate protection of human health and the environment, and creating the internal market for biotechnological products - refer to table 1 below for information on the regulatory framework.
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Who is responsible for GMO policy in Ireland?
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The Government has overall responsibility for policy matters in this area. The Minister for the Environment and Local Government has overall responsibility for policy matters in relation to Directive 98/81/EC amending Directive 90/219/EEC, and Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.
The department 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 Food Safety Authority of Ireland (FSAI) has responsibility for food safety aspects of GMOs and products derived from GMOs.
The Department of Agriculture Food and Rural Development is responsible for the licensing of pesticides for use on crops including GM crops, seed for cultivation and animal feed. 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. This Department, under the auspices of BioResearch Ireland is also responsible for promoting and enhancing national biotechnology infrastructure. The Department of the Environment and Local Government is responsible for the proposed Regulation on the transboundary movement of GMOs, which will implement the provisions of the Cartagena Protocol on preventing biotechnological risks.
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What is the role of the Interdepartmental Group (IDG) on Biotechnology set up by the Government?
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The IDG on Biotechnology was set up in March 1999, arising from policy statement by the Government to address a range of concerns in relation to genetic modification. The Group is chaired by the Department of Enterprise, Trade and Employment and consists of representatives from various government departments (Health and Children, Agriculture, Food and Forestry, Environment and Local Government, Education and Science, Arts, Sport and Tourism and representatives from Forfas, Enterprise Ireland, Environmental Protection Agency, Food Safety Promotion Board and Teagasc).
The policy statement on Genetically Modified Organisms and the Environment issued by the Minister for the Environment and Local Government in October 1999, with the approval of the Government, expressly requested the Group to consider the following issues:
* information dissemination on genetic engineering, particularly in relation to information being made available by the various State agencies and also the overall co-ordination of that information;
* the case for a national biotechnology ethical committee to oversee developments in modern biotechnology;
* the teaching of science, particularly at secondary level, having regard to potential economic growth in biotechnology.
* future policy and administrative co-ordination on genetic engineering;
* the possible establishment of an independent body at EU level (funded by a levy on the biotechnology industry) to validate scientific data and to undertake independent research on genetic engineering;
* a possible research role for the EU Food and Veterinary Office.
The report, produced in 2000, states that the formulation of public policy on biotechnology involves attempting to strike an appropriate balance between benefits and risks, long and short-term needs, and the interests of different groups such as producers and consumers.
The report also states that it is vital that risks associated with modern biotechnology are rigorously assessed and managed in accordance with best scientific practice. It suggests that, on the evidence to date, effective provision for pre-release testing of GMOs, ongoing independent research, and post-release monitoring can ensure that the benefits of biotechnology are maximised and the risks minimised without compromising on the protection of health and the environment. According to the conclusion in the Report, GM products must continue to be rigorously assessed on a case-by-case basis. The IDG meet 2-3 times per year in order to implement the recommendations of the IDG report.
The report can be accessed in full at "http://www.entemp.ie/publications.htm" on the Department of Enterprise, Trade and Employment website and from Government Publications Sale Office.
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Who regulates GM foods and food ingredients derived from GMOs in Ireland?
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The Food Safety Authority of Ireland (FSAI) (www.fsai.ie) is responsible for implementing the Novel Foods & Novel Food Ingredients, Regulation 258/97/EC. This Regulation concerns the placing on the market of novel foods and novel food ingredients. It includes:
* foods and food ingredients containing or consisting of genetically modified organisms, and
* foods and food ingredients produced from, but not containing, genetically modified organisms
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Who regulates pesticides for use in the cultivation of GM crops in Ireland?
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The Pesticide Control Service of the Department of Agriculture & Food are responsible for implementing Directive 91/414/EEC- regulation of the use of plant protection products (for example, herbicides, insecticides & fungicides etc.) on crops including GM crops. http://www.devweb4.agriculture.gov.ie/
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What are the current rules on genetically modified seeds in Ireland?
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The Department of Agriculture & Food are responsible for implementing Directive 98/95/EC, which 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 Commission. The Commission examines the information supplied by the Member State concerned and its compliance with the provisions of Community seeds legislation. If such is the case, the Commission includes the variety concerned in the "Common Catalogue of varieties of Agricultural Plant Species" which means the seed can be marketed throughout the EU. The seed legislation furthermore requires that GMO seed varieties have to be authorised in accordance with Directive 2001/18/EC before they are included in the Common Catalogue and marketed in the EU. If the seed is intended for use in food, it also has to be authorised in accordance 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 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 are to be proposed.
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What is the role of the EPA in the regulation of Genetically Modified Organisms (GMOs) in Ireland?
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The EPA is the Competent Authority in Ireland for the implementation of the GMO Regulations on the contained use and the deliberate release into the environment.
EU Directives 90/219/EEC (contained use) and 90/220/EEC (deliberate release), were transposed into Irish law in December 1994 by the Genetically Modified Organisms Regulations, 1994 (S. I. No. 345 of 1994). Amendments to the Regulations were made in 1996 and 1997 (S. I. No. 348 of 1996 and S. I. No. 332 of 1997).
Directive 98/81/EEC amending Directive 90/219/EEC was transposed into Irish law on 15th March 2001 as S.I No. 73 of 2001- (Genetically Modified Organisms (contained use) Regulations, 2001)-http://www.environ.ie/environ/envindex.html
Also, refer to a Guidance note for users- New Genetically Modified Organisms (Contained Use) Regulations-S.I. No. 73 2001-Guidance for users of GMOs (contained use) in Ireland. http://www.epa.ie/default.htm
Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms repealing Council Directive 90/220/EEC came into force in EU Member States on 17th October 2002. It is anticipated that Directive 2001/18/EC will be transposed into Irish law in late 2003, which will result in new regulations. A guidance note will be produced by the EPA when the Directive is transposed into law.
There are two areas of GMO activities that are regulated by the EPA:
(a) Contained uses - for example, use in laboratories and in industry;
(b) Deliberate release into the environment for -
(i) Research and Development purposes (R&D) purposes-Part B releases or field
trials
(ii) Placing GMO products on the market- Part C releases
The 2001 contained use Regulations stipulate that GMM contained use activities be classified into one of four classes-Class 1, Class 2, Class 3, or Class 4. This classification is directly related to the containment level required to control the risk as identified on completion of the Risk Assessment (RA). All existing GMO contained users must be re-classified in accordance with the requirements of the 2001 Regulations. The EPA are required to provide and update a register of GMO users, consider notifications for first time use of premises and new users and to evaluate notifications for field trials and the placing on the market of products containing GMOs for seed and animal feed use. In all cases the procedures in the GMO Regulations must be followed.
The EPA routinely carries out site inspections of GMO premises to ensure that contained users are in compliance with the Regulations.
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What is the role of the Advisory Committee on Genetically Modified Organisms (GMOs)?
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An Advisory Committee on GMOs was set up in 1995, under Part VI of the GMO Regulations to advise the EPA in relation to any aspect of its functions under the Regulations. The Committee is appointed for a three-year term. It meets quarterly and advises the Agency on relevant GMO issues. A new GMO Advisory Committee was appointed in October 1998. The Committee consists of 14 members nominated by both Government and non-Government organisations (NGOís). Nominating bodies include:
* EPA
* Minister for the Environment & Local Government
* Minister for Agriculture & Food
* Minister for Health & Children
* Minister for Enterprise and Employment
* Commissioners for Public Works in Ireland
* National Authority for Occupational Safety and Health
* Organisations which in the opinion of the EPA are representative of persons whose professions or occupations relate to biotechnology research or the biotechnology industry.
* Organisations which in the opinion of the EPA are concerned with environmental protection.
* Consumer interest groups
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Who else advises the EPA in relation to GMOs?
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The GMO and Novel Foods Working Group (now known as GMO & Novel Foods Sub-Committee under the Food Safety Authority of Ireland Scientific Committee) was set up by the Microbiology Committee of the Food Safety Advisory Board in 1996 in response to a request from the EPA for advice on safety issues concerning ëliveí GMOs under the GMO Regulations.
The Sub-Committee consists of 15 members nominated by Government Departments, State bodies, industry and academia. Experts on this Sub-Committee have expertise which includes:
plant molecular biology, food microbiology, genetics, plant breeding, agronomy, animal nutrition, toxicology etc.
The EPA also consults Government Departments, State Bodies and academic institutions for advice on GMO notifications and dossiers.
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What is the Register of GMO users in Ireland?
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The EPA maintains a Register of GMO Users in Ireland and this is available for inspection by the public during office hours at the EPAís headquarters in Wexford. Up to the end of July 2003, there are 160 entries on the Register of GMO users in Ireland, ninety five percent (95%) of which are contained users, the remainder are deliberate release users. The vast majority of the contained use activities are carried out in 3rd level institutions and the remainder by industrial users.
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What is a deliberate release into the environment for research & development purposes-also known as a Part B release?
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This is a release of GMOs (plants, microbes or animals) into the environment for R&D purposes - field trials. Thirteen (13) field trials were carried out with genetically modified herbicide tolerant sugar beet in Ireland between 1997 and 2000, regulated under the Genetically Modified Organisms Regulations, 1994. The EPA granted consent in September 2002, to Schering Health Care Ltd. to conduct a clinical trial (deliberate release into the environment) in patients suffering from angina pectoris (chest discomfort or pain, usually caused by narrowing of the blood vessels to the heart) using a Genetically Modified Micro-organism (GMM). In addition to the consent from the EPA, Schering Health Care Ltd. required approval by the Irish Medicines Board under the control of Clinical Trials Acts and by the relevant hospital authorities. The EPA's consideration was in relation to the potential risk of the GMM moving from the patient into the wider environment and the consequence of such a risk. Consideration of the risks that the treatment might pose for the patient, as an individual volunteering to participate in the trial, is a matter for the Irish Medicine's Board.
From 21 October 1991 to 10th July 2002, there have been 1775 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. Seventy (70) field trials have been carried out in the EU on GMOs other than plants, e.g. bacteria. For more information on these SNIFS (Summary Notification Information Formats) and for information on SNIFs that have been submitted under Directive 2001/18/EC (e.g. after 17 October 2002) refer to the following web page: http://gmoinfo.jrc.it/
Part B releases are now regulated under Directive 2001/18/EC (repealing Council Directive 90/220/EEC), which came into force in EU Member States on 17th October 2002. (http://biosafety.ihe.be/GB/Dir.Eur.GB/Del.Rel./2001_18/2001_18_TC.html)
Implementing regulations have not yet been enacted in Ireland but are expected by late 2003.
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What is the placing on the market of products containing GMOs under Part C of Directive 90/220/EEC?
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The placing of products containing GMOs (plants, microbes or animals) on the market in the EU is the commercial release of products. This is called a Part C release and is now regulated under Directive 2001/18/EC (repealing Directive 90/220/EEC) which came into force in EU Member States on 17th October 2002.
Under Directive 2001/18/EC, a company intending to market a GMO in the EU must first submit a notification to the national competent authority of the Member State where the product is to be placed on the market for the first time. The notification is composed of a technical dossier (including the environmental risk assessment, a plan for monitoring, a proposal for labelling and a proposal for packaging) and a summary of the dossier (SNIF).
If the national authority (also called the evaluating CA) gives a favourable opinion (within a 90-day period after receiving the notification) on the placing on the market of the GMO concerned, this Member State informs the other Member States via the Commission. If there are no objections within the prescribed 60-day period from other EU Member States, the competent authority that carried out the original evaluation grants the consent for the placing on the market of the product. The product may then be placed on the market throughout the European Union in conformity with any conditions required in that consent. Consent is given for a maximum period of 10 years for the initial consent. After 10 years a renewed application has to be submitted, which, in principle, is subject to the same time-limitation, i.e. 10 years.
If an objection is raised by another EU Member State within the 60 day period, a decision has to be taken at Community level. The Commission first asks for the opinion of its Scientific Committees. If the scientific opinion is favourable, the Commission then proposes a draft Decision to the Regulatory Committee composed of representatives of Member States for opinion. If the Regulatory Committee gives a favourable opinion, the Commission adopts the Decision. If not, the draft Decision is submitted to the Council of Ministers for adoption by qualified majority or rejection. If the Council does not act within 3 months, the Commission can adopt the decision.
Up to 17th October 2002, 18 GMO products had received consent under Part C of Directive 90/220/EEC which has now been repealed by Directive 2001/18/EC and these products can be marketed in any EU Member State. They are:
* Three (3) animal vaccines: two against aujeszky's disease; one against rabies
* Tobacco-HT (herbicide tolerant)
* Four (4) oilseed rape-hybrid, HT
* Soybeans-HT
* Male sterile chicory-HT
* Four (4) GM maize-insect & HT, HT
* GMMs-kit to detect antibiotics in milk
* Three (3) GM carnations-colour changes & increased vase life.
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What are the main changes under 2001/18/EC - on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC?
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Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms repealing Council Directive 90/220/EEC came into force in EU Member States on 17th October 2002.
The new Directive 2001/18/EC provides for a more detailed pre-market scientific evaluation of GMOs and improved transparency throughout the different stages of the authorisation procedure and subsequent handling of GMOs.
The Directive covers all types of GMOs, including plants, animals and micro-organisms. The only GMOs that are not within the scope of the Directive are genetically modified novel foods and medicinal products, as these are covered by specific sectoral legislation providing an equivalent level of protection to human health and the environment.
In common with Directive 90/220/EEC there are two different types of deliberate release covered by Directive 2001/18/EC and these are for:
* Part B - Deliberate Release of GMOs for any other purpose than for placing on the market, for example, field trials in the case of GM crops or hospital clinical trials in the case of GMMs used for gene delivery systems for medicinal purposes.
* Part C- Placing on the market of GMO as or in products.
Notifications for Part C releases are made to a Member State who acts as the evaluating CA, but the decision on whether or not to approve a release is made by all Member States and the Commission acting jointly. In contrast, decision-making on Part B releases or field trials will be made at the Member State level.
Re-start of the GMO Regulatory process under Directive 2001/18/EC
As was stated earlier, 18 GMO products have received consent under Part C of Directive 90/220/EEC and these products can be marketed in any EU Member State. However, it should be noted that no GMOs (food, feed or seed) have been approved in the EU since 1998, due to a defacto moratorium that is in place in the EU.
However, in January 2003, two dossiers, C/ES/00/01- Roundup Ready (glyphosate tolerant) maize, event NK603 and C/NL/98/11- Roundup Ready (glyphosate tolerant) oilseed rape, event GT73, were the first dossiers to be circulated under Directive 2001/18/EC, for the placing on the market in the EU. As of end April 2003, there are 17 other summary dossiers published on the Commission's webpage which are currently going through the regulatory process in accordance with the provisions of Directive 2001/18/EC for EU Member States Competent Authorities for comments or reasoned objections.
Main changes introduced by Directive 2001/18EC are:
* Principles for environmental risk assessment (ERA) has been extended to cover potential direct/indirect immediate and long-term effects of GMOs e.g. wider impacts on biodiversity); http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_200/l_20020020730en00220033.pdf
* Post-market monitoring is now required for Part C releases to look for unanticipated effects of the GMO that has been released;
* There is now a 10-year time limit on Part C consents after which the consent must be re-assessed.
* Mandatory consultation of EU Scientific Committees for Part C releases where objections are raised by EU Member States
* Provision for consultation of Ethics Committees at both EU & at Member State level
* Phasing out of antibiotic resistance marker genes-special consideration in the ERA- phasing out-end of 2004- for commercial releases (Part C) and end 2008 for research purposes (Part B)
* Traceability and labelling-at all stages
* Information to the public (mandatory public consultation before decisions are taken on notification for consents to release GMOs). The Commission has developed a webpage (http://gmoinfo.jrc.it.) which will contain information on new applications for the placing on the market of GMOs and also pertinent information regarding GMO Part B releases-field trials.
* The Commission has an obligation to consult the European Parliament on decisions to authorise the release of GMOs and
What are the principles for the environmental risk assessment under Directive 2001/18/EC?
The safety of GMOs depends on the characteristics of the inserted genetic material, the GMO that is produced from the genetic modification, the receiving environment and the interaction between the GMO and the environment. The objective of the environmental risk assessment is to identify and evaluate potential adverse effects of the GMO(s), either direct or indirect, immediate or delayed, taking also into account the cumulative and long term effects on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The environmental risk assessment also looks specifically how the GM product was developed and examines the potential risks associated with the gene products in the product (for example toxic or allergenic proteins), and the possibility of a gene-transfer (for example of antibiotic resistance genes).
The risk assessment procedure is as follows:
* Identification of any characteristics of the GMO(s) which may cause adverse effects
* Evaluation of the potential consequences of each adverse effect
* Evaluation of the likelihood of the occurrence of each identified potential adverse effect
* Estimation of the risk posed by each identified characteristic of the GMO(s)
* Application of management strategies for risks from the deliberate release or placing on the market of GMO(s)
* Determination of the overall risk of the GMO(s)
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What is the EPA position in relation to labelling of GMOs?
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One of the major issues for consumers is the labelling of products, which contain genetically modified organisms or products derived from GMOs. The EPA have always held that consumers should be informed if products contain or are derived from GMOs and put that view to the EU Commission in 1996.
Under Directive 90/220/EEC there was a requirement that if a product contains or consists of GMOs that the accompanying labels or documentation must indicate that this is the case. In the case of products to be placed on the market in mixtures with non-genetically modified organisms, information on the possibility that the GMOs may be present is sufficient. For food products containing or consisting of GMOs or products derived from GMOs there are specific labelling requirements under Regulation 258/97/EC-refer to FSAI for more information. (The FSAI have recently published a document on Food Labelling, which contains information on the labelling requirements of novel food and genetically modified foods).
What are the new proposed labelling rules and what is the difference with the existing rules?
Directive 2001/18/EC provides for more stringent labelling provisions, requiring labelling at all stages of the placing on the market of GMOs.
Whilst Directive 2001/18 includes general provisions on which a traceability system for GMOs could be based, it neither contains a definition of traceability for GMOs, nor does it include the objectives of traceability or a complete approach for its implementation. The Commission's proposal concerning traceability and labelling of GMOs extends the current labelling provisions to all genetically modified food or feed, irrespective of the detectability of genetically modified DNA or protein. All food and feed, which consist of, contain or are produced from GMOs, would have to 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 current GM labelling system (under Novel Food Regulation) is based on the detectability of genetically modified DNA or protein in the final food product. In practice this means that highly processed foodstuffs produced from GM material, such as highly refined oils, do not need to be labelled. The proposed labelling rules extend the labelling requirements to all food and ingredients produced from GMOs to allow consumers to exercise their freedom of choice.
Genetically modified feed will need to be labelled along the same principles to give livestock farmers accurate information on the composition and properties of feed. This will mean that a large number of feedstuffs currently not subject to GM labelling requirements, such as GM soy meal in feed or compound feedstuffs and the four genetically modified feed plants authorised under Directive 90/220/EEC will in future need to be labelled.
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Are GMOs safe?
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As already stated the EPA regulate the environmental and animal feed aspects of GMOs under the GMO Regulations. Human food consumption aspects are controlled by FSAI.
The EPA welcomes proposed EU legislation which will regulate animal feed containing or consisting of GMOs, for example, GM soybean (unprocessed) seed and animal feed derived from GMOs, for example, heat processed maize gluten. This legislation will be implemented by the Department of Agriculture & Food.
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 EPA in looking at notifications related to Genetically Modified Organisms is to ensure that their use does not have an adverse effect on human health or the environment.
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What is the role of the European Food Safety Authority (EFSA)?
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The European Food Safety Authority (EFSA) was established in January 2002, and has been given responsibility to provide independent scientific advice on all matters with a direct or indirect impact on food safety. This covers GMOs (food and feed) where the Authority has outlined that it will give independent scientific advice to community legislation. A scientific panel specific to GMOs will also be set up by the EFSA to advise on GMO matters. It will also be involved in giving information to the general public about food risks. Dr. Pat Wall, Chief Executive Officer of the FSAI is the Irish representative on the 14 member Board. Further information can be found on the EFSA website: http://www.efsa.eu.int.
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Who is responsible for inspection control and traceability of GMOs that are used in Ireland for cultivation, animal feed or human food?
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Ireland is in agreement with the EU that a positive but precautionary approach be maintained with respect to modern biotechnology and any derived products. Irish legislation governing the labelling, use and marketing of GMOs, and products derived from GMOs is in line with the relevant EU Directives and regulations. This ensures that, based on the best available scientific knowledge, novel food derived from GMOs as well as GM seed planted, or used in animal feed in Ireland are as safe as their non-GM counterparts. Irish agencies with regulatory responsibilities in relation to GMOs (EPA, FSAI, DAFRD) have agreed on a modus operandi pertaining to inspection, control and traceability of GMOs and their derived products and have set up a working group (WG) to deal with this issue. DAFRD is the competent authority for animal feeding stuffs as well as seed used for cultivation. The EPA is responsible for regulating GM seed used for field trial evaluation (S. I.. No 345 of 1994 & Part B of Directive 2001/18/EC) and for 'live' or unprocessed GM seed (until Novel Feed legislation is adopted by the EU) used for animal feed (Part C of Directive 2001/18/EC). The FSAI is the competent authority in Ireland for novel food and novel food ingredients, including GM food and food ingredients, and regulates their marketing and labelling through EC Regulations 258/97, 1139/98, 49/2000 and 50/2000. The State Laboratory (SL) in Abbottstown has been designated as the reference laboratory to carry out GM testing procedures as requested by the different agencies.
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What other regulatory authorities are responsible for regulating GMOs in Ireland apart from the EPA?
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The table below contains a list of competent authorities
Table 1- Regulatory authorities who are responsible for regulating GMOs in the Republic of Ireland:
Directive/ Regulation
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Purpose
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Competent Authority
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Aspects regulated
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Directive 98/81/EEC amending Directive 90/219/EEC
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Regulates the contained use of GMM
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EPA
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* Contained use of GM Microorganisms (GMM).
* Risk Assessment must be sent to EPA for GM animals & GM plants prior to use in contained use facilities.
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Directive 2001/18/EC
Repealing Directive 90/220/EEC
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Regulates the deliberate release of GMOs into the environment for:environment for:
(i) R&D purposes-Field Trials
(ii) Placing GMO products on the market
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EPA
Department of Environment & Local Government are responsible for certain functions, e.g., decisions to place GMOs on the market under Article 18 of this Directive.
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* Environmental assessment for the cultivation and importation of GMOs in the EU
* Animal feed aspects ‚ feeding of ëliveí GMOs to animals
* Human health aspects (including toxicity and allergenicity), related to the cultivation of GM crops in the EU.
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Directive 2000/54/EEC
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Regulates biological agents in the workplace
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Health and Safety Authority (HSA)
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* Workplace contact
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Directive 94/55/EC
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Regulates the transportation of certain GMOs
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Department of Enterprise Trade & Employment
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* Transportation
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Regulation 258/97/EC
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Regulates Novel Foods & Novel Food Ingredients- including GMOs
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FSAI
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* Foods and food ingredients containing or consisting of GMOs
* Foods and food ingredients produced from, but not containing
GMOs, for example, oil from GM soybeans.
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Regulation 1139/98/EC
|
Regulates the labelling of certain foodstuffs produced from GMOs
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FSAI
|
* Labelling of foods derived from GM soybean and GM maize (Ciba maize).
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Regulation 49/2000 amending Council Regulation (EC) No 1139/98
|
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FSAI
|
* Labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC
|
Regulation 50/2000
|
Regulates the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from GMOs
|
FSAI
|
* Labelling of food and food products containing additives and flavourings containing or produced from GMOs
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Regulation 2309/93/EEC
|
Regulates the use of plant protection products
|
Pesticide Control Service of the Department of Agriculture Food and Rural Development
|
* Regulates the use of herbicides, insecticides & fungicides etc. on crops including GM crops.
|
Directive 91/414/EEC
|
Regulates the use of plant protection products
|
Pesticide Control Service of the Department of Agriculture Food and Rural Development
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* Regulates the use of herbicides, insecticides & fungicides etc. on crops including GM crops.
|
Directive 98/95/EEC
|
Regulates the marketing of GM plant varieties and amends current Directives relating to seed
|
Department of Agriculture Food and Rural Development
|
* Regulates GM seed to be placed on catalogues.
|
Directive 70/524/EEC as amended
|
Regulates the authorisation, marketing and use of additives in feedingstuffs
|
Department of Agriculture Food and Rural Development
|
* Authorisation procedures; conditions of use;
* labelling and distribution of additives in animal nutrition
* Establishes an EU list of approved additives
|
Directive 87/153/EEC
|
Regulates guidelines for the assessment of additives in animal nutrition
|
Department of Agriculture Food and Rural Development
|
* Sets out the studies to be undertaken and information provided in an additive dossier submitted for assessment
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Table 2 EU Legislation in preparation:
Directive
|
Purpose
|
Competent Authority
|
(a) Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed
|
The proposal will bring the regulation of food and feed
to-gether within one instrument. It will cover all products containing a GMO and products derived from a GMO (whether or not DNA or protein is detectable).
|
FSAI (Food Safety Authority of Ireland) - food aspects
DAF (Department of Agriculture, Food and Rural Development) - animal feed aspects
|
(b) Proposal for a regulation of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
|
The proposal sets up 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 and their deliberate release into the environment. It aims to put into place a stringent regulatory framework and to close existing legal gaps. 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, or not. It will also allow for the presence of traces of non-approved GMOs what is referred to as the adventitious or unintended presence of GMOs in products, i.e, GMOs present no higher than 0.9% for approved events and 0.5% for non approved events.
|
FSAI (Food Safety Authority of Ireland) - food aspects
DAF (Department of Agriculture, Food and Rural Development) - animal feed aspects
|
(c) Proposal for a Regulation of the European Parliament and of the Council on the transboundary movement of genetically modified organisms.
|
The main elements of the proposal are the following:
* obligation to notify exports of GMOs intended for deliberate release into the environment;
* obligation to provide information to our international partners on Community practices, legislation and decisions on GMOs, as well as on accidental releases of GMOs;
* a set of rules for identifying GMOs for exports.
|
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(d) Proposal for a Directive
of the European Parliament
and of the Council on
environmental liability with
regard to the prevention
and remedying of
environmental damage
|
Applies to environmental damage threatened by a range of occupational activities which present a risk to human health or the environment including activities covered by Directives 90/219/EEC and 2001/18/EC
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