Food Safety and Genetically Modified Foods Genetically Modified Organisms and Novel Foods Food Safety and Genetically Modified Foods Published by: Food Safety Authority of Ireland Abbey Court Lower Abbey Street Dublin 1 Tel: 8171 300, Fax: 8171 301 Email: [email protected] Website: www.fsai.ie © 1999 ISBN 0-9533624-2-6 F OOD SAFETY AUTHORITY OF IRELAND 99 CONTENTS FOREWORD i 1. BACKGROUND 1 2. THE TECHNIQUES OF GENETIC MODIFICATION 2 2.1 Genetic Modification of Plants 2.1.1 How are Plants Modified? 2.2 Genetic Modification of Microorganisms 2.2.1 How are Microorganisms Modified? 2.3 What Kind of Genes are used in Genetically Modified Organsims? 3. HOW ARE GENETICALLY MODIFIED ORGANISMS REGULATED IN THE EU? 5 3.1 Council Directive 90/220/EEC 3.1.1 Information Required under Directive 90/220/EEC 3.2 EU Regulation 258/97 3.3 EU Regulation 1139/98 3.4 Interplay between Regulation 258/97 and Directive 90/220/EEC 3.5 Role of the Environmental Protection Agency (EPA) and the Department of Health and Children in relation to Genetically Modified Food and Feed Products 4. PROCEDURE FOR PLACING GENETICALLY MODIFIED FOODS ON THE MARKET UNDER EU REGULATION 258/97 10 5. PRODUCTS REVIEWED BY THE GMO AND NOVEL FOODS SUB- COMMITTEE 11 5.1 Products Reviewed under EU Regulation 258/97 5.2 Products Approved under Directive 90/220/EEC 5.2.1 Part C of Directive 90/220/EEC 5.2.2 Part B of Directive 90/220/EEC 6. WHAT FOOD SAFETY CONCERNS HAVE BEEN EXPRESSED ABOUT GENETICALLY MODIFIED FOODS? 13 6.1 Labelling 6.2 Use of Antibiotic Resistant Marker Genes in Genetically Modified Foods 6.3 Allergenicity and Toxicity 7. WHAT ARE THE ADVANTAGES OF GENETICALLY MODIFIED FOODS? 17 8. ISSUES ADDRESSED BY THE GMO AND NOVEL FOODS SUB-COMMITTEE 18 9. CONCLUSIONS 19 10. APPENDIX 20 Table A.1 European Union Legislation Regulating Genetically Modified Organisms Table A.2 European Union Legislation in Preparation GLOSSARY 22 REFERENCES 23 MEMBERS OF THE GMO AND NOVEL FOODS SUB-COMMITTEE 24 FOREWORD 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 varieties of cattle selectively bred for beef production. Scientists are now capable of identifying the genes that are responsible for some of these desired traits and are able to manipulate them. This technique is known as genetic engineering or genetic modification and we can expect an increasing number of foods arriving on the market that have been produced using this method. A wide variety of such foods are already on the market in the U.S.A., but in Europe there are only a small number of genetically engineered food ingredients on the shelves. However, consumers have expressed concerns about these food products. These concerns cover a wide range of issues such as food safety, potential damage to the environment, disruption of ecosystems and ethical or moral objections. The GMO and Novel Foods Sub-committee of the Food Safety Authority of Ireland (FSAI), formerly of the Food Safety Advisory Board, was formed in November 1996. This Sub-Committee was established in response to a request from the Environmental Protection Agency (EPA) for advice on food and feed safety issues concerning ‘live’ Genetically Modified Organisms (GMOs) such as unprocessed GM soyabean seed. In accordance with its remit, the Sub- Committee has considered the GMO issue only in terms of potential risks to consumer and animal health and not in terms of environmental, economic or ethical considerations. This report sets out to address a number of issues; the nature of GMOs, the mechanism by which GMOs are regulated in the EU, the issues considered by the Sub-committee to date, concerns expressed about this new technology and potential benefits from the technology. Genetic engineering is a powerful tool that must be treated with respect. Like any tool, if it is used unwisely, it could have unfortunate consequences,but if used cautiously, it could prove to be extremely beneficial. The GMO and Novel Food Sub-committee of the FSAI will continue to play a role in reviewing each product for safety before it can be launched on the market. I would like to take this opportunity to thank the members of the GMO and Novel Foods Sub-committee and the staff of the Food Safety Authority of Ireland for their assistance in producing this report. Colin Hill, Chair, GMO and Novel Foods Sub-committee F OOD SAFETY AUTHORITY OF IRELAND i F OOD SAFETY AUTHORITY OF IRELAND ii CHAPTER 1: BACKGROUND Biotechnology is the application of biological systems and strategies for expression. This systems in industrial processes. This can be genetic system comprises genes, which are found achieved through the use of a living organism or a in every cell of every living organism. Genes biological agent derived from an organism such as consist of strands of a chemical known as an enzyme. One of the principal techniques deoxyribonucleic acid or DNA. In recent years, it employed by biotechnologists to improve biological has become possible to introduce changes to the processes has been to take advantage of the natural DNA of living organisms in a precise manner tendency of living organisms to undergo genetic using recombinant DNA technology (often variation. Modification of the genetic material of referred to as genetic modification or genetic plants, animals and microorganisms can be engineering). Essentially, DNA (encoding a exploited in order to achieve certain desired specific property) is isolated from one organism, products or results. Biotechnology in this form has purified and introduced to the same or a second been practised for millennia. Examples of this organism. When the proper signals have been method of genetic manipulation include: provided,the newly introduced DNA is functional • plant breeders selecting seed from their best and the new property is conferred on the host. plants for subsequent planting This ‘new’ organism is referred to as a GMO and • livestock farmers selectively breeding faster in EU legislation it is defined as: maturing poultry, poultry laying more eggs, pigs producing leaner meat, cows yielding "any cellular entity capable of replication or of greater quantities of milk and cattle for beef transferring genetic material in which the genetic production material has been altered in a way that does not occur • growers cross breeding to produce valuable naturally by mating or by natural recombination."1 new hybrids • food processors selecting the best microbial Over the past 25 years,these ‘new’ techniques have strains for food fermentations e.g. cheese, brought about many useful advances in medicine, yoghurts and fermented meats. agriculture, food processing, bioremediation and other areas. In contrast to foods derived from While these examples all involve heritable what are deemed natural processes, foods derived changes in the genetic material of living from genetic modification are subjected to organisms, none of the products derived in this stringent regulatory control. manner is subject to regulatory control since they are deemed to be natural processes. This report primarily concerns itself with the use of GMOs or products derived in the food chain All living organisms use the same basic genetic from GMOs. F OOD SAFETY AUTHORITY OF IRELAND 1 CHAPTER 2: THE TECHNIQUES OF GENETIC MODIFICATION Genetic modification has been applied on an The process of introducing DNA into plants is experimental basis to animals, plants and called transformation and it can be achieved both microorganisms but only those plants and in monocotyledonous plants, such as wheat, microorganisms that have undergone extensive barley, and rice, and in dicotyledonous plants, such safety tests are available on the market. as soyabean, potato, and tomato, mainly using the following two methods: 2.1 Genetic Modification of Plants It is now possible, using the techniques of genetic a. Agrobacterium tumefaciens is a soil modification, to produce plants that have the bacterium that causes ‘crown gall’ disease on following properties: some plants. Many dicotyledonous species • disease and pest resistance are susceptible to infection by this species. In • greater yields causing ‘crown gall’ disease A. tumefaciens • herbicide tolerance transfers DNA (the transferred DNA or • modified protein and oil content T-DNA) from the bacterium to the plant. In • improved nutritional properties nature the transferred bacterial DNA cause • improved flavour due to delayed ripening the symptoms associated with ‘crown gall’ • resistance to environmental stress e.g. disease. In the early 1980s scientists removed drought, salinity, or cold the disease causing genes from this bacterium • production of pharmaceuticals and other and the T-DNA is now routinely used to chemical substances transport foreign genes into plants. Agrobacterium cells, carrying the foreign 2.1.1 How are Plants Modified? gene(s) of interest, are incubated with A transgenic plant is one that has received a cultured cells of the recipient crop plant and segment of DNA or gene(s) from another transgenic plants are regenerated from them. organism. The DNA that has been transferred Not all cells subjected to this process are using recombinant DNA techniques is known as successfully modified so it may be necessary heterologous or foreign DNA. The foreign to identify the modified cells using marker segment of DNA is incorporated (i.e. integrated) genes which are closely linked to the genetic through natural systems present in plant cells into material that is transferred.