BioEthics_opinion_Inner 23/11/2005 15:21 Page i Preface The potential introduction of GM crops and foods in Ireland has raised and sustained a polarised debate, with conflicting opinions and evidence being presented to the public. With this report, the Irish Council for Bioethics aims to provide a balanced and dispassionate review of the benefits and risks, for human health and environmental preservation, which can fairly be attributed to the development of GM crop technology. The ethical consequences of adopting GM crops and foods are considered throughout and the Council hopes the report will clarify the main scientific and ethical considerations involved in the GM debate, thereby encouraging constructive discussion. I would like to sincerely thank the members of the working group and Council who gave generously of their time and expertise. The Council is very grateful to all those who took time to contribute to the public consultation, as their input greatly benefited the report. Dermot Gleeson SC Chairman Irish Council for Bioethics i BioEthics_opinion_Inner 23/11/2005 15:21 Page ii Foreword One hundred and forty years ago, Gregor Mendel published a paper detailing his studies on the inheritance of certain characteristics in peas.1 From this work, Mendel postulated the existence of particulate units of inheritance, passed on from generation to generation. It took a further 80 years before Avery, McLeod and McCarty demonstrated that these units of heredity were composed of deoxyribonucleic acid (DNA).2 Eight years later, Watson and Crick determined and published the structure of DNA.3 In just over 50 years since then, molecular biologists have invented powerful techniques to manipulate the genetic material, firstly of simple organisms such as bacteria and yeasts, and subsequently of plants, animals and even humans. Genes can be added, cut out, or modified in almost any species of organism. This technology (genetic engineering) is starting to have enormous impacts, particularly in medicine and agriculture. These developments have hardly occurred without controversy. Serious questions have been raised concerning the morality of changing the genetic structure of any organism and whether particular genetic modifications might threaten harm to individuals, to particular groups, to society as a whole, or to the environment. This report focuses on one particular aspect of this new genetics in response to a request from the Food Safety Authority of Ireland – the genetic modification (GM) of crops and food. Claims are made that GM may make significant contributions to the improvement of the productivity and quality of our food, to the provision of sustainable sources of pharmaceuticals, fuels, plastics and other consumables, and to ensuring the supply of food and health resources for developing countries. On the other hand, it is suggested that GM poses a threat to food safety, environmental integrity and the welfare of farmers and growers throughout the world. The results of the public attitude survey carried out for the purposes of this report clearly show a polarisation of attitudes, with the great majority of those who responded clearly displaying a strongly negative attitude towards GM. The progression of this debate could very well be critical for Ireland given our investment in agriculture and perceived “clean green” image. The objective of this report was to provide a reasoned evaluation of the ethical issues surrounding GM crop and food production. We have not attempted a comprehensive account of the science underpinning GM technology as this has been adequately covered elsewhere. Only that science necessary to understand the ethical issues has been given. The ethical considerations encompass any aspect of GM crops/food that is morally relevant, either for good ii 1 Mendel G. Versuche tiber Pflanzen-Hybriden. Verb Naturf Ver Brünn, 4 (1), (1865). 2 Avery O.T., MacLeod C.M., McCarty M. Studies of the chemical nature of the substance inducing transformation of pneumococcal types. Induction of transformation by a desoxyribonucleic acid fraction isolated from Pneumococcus Type III. J Exp Med. 79, 137–158 (1944). 3 Watson J. and Crick F. Molecular Structure of Nucleic Acids. Nature, 171, 737-738 (1953). BioEthics_opinion_Inner 23/11/2005 15:21 Page iii or bad. These include safety issues, environmental impacts, considerations for developing world agriculture and health, and the interests of consumers and farmers. We have tried to provide a balanced and dispassionate assessment of the situation with emphasis on the Irish dimension. In view of Irish involvements in developing world welfare, some prominence has been given to considerations in this area. The report does not attempt to produce a list of ethical “dos” and “do nots” for GM crops. Rather it is hoped that it will provide a guide for those legislators and other members of the public who find it difficult to discern the difference between science-fact and science-fiction in this area, and to see beyond the very polarised debate that has taken place to the core ethical issues raised by GM technology. The science of genetics has too much to offer to the world – and to Ireland – for its progress to be driven purely by commercial or anti-commercial imperatives. Ethical considerations demand that new applications of genetics should be based on sound science with generally acceptable objectives, and progressed in a cautious but not fearful manner. I would like to thank the members of the working group who have contributed their particular expertise to discussions so selflessly. All have given freely and generously of their time. Other members of the working group are greatly indebted to Dr. Patrick Flanagan who undertook the analysis of the survey of public attitudes. Thanks are also due to those members of the public who responded to the survey. We would also like to thank other members of the Council who have provided helpful suggestions and information and have patiently waited for the appearance of this report that has had a protracted gestation period. The members of the working group would particularly like to express their gratitude to the secretariat of the Council. It is not possible to overstate the contributions made by the Scientific Director, Dr. Siobhán O’Sullivan and Researchers Dr. Stephanie Dyke, Mr. Paul Ivory and Ms. Emily de Grae. They provided us with much relevant documentation, bringing to our attention any salient information. Most of all they integrated the disparate contributions of working group members into a coherent and readable whole. In short they made my job as Chair of the working group possible. Peter Whittaker Chairman, Working Group on Genetically Modified Organisms Vice Chairman, Irish Council for Bioethics iii BioEthics_opinion_Inner 23/11/2005 15:21 Page iv Table of Contents Preface .............................................................................................i Foreword..........................................................................................ii Introduction .....................................................................................1 Ethical Assessment of Genetic Modification .........................................4 Should we Modify Nature? ............................................................4 What is Genetic Modification?........................................................4 Crossing the Species Barrier ..........................................................6 Applications of Genetic Modification ...................................................7 Genetically Modified Crops and Food..............................................7 Genetically Modified Animals.........................................................8 Scientific and Medical Research.....................................................9 Bioremediation...........................................................................10 Ethical Framework for the Assessment of GM Crop Technology............11 Consequentialism and General Welfare .........................................11 Distributive Justice .....................................................................12 Autonomy..................................................................................13 The Precautionary Principle .........................................................13 Health Impact of GM Crops .............................................................15 Genetic Modification Techniques ..................................................15 Risks Introduced by the Technology..............................................16 Risks Introduced by GM Traits .....................................................17 Feeding Studies .........................................................................17 Regulatory Framework ................................................................19 Environmental Impact of GM Crops ..................................................20 Horizontal Gene Transfer .............................................................20 Gene Flow.................................................................................20 Environmental Impact of Particular Traits ......................................22 Overall Environmental Impact ......................................................23 BioEthics_opinion_Inner 23/11/2005 15:21 Page v Impact of GM Crop Technology on General Welfare ............................24 Irish Consumers .........................................................................24 Dialogue and Transparency..................................................25 Autonomy..........................................................................25 Irish Farmers .............................................................................26 Profitability ........................................................................26 Autonomy..........................................................................29 Developing Countries ..................................................................31 Potential Benefits................................................................31 Collaboration......................................................................33 Intellectual Property Rights (IPR)..........................................34 Conclusion .....................................................................................36 Appendix .......................................................................................38 Introduction ...............................................................................39 The Questionnaire ......................................................................39 The Results of the Consultation....................................................40 The Findings..............................................................................41 Analysis of Comments Submitted in Section 17.............................42 Conclusion ................................................................................47 Sample Questionnaire.................................................................48 Section by Section Analysis of the Responses Received ..................51 Origins Of Responses..................................................................58 Background Information ......................................................58 Gender of Respondents .......................................................58 Age Group of Respondents ..................................................58 County of Residence of Respondents ....................................58 Working Group on Genetically Modified Organisms.............................59 The Irish Council for Bioethics .........................................................60 Abbreviations .................................................................................61 Regulatory Instruments ...................................................................62 Glossary ........................................................................................63 Bibliography...................................................................................67 BioEthics_opinion_Inner 23/11/2005 15:21 Page 1 Introduction The cultivation of genetically modified (GM) crops and their introduction into the food chain is at the heart of an animated debate in Ireland and other parts of Europe. Despite claims that the technology could deliver sustainable farming practices, the European public has widely rejected the use of GM technology in the area of food production. Concerns range from the hazards GM crops could present for human health and the environment, to the monopolising power GM technology may bestow upon multinational corporations.1,2,3 In Ireland, GM crop technology was brought to the public’s attention when the multinational company Monsanto initiated experimental field trials of herbicide-tolerant GM sugar beet. Some of the plots were destroyed by the Gaelic Earth Liberation Front on September 28th 1997, marking the birth of a public opposition campaign, primarily voiced by non-governmental organisations and interest groups. Given the public concern, the Department of the Environment and Local Government issued a consultation paper on a national policy position regarding the growth of GM crops in Ireland. The consultation process allowed for a debate between representatives of industry, academic science, non-governmental organisations, and the public. On consideration of the debate, the Minister for the Environment and Local Government published a policy statement highlighting precaution, sustainability, transparency, stability, balance, and flexibility, as guiding principles for a safe and competitive application of GM technology within Irish agriculture.4 The InterDepartmental Group on Modern Biotechnology, chaired by the Department of Enterprise, Trade and Employment, was charged with examining the wider issues of consumer choice and public information on progress in biotechnology. The group released a report in November 2000 recommending that new means of informing and engaging with the public be piloted and developed, and that a committee responsible for addressing the ethical issues associated with progress in biotechnology be established.5 The Irish Council for Bioethics was established in 2002 as an independent autonomous body.6 1 1 European Commission, The Europeans and Modern Biotechnology: Eurobarometer 46.1, European Commission Directorate General XII. Science, Research and Development, Brussels (1997), http://europa.eu.int/comm/public_opinion/archives/ebs/ebs_108_en.pdf 2 GM NATION? The findings of the public debate (2003), http://www.gmnation.org.uk 3 Report of the Irish Council for Bioethics Public Consultation on Genetically modified Crops/Foods, see Appendix. 4 The Department of the Environment, Heritage, and Local Government, http://www.environ.ie/DOEI/DOEIPol.nsf/0/058576aeccca70c580256f0f003bc7f0/$FILE/GMO%20Policy%20Cover.pdf 5 Inter-Departmental Group Report on Modern Biotechnology. Irish Government Report, Government Publications Office, Nov. 20th, p159-160 (2000). 6 Irish Council for Bioethics, http://www.bioethics.ie BioEthics_opinion_Inner 23/11/2005 15:21 Page 2 In 1998, the European Commission (EC) responded to the anti-GM sentiment emerging across Europe by ceasing to approve GM crops for cultivation, import and sale in the European Union (EU), with a view to re-evaluating the risks associated with GM crops,7 and the rigour of the Community authorisation process. At the time, only food products made from GM maize and soybean were established on the European food market and insect-resistant maize was the only GM crop to have received approval for cultivation in the EU. Over the next six years, under what was referred to as a de facto moratorium, with the exception of food products containing GM rapeseed or cottonseed oil, the EC did not approve any new GM crops or foods. During this time, the EC negotiated new food safety and environmental rules for the safe application of GM crop technology and its derived food and feed products in Europe.8 The EU Deliberate Release Directive (2001/18/EC), concerning the environmental and health safety of GM crops and foods, was developed to meet the specific needs of European agricultural landscapes and European consumers, and came into force in October 2002. EU regulations (EC) No 1829/2003 and (EC) No 1830/2003 concerning the authorisation, traceability, and labelling, of GM organisms (GMOs) and their derived products, were developed with a view to ensuring food safety and consumer choice, and came into force in April 2004. In May 2004, the European Commission effectively lifted the moratorium by authorising a genetically modified sweet-corn variety (Bt-11) for import into the EU, thereby opening the door for further authorisations. Nonetheless, some EU member states have invoked national bans on GMOs under Article 23 of the EU Directive 2001/18/EC. This “safeguard clause” allows individual states to ban the cultivation and/or import of GM crops and products already approved for use across the EU within their own borders. Member states are entitled to enact a national ban on a particular GMO if they have grounds for concern over a possible risk to human health or the environment, however, they are obliged to justify this concern. Five member states (Austria, Luxembourg, Germany, France and Greece) have established eight bans or restrictions on the cultivation, import and/or use of various GM crops. The responsible scientific committee in the European Commission deemed that the information submitted by the member states as justification for these bans did not change the original risk assessments, which had been carried out as part of the initial authorisation process. As a result, the European Commission asked member states to endorse an order to lift the national bans. In 2005, 22 member states (including Ireland), rejected proposals to lift the national bans. Meanwhile, in May 2003, America, Canada and Argentina filed a complaint with the World Trade Organisation (WTO) about the de facto moratorium in operation within the EU. These countries argued that the moratorium was an illegal trade barrier because it did not have a solid scientific basis. The preliminary WTO decision on this matter is expected in December 2005. 7 The European Commission invested in the ENTRANSFOOD research programme, http://www.entransfood.com 8 European Commission GM crops and foods website, http://europa.eu.int/comm/food/food/biotechnology/gmfood/legisl_en.htm 2 BioEthics_opinion_Inner 23/11/2005 15:21 Page 3 Currently, there are no GM crops growing in Ireland or Northern Ireland, although thirteen field trials were carried out with herbicide-tolerant GM sugar beet between 1997 and 2000 under the GMO Regulations.9 There are more than 200 users of GMOs (bacteria, viruses, cells, plants, animals) in contained laboratory environments that have registered with the Environmental Protection Agency (EPA). Of these, the vast majority are public university and hospital laboratories, carrying out biological and medical research.10 The EPA also granted consent to Schering Healthcare Ltd. in September 2002 for a GM clinical trial in patients suffering from angina pectoris using a genetically modified micro-organism.11 In addition to consent from the EPA, Schering Healthcare Ltd. required approval from the Irish Medicines Board under the control of Clinical Trials Acts12 and from the relevant hospital authorities.13 In 2004, an estimated 200 million acres of GM crops were planted worldwide, representing close to a quarter of the planet’s cultivated land and the practice of over eight million farmers from 17 different countries.14 These crops are mainly grown in the United States (US), Argentina, Canada, Brazil and China (98%), however, Spain has been growing GM maize since 1998 and a range of new GM crops and foods have recently been approved under the new EU regulations.15 Given the speed at which the world is adopting GM crops and foods, the importance of agriculture for Ireland, and the serious public concern, it is urgent that the ethical issues associated with this technology be addressed. On top of worries about health and environmental consequences, objections stem in many cases from individual values and beliefs, including a widespread perception that the technology is unnatural.16 3 9 S.I. No. 345 (1994) Genetically Modified Organisms Regulations, Dublin (1994), http://www.irishstatutebook.ie/ZZSI345Y1994.html 10 19 corporations were listed in September 2005. 11 Angina pectoris is a chest discomfort or pain, usually caused by a narrowing of the blood vessels to the heart. 12 S.I. No. 190 (2004) European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, Dublin (2004). 13 This clinical trial was terminated (not on safety grounds) by Schering Healthcare Ltd. in February 2004. 14 James C. Global Status of Commercialized Biotech/GM Crops: 2004, International Service for the Acquisition of Agri-biotech Applications (2004), http://www.isaaa.org 15 A list of authorised GM crops, food and feed products, is available from the European Commission website, http://europa.eu.int/comm/food/dyna/gm_register/index_en.cfm 16 Report of the Irish Council for Bioethics Public Consultation on GM Crops/Foods, see Appendix. BioEthics_opinion_Inner 23/11/2005 15:21 Page 4 Ethical Assessment of Genetic Modification Morality can be described as the process of exploring the right relationship with each other and with the world about us, a project which confronts humans to the extent that we have a choice in how we relate, and can reason about the nature and effects of our choices. Ethics is a reflection on this project, and among its tasks is that of searching for guidelines on choice in particular areas. Bioethics reflects on the various “life issues”, and in recent times a major preoccupation has been the possibilities raised by dramatic advances in our understanding of genetic biology. Modifying genetic material is obviously a matter of ethical concern as it offers astonishing new choices about the kind of world we may inhabit. Should we Modify Nature? For an ethical appraisal of GM technology, the most fundamental question seems to be whether there are limits to the extent to which it is permissible to modify nature, and if so, where those limits lie. This raises the question of how we are to view nature, and the human role in its regard. The answer to this question will be shaped by philosophical and/or religious convictions, and there are differences between the traditions. Western ethical thinking, influenced as it is by Judaeo-Christian religious perspectives and Graeco-Roman philosophy, tends towards the concept of creative stewardship, in which the human task is seen as an active pursuit of human flourishing. Though there are differences in detail or emphasis between the traditions, drawing on nature’s resources to improve the human condition, and intervening when its course is destructive, underlies most views of our relationship with the natural world. The widespread support of modern medicine is perhaps the strongest indication of this choice. What is Genetic Modification? The works of Jean-Baptiste Lamarck and Charles Darwin established the theory of evolution in the 19th century: species evolve with time, through interaction with their environment.17,18 This theory implied that there must be some transmission of traits from generation to generation, an inheritance of features. In 1865, Gregor Mendel proved that there was a biological structure 17 Lamarck J.B. Philosophie Zoologique (1809), translated by Elliot H. as Zoological Philosophy: An Exposition with Regard to the Natural History of Animals with introductory essays by Hull D.L. and Burkhardt R.W.Jr. (Univ of Chicago Press, 1984). 18 Darwin C.R. On the Origin of Species by Means of Natural Selection, or the Preservation of Favoured Races in the Struggle for Life (John Murray, London, 1859). 4 BioEthics_opinion_Inner 23/11/2005 15:21 Page 5 responsible for heredity and gave birth to the field of genetics.19 The word gene was used to describe features or traits that are inherited. It took almost a century to identify and characterise the repository of heredity, deoxyribonucleic acid (DNA), which is found in cells in the compacted form of chromosomes. The resolution of the structure of the DNA molecule, by James Watson and Francis Crick in 1953, led to our understanding of the genetic code.20 Genes have been defined more accurately as specific sections of chromosomal DNA that mainly code for proteins, the machinery of the cell. Genes are defined by the specific ordering of the four base pairs that compose the DNA structure and execute their cellular functions via the expression of proteins, the structure of which is based on the gene’s DNA sequence. Every cell in our body is to some extent governed by its DNA and this is true for every living organism, from unicellular bacteria to multi-cellular plants and animals. Many would view genetic modification as a deeper interference with nature than other human interventions. However, it must be recognised that humanity has harnessed the genetic nature of life since the dawn of civilisation. Indeed, genetic selection through generations of careful breeding has allowed Man to domesticate wild animals and develop agricultural crop varieties. This process of genetic modification was somewhat unconscious, but we now understand that conventional breeding exploits two genetic techniques: mutation and sexual crossing. Genetic mutation is a change in DNA structure that may occur spontaneously or in response to environmental factors such as gamma- or X-irradiation, exposure to certain chemicals, or viral infection. Mutation is thought to be the main driving force of evolution and the basis for natural variability. Mutation can diminish, enhance or modify the function performed by a gene. Sexual crossing, also referred to as hybridisation, is the mixing of thousands of genes from two parental organisms to generate an offspring carrying a new combination of genes. The diverse breeds of cats and dogs are illustrative examples of man-mediated genetic manipulation. Also referred to as genetic engineering, or transgenesis, GM technology was developed in the 1960s and has been refined over the years for applications in research and medicine. GM technology involves altering an organism’s DNA by deleting or modifying a gene or its regulation, or by inserting a new gene into an organism. The aim is usually to introduce a new characteristic to the organism, beyond what is possible through traditional breeding and selection, in order to increase its usefulness e.g., insect-resistant corn. A gene that confers resistance to the European corn borer, an insect pest, was taken from the soil bacterium Bacillus thuringiensis (Bt), which is widely used in organic farming as a natural insecticide. This gene was added to the corn’s genetic material and its cells now produce the Bt protein, protecting it from the corn borer. The advantage of this approach is that insecticidal spraying is not required and only pests attacking the corn are harmed while non-target insects in the environs of the crop are not affected by spray drift. 5 19 Mendel G. Experiments in Plant Hybridisation. Versuche tiber Pflanzen-Hybriden. Verb Naturf Ver Brünn, 4 (1), (1865). 20 Watson J.D. and Crick F.H. Structure for Deoxyribose Nucleic Acid. Nature, 171, 737-738 (1953). BioEthics_opinion_Inner 23/11/2005 15:21 Page 6 Crossing the Species Barrier One of the key features of genetic modification is that a single or small number of selected genes can be transferred from one organism to another species e.g., scientists have created a frostresistant tomato by adding an antifreeze gene from the flounder, a cold-water fish, to its genome.21 This contrasts with traditional breeding techniques that limit modifications to a sharing of genes between closely related organisms. Swapping genes between species can be seen as less acceptable than accelerating or focusing the breeding process, given that such exchanges would not normally occur naturally. Our evolutionary heritage has nonetheless endowed very different species with common ancestral genes. Human DNA shares 7% of its sequence with bacteria, 36% with the fruit fly, and 98% with our closest relative, the chimpanzee. The genetic code is said to be universal, it is used in all living organisms; this is why a gene that has been identified and isolated in a fish can function in a tomato. It should also be noted that gene transfer between different species is a naturally occurring phenomenon. Fungal genes are widespread in many flowering plants22 and there is evidence to suggest that genes can be transferred between bacteria and insects.23 It is difficult to argue that, in principle, using our knowledge of genetics to improve natural resources with GM technology is immoral, while selective breeding, which may equally be guided by genetic knowledge and aimed at results that would never occur without human intervention, is not.24 However, it must be recognised that GM technology offers more choice than selecting genetic modifications through conventional breeding practices. This calls for an ethical examination of the goals sought out through GM technology, as well as of its potential consequences. 21 Hightower R., Baden C., Penzes E., Lund P., Dunsmuir P. Expression of antifreeze proteins in transgenic plants. Plant Mol Biol, 17 (5), 1013-1021 (1991). 22 Cho Y., Qiu Y-L, Kuhlman P., Palmer J.D. Explosive invasion of plant mitochondria by a group I intron. Proc Natl Acad Sci, 95 (24), 14244-14249 (1998). 23 Hawtin R.E., Arnold K., Ayres M.D., de A Zanotto P.M., Howard S.C., Gooday G.W., Chappell L.H., Kitts P.A., King L.A., Possee R.D.. Identification and Preliminary Characterization of a Chitinase Gene in the Autographa californica Nuclear Polyhedrosis Virus Genome. Journal of Virology, 75 (17), 8117-8126 (2001). 24 For related discussions, see Hughes J. Genetically modified crops and the precautionary principle: Is there a case for a moratorium, in Almond B. and Parker M. (eds.) Ethical Issues in the New Genetics: Are Genes Us? (Ashgate, 2003); and Häyri M. Categorical objections to genetic engineering – a critique, in Dyson A. and Harris J. (eds.) Ethics and Biotechnology (Routledge, London, 1994). 6 BioEthics_opinion_Inner 23/11/2005 15:21 Page 7 Applications of Genetic Modification G e n e t i c a l l y M o d i f i e d C r o p s a n d Fo o d The most well known, and perhaps one of the most controversial applications of genetic modification, is the production of genetically modified crops and food. The vast majority of these crops were designed to be resistant to a particular herbicide or an insect pest. There have also been field tests of virus- and fungus-resistant crops.25,26 The purpose of conferring such resistance to crops is to increase their productivity.27 More recently, genetic modification has been used to alter the nutritional content of food. Rice seeds have been genetically modified to increase iron storage in rice kernels and iron absorption from the digestive tract.28 Genetic modification is also being used to develop foods that have medicinal properties, so-called functional foods or “nutraceuticals” e.g., tomatoes with increased lycopene content.29 Lycopene is a antioxidant and has been implicated as a useful agent in the prevention and treatment of prostate cancer and heart disease.30,31 Some of the strongest arguments that have been made in favour of GM crop development concern the technology’s potential to counter world hunger and suffering.32 Drought tolerant plants, cold or heat tolerant plants and salt tolerant plants are being investigated for the specific contexts of developing countries as a means of increasing crop yields.33,34 Another good example of research efforts aimed at improving human health is the Golden Rice Project.35 Scientists have 7 25 The Kenya Agricultural Research Institute, in cooperation with Monsanto and universities in the US, developed a feathery mottle virus-resistant sweet potato in the early 1990’s, http://www.kari.org 26 The Council for Scientific and Industrial Research has genetically engineered maize with a gene isolated from beans to develop resistance to the most serious fungal pathogen, Stenocarpella maydis, http://www.csir.org.gh 27 Qaim M. and Zilberman D. Yield effects of genetically modified crops in developing countries. Science, 299, 900-902 (2003). 28 Lucca P., Hurrell R., Potrykus I. Fighting iron deficiency anemia with iron-rich rice. J Am Coll Nutr, 21 (3), 184-190 (2002). 29 Mehta R.A., Cassol T., Li N., Ali N., Handa A.K., Mattoo A.K. Engineered polyamine accumulation in tomato enhances phytonutrient content, juice quality, and vine life. Nat Biotech, 20 (6), 613-618 (2002). 30 Gann P.H., Ma J., Giovannucci E., Willett W., Sacks F.M., Hennekens C.H. Lower prostate cancer risk in men with elevated plasma lycopene levels: results of a prospective analysis. Cancer Research, 59, 1225-1230 (1999). 31 Arab L and Steck S. Lycopene and cardiovascular disease. Am J Clin Nutr, 71, 1691-1695 (2000). 32 Nuffield Council on Bioethics, UK. The use of genetically modified crops in developing countries: a follow-up discussion paper. (2004). 33 Bänziger M. and Diallo A.O. Progress in developing drought and N stress tolerant maize cultivars for Eastern and Southern Africa. In Friesen D.K. and Palmer A.F.E. (eds.) Integrated Approaches to Higher Maize Productivity in the New Millennium. Proceedings of the Seventh Eastern and Southern Africa Regional Maize Conference, p189-194 (2001), http://www.cimmyt.org/english/docs/proceedings/africa/pdf/42_Banzinger1.pdf 34 The First International Meeting on Cassava Plant Breeding and Biotechnology is scheduled for 1-5 Dec 2006. Sponsored by the International Society of Food, Agriculture, and the Environment of Helsinki, Finland, the theme of the conference is Cassava improvement to improve livelihoods in sub-Saharan Africa and North-Eastern Brasil. 35 Golden Rice Project, http://www.goldenrice.org BioEthics_opinion_Inner 23/11/2005 15:21 Page 8 developed a GM rice variety that supplements the vitamin A synthesis pathway. Vitamin A deficiency is a serious burden on the health of millions of children living in developing countries who cannot afford alternative sources of the vitamin.36 GM crop technology may also allow pharmaceuticals and vaccines to be “grown” in plants. This is seen as a potentially inexpensive approach for producing medicines and vaccines in developing countries, as it would obviate the need for costly refrigeration and sterile needles. Researchers have already produced a variety of transgenic potatoes that contains a small portion of the cholera toxin and immunises against the disease upon ingestion. There are other examples of transgenic plants that have been developed to immunise against the Hepatitis B and Norwalk viruses, both of which are of substantial concern for individuals living in developing countries. In 2004, the European Union Sixth Framework Programme awarded the PharmaPlanta Programme a grant of €12 million to genetically modify plants to grow vaccines against rabies and tuberculosis, and eventually, diabetes and HIV.37 Another medical application of GM crops exploits a soybean protein (alpha-glycinin) that has been mutated to exhibit antihypertensive properties. The mutated protein can be purified from the soybeans and was able to lower blood pressure in hypertensive laboratory animals.38 Genetically Modified Animals The ability to genetically modify animals in order to produce valuable products, such as pharmaceuticals, in their milk has been one of the most innovative applications of genetic modification techniques. Alpha-1-antitrypsin (a protein that is deficient in patients with respiratory conditions such as emphysema and cystic fibrosis) can be produced in the milk of sheep by adding the human gene to the genome of a sheep.39 PPL Therapeutics recently announced that alpha-1-antitrypsin produced from one of their transgenic flock of sheep is being used to treat cystic fibrosis patients in phase 2 clinical trials. Medicines produced in milk could be manufactured and distributed cheaply, and made more accessible to people around the world. Although still at an experimental stage, the production of animals to provide organs for transplantation to humans (xenotransplantation) is another application of genetic modification. In this case, the modification is aimed at altering proteins on the animal’s cells, so that their organs appear to be of human origin, and are therefore not rejected by the human immune 36 For further discussion of the role GM crops could play in developing countries, see section: Developing countries, p31. 37 Programme website, http://www.pharma-planta.org 38 Matoba N., Doyama N., Yamada Y., Maruyama N., Utsumi S., Yoshikawa M. Design and production of genetically modified soybean protein with anti-hypertensive activity by incorporating potent analogue of ovokinin (2-7). FEBS Letters, 497, 5054 (2001). 39 Wright G., Carver A., Cottom D., Reeves D., Scott A., Simons A., Wilmut I., Garner I., Colman A. High level expression of active human alpha-1-antitrypsin in the milk of transgenic sheep. Biotechnology, 9 (9), 830-834 (1991). 8 BioEthics_opinion_Inner 23/11/2005 15:21 Page 9 system after transplantation. Current research is focused on the genetic modification of pigs to avoid the stimulation of a rejection response immediately after transplantation.40 Currently, the main application of transgenic animals, and especially of genetically modified mice, is as models of human disease to test and develop potential therapies. Once a gene is identified it has become almost routine to seek to “knock out” the equivalent gene in a mouse and try and identify the function of the gene. Genetically modified mice, in which mutations found in human genetic diseases have been introduced, provide good models for studying specific diseases. Studies conducted in mouse models of Huntington’s disease have identified a number of potential therapies that are candidates for clinical trials.41 Scientific and Medical Research The first major medicinal product of genetic modification, human insulin, was developed in 1982 for the treatment of diabetes. Until the mid-1980’s, most insulin was produced by extracting a human-equivalent insulin from the pancreas of animals (usually pigs). The technique of genetic modification allowed the human form to be produced inexpensively and in large quantities from GM bacteria. A genetically modified virus has had some success in targeting and destroying cancer cells, while leaving healthy cells undamaged.42 Cancer Research UK scientists examined the effect of the genetically modified virus on pancreatic, lung, ovarian, liver and colorectal cancers in vitro as well as in tumour bearing mice. The modified virus replicated vigorously within the cancer cells and spread through the tumour tissue, causing the cells to die. The predominant mode of HIV transmission worldwide is via heterosexual contact, with the cervico-vaginal mucosa serving as the main site of viral entry in women. Genetically modified bacteria may be able to serve as a barrier by secreting proteins that protect women against HIV infection. A natural component of the vaginal microbial flora Lactobacillus jensenii has been genetically modified to secrete soluble CD4 (a protein that HIV specifically binds in order to gain access to cells and infect them), and has been shown to block laboratory strains of HIV from infecting human cells.43 9 40 Kolber-Simonds D., Lai L., Warr S.R., Denaro M., Arn S., Augenstein M.L., Betthauser J., Carter D.B., Greenstein J.L., Hao Y., Im G.S., Liu Z., Mell G.D., Murphy C.N., Park K.W., Rieke A., Ryan D.J., Sachs D.H., Forsberg E.J., Prather R.S., Hawley R.J. Production of alpha-1,3-galactosyltransferase null pigs by means of nuclear transfer with fibroblasts bearing loss of heterozygosity mutations. Proc Natl Acad Sci USA, 101 (19), 7335-7340 (2004). 41 Hersch S.M. and Ferrante R.J. Translating therapies for Huntington’s disease from genetic animal models to clinical trials. NeuroRx. 1, 298-306 (2004). 42 Liu T.C., Hallden G., Wang Y., Brooks G., Francis J., Lemoine N., Kirn D. An E1B-19 kDa gene deletion mutant adenovirus demonstrates tumor necrosis factor-enhanced cancer selectivity and enhanced oncolytic potency. Mol Ther, 9 (6), 786-803 (2004). 43 Chang T.L.Y., Chang C.H., Simpson D.A., Xu Q., Martin P.K., Lagenaur L.A., Schoolnik G.K., Ho D.D., Hillier S.L., Holodniy M., Lewicki J.A., Lee P.P. Inhibition of HIV infectivity by a natural human isolate of Lactobacillus jensenii engineered to express functional two-domain CD4. Proc Natl Acad Sci USA, 100 (20), 11672-11677 (2003). BioEthics_opinion_Inner 23/11/2005 15:21 Page 10 Bioremediation Bioremediation is the use of organisms to degrade waste materials into less toxic or non-toxic material in the environment. Naturally occurring organisms (e.g., bacteria, yeast, fungi) can be used as bioremeditors to clean up industrial or general waste such as sewage, pesticides, heavy metals and nuclear waste. It has been suggested that genetic modification of such organisms can increase the effectiveness of bioremediation. The bacterium Deinococcus geothermalis shows remarkable resistance to ionizing radiation. This characteristic was the impetus for sequencing the genome of D. geothermalis and the ongoing development of its use for bioremediation of radioactive waste.44 Techniques of phytoremediation, the use of living plants to absorb toxic waste, also show substantial promise. The yellow poplar (Liriodendron tulipifera) has been genetically modified to express bacterial mercuric reductase. This allows the poplar to grow in normally toxic levels of ionic mercury. Furthermore the modified poplar is able to convert the highly toxic ionic mercury to the much less toxic elemental form of mercury up to twelve fold faster than poplars that have not been genetically modified.45 44 Brim H., Venkateswaran A., Kostandarithes H.M., Fredickson J.K., Daly M.J. Engineering Deinococcus geothermalis for bioremediation of high-temperature radioactive waste environments. Appl Environ Microbiol, 69 (8), 4575-4582 (2003). 45 Rugh C.L., Senecoff J.F., Meagher R.B., Meikle S.A. Development of transgenic yellow poplar for mercury phytoremediation. Nat Biotech, 16, 925-928 (1998). 10 BioEthics_opinion_Inner 23/11/2005 15:21 Page 11 Ethical Framework for the Assessment of GM Crop Technology If the technique of genetic modification is deemed acceptable in principle, then moral questions of a more specific sort arise. How should GM technologies be used? What sorts of organisms should be developed, for what purposes, and how should they be used? Given our awareness of the intimate link between human welfare and natural resources, GM crop technologies must be assessed in terms of their potential impacts on humanity and its environment, which includes all living beings as well as the planet’s natural resources. The concept of progress, through which humanity should strive to ameliorate its condition, implies that new developments should be environmentally sustainable and beneficial on a global scale. In considering the practical options offered by science to assist in this human endeavour, promotion of welfare should be a guiding principle for decisions. In pursuing this goal, however, due care must be given to respect for individual rights and freedoms, and to issues of social justice. C o n s e q u e n t i a l i s m a n d G e n e r a l We l f a r e One way of assessing GM crop technology would be to use the ethical theory of consequentialism. Consequentialism is the view that the right action or policy is the one that produces the best overall consequences. A consequentialist assessment of a new GM crop would consider whether and by how much the total benefits of growing that crop exceed the total costs. If the new variety produces a larger surplus of benefits over costs than the available alternatives, then the crop should be used; otherwise it should not. Utilitarianism is a specific form of consequentialism, based on the premise that the welfare of humans and other sentient creatures is the ultimate value. According to utilitarianism, decisions about the development and implementation of GM crop technologies should depend on their overall impact on general welfare, measured through some system of cost-benefit analysis. Such an approach faces practical objections resulting from the difficulty of predicting and measuring the consequences of new technologies. In some cases utilitarians may be able to rely on assessments of the probabilities of various risks and benefits to calculate the “expected utility” of a policy.46 However, in many cases even the probabilities of various risks or benefits cannot be stated with any confidence, and it is this circumstance that leads some to advocate the application of a “precautionary principle” (see below). 46 11 Expected utility is the sum of benefits minus costs, each multiplied by its probability. BioEthics_opinion_Inner 23/11/2005 15:21 Page 12 A more fundamental worry is that a consequentialist approach to the ethical assessment of GM crops is “distributionally insensitive”. That is to say, a consequentialist approach says nothing about how benefits and burdens should be distributed. In principle, an unqualified consequentialism would sanction the sacrifice of some individuals’ interests for the greater good whenever a net gain would result. Such an approach is considered by many to fail to account for the separateness and inviolability of persons.47 To take seriously the separateness of persons and the distribution of benefits and burdens is to be concerned with distributive justice. That, in turn, enables one to discriminate between different GM technologies on the basis of who they benefit and how they do so. Yet before one can do this, one has to approach the rather difficult question of what a just distribution actually is. Distributive Justice A common objection to utilitarianism is that its willingness to sacrifice individual interests to promote the welfare of society as a whole violates the Kantian maxim that people should be treated as “ends in themselves”, never merely as means to the ends of others.48 This rules out exploiting people for the benefit of others, but raises the question of how far such a principle should extend. Some theorists believe that respecting people as ends in themselves entails leaving them alone as much as possible. This would imply that our rights are largely negative ones forbidding others, including the state, from interfering in our lives. The problem with this is that people have very different natural and social endowments, ranging from inherited wealth and education through talents, health and disability, to natural environment, climate and resources. Leaving people to fend for themselves in this context leads to great disparities in peoples’ life chances. This in itself can be viewed as a violation of the principle that people should be respected equally as ends in themselves, and leads many theorists of justice to conclude that, although people’s interests should not be sacrificed merely to benefit others, there is an obligation on those who are relatively fortunate to assist those who are less well-off through no fault of their own. John Rawls, for example, suggests that inequalities of wealth and income should be permitted, but should be limited and arranged in such a way as to produce maximum benefit for the worst-off.49 This view is reflected, at least roughly, in the organisation of many modern societies, including Ireland. Differences in wealth and income are allowed, but the better off are required 47 Buchanan A., Brock D., Daniels N. & Wikler D., From Chance to Choice: Genetics and Justice, p11 (Cambridge University Press, 2000). 48 Kant I. Groundwork of the Metaphysic of Morals (1785). 49 Rawls J. A Theory of Justice (Harvard University Press, 1971). 12 BioEthics_opinion_Inner 23/11/2005 15:21 Page 13 to contribute to a taxation system that is designed, amongst other things, to ensure that the worst-off do not go without essential goods and services. What does all this mean for GM crops? A Rawlsian framework suggests that the ethical assessment of GM crops should take account not only of the extent of any benefits and risks, but of who the recipients of the benefits and risks are likely to be. To the extent that prioritising the needs of the worst off is both defensible and desirable, so is both employing GM technology and regulating market freedom to this effect. In addition, there may be more reason to entertain some risk where the benefits of GM technology are likely to be significant and targeted at the worst-off. Prioritising the needs of the worst-off is especially pertinent in a global context given the greater moral urgency to alleviate conditions of absolute rather than relative poverty. The advantage of the distributive approach is that it puts employing GM technology in the service of central human needs at the core of the justification of its use. Autonomy Autonomy is a central value in the Kantian tradition of moral philosophy. Personal autonomy can be interpreted in various manners but refers generally to the ability to live according to motives that can be defined as our own rather than imposed on us externally. At the core of most interpretations of individual autonomy is the idea that people should have and exercise the right to reflect, choose, and act on the basis of desires and values that are somehow personal and authentic, and on the basis of adequate information, understanding and reflection. In relation to the potential adoption of GM crops, structures that allow consumers and farmers to make informed choices about whether to avail of the technology and its products will be required to protect individual autonomy. It should also be noted, however, that the freedom of individuals to pursue their autonomous choices must be constrained by the obligation to avoid causing harm to others. T h e Pr e c a u t i o n a r y Pr i n c i p l e The main reason the public has refused GM crop technology has been perceived food safety and environmental dangers.50,51,52 Although every effort is made by the scientific community to ensure a high level of confidence in the knowledge it generates, elements of uncertainty are unavoidable in science, and this is especially true of a rapidly developing field like genetics. 13 50 European Commission, The Europeans and Modern Biotechnology: Eurobarometer 46.1, European Commission Directorate General XII. Science, Research and Development, Brussels (1997), http://europa.eu.int/comm/public_opinion/archives/ebs/ebs_108_en.pdf 51 GM NATION? The findings of the public debate (2003), http://www.gmnation.org.uk 52 Report of the Irish Council for Bioethics Public Consultation on Genetically modified Crops/Foods, see Appendix. BioEthics_opinion_Inner 23/11/2005 15:21 Page 14 Uncertainty and gaps in scientific knowledge introduce risks when science embraces medicine, engineering and technology as a means of delivering benefits to humanity. The Precautionary Principle is frequently advocated in face of potential risks posed by new technologies, and has been incorporated into a number of international treaties, including that of the European Community.53 Formulations of the Precautionary Principle vary, but in general it calls for a cautious approach to the adoption of new technologies in cases where science does not provide a clear estimate of the magnitude of its associated risks. The principle is most frequently invoked in relation to environmental risks, but may be applied to other areas of scientific uncertainty, including risks to human health. The Precautionary Principle itself is a matter of debate. Much of the discussion, particularly of its legal implementations, has focused on how the principle should be applied.54 The principle is usually taken to include the following injunctions: decision-makers should act to avoid harm in advance of scientific certainty concerning risks; the burden of proof should be shifted onto the proponent of an activity, rather than left to those who are reasonably concerned about potential dangers. If the feared outcome is sufficiently serious, even weak evidence that the risk is real may be sufficient to justify action.55 However, while we should be prepared to act in advance of scientific certainty to prevent serious outcomes, we should not sacrifice the benefits of a technology on spurious grounds. The philosopher Hans Jonas has described a fear heuristics, which consists in thinking of the worst possible consequences before making decisions. This approach can significantly undermine technological progress and lead to the loss of great benefits. 53 Article 174, Maastricht Treaty (1992). 54 European Commission, Communication from the Commission on the Precautionary Principle, Brussels, 2.2.2000 COM (2000) 1 final, and O’Riordan T. and Cameron J. (eds.), Interpreting the Precautionary Principle (Earthscan, London, 1994). 55 Shrader-Frechette K.S. Risk and Rationality. ch. 9 (University of California Press, 1991). 14 BioEthics_opinion_Inner 23/11/2005 15:21 Page 15 Health Impact of GM Crops So far, GM improvements in crop varieties have mainly focused on alleviating agricultural fieldlevel problems (weed and pest control) and have yet to deliver substantial health or financial benefits for consumers. Typically, genes conferring herbicide-tolerance and/or pest-resistance have been incorporated into a wide range of food crops (maize, soybean, sugar beet, oilseed rape, potato and cotton). Although the management of these crops may in some cases reduce the amount of pesticides and herbicides consumers ingest with their food, the European public is not convinced that they are likely to benefit their health. Current research into the development of nutrient-enhanced and medicinal crops aims to benefit consumer health more directly.56 Alongside legislative debates, the European Commission invested in a European-wide interdisciplinary research programme with the aim of reassessing the public health implications of implementing GM crops and foods in Europe. The result of this work has been the publication of an in-depth review of the health risks associated with the introduction of GM technology into farming practice, with an emphasis on risk evaluation, safety assessment, and testing methods.57 There are two levels at which GM crops and their derived foods must be examined. First of all, does GM technology itself introduce risks for consumer health? Secondly, does the new trait of the GM crop impact negatively on the plant’s production of nutrients or engender other health risks? G e n e t i c M o d i f i c a t i o n Te c h n i q u e s Several methods have been developed to genetically modify plants, two of which are relevant for current crops. The first method uses the bacterium Agrobacterium tumefaciens, which has been referred to as “nature’s genetic engineer” because it normally transfers some of its own genes into the cells of plants it infects. Agrobacterium stores the genes it will insert in a circular piece of DNA, referred to as a plasmid. Genetic engineers hijack this bacterium’s natural GM process by replacing most of the genes of its plasmid with ones that may be useful to the crop. The engineered plasmid is called the vector of genetic modification and the GM process will be carried out by the bacterium as if it were infecting a plant. The second GM technique involves the coating of gold or tungsten particles with the vector that is then delivered at high speed into the plant cell where the gene(s) can integrate with the host genome using a “Gene Gun”. 15 56 For a review of the potential developments in GM crops, see section: Applications of Genetic Modification, p7. 57 European Network on Safety Assessment of Genetically Modified Food Crops (ENTRANSFOOD). The results of this research have been published in a special issue of Food and Chemical Toxicology 42 (7), 1043-1202 (2004), available at http://www.entransfood.com BioEthics_opinion_Inner 23/11/2005 15:21 Page 16 DNA vectors typically contain genes, other than the gene of interest, which are bacterial or viral in origin. These genes do not cause infection and are included to help integrate the gene of interest, which is commonly identified and/or produced in bacteria, into the plant’s chromosomal DNA. The main reason for their use is that, being relatively simple organisms, bacteria and viruses have been extensively studied and are relatively well determined. In its current state, GM technology relies on an antibiotic resistance gene, which is included in the DNA vector, to identify plant cells that have been successfully modified. This gene is called a marker gene; it renders the cells that have incorporated the gene of interest resistant to a particular antibiotic, thus allowing for their selection when the antibiotic is applied to a selective media on a petri dish. R i s k s I n t r o d u c e d b y t h e Te c h n o l o g y Regardless of the delivery technique used, the integration site(s) of the transferred gene(s) in the host genome cannot be predicted. As a result, the insertion of a new gene may interrupt the expression or regulation of a gene that is encrypted in the plant’s DNA. Genes are expressed as proteins only when attached to DNA sequences called promoters (at the front) and termination sequences (at the end). It has been shown that the promoter attached to the gene inserted can affect the expression of neighbouring or associated plant genes. Either of these scenarios could potentially affect the crop’s nutritive content by disturbing the plant’s metabolism.58,59 While major changes in the structure or expression of the host plant genome can result in the failure of that plant to reproduce and/or survive, less catastrophic changes resulting in the production of new or altered levels of nutrients or toxins would most likely be detected during the stringent quality control testing that GM crops must currently undergo before they are approved for food use (nutrients and toxins must be assessed).60 The horizontal gene transfer (the transfer of genetic material from one organism to another, of the same or different species, by other means than reproduction) of an entire and functional antibiotic resistance gene from ingested GM food to the bacteria in our guts, is a possibility but has never been reported.61 Strategies to avoid the reliance of GM technology on antibiotic resistance marker genes are being developed. The general overuse and misuse of antibiotics, 58 Almon E., Horowitz M., Wang H.L., Lucas W.J., Zamski E. and Wolf S. Phloem-specific expression of the tobacco mosaic virus movement protein alters carbon metabolism and partitioning in transgenic potato plants. Plant Physiology, 115, 15991697 (1997). 59 Thiele A., Herold M., Lenk I., Quail P.H. and Gatz C. Heterologous expression of Arabidopsis phytochrome B in transgenic potato influences photosynthetic performance and tuber development. Plant Physiology, 120, 73-81 (1999). 60 Cellini F., Chesson A., Colquhoun I., Constable A., Davies H.V., Engel K.H., Gatehouse A.M.R, Kärenlampi S., Kok E.J., Leguay J-J, Lehesranta S., Noteborn H.P.J.M., Pedersen J., Smith M. Unintended effects and their detection in genetically modified crops. Food and Chemical Toxicology, 42 (7), 1089-1125 (2004). 61 The World Health Organisation and the Food and Agricultural Organisation of the United Nations expert panels have concluded that this event cannot be completely ruled out and should be considered by risk assessors. Modern Food Biotechnology, Human Health and Development: an evidence-based study. Food Safety Department, World Health Organisation, p15 (23 June 2005). 16 BioEthics_opinion_Inner 23/11/2005 15:21 Page 17 in human and veterinary medicine, is considered to be responsible for widespread antibiotic resistance in bacterial populations. It has therefore been deemed unlikely that horizontal transfer of antibiotic resistance will have a significant impact on human health. Further, antibiotic resistance genes that should not compromise the use of clinically relevant antibiotics have been identified and authorisations will be granted accordingly.62,63 Article 4(2) of Directive 2001/18/EC states that “Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment”’. R i s k s I n t r o d u c e d b y G M Tr a i t s The possibility of creating new allergens has been identified as a risk that does not relate directly to the use of GM technology, but depends on the particular gene that has been added to a GM crop. Allergies develop when an individual is repeatedly exposed to a particular protein allergen. This exposure sensitises the immune system and gradually leads to the triggering of an allergic reaction upon contact with the protein. It is not well understood how certain proteins become allergens, and why certain individuals become sensitised. Scientists have stressed that the most important aspect for GM food safety with respect to allergies, is that every new crop be evaluated on a case-by-case basis. There is an accepted approach, based on a standard set of in vitro and animal safety tests, to assess allergenic potential.64 Fe e d i n g S t u d i e s Feeding studies carried out in farm and laboratory animals (mice, rats, chickens, pigs and cows) have shown that several GM diets appear to be substantively equivalent to their non-GM counterparts.65 However, two independent studies have indicated that GM crop consumption 17 62 Van den Eede G., Aarts H., Buhk H-J, Corthier G., Flint H.J., Hammes W., Jacobsen B., Midtvedt T., van der Vossen J., von Wright A., Wackernagel W., Wilcks A. The relevance of gene transfer to the safety of food and feed derived from genetically modified (GM) plants. Food and Chemical Toxicology, 42 (7), 1127-1156 (2004). 63 A working group (WG) was set up in June 2002 to address the use of antibiotic resistance marker (ARM) genes in GMOs at EU level. Arising form the work of this group, competent authorities under Directive 2001/18/EC have agreed to establish two lists of antibiotic resistance marker genes: one will include antibiotic resistance marker genes which will have to be phased out, while the other will include the antibiotic resistance marker genes which might still be used in GM constructs after a case-by-case risk assessment. 64 König A., Cockburn A., Crevel R.W.R., Debruyne E., Grafstroem R., Hammerling U., Kimber I., Knudsen I., Kuiper H.A., Peijnenburg A.A.C.M., Penninks A.H., Poulsen M., Schauzu M., Wal J.M. Assessment of the safety of foods derived from genetically modified (GM) crops. Food and Chemical Toxicology, 42 (7), 1047-1088 (2004). 65 A list of peer-reviewed published feeding studies can be found at: http://www.agbioworld.org/biotech-info/articles/biotechart/peer-reviewed-pubs.html BioEthics_opinion_Inner 23/11/2005 15:21 Page 18 may irritate the digestive tract of rodents.66,67 One of these studies, Professor Arpad Pusztai’s study of GM potatoes, has been discredited as represented in a report of the UK Royal Society.68 A further two studies have shown minor effects on the weight of animals fed on GM diets.69,70 It is likely that these unexpected results are linked, either to the specific gene added to the GM crop tested, or, more specifically, to the particular side-effects of a genetic transformation event which can potentially disturb plant metabolism as discussed above. In addition, animal feeding studies involve statistical analysis and an interpretation of the results, which can vary between scientists. This was exemplified in 2005, when the European Food Safety Authority (EFSA) issued a positive safety opinion on GM maize MON863 following the assessment of a rat feeding study provided by Monsanto. The GMO panel of the EFSA, composed of twenty one independent scientists, was not unduly concerned by minor differences in blood sugar levels, kidney development and immune status observed between animals fed on GM MON863 corn and controls that were given a conventional corn diet. However, Professor Pusztai came to different conclusions, and considered that these were indeed biologically significant differences. Critics of GM technology have suggested that human feeding trials, conducted in a manner similar to clinical trials, should be carried out in order to provide further safety evidence. Given the diversity of human diets, and the nature of the proposed risks, such an assessment would be virtually impossible to realise. It is worth noting that to date there have been no verifiable toxic or nutritionally deleterious effects from the consumption of GM crops or their derived foods. This can be seen as a good indication of their general safety, given their widespread consumption in North America for close to a decade. Nevertheless, this does not rule out the possibility of problems emerging in the future, hence the need for careful monitoring. A scientific risk assessment involves predicting possible harmful consequences and estimating their likelihood in order to generate some measure of the risk taken. Successfully predicting the consequences any new technology may engender is extremely difficult, and unanticipated side effects commonly emerge from the introduction of new technologies. The risks reviewed above should not cause panic; they reflect the inherent nature of scientific progress, which will always involve some side effects. 66 Ewen S.W.B. and Pusztai A. Effects of diets containing genetically modified potatoes expressing Galanthus nivalis lectin on rat small intestine. The Lancet, 354, 1353-1354 (1999). 67 Fares N.H. and El-Sayed A.K. Fine Structural Changes in the Ileum of Mice Fed on Delta-Endotoxin-Treated Potatoes and Transgenic Potatoes. Natural Toxins, 6 (6), 219-233 (1998). 68 In June 1999 the Royal Society published Review of data on possible toxicity of GM potatoes available at: http://www.royalsoc.ac.uk/displaypagedoc.asp?id=6170 69 Zhu Y., Li D., Wang F., Yin J., Jin H. Nutritional assessment and fate of DNA of soybean meal from Roundup Ready or conventional soybeans using rats. Arch Anim Nutr, 58 (4), 295-310 (2004). 70 El Sanhoty R., El-Rahman A.A., Bogl K.W. Quality and safety evaluation of genetically modified potatoes spunta with Cry V gene: compositional analysis, determination of some toxins, antinutrients compounds and feeding study in rats. Nahrung, 48, 13-18 (2004). 18 BioEthics_opinion_Inner 23/11/2005 15:21 Page 19 R e g u l a t o r y Fr a m e w o r k The EU regulatory framework for the approval of GM products has been updated in consideration of the work carried out by the ENTRANSFOOD research programme. Directive 2001/18/EC provides strict guidelines for the scientific assessment each GM crop must undergo for approval (each modification event of each individual trait for every crop type), and includes a thorough evaluation of the possible risks for human health.71 The guidance document prepared for the EU Scientific Steering Committee by the Joint Working Group on Novel Foods and GMOs (6-7 March 2003) outlines reasonable means of minimising the potential dangers: consideration will be given to all elements of GM vectors; resistance genes for medically useful antibiotics are to be avoided; and an extensive analysis of the crop’s nutritive content, toxicity, and allergenicity must be carried out. Regulation (EC) No 1829/2003 details the authorisation procedure and labelling criteria for GM food and animal feed. Authorisations, valid throughout the Community, are subject to a single risk assessment under the responsibility of the European Food Safety Authority and a single risk management process involving the Commission and the member states through a regulatory committee procedure. The current EU regulatory process, applied rigorously, is a reasonable implementation of the Precautionary Principle in respect of human health protection. “Nothing would be done at all if a man waited till he could do it so well that no one could find fault with it”, Cardinal John Henry Newman. 71 19 Directive 2001/18/EC has been transposed into Irish law as S.I. No. 500 (2003). BioEthics_opinion_Inner 23/11/2005 15:21 Page 20 Environmental Impact of GM Crops There has been considerable public concern regarding the impact GM crops may have on the environment and biodiversity. There is some evidence that a reduction in pesticide use and an increase in biodiversity can be achieved with the improved management regime of particular GM crops,72 however, their promise to deliver more sustainable farming practices has been contested.73 H o r i z o n t a l G e n e Tr a n s f e r Horizontal gene transfer between GM crops and soil bacteria has been raised as a potential risk of genetic modification. However, considering the horizontal transfer of an entire and functional antibiotic resistance gene to bacterial hosts in the soil occurs at low frequencies, if at all, the use of these marker genes in GM plants is not likely to significantly increase the problem of antibiotic resistant bacteria. Gene Flow The risk of GM traits spreading out of the farming environment, through seed dispersion or cross-pollination between GM crops and wild relatives or other crop varieties, has been the focus of many critics of the technology. In 2001, the scientific journal Nature published evidence that transgenic maize genes had become incorporated by cross-pollination into landraces of maize in Mexico.74 The publication was subsequently retracted for experimental flaws, but has highlighted the importance of giving due consideration to the potential consequences of gene flow.75 The risk of gene flow is essentially identical to that of conventionally bred crop varieties and has been identified as a threat to biodiversity following experience with the introduction of exotic plants into native ecosystems worldwide. The flow of DNA from crops to wild relatives may impact on the genetic identity and integrity of wild populations and could affect local genetic diversity. 72 See the results of the UK Farm Scale Evaluations of herbicide-tolerant crops: the UK Department for Environment, Food and Rural Affairs, GM crops: Non technical summary, effects on farmland wildlife (2005), http://www.defra.gov.uk/environment/gm/fse 73 See various NGOs: Greenpeace (http://www.greenpeace.org/international), Friends of the Earth (http://www.foe.co.uk), GeneWatch (http://www.gene-watch.org), Institute of Science in Society (http://www.i-sis.org.uk), Union of Concerned Scientists (http://www.ucsusa.org). 74 Quist D. and Chapela I. Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico. Nature, 414, 541–3 (2001). 75 According to the Food Safety Department of the World Health Organisation, the introgression of transgenic DNA into traditional landraces of maize in Mexico has recently been confirmed (Modern Food Biotechnology, Human Health and Development: an evidence-based study. Food Safety Department, World Health Organisation, p18, 23 June 2005), however, a recent peer reviewed publication has failed to detect any transgenic DNA in the same Mexican landraces of maize: Ortiz-García S., Ezcurra E., Schoel B., Acevedo F., Soberón J. and Snow A.A. Absence of Detectable Transgenes in local landraces of maize in Oaxaca, Mexico (2003-2004). Proc Natl Acad Sci USA, 102 (35), 12338-12343 (2005). 20 BioEthics_opinion_Inner 23/11/2005 15:21 Page 21 The risk of hybridisation mainly depends on the extent to which wild relatives that can interbreed with the GM crop are present in the environment. Irish farmers grow a variety of native and non-native crops: wheat, potatoes, barley, peas, runner beans, and maize do not have inter-fertile wild relatives in Ireland; ryegrass, clover, sugar beet, oats, carrots, oilseed rape and apples are either native or inter-fertile with other wild relatives. Commercial varieties of GM crops that could soon be available to Irish farmers include: GM sugar beet, maize, potato, fodder beet, oilseed rape, fodder rape, and swede rape. Maize and potato are the only ones that do not have wild relatives in the Irish flora.76 It would be relatively difficult and costly to completely isolate cultivated GM crops from their surrounding environment, but there are farming practices that can be deployed to minimise what has been referred to as “genetic contamination”. Irish wheat, barley, and potato are predominantly inbreeding and would typically require small isolation distances (of under 20 metres) to ensure less than 0.5% of the pollen reaches prospective hybrid partners. However, crops such as maize, oilseed rape, and sugar beet, require much larger distances for physical isolation (estimates range from a few hundred metres to kilometres).77 GM crops escaping the farmland, or hybrids resulting from GM pollen mixing with relatives, present a serious threat to biodiversity if the GM trait acquired confers a significant advantage in the “wild” environment. This is not the case for crops designed to resist a particular herbicide, and is unlikely to concern crops modified in respect of their nutritional content, but could raise concern for pest-resistant crops or crops designed for growth performance (competitive advantage). The issue of gene flow will also be of greater concern for future non-food GM crops. Several studies have shown that transgene stability is a determinant factor of crop fitness and can affect seed production and the rate of GM crop out-crossing.78,79 In view of limiting the introgression of GM traits into wild populations, researchers are examining new GM techniques that offer control over the expression or spread of gene inserts (chemically-inducible promotors80 and transplastomic crops81).82 Terminator technology, which makes GM plants produce sterile seeds, has been developed to counter environmental concerns and protect the intellectual property rights of biotechnology seed companies, but it has been heavily criticised for amplifying farmer dependence on suppliers. 21 76 Meade C.V. and Mullins E.D. GM crop cultivation in Ireland: ecological and economic considerations, Biology and Environment: Proceedings of the Royal Irish Academy, 105B, No. 1, 33-52 (2005). 77 Eastham K. and Sweet J. GMO’s: the significance of gene flow through pollen transfer. European Environment Agency, Environmental Issue Report No. 28, Copenhagen (2002). 78 Purrington C.B. and Bergelson J. Fitness consequences of genetically engineered herbicide and antibiotic resistance in Arabidopsis thaliana. Genetics, 145, 807-14 (1997). 79 Bergelson J., Purrington C.B., Wichmann G. Promiscuity in transgenic plants. Nature, 395, 25 (1998). 80 Zou J. and Chua N-H. Chemical-inducible systems for regulated expression of plant genes. Current Opinion in Biotechnology, 11, 146-151 (2000). 81 Belzile F.J. Transgenic, transplastomic and other genetically modified plants: a Canadian perspective. Biochimie, 84, 11111118 (2002). 82 Transplastomic GM crop technology aims to insert the transgene into the DNA of a plant cell organelle such as the chloroplast rather than into the DNA of the cell nucleus because this DNA does not spread via pollen. Chemically-inducible promotors would allow the expression of GM traits to be controlled. BioEthics_opinion_Inner 23/11/2005 15:21 Page 22 E n v i r o n m e n t a l I m p a c t o f Pa r t i c u l a r Tr a i t s A founding principle of natural selection is that submitting an organism to pressure will increase its probability of evolutionary adaptation; this is how bacteria developed antibiotic resistance. The wide-scale implementation of herbicide-resistant crops could eventually lead to the emergence of weed varieties that resist the particular herbicide.83 The same process occurs whereby target insects become resistant to an insect-resistant GM crop through mutation and natural selection. The incorporation of pest refuges into Bt-corn farming has been shown to delay the emergence of resistant strains of corn borer, as the refuges provide feeding and reproduction grounds for Bt-susceptible pests.84 The situation is similar to that of conventional crop varieties managed using agro-chemicals (herbicides and pesticides), and the trait of herbicide tolerance is not specific to GM crops, it has also been produced by conventional selective breeding techniques.85 More than 120 herbicide-resistant weed species have emerged worldwide over the last 40 years from sub-optimal herbicide-resistant crop management.86 The impact of transgenic pest-protection strategies on non-target organisms has also raised concern. A laboratory study published in 1999 stirred the research community by announcing that the insecticidal Bt protein produced by GM corn and targeted at the European corn borer could potentially harm monarch butterfly larvae.87 This led to a collaborative research programme to assess the impact of GM Bt-maize on the butterfly under field conditions. The researchers found that although Bt pollen has a toxic effect on the larvae, pollen densities are too low to pose a significant risk for the monarch butterfly.88 The concept of baseline environmental impact is relevant because there is good evidence that the pesticidal sprays used on maize may be more harmful to the monarch butterfly than Bt-corn pollen. The fate and consequence of insecticidal or other toxins in soil must also be considered. Bacillus thuringiensis is a common soil-borne bacterium that normally releases Bt toxins into the soil, but crop sources (pollen, root secretion, dead plant material incorporated into the soil after harvest) are likely to result in additional exposure of soil organisms to Bt. Studies of Bt toxicity on a wide variety of terrestrial and aquatic invertebrates, as well as counts of soil organisms (nematodes, protozoa, bacteria, and fungi), indicate that the impact is very small compared with baseline environmental impact.89,90 83 This is an evolutionary acquiring of the resistance, which is distinct from the spread of GM resistance traits through gene flow (discussed above in section Gene flow). 84 Requested by the US Environmental Protection Agency for Bt-corn cultivation. 85 The case of Pioneer’s Hi-Bred Smart Canola oilseed rape is reported in New Scientist, 27 February 1999, p4. 86 From both GM and conventional crop varieties, see UK GM Science Review Panel, An open review of the science relevant to GM crops and food based on the interests and concerns of the public first report (July 2003), http://www.gmsciencedebate.org.uk/default.htm 87 Belzile F.J., Transgenic, transplastomic and other genetically modified plants: a Canadian perspective. Biochimie, 84, 11111118 (2002). 88 Sears M.K., Hellmich R.L., Stanley-Horn D.E., Oberhauser K.S., Pleasants J.M., Mattila H.R., Siegfried B.D., Dively G.P. Impact of Bt corn pollen on monarch butterfly populations: a risk assessment. Proc Nat Acad Sci USA, 98, 11937-11942 (2001). 89 Sims S.R., Bacillus thuringiensis var kurstaki [CryIA(c)] protein expressed in transgenic cotton: effects on beneficial and other non-target insects. Southwestern Entomologist, 20, 493-500 (1995). 90 Saxena D. and Stotzky G. Bacillus thuringiensis (Bt) toxin released from root exudates and biomass of Bt corn has no apparent effect on earthworms, nematodes, protazoa, bacteria and fungi in the soil. Soil Biology and Biochemistry, 33, 1225-1230 (2001). 22 BioEthics_opinion_Inner 23/11/2005 15:21 Page 23 Several GM plants are being developed with the specific aim of addressing environmental concerns.91 GM poplars that allow a more environmentally friendly paper production process and GM thistles grown for electricity generation are good examples. Eventually, it may be possible to grow oil and carbohydrate crops, and special rapeseeds for fuel, lubricants, and plastics. Coloured cotton is already available on a niche market basis and reduces the need for chemical dyes. These developments may well alleviate environmental burdens, however, they could still present environmental threats in themselves. Overall Environmental Impact There are contesting views about the global impact GM crop farming will have on the environment and wildlife. All farming practices affect the environment, but will GM crop farming practice affect it more or less than conventional crops? With the “Green Revolution” of the 1960s, agrochemicals started to replace tillage and cultivation practices of weed control. In Ireland, 90% of cultivated land is given to pasture, meadow and silage,92 nevertheless, arable fields are still an ecological resource and support a wide range of plants and animals.93 Changing agricultural practices through intensification, the switch from spring to winter crops, a loss of marginal hedgerows, and an overall decrease in the area under cultivation, has resulted in a dramatic decline of many species dependent on arable practices.94 In 1999, the UK government asked an independent consortium of researchers to investigate the impact of herbicide-tolerant GM crops on the abundance and diversity of farmland wildlife compared with growing their conventional equivalents; GM herbicide-tolerant winter and springsown oilseed rape, sugar beet, and maize were tested.95 These farm scale evaluations are the largest ever field trials of GM crops (266 fields). The results showed that different GM crops have varying degrees of positive and negative impacts on different weed and insect species. GM maize was overall less environmentally damaging than its conventional counterpart. Researchers stress that the differences they find do not arise from the genetic modification of the crops, but from the new weed control options they offer farmers; different herbicides are used and applied differently. This emphasizes again the importance of a case-by-case evaluation of each GM crop. 23 91 Economic Impact of Genetically Modified Crops on the Agri-food Sector, a first review. Working document rev.2 DirectorateGeneral for Agriculture, Commission of the European Communities. p20 92 Crop and livestock survey, Central Statistics Office, Dublin (2002). 93 Taylor A.J. and O’Halloran J. The decline of the Corn Bunting (Miliaria calandra) in the Republic of Ireland, with reference to other seed eating farmland birds. Biology and Environment: Proceedings of the Royal Irish Academy, 102B, 165-175 (2002). 94 Meade C.V. and Mullins E.D. GM crop cultivation in Ireland: ecological and economic considerations, Biology and Environment: Proceedings of the Royal Irish Academy, 105B, No. 1, 33-52 (2005). 95 The results of the UK Farm Scale Evaluations of herbicide-tolerant crops: The UK Department for Environment, Food and Rural Affairs, GM crops: Non-technical summary, effects on farmland wildlife (2005), http://www.defra.gov.uk/environment/gm/fse BioEthics_opinion_Inner 23/11/2005 15:21 Page 24 Impact of GM Crop Technology on General Welfare Irish Consumers Research into the public perception of risk has shown that many factors, including whether individuals have control over a risk (the choice of taking it or not) and whether it is equally distributed, play a significant role in determining the public acceptance of risk.96 In general European consumers feel that the risks associated with GM crops and foods would only be worth taking if the benefits substantially outweighed the risks.97,98 Early research into GM focused mainly on alleviating agricultural difficulties, such as improving weed and pest control or increasing the shelf life of certain foods. While these improvements clearly benefited farmers, the chemical/biotechnology industry, and food manufacturers, benefits to consumers were less obvious. Whereas consumers perceived numerous risks e.g., negative health and environmental effects, greater control of markets by multinational biotechnology companies and thus greater disadvantage to developing countries, they perceived little or no direct benefits to themselves. Recent research has taken these perceptions into account and has focused on developing GM products which have direct benefits for consumers, such as increasing the nutritional value of foods (e.g., inserting more Omega-3 fatty acids which benefit the heart), eliminating allergenic proteins in certain foods (e.g., nuts), and allowing pharmaceuticals and vaccines to be produced in crops (e.g., potatoes being grown containing small amounts of the cholera toxin which would immunise against the disease once ingested). Public acceptance of GM is likely to grow with the development of GM products that are of tangible benefit either to individuals or to society. Perceived knowledge about GM is also expected to have an influence on risk-benefit perceptions i.e., people perceive risks that are familiar to them to be lower than those that are unfamiliar.99 Worldviews and trust play a significant role in framing perceptions and indeed misperceptions of biotechnology.100 Research has suggested that public perceptions of GM technology are due in part to the manipulation of opinion by interest groups and the media.101 96 Slovic P. Perception of risk. Science, 236, 280-285 (1987). 97 European Commission, The Europeans and Modern Biotechnology: Eurobarometer 46.1. European Commission Directorate General XII. Science, Research and Development, Brussels (1997), http://europa.eu.int/comm/public_opinion/archives/ebs/ebs_108_en.pdf 98 GM NATION? The findings of the public debate (2003), http://www.gmnation.org.uk 99 Miller H. The Emotional Response to Risks: Inevitable but not unmanageable. AgBioForum, 1 (1), 14-16 (1998), http://www.agbioforum.org 100 Siegirst M. The Influence of Trust and Perceptions of Risk and Benefits on the Acceptance of Gene Technology. Risk Analysis, 20 (2), (2000). 101 Renn O., Burns W.J., Kasperson J.X. The Social Amplification of Risk- Theoretical Foundations and Empirical Applications. Journal of Social Issues, 48 (4), 137-160 (1992). 24 BioEthics_opinion_Inner 23/11/2005 15:21 Page 25 A widely supported solution is the dissemination of accurate risk information by credible and trustworthy sources. In Scotland, the Department of Agriculture have set up a website, which provides information on both the risks and benefits of GM technology and is accessible to the general public.102 In order to ensure that consumers’ perceptions of GM crops are based on balanced risk information, it may be beneficial that a similar database be established in Ireland. Dialogue and Transparency There is an increasing awareness that legislating without considering citizens’ participation, especially in matters that affect them directly, is wrong. EU legislation concerning the regulation of GM crops and foods has responded to developments in public concern and Directive 2001/18/EC103 outlines Community obligations to improve transparency throughout the different stages of their authorisation and subsequent handling. This includes mandatory information for the public, including access to lists of GM users and products currently approved or pending notice. In Ireland, a register of GMO users is maintained by the Environmental Protection Agency (EPA) and is open to the public for inspection. Additionally, the EPA GMO advisory committee includes representation from consumer interest groups. Autonomy The right to abstain from using/consuming GMOs should be protected for each individual within reasonable limits. However, this right should not be extended to impose particular views on the general public and must not be to the detriment of others. For example, Food Safety Authority of Ireland surveys have shown that many processed foods have low levels of GM maize or soya ingredients that are below the labelling threshold. While it would be ideal, though not possible for a number of reasons, to have all GM containing foods labelled as such, it would be unreasonable and impractical to ban all processed food on the basis that some may contain low levels of GM ingredients.104 Labelling legislation drawn up at the European level and transposed into Irish law in 2001 was established to guarantee that the autonomy of European consumers is maintained. Regulations (EC) 1829/2003 and (EC) 1830/2003 ensure adequate labelling and GM product traceability. Any food product containing above 0.9% of GM ingredients must be labelled “this product contains genetically modified organisms”, regardless of the presence or absence of DNA or proteins from the original GMO. This threshold is meant to account for unintentional contamination, which may occur as a result of gene flow or along the production line. 25 102 http://www.scotland.gov.uk/gm 103 Regulation for the deliberate release of GMOs into the environment (2001). 104 A study carried out by the Food Safety Authority of Ireland also detected GM material below the labelling threshold (0.9%) in several food products carrying GM-FREE or organic labels (GM Food Survey 2002, published April 2003). BioEthics_opinion_Inner 23/11/2005 15:21 Page 26 A temporary lower tolerance level for non-authorised GM food/feed has also been introduced (0.5%), provided that the crop has been subjected to an acceptable EU safety assessment. There is a risk that labelling and traceability generate suspicion towards GM foods, but it has been deemed necessary to allow individuals to consume according to their convictions. Labelling incorporating information about the origin of the gene introduced may allow vegetarians, vegans, and other adepts of particular diets, to reap the benefits certain GM products may deliver without compromising their beliefs. I r i s h Fa r m e r s Is the introduction of GM crops into Irish agriculture likely to increase the welfare of Irish farmers? A survey of US growers showed that the adoption of GM crops was driven by strong profitability expectations, yet economic analyses show variable results.105 Profitability In very broad terms, herbicide and pest resistant crops should be profitable for growers, despite the higher cost of their seed, because less agrochemicals, energy, and labour should be required to manage these crops and increases in crop yields can be expected. However, due to the emergence of resistant pests and weeds, and other potential problems,106 additional chemical treatments may gradually become necessary. One study of herbicide-resistant soybean showed an increase of 15-25% in terms of average pounds of herbicide necessary per acre from one year to the next in America. Crop yields may also be reduced by the incorporation of pest refuges to delay the emergence of resistant insects.107 The economic benefits of Bt insectresistant maize vary from year to year, depending mostly on the burden of the corn borer. A study conducted by the United States Department of Agriculture did not find evidence of a significant change in variable profits in 1997, the year following a dramatic increase in GM soybean sowing. However, some crops have shown more promising results. In Canada, the proportion of farmers growing GM herbicide-resistant canola (a variety of oilseed rape) has increased from 7% in 1995 to 80% in 2000. The Canola Council of Canada commissioned a study to look at the results of this culture. In 2000 alone, net return by acre increased by 32%, pesticide use was reduced by 6000 tons and fuel consumption by 31 million litres. These 105 Economic Impact of Genetically Modified Crops on the Agri-food Sector, a first review. section 3, Working document rev.2 Directorate-Geberal for Agriculture, Commission of the European Communities. 106 Other potential problems include the presence of herbicide-resistant volunteers (of particular concern in sugar beet farming) and the stacking of herbicide resistance genes from the hybridisation of different herbicide-resistant GM varieties grown without the appropriate isolation distances, see Hall L., Topinka K., Huffman J., Davis L., Good A. Pollen flow between herbicide-resistant Brassica napus is the cause of multiple-resistant B. napus volunteers. Weed Science, 48, 688-694 (2000). 107 Requested by the US Environmental Protection Agency for Bt-corn cultivation. 26 BioEthics_opinion_Inner 23/11/2005 15:21 Page 27 represent real tangible benefits for the farmer and the environment.108 However, estimates of the effect on crop yield in Alberta range from an increase to a decrease of 15% depending on the region and variety of canola, indicating that multiple factors are determinant of GM crop productivity.109 These varying degrees of profitability suggest that in practice the motivation of farmers to adopt GM crops has been a combination of their satisfaction with the yield increase and/or the decrease of input costs, along with their ease of management (a convenience effect). A system that provides more flexibility and reduces labour time may appeal to Ireland’s part-time farmers even if they do not benefit economically. In a US survey, 12% of growers listed increased planting flexibility as a reason to opt for GM crops.110 The potential impact of GM crop cultivation must be evaluated on a case-by-case basis. Of the arable Irish cropland, approximately two-thirds are dedicated to cereals and maize and the rest to fruit, vegetables, and root crops. An Irish study has examined crops that would be relevant in Ireland (winter wheat, sugar beet, spring barley and potato), and carried out an economic cost-benefit analysis of their implementation in Irish agriculture.111 The results confirm that GM crops have varying degrees of potential to increase crop profitability and must be assessed individually. Tourism Ireland and Board Bia have carefully cultivated a “clean green” image for Ireland in the last number of years, so that people want to eat what we produce and experience our unspoilt environment. The agri-food sector accounts for approximately 8% of our GDP,112 and a total foreign and domestic tourism revenue of €5.1 billion was generated in 2004.113 Concerns have been raised by The Green Party,114 Sustainable Ireland,115 and The Irish Cattle and Sheep Farmers Association,116 that Ireland’s “clean green” image would be adversely affected should Ireland choose to grow GM crops, thereby exerting a deleterious effect on the Irish economy. Ireland is by no means the only country to use the “clean green” image as part of its marketing strategy. In 2001, as part of the New Zealand Government formulation of policy on genetically modified crops, the Ministry for the Environment commissioned a report to estimate 27 108 http://www.canola-council.org/production/gmo_toc.html 109 Economic Impact of Genetically Modified Crops on the Agri-food Sector, a first review. section 3, Working document rev.2 Directorate-Geberal for Agriculture, Commission of the European Communities. 110 Ibid. 111 Flannery M-L., Thorne F.S., Kelly P.W., Mullins E. An economic cost-benefit analysis of GM crop cultivation: an Irish case study. AgBioForum, 7 (4), 149-157 (2004). 112 http://www.teagasc.ie/agrifood 113 http://www.failteireland.ie, see Preliminary Tourism facts 2004. 114 http://www.greenparty.ie/en/library/annual_convention_cork_2005/speeches/ireland_s_clean_and_green_environment_is_key_ to_our_future 115 http://www.sustainable.ie/resources/food/art01.htm 116 http://www.icsaireland.com BioEthics_opinion_Inner 23/11/2005 15:21 Page 28 the dollar value of New Zealand’s “clean green” image.117 The report found that New Zealand’s environmental image is a key factor in the value of their goods and services on the international market. The report noted that, in the short-term, limited field trials of GM crops for research purposes would not affect New Zealand’s organic sector. However, in the longer term, buyers would probably source organic produce from other markets. It was also noted that a policy of uncontrolled release would almost certainly see New Zealand suffer immediate losses in the organic sector. Therefore, it is reasonable to assume that Ireland’s “clean green” image does in fact have a euro value. It has been argued in the context of the GM debate that Ireland’s “clean green” image is exactly that, an image rather than a reflection of the reality. Traditional agricultural practices have placed stresses on the environment, which has caused pollutants to enter surface and ground water supplies and even the food chain. In fact, almost half of all river pollution in Ireland is caused by agriculture. In particular, the eutrophication of rivers and lakes due to phosphorus loss from farming is the most critical impact of agriculture on water quality in Ireland.118 Ireland’s “clean green” image has been further dented following the admission that Ireland’s “greenhouse gas” emissions are almost double the target outlined in the Kyoto Protocol despite decreases in the emission of some greenhouse gases.119 These examples of environmental problems in Ireland are by no means exhaustive nor do they reflect the overall trend but they help to assuage the perception of Ireland’s wholly “clean green” image with a more realistic one. Therefore, fears over the loss of Ireland’s “clean green” image, solely on the basis of the introduction of GM crops, would appear to be somewhat misplaced. Consumer desires should not be neglected in economic analyses of the profitability of GM crops. Retailers in Europe have a strong market power and their strategy is to anticipate and amplify consumer demands. This has a cascading impact on the whole of the food industry: food processors, grain suppliers, and ultimately farmers. Given that GM foods will be labelled, the benefits of GM technology must be passed on to those who are taking to some extent a risk (even that of a perceived risk), and therefore GM products that do not present direct consumer benefits will most likely be sold at cheaper prices. Economic studies that are based on the premise that GM and non-GM crops will be sold at similar prices may be misleading. Further, segregation and monitoring expenses, which are likely to result from consumer and non-GM farmer concerns, should be given due thought. Biotechnology, in its most general form, has been identified as one of the most promising strategies to address the industrial, agricultural, environmental and health issues of the future. 117 The Ministry for the Environment. Our clean green image: What’s it worth? (2001), http://www.mfe.govt.nz/publications/susdev/clean-green-image-value-aug01/clean-green-leaflet-aug01.html 118 Environmental Protection Agency. Ireland’s Environment 2004 – the State of the Environment. Ireland, (2004). 119 European Environment Agency. Annual European Community greenhouse gas inventory 1990-2003 and inventory report 2005. Submission to the UNFCCC Secretariat. EEA Technical report No 4/2005. Luxembourg: Office for Official Publications of the European Communities, (2005). 28 BioEthics_opinion_Inner 23/11/2005 15:21 Page 29 The European Community has recommended that member states develop strong biotechnology sectors in order to become producers in this field.120 In Ireland, successive Governments have emphasised the importance of generating wealth through science and technology based economic development and a National Biotechnology Programme was adopted in 1987. The country has since developed a strong basis of research activity, third-level education, and international and domestic corporate investment in the field, allowing for a place within this competitive knowledge economy. Concerning the cultivation of GM crops in Ireland, a balance needs to be struck between the protection of consumers and farmers, and an eagerness to be in the vanguard of biotechnology. Autonomy The risk of gene flow, from fields planted with GM crops to conventional and organic farms, or of crop contamination further down the production line, could potentially pose a threat to the autonomy and welfare of farmers who wish to produce non-GM products. This has led Irish farmers to establish 1000 GM-free zones around the country in April this year.121 A field study conducted in Australia examined the transmission of herbicide tolerance from GM canola and found that the highest level of contamination in neighbouring fields was 0.07%. This contamination level is well below the 0.9% threshold set by the EU as the limit above which labelling is required. Given that oilseed rape is one of the most out-breeding crops available, the proximity of transgenic crops should not be an obstacle to meeting EU criteria.122 However, organic farmers have established a zero-tolerance rule for GM and their autonomy could be compromised if cooperation is not established within farming communities. The question of respect of farmers’ autonomy also raises the issue of liability in cases where compensations may be sought. In July 2003, the European Commission provided guidance to member states “for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming”.123 Denmark was the first EU member state to draw up proposals for a strategy for coexistence. The report prepared by the Danish Ministry of Food, Agriculture and Fisheries was published in 2003.124 The report concluded that with a limited production in Denmark and provided the use of control measures, coexistence of GM crops with conventional and organic crops was possible for 92% of the crops currently 29 120 European Commission, Beiotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage. COM (94) 219 Final (1994). 121 See details of the GM Free Ireland campaign at http://www.gmfreeireland.org 122 Rieger M.A., Lamond M., Preston C., Powles S.B., Roush R.T. Pollen-mediated movement of herbicide resistance between commercial canola fields. Science, 296, 2386-2388 (2002). 123 The European Commission has published a Recommendation concerning the development of national strategies for the coexistence of GM with conventional and organic farming, Recommendation 2003/556/EC (23 July 2003). 124 Danish Ministry of Food, Agriculture and Fisheries, Report from the Working Group on the coexistence of genetically modified crops with conventional and organic crops (2003), http://www.fvm.dk BioEthics_opinion_Inner 23/11/2005 15:21 Page 30 grown in Denmark. This report provided the basis for the legislation passed by the Danish parliament on coexistence between GM and conventional and organic crops. With the exception of the liability provisions, the law came into force in April 2005. Under the law, growers of GM crops are responsible for maintaining the separation distance requirements and crop rotations as laid out in the 2003 report. In addition, the legislation requires farmers who wish to plant GM crops to inform the Danish Plant Directive of GM crop planting as well as giving prior notice to neighbouring farmers of their intention to plant a GM crop. All farmers who want to plant GM crops are also required to pass a training course and obtain a permit before planting GM crops. In turn, farmers growing conventional or organic crops need to take measures to minimise the adventitious presence of GM material in those crops by controlling volunteer plants and cleaning machinery used in the harvesting of crops. The Dutch Agricultural Ministry has opted not to legislate for coexistence, rather they have supported stakeholders to reach a voluntary agreement on rules on how to separate GM, traditional and organic crops. The Department of Agriculture and Food in Ireland set up an interdepartmental/interagency working group in late 2003 to develop a national strategy and best practices to ensure the coexistence of GM and non-GM crops in Ireland. The working group is expected to report before the end of 2005. The question of the best means of financial redress for farmers who suffer financial loss from their produce exceeding non-GM statutory thresholds as a result of coexistence has generated much debate. The Danish law on coexistence adopts the “polluter pays” principle. Farmers who grow GM crops and are found to be in breach of the legislation, resulting in conventional or organic crops containing GM material above the legal threshold of 0.9%, are liable to pay compensation. In cases where crops become contaminated even when the legislation is adhered to, producers of conventional or organic crops can apply to the government for compensation. Compensation will be financed by a fund based on taxes paid by farmers and on a tax per hectare on GM crops. The Agriculture and Environment Biotechnology Commission in the UK suggests that an insurance system is the best method of dealing with compensation claims.125 They have suggested that monitoring during the introductory period of GM crop cultivation could help an insurance market to develop by providing insurance companies with data in order to assess risk. The development of protocols for coexistence is essential to provide freedom of choice for farmers and consumers in relation to the use or consumption of GM crops/foods. The introduction of control measures for coexistence should be phased in over a period of time, which would allow careful auditing and monitoring of the arrangements. Measures should be updated and/or amended on the basis of new scientifically validated information becoming available. Such a precautionary approach would ensure that the autonomy of both GM and non-GM farmers would be respected. 125 The UK Agriculture and Environment Biotechnology Commission, GM crops? Coexistence and Liability (2003), http://www.aebc.gov.uk/aebc/coexistence_liability.shtml 30 BioEthics_opinion_Inner 23/11/2005 15:21 Page 31 Developing Countries Ireland has a long tradition of supporting developing countries through aid and the deployment of personnel. In 2005 Ireland donated 545 million in Official Development Assistance and by 2012 Ireland should reach the UN aid target of 0.7% GDP.126 Many conceptions of distributive justice define a moral obligation to give priority to meeting the urgent needs of the worst off, and for citizens in developing countries one of the main problems that has been identified is food insecurity.127 Advocates of GM crops claim that GM technology could alleviate world hunger and its associated health problems. Critics argue that the fact that people are still starving in countries with food surpluses indicates that bad governance, poor infrastructure, economic pressures and geographical factors, are more significant than deficiencies in crop production.128 The role GM crops could play in countering food insecurity, now and in the future, should not be disregarded, nor should GM crops be seen as the sole solution to the problems. Potential Benefits The majority of the improvements in crops made through genetic modification have, so far, been associated with increasing crop productivity.129 This advantage has been conferred through developing herbicide-tolerant and pest-resistant GM varieties, and more recently with the development of virus- and fungus-resistant crops. Additionally, GM technology has been used to generate crops that are tailored to particular environments e.g., drought resistant varieties or crops that are tolerant of high soil salinity.130,131 African climates vary so considerably that it is a real challenge to breed varieties that will grow from region to region. The ability to design crops suited to particular regional climatic and environmental conditions would certainly offer benefits to developing countries. One successful example is a GM dwarf strain of basmati rice that has been developed in India, for areas where it is the preferred variety of rice, and which has shown increased yields over strains selected through conventional breeding.132 31 126 Speech by the Taoiseach, Mr. Bertie Ahern T.D. at the General Assembly, 14th Sept 2005. http://www.dci.gov.ie/latest_news.asp?article=573 127 Pinstrip-Anderson P. The future world food situation and the role of plant diseases. American Phytopathological Society (2000), http://www.apsnet.org/online/feature/FoodSecurity/Top.html 128 GM NATION? The findings of the public debate (2003), http://www.gmnation.org.uk. 129 Qaim M. and Zilberman D. Yield effects of genetically modified crops in developing countries. Science, 299, 900-902 (2003). 130 Bänziger M. and Diallo A.O. Progress in developing drought and N stress tolerant maize cultivars for Eastern and Southern Africa. In Friesen D.K. and Palmer A.F.E. (eds.) Integrated Approaches to Higher Maize Productivity in the New Millennium, Proceedings of the Seventh Eastern and Southern Africa Regional Maize Conference. p189-194 (2001), http://www.cimmyt.org/english/docs/proceedings/africa/pdf/42_Banzinger1.pdf 131 Garg A.J., Kim J.K., Owens T.G., Ranwala A.P., Choi Y.D., Kochian L.V. and Wu R.J. Trehalose accumulation in rice plants confers high tolerance levels to different abiotic stresses. Proc Nat Acad Sci USA, 99, 15898-15903 (2002). 132 Peng J., Richards D.E., Hartley N.M., Murphy G.P., Devos K.M., Flintham J.E., Beales J., Fish L.J., Worland A.J., Pelica F., Sudhakar D., Christou P., Snape J.W., Gale M.D. and Harberd N.P. “Green revolution” genes encode mutant gibberellin response modulators. Nature, 400, 256-261 (1999). BioEthics_opinion_Inner 23/11/2005 15:21 Page 32 Some GM improvements may offer additional benefits, for example, GM rice in China requires less pesticide spraying in addition to increasing crop yields.133 This has been shown to lower incidences of pesticide poisoning and could reduce environmental pollution.134 Critics of the technology believe that GM pest-resistant strategies will lead to the evolution of pest resistance to these crops in the long term, which would impact on both GM and conventional agriculture.135 Similar arguments have been made for and against herbicide-resistant GM crops. Therefore, promoting education and changing certain farming practices, such as adopting more integrated approaches to pest control, would be valuable. Biofortification of the micronutrient content of food crops such as cassava, maize, rice, wheat and sweet potatoes is currently being attempted in a number of developing countries through the selective crossbreeding of different crop varieties to develop particular traits. However, Harvest Plus, an international interdisciplinary research programme, have recognised that conventional selective breeding, even with the assistance of technology for identifying and marking the trait of interest, has its limitations and that genetic modification could be valuable for biofortification.136 They have decided that GM technology would be considered if large social benefits could be obtained at minimal risks, such as in the case of incorporating a desirable trait from a crop’s wild relative. There are a number of research projects focusing specifically on the development of GM crops with improved nutritional content to help combat micronutrient deficiencies in the developing world. The most famous of these is Golden Rice, which was developed to contain a betacarotene supplement (a precursor to vitamin A).137 This crop was developed to combat vitamin A deficiency, a problem that causes up to 500,000 cases of childhood blindness and between two to three million deaths annually.138,139 The latest version of Golden Rice (Golden Rice 2) has been developed with a much higher proportion of beta-carotene than the original crop, following criticism of the original strain. Researchers hope that the additional beta-carotene in Golden Rice 2 could help produce higher doses of vitamin A.140 However, questions have been raised regarding the ability of the body to absorb the beta-carotene from the rice and even whether the 133 Huang J., Hu R., Rozelle S. and Pray C.E. Insect-Resistant GM rice in farmers fields: assessing productivity and health effects in China. Science, 308, 688-690 (2005). 134 Prey C.E., Huang J., Hu R., and Rozelle S. Five years of Bt cotton in China- the benefits continue. Plant J. 31, 423-430 (2002). 135 In the case of GM Bt-resistance to the European corn borer, if corn borers develop resistance to Bt, then GM, conventional, and organic farmers will lose their pest-protection tools. Conventional and organic farmers use Bt sprays as a biological pesticide, which would no longer be efficient against strains of corn borers that have developed a resistance to Bt. 136 Harvest Plus. www.harvestplus.org/index.html 137 Golden Rice Project, http://www.goldenrice.org 138 World Health Organisation, http://www.who.int/nut/vad.htm 139 Council for Biotechnology Information, http://www.whybiotech.com/index.asp?id=4983 140 Paine J.A., Shipton C.A., Chaggar S., Howells R.M., Kennedy M.J., Vernon G., Wright S.Y., Hinchliffe E., Adams J.L., Silverstone A.L. and Drake R. Improving the nutritional value of Golden Rice through increased pro-vitamin A content. Nature Biotechnology, 23, 482-487 (2005). 32 BioEthics_opinion_Inner 23/11/2005 15:21 Page 33 molecule will survive the cooking process.141,142 Trials will be carried out on human volunteers in the US in late 2005 to try and answer these questions. In addition, field trials have been authorised in India and the Philippines, two countries where vitamin A deficiency is a major problem. Another potential application of GM technology is the development of crops containing vaccines or other pharmaceutical products. Such medicinal products may be easier and cheaper to produce, store, and distribute in developing countries. Potatoes producing vaccines against hepatitis B and the Norwalk virus (which causes severe diarrhoea) are being investigated.143 However, there are fears over the health risk posed if the vaccine-laden crops entered the food chain. A potential solution to this risk is to produce vaccines in non-food crops, such as tobacco, which would then be developed in pill form. There have also been concerns expressed regarding dosage controls with plant crop produced vaccines. Collaboration The examples above illustrate that GM technology can be used to help alleviate health problems and food insecurity in the developing world. However, although many conceptions of distributive justice encourage the fair dissemination of resources, whether physical, financial, intellectual or technological, to all, this should not be done in a purely paternalistic fashion, without due consideration of the opinion and feelings of the people of the developing world. Governments and citizens of developing nations should be involved in the decision-making process on the use of GM crops in their countries. The famine in southern Africa in 2002 raised this question in the media. Despite the risk of starvation of millions of people, the Zambian government refused to accept GM food aid (maize) donated by the US through the World Food Programme. The reasons cited for the Zambian government’s refusal were concerns over the uncontrolled spread of the GM maize if the kernels were planted, which would have knock on effects on future export markets from Zambia to the EU in particular,144,145 and worries about health risks for the people who ate the GM maize. Milling the grains, thus preventing them from being planted, could have averted the problem of the spread of GM maize. Other countries facing the same food crisis accepted the aid in milled form. The situation in Zambia highlighted the need for some international guidance on the use of GM crops in food aid donations. 33 141 Ibid. 142 Grusak M.A. Golden Rice gets a boost from maize. Nature Biotechnology, 23, 429-430 (2005). 143 See National Geographic news article: http://news.nationalgeographic.com/news/2005/02/0215_050215_potato.html 144 It has been suggested that the restrictions in place regarding the trade of GM foods within the EU had a bearing on the decision of the Zambian government to refuse donated GM maize despite their country experiencing a food crisis. Nuffield Council on Bioethics UK, The use of genetically modified crops in developing countries a follow-up discussion paper, p78 (2004). 145 Pringle P. Food, Inc. Mendel to Monsanto – The Promises and Perils of the Biotech Harvest. p186 (Simon & Schuster Paperbacks, New York, 2005). BioEthics_opinion_Inner 23/11/2005 15:21 Page 34 Some collaborative research initiatives have already been established between the biotechnology industry and national or international organisations, with a view to targeting research on GM and conventional crops to the needs of the developing world e.g., the International Rice Research Institute, the Golden Rice Network, the Kenya Agricultural Research Institute and the International Crops Research Institute for the Semi-Arid Tropics in India.146 Intellectual Property Rights (IPR) One of the major concerns about the use of GM technology in developing countries surrounds the sustainability of these GM initiatives on the ground. A widely cited criticism is that seeds will be further monopolised by a few large multinational biotechnology companies.147 In fact, even technology that has been developed in the public sector has, through patenting and licensing agreements, come under commercial control.148 This situation could lead to increasing farmer dependence on a limited number of suppliers for crop protection, which is of particular concern for small-scale farmers in developing countries. To provide a genuine choice of suitable seeds it is important that support for the public research sector be sustained and that policies to keep the private supply of seeds reasonably competitive are in place.149 Resources from public sources should support the development of crops that will benefit those who need them the most. Corporate social responsibility is an emerging strategy to manage, in the long-term, economic growth and social cohesion.150 The following example illustrates that while obstacles created by patents can be overcome, the situation can be quite complexe. Golden Rice, as discussed above, was developed to combat vitamin A deficiency in the developing world. The project was a humanitarian development predominantly targeted at subsistence farmers, and originally funded by donations from the charitable Rockefeller Foundation. After six years of research and donations of $600,000 from the Rockefeller Foundation, the scientists involved acquired more funding from the EU, the Swiss government, and the pharmaceutical company AstraZeneca, bringing the overall funding of the project to over $1 million. Once the Golden Rice was developed, questions emerged concerning the ownership of the technology. As part of their funding agreement, AstraZeneca had certain rights over Golden Rice. On top of this, the scientists involved had infringed 70 different patents in developing the GM rice, including patents held by large agribusiness companies. It was clear that unless AstraZeneca and other companies agreed, the scientists could not provide the Golden Rice technology for free. In order to get around this problem the 146 International Rice Research Institute (http://www.irri.org). Kenya Agricultural Research Institute (http://www.kari.org). International Crops Research Institute for the Semi-Arid Tropics (http://www.icrisat.org). 147 Economic Impact of Genetically Modified Crops on the Agri-food Sector, a first review. Working document rev.2 DirectorateGeberal for Agriculture, Commission of the European Communities. p26 2.2.2.. 148 Nuffield Council on Bioethics UK, The use of genetically modified crops in developing countries a follow-up discussion paper, p85 (2004). 149 Ibid. p52, 4.19. 150 See Ethical Trading Initiative and Global Reporting Initiative, and also the Green Book of the EU: Encourage a European framework for the social responsibility of companies (2001). 34 BioEthics_opinion_Inner 23/11/2005 15:21 Page 35 scientists patented a specific part of the Golden Rice technology and eventually brokered a deal with AstraZeneca, which allowed them to provide Golden Rice seeds to farmers in developing countries. AstraZeneca still retained the right to market Golden Rice in the developed world. Following this affair, a number of the other companies with patents pertaining to Golden Rice also waived their rights. It should be noted that despite donating over half of the funds for the project, the Rockefeller Foundation had no intellectual property rights to Golden Rice. The Humanitarian Rice Board was established in 2000 to further develop locally adapted varieties of Golden Rice through numerous public research institutions as part of the Golden Rice Network.151 The resulting varieties of Golden Rice, such as Golden Rice 2, will also be available to impoverished farmers in developing countries free of charge. It is clear that current and future development of GM crops for use in developing countries will require the review and possibly revision of intellectual property rights. Critics feel that IPR will restrict the development of GM crops because the exclusive licences and/or overly broad patents preclude access to the existing technology. In some cases, a patent owned by one company or research group could affect the ownership, and therefore, the distribution of GM technology developed in the future by another research group or company. Although the resolution of the IPR issues surrounding Golden Rice was a protracted process, it may, ultimately, have opened the door for IPR to be waived for developing nations in the future.152,153 Structures enabling efficient IPR reviews would be valuable to avoid some of the delays and problems seen with the original Golden Rice project. Furthermore, through increased funding of research in the public sector, some of the issues surrounding the ownership of valuable technology may become more transparent. In certain cases, and in parallel with improvements of socio-political design, GM crops can contribute to improving the nutrition and health of the world’s poorest citizens.154 If Ireland is committed to addressing the causes of food insecurity as well as promoting trade with, investment in and the transfer of technology to the developing world,155 then we have a role to play in furthering the necessary research to achieve these goals. By participating in and helping to advance biotechnology research, we can have a say in the regulation and safeguarding of the biotechnology sector and GM foods in particular. Although such research may not be of an immediate benefit to Ireland, research into GM foods and crops is likely to benefit society, especially in the developing world. 35 151 Statement from the Golden Rice Humanitarian Board on Development of New Golden Rice Strain with Higher Levels of BetaCarotene. 28th March 2005. http://www.medicalnewstoday.com/medicalnews.php?newsid=21864 152 Nuffield Council on Bioethics UK, The use of genetically modified crops in developing countries a follow-up discussion paper, p86 (2004). 153 Pringle P. Food, Inc. Mendel to Monsanto – The Promises and Perils of the Biotech Harvest. p35 (Simon & Schuster Paperbacks, New York, 2005). 154 Nuffield Council on Bioethics UK, The use of genetically modified crops in developing countries a follow-up discussion paper, p62, 4.48 (2004). 155 Speech by the Taoiseach, Mr. Bertie Ahern T.D. at the General Assembly, 14th Sept 2005. http://www.dci.gov.ie/latest_news.asp?article=573 BioEthics_opinion_Inner 23/11/2005 15:21 Page 36 Conclusion On balance, the Irish Council for Bioethics does not view the genetic modification of crops as morally objectionable in itself. GM crop and food technology holds a great deal of promise, however, it also introduces new risks for consumers, farmers, and the environment. The scientific community has widely agreed that the risks for human health associated with GM crop consumption are very low given the thorough safety assessments required for market approval.156 The magnitude of the environmental risks is more difficult to estimate, however, these risks appear to be manageable through careful implementation strategies, and therefore the introduction of GM crops into Irish farming would not necessarily be irreversible. The legitimate concerns will vary with the particular genetic modification, the nature of the crop species modified, and the anticipated cultivation regime. In this respect, a case-by-case assessment of potential impact is desirable. Further, GM technology is continually improving with a view to reducing its capacity to engender undesirable side effects; in particular, strategies to avoid the reliance on antibiotic resistance marker genes and limit the spread of GM traits into the environment are actively being developed. The Council has concluded that an ethical approach to the development of a new and potentially beneficial technology that poses some risk would not be to abandon the technology, but to progress it in a cautious and stepwise manner. The potential impacts GM crops and food technology may have on human welfare in more general terms (personal autonomy, general welfare, and social justice) have also been examined. The Council considers that so long as the individual autonomy of consumers and farmers is protected through adequate labelling and coexistence strategies, and a real choice provided for all parties, the potential benefits of GM crop technology can be made accessible to those who wish to avail of them. While it behoves regulators to protect the public from harm, it must be left up to the consumer/public to decide whether or not they want to avail of a particular technology, so long as it does not present any significant threat. Given that food is a central element of both human survival and pleasure, and that agriculture holds a special place in Ireland’s cultural heritage, 156 Positive statements concerning the safety of approved GM food and feed products have been issued by: UK GM Science Review Panel first and second reports, An open review of the science relevant to GM crops and food based on the interests and concerns of the public (July 2003 and January 2004, http://www.gmsciencedebate.org.uk/default.htm); the UK Royal Society Genetically Modified Plants for Food Use and Human Health - an update (London, 2002); the WHO Food Safety Department Modern food biotechnology, human health and development: an evidence-based study, p23 (23 June 2005). 36 BioEthics_opinion_Inner 23/11/2005 15:21 Page 37 public concerns must be addressed satisfactorily. The public should have access to factually correct information, in so far as it is available, and the risks and benefits of choosing GM over non-GM, or vice-versa, should be clearly set out. This need could be addressed by the establishment of a database containing peer-reviewed publications relating to developments in GM technology and a listing of all GM activities in the country. GM technology has been widely promoted as part of the solution to global food insecurity. The potential beneficial role GM crop technology may play in this respect should not be seen to justify a moral imperative to promote GM crops in general. Rather, it justifies pursuing the specific avenues of research from which the most valuable benefits are likely to flow. The Council would encourage public research programmes in GM crop development that are justly targeted at the needs of developing countries. This research should embrace collaborative efforts with the concerned farmers and nations, in order to develop initiatives that will be significant and acceptable. 37 BioEthics_opinion_Inner 23/11/2005 15:21 Page 38 Appendix: Irish Council for Bioethics Public Consultation on Genetically Modified Crops/Food BioEthics_opinion_Inner 23/11/2005 15:21 Page 39 Introduction A key element of the remit of the Irish Council for Bioethics is interaction with the public, firstly, to inform it of the activities and findings of the Council and, secondly (and equally importantly), to ascertain the views of the population on the topics currently being addressed by the Council, in order to help it arrive at its findings. Thus, the various working groups established by the Council have correspondingly taken this task in hand. The process of public consultation is rather more complex than might at first appear, and the GMO working group considered the matter at some length before adopting the following approach. The group decided that the task of public consultation would be carried out by the issue of a carefully designed questionnaire, which would be issued to all members of the public expressing an interest in the topics of GM crops and foods. The questionnaire would be issued in printed form and would also be posted on the Council website, with provision for completion on-line. The consultation was brought to the attention of the public by means of prominent advertisements in the principal newspapers throughout the island. In addition, the Scientific Director gave interviews and made submissions to both print and broadcast media. The working group was aware of the inherent limitations of this approach, for example, the responses received would not lend themselves to a quantitative analysis as would those in a country-wide survey or opinion poll. In addition, it was always possible, if not probable, that those responding would be persons holding definite views, with a committed viewpoint on the topic of GMOs, rather that the “average” member of the public. However, the group took the view that those submitting their opinions should have the maximum freedom to express whatever views they wished, without being “led” in any way. It is most important that the reader should be aware that the present Appendix discusses the carrying out of the consultation and the subsequent analysis of the views expressed by the respondents. Accordingly, the views expressed hereunder in regard to multiple aspects of GMOs are those of the respondents. The Questionnaire The questionnaire issued by the working group comprised a short initial section requesting details of contributors (age group, gender and county of residence only), followed by a series of 16 numbered sections. Each of the latter consisted of a relevant statement or proposition, e.g. “All foodstuffs that contain GM ingredients should be clearly labelled”, to which the respondent could react appropriately. Thirteen of these propositions could be responded to by indicating a choice from the alternatives: “Agree strongly”, “Agree”, “Disagree”, Disagree strongly” and “Don’t know/Unsure”. The remaining three statements required one or more choices from more particular alternatives, as described below. 39 BioEthics_opinion_Inner 23/11/2005 15:21 Page 40 Despite the intentionally broad and objective scope of these 16 sections as a whole, it was always possible, if not likely, that respondents would regard some of the propositions and the response options available as unduly restrictive, or, indeed, leading. Accordingly, an additional section (No. 17) offered contributors the facility of making additional comments or observations as they wished, without any limitation as to length or content. The group took the view that this final section was of the first importance, in that it provided respondents with an unfettered opportunity to state their views exactly as they wished to. The Results of the Consultation A total of 560 submissions were received by the working group, which considered the outcome very satisfactory, especially as over 300 respondents expressed their individual opinions in Section 17 of the questionnaire. This additional material - whether of greater or lesser brevity added greatly to the value of the consultation. Each of the responses received, whether by post or via the website, was scrutinised independently by three persons, one of whom undertook the detailed analysis of the submissions. His two colleagues then examined his analysis separately. Processing of the various responses to Sections 1-16 was straightforward, and the total numbers under the headings of the respective options were ascertained conveniently. The latter were tabulated, section by section, and the corresponding percentage figures added. In the case of Section 17, however, each entry was unique, and analysis of these comments was a considerably more complicated process. Nonetheless, it was essential that each submission be examined carefully in order to ensure, for example, in the numerous instances where respondents chose to address two or more aspects of GMOs, that every topic referred to was logged. It should be noted that all submissions made in Section 17 were considered separately, and that no entry was excluded from scrutiny. In the case of Section 17 any arithmetical ranking of the occurrences of a given topic would accordingly have been inappropriate, as this was a consultative exercise, not a quantitative survey. Thus, every topic raised in a submission was recorded. However, as a general indicator of priorities perceived by the public a breakdown of the contributions by topic appears below. 40 BioEthics_opinion_Inner 23/11/2005 15:21 Page 41 The Findings The findings of the consultation are presented here in summary form. However, they are then presented in detail, along with details of the gender/age distribution/county of residence statistics of the respondents. Table 1: Summary of Responses (shown as percentages of Total) received to issues raised in Section 1-16 For simplicity “Agree/Agree strongly” and “Disagree/Disagree strongly” responses, respectively have been combined in this Table; full details appear in the following section. Figures shown in bold type are maxima; those in italic type are minima. Section Theme [Summary of proposition shown above] Agree Disagree Unsure 1 I am personally informed about the use of GM in crop production 58.8 34.6 6.6 2 See detailed breakdown1 3 I trust scientist and Govt organisations to provide factual information 15.2 78.6 6.2 4 I trust environmental and NGOs to provide factual information 68.2 24.8 7.0 5 GM of crops interferes more unacceptably than before 86.3 9.1 4.6 6 GM foods currently on sale are safe for human consumption 9.1 57.1 33.8 7 GM of food will adversely affect future generations 71.4 6.1 22.5 82.0 6.6 11.4 10 GM crops can safely co-exist with conventional/non-GM crops 7.1 80.9 12.0 11 GM foods may contain less pesticide than non-GM foods 28.6 29.3 42.1 12 I am confident that GM crops/food is carefully regulated 8.6 84.8 6.6 13 All foodstuffs containing GM should be clearly labelled 98.0 1.8 0.2 14 GM crops can improve food supply in developing countries 21.2 60.2 18.6 14.3 77.7 8.0 1 8 See detailed breakdown 9 GM crops pose a threat to the environment 15 See detailed breakdown1 16 I support controlled cultivation of GM crops in Ireland 1 41 The headings of the five response options in Sections 2, 8 and 15 are unique to each section. As they differ from those used in all the other sections it is necessary to refer to the detailed breakdown. BioEthics_opinion_Inner 23/11/2005 15:21 Page 42 The majority opinions of the respondents emerge very clearly from the above table and extended comment is unnecessary. Respondents to the consultation have the following views: • They are reasonably informed about GM crops • They do not trust in scientists or governmental organisations to provide facts • They do trust environmental/non-governmental organisations to provide facts • Genetic modification of crops is an unacceptable interference with nature • GM foods currently on sale are not safe for human consumption • GM modification of food will adversely affect future generations • GM crops pose a threat to the environment • GM crops cannot coexist safely with conventional/non-GM crops • They are unsure about the pesticide content of GM foods • They are not confident that GM crops/food are carefully regulated • All GM foodstuffs should be clearly labelled • GM crops can not improve food supply in developing countries • They do not support controlled cultivation of GM crops in Ireland. Analysis of Comments Submitted in Section 17 The complexity of collating and analysing the very many comments made and opinions expressed has been referred to earlier. While there were 311 respondents in all, the total number of observations made was greatly in excess of this, as the opportunity to comment at will was availed of by the majority of persons to cover more than a single issue in their responses. This was a welcome outcome, as respondents’ detailed views were of considerable value. It should be noted, however, that all the principal points referred to in Section 17 submissions had been covered by the propositions in the questionnaire. This is not to decry the value of the views expressed; indeed, the vigour and sincerity with which they were recorded makes for a most informative and positive contribution to the consultation. It is clearly impractical to rehearse the many individual submissions in full, and for the purposes of clarity in reporting a significant degree of compression has had to be applied to the original comments. Further, as they cover very many relevant aspects of GM foods and crops, in addition to policy and other considerations, it was found useful to classify the comments according to keywords which reflected the topic(s) under consideration. The classification or identification of the topics was necessarily somewhat arbitrary, but it is considered to reflect quite accurately the overall thrust of the observations made under Section 17 of the questionnaire. 42 BioEthics_opinion_Inner 23/11/2005 15:21 Page 43 It is impractical to deal in the present report in detail with individual or even group observations, but a summary is given of the views expressed under each of the identified keywords/headings. It will be apparent that there is a degree of overlap2 between some of the headings and also between the submissions treated under the respective headings. However, the working group is of the view that a moderate degree of repetition is preferable to the overcompression of responses which could lead to a loss of salient information. In the following text, the respective keywords are shown in BOLD CAPITALS and are listed in alphabetical order. A BAN on GM crops/foods: Sixteen (70%) of the 23 responses under this heading favoured a complete ban, another respondent calling for a “stop [to] the madness.” Two comments suggested a moratorium pending availability of long-term data, while three noted that the precautionary principle indicated a negative response. One reply noted that most respondents in a UK survey were anti-GM. The BENEFITS of GM crops/foods: Some 70 observations were made in regard to “benefits”. Among the views expressed were: GMs are recent, hence future benefits are unknown; the claimed benefits are dubious; there would be no benefits to farmers or consumers or to developing countries. However, 60 of those responding were unequivocal in their view that the benefits would accrue to the multinational companies promoting GM technology, for whom profit was the main consideration, as they were driven by enormous greed. Related points made were that it was not for such firms to influence policy on the issue, and that pressure from the US should be resisted by the Government. Effects on BIODIVERSITY: Several respondents expressed concern at the threats to biodiversity, which would be eroded. Comments on this CONSULTATION: Some 35 submissions were received in regard to the consultation exercise. Most were critical, to a greater or lesser degree, of the format and/or content of the questionnaire issued by the working group and some detected a degree of bias. Such comments were welcome, as the true opinions of the particular respondents, and they were considered carefully. While aspects of the questionnaire may well have been unsatisfactory to some - there is not yet a “perfect” format - who may have wished to address Sections 1-16 in a different manner, it is considered that the points made are rendered invalid by the incorporation of Section 17, in which respondents were free to comment at will, and to amplify in any way they wished the responses necessitated by the format of preceding sections. Other respondents raised the following points: that the questionnaire would not give people’s true views3; that the results should be published with due consideration; that if the government 43 2 This refers to the headings only; responses on any specific topic are cited once, without duplication. 3 From the volume of submissions under Section 17 this was clearly not the case. BioEthics_opinion_Inner 23/11/2005 15:21 Page 44 will permit GMs, the survey is unnecessary; and a general query in regard to the purpose of the survey and if and when its results would be published. Finally, a few respondents expressed the view that the GM leaflet produced by the Food Safety Authority of Ireland should not have been circulated with the questionnaire as it was considered as biased towards GM foods. EFFECTS of GM crops/foods: Almost 30 submissions expressed concern under this heading, most stressing the lack of knowledge - or unknowability - of the long-term effects. The point was made that most GM trials had shown adverse environmental effects on flora and fauna. One response noted that “future generations will hold us accountable.” GM crops and the ENVIRONMENT: As a rider to the preceding heading, some submissions expressed worries about environmental species, noting that the environmental impact was of paramount concern. FOOD concerns: There were relatively few views (<20) under this heading which excluded global food considerations, dealt with below. However, an important range of topics was raised: concern about the future quality of food, and the possibility of GM dependency; restriction of food diversity in favour of mass production of GM foods; the far too premature appearance of GM foods; the probable increased difficulty of access to non-GM foods, and the increased cost of purchasing the latter, if available. In contrast, individual responses expressed the views that GM foods were under-utilised. GENERAL Observations: This heading has been included to cover largely individual views which might otherwise be overlooked, although 10 (of 17) responses note that there is no need for GM production, another adding that there is no logic for GM crops in Ireland, even on trial. The other points made were: that GM crops are unwise (“just because we can doesn’t mean we should”); many views in regard to GMs are based on emotion and not fact; scare campaigns are let go unchallenged; it is not at all retrograde to oppose GMs, the analogy being made with nuclear power proposals; politicians’ decisions are short-term. One further response noted that “GM takes the soul away from plants.” GENES [Genetic Modification]: Some 10 views were expressed on various aspects of this topic, half referring to genome transplants/gene insertion. One respondent noted that not all aspects of GM research were comparable - some might not be acceptable but other aspects would be non-contentious; however, the sources of genes should be declared. The point was made that upgraded teaching of science in schools would make for a greater awareness of scientific advances. Other submissions mentioned “Frankenstein science,” the so-called “terminator gene,” and a worry that GM developments could lead to hybrids monopolised by industry. GLOBAL FOOD Concerns: Almost 50 respondents expressed their views under this heading. Two fifths of submissions considered that GM crops would not be beneficial to developing countries and that such crops would not cure world hunger, the probable influence on the global food supply being negligible. One third of submissions noted that global food production was 44 BioEthics_opinion_Inner 23/11/2005 15:21 Page 45 adequate and that the recognised problems in developing countries were due to inefficient transport, distribution and other soluble problems. Several replies expressed horror at the fact that seed in the developing world would have to be purchased from industry, rather than being available naturally, and that - apart from cost - access to GM seed would be difficult. GM CROPS [General observations]: Considerations noted were that such crops are “too far from what is natural”, their introduction would be unwise, and that they cannot be considered collectively. HEALTH aspects: Very few submissions adverted to human health considerations, although several respondents were concerned over GM-induced allergies. The view was also expressed that new diseases could be created. INFORMATION on GMs: Replies, numbering almost 40, were emphatic that there was a severe information deficit, the whole issue being “clouded in confusion and obfuscation,” according to one respondent. Calls were made for a debate on the topic of GM crops/foods and a suggestion was made that an information pamphlet should go to all households. Some replies expressed a wish to make a fully informed choice. IRELAND and the QUALITY OF IRISH LIFE: The point was repeatedly made that Ireland’s “green image” and its reputation for good food would be seriously at risk if GMs were permitted. The opposite course was recommended, it being pointed out that, if GM-free, Ireland could have an opportunity to boost its exports on foot of a high-quality industry. LABELLING of GM products: All submissions on labelling called for the most stringent approach, with clarity and adequacy of information essential. LEAKAGE of GMOs into the environment: The impossibility of the coexistence of GM and nonGM crops was mentioned, as was the fact that the former can neither be contained not policed by “control measures.” Most of the 40+ respondents were concerned about cross-fertilisation dangers, and some noted that such releases of GM as had occurred were irreversible. LEGAL Consequences of GMs: One submission raised important issues under this heading - the problem of harmonising diverse laws (EU, national, international); the legal implications of the inadvertent presence of GMs outside approved areas; the matter of legal liability for GM contamination of organic farming activities. NATURE and GMs: Points made earlier are relevant to the present heading, but it must be noted that some 15 respondents expressed concerns about tampering with natural crop/growth processes. Several commented that nature controls man, rather than the opposite, and that nature will have its eventual “revenge.” NGOs [Non-Governmental Organisations]: Two respondents regarded the reactions of NGOs to GM crops as hysterical, while one stated that NGOs were without affiliations to government or big business and were accordingly independent. 45 BioEthics_opinion_Inner 23/11/2005 15:21 Page 46 ORGANIC FARMING and GM crops: Numerous replies were received, over half expressing concerns that organic farming would be undermined as a consequence of crop contamination from GM crops grown nearby. Several respondents urged support for an organic farming industry as an alternative to GM crops. PATENTS of GM materials: Several respondents addressed the consequences of the improper use of patents of GM materials, with particular reference to the developing world and the overall control of food production. Usage of PESTICIDES: Opinions varied as to whether GM crops would lead to reduced or increased use of pesticides. Some replies expressed the view that resistance to weedkillers was undesirable and that uncontrollable weeds could develop. RESEARCH on GMOs: Various topics were addressed, including: the inadequacy of research into the effects of GMOs; the need for research into biodiversity, food supply, and legal matters; and querying the need for rush into GMOs considering such research was in its infancy. RISKS attached to GM crops/foods: A few respondents noted that the potential risks were frightening and that they outweighed any theoretical advantages. One remarked that the risks were a “time bomb” endangering all species on the planet, while another noted that difficulties in obtaining insurance for GM-associated activity belied the claim that the latter was risk-free. SAFETY of GM crops/foods: Some respondents felt that the safety of GM crops/food, as a serious question, should be proven prior to their introduction, while one pointed out that only after a very long time could this be done. Others noted that the safety testing currently carried out was very deficient. TESTING of GM crops/foods: Some submissions noted that insufficient testing was currently being carried out, and that all testing should be independent and the results published. The issue of TRUST: A significant number of respondents addressed various aspects of trust and in whom it should be placed. NGOs are considered to be trustworthy, the opposite being the case of multinational companies and those involved in GM technology. The latter included Government, which was considered to be unduly influenced by the industry. It was remarked that neither pro- nor anti-GM “sides” gave truly impartial advice, while another considered that the Council was not impartial. Several respondents were very critical of scientists, expressing the view that GM engineering was a dangerous gamble by arrogant technologists; the motives of geneticists were often suspect; and that some scientists backed GM studies in order to increase their research budgets. UNKNOWN aspects of GMOs: Concerns were expressed about the unknown future implications of GM technology. 46 BioEthics_opinion_Inner 23/11/2005 15:21 Page 47 Conclusion It is abundantly clear from the findings of the consultation that those responding are greatly opposed to the introduction of GM crops, and are largely of the view that GM foods currently on sale are not safe for human consumption. It is also apparent from the comments of the majority of respondents who opted to add their individual views in Section 17 of the questionnaire that there are many reasons underlying the opposition to GMOs, and that there is a high degree of concern about many aspects of GM crops and food. Because of their breadth and diversity, the many responses to the consultation (whether confined to Sections 1-16 or not) have constituted a major input to the activity of the working group, which is most grateful to all who contributed. 47 BioEthics_opinion_Inner 23/11/2005 15:21 Page 48 Sample Questionnaire 48 BioEthics_opinion_Inner 49 23/11/2005 15:21 Page 49 BioEthics_opinion_Inner 23/11/2005 15:21 Page 50 50 BioEthics_opinion_Inner 23/11/2005 15:21 Page 51 Section by Section Analysis of the Responses Received Section 1: I am personally informed about the use of genetic modification in crop production 7% Agree 20% 43% Agree Strongly Disagree Disagree Strongly Unsure 15% 15% Section 2: I have heard about genetically modified crops/food: On TV On the Radio In the Newspapers In Supermarkets Not heard anything - - - 4 - - - 66 - - - - - - 3 - 22 - - - - 1 - 1 - - 33 33 - - 3 3 3 - 29 - - - - 2 - - 2 - 47 - 47 - - 7 - 7 7 - 13 13 - - - 1 1 - 1 - 270 270 270 - - 59 59 59 59 - Note that the figures in italics denote responses indicating more than one source of information. However, such entries have been counted as single responses. 51 BioEthics_opinion_Inner 23/11/2005 15:21 Page 52 Section 3: I trust scientist and government organisations to provide factual information 6% 14% 2% Agree Agree Strongly 40% Disagree Disagree Strongly 38% Unsure Note that “unsure” and “blank” responses have been combined because of the paucity of the latter. Section 4: I trust environmental and non government organisations to provide factual information 7% 8% Agree Agree Strongly 17% 53% Disagree Disagree Strongly Unsure 15% Section 5: Genetic modification of crops interferes with nature in a more unacceptable way than conventional crops 4% 6% 5% 24% Agree Agree Strongly Disagree Disagree Strongly Unsure 61% 52 BioEthics_opinion_Inner 23/11/2005 15:21 Page 53 Section 6: GM foods currently on sale are safe for human consumption 7% 3% 33% Agree 25% Agree Strongly Disagree Disagree Strongly Unsure 32% Section 7: Genetic modification of food will adversely affect future generations 23% 21% Agree Agree Strongly 3% Disagree 4% Disagree Strongly Unsure 49% 53 BioEthics_opinion_Inner 23/11/2005 15:21 Page 54 Section 8 : I would be willing to eat foods with GM ingredients if they were: Cheaper Healthier Tasted better Contained less pesticide residue Under no circumstances 3 - - - - 2 - - 2 - 5 5 - - - 1 1 1 - - 19 19 19 19 - 1 - 1 1 - - - - 21 - - 58 - - - - 27 - 27 - - 3 3 - - - 18 18 18 - - - 1 - - - - - - 401 Note that the figures in italics denote responses indicating more than one choice. However, such entries have been counted as single responses. Section 9: GM crops pose a threat to the environment 11% 23% 3% 4% Agree Agree Strongly Disagree Disagree Strongly Unsure 59% 54 BioEthics_opinion_Inner 23/11/2005 15:21 Page 55 Section 10: GM crops can safely co-exist with conventional or non GM crops 6% 1% 12% 21% Agree Agree Strongly Disagree Disagree Strongly Unsure 60% Section 11:GM foods may contain less pesticide residues than conventional or non GM foods 25% Agree 42% Agree Strongly 4% Disagree Disagree Strongly Unsure 16% 13% Section 12: I am confident that development of GM crops/food is carefully regulated 7% 7% 2% Agree 28% Agree Strongly Disagree Disagree Strongly 56% 55 Unsure BioEthics_opinion_Inner 23/11/2005 15:21 Page 56 Section 13: All foodstuffs that contain GM ingredients should be clearly labelled 1% 1% 8% Agree Agree Strongly Disagree Disagree Strongly Unsure 90% Section 14: Genetically modified crops can improve food supply in developing countries 19% 16% 5% Agree Agree Strongly Disagree Disagree Strongly 23% Unsure 37% 56 BioEthics_opinion_Inner 23/11/2005 15:21 Page 57 Section 15: Genetically modified crops and foods will benefit: Biotechnology companies Farmers The developing world The consumer No-one will benefit 334 - - - - 60 60 - - - 3 3 - 3 3 34 34 34 - - 11 - - - 11 3 - - 3 - 24 - 24 - - - 1 - - - - 1 - - 1 - 1 - 1 - - 1 1 - - - 2 2 2 - - - - - 71 - - - 3 - - - 9 - - - - 2 2 - Note: figures in italics denote responses indicating more than one choice. However, such entries are counted as single responses. Section 16: I support carefully regulated and monitored cultivation of GM crops in Ireland 8% 7% 8% Agree Agree Strongly 19% Disagree Disagree Strongly Unsure 58% 57 BioEthics_opinion_Inner 23/11/2005 15:21 Page 58 Origins Of Responses Background Information A total of 560 submissions were received by the working group. Of these, 304 were from female and 256 from male respondents. Age groups from 16-25 years to over 66 years were represented, with the highest response numbers occurring in the 26-35 and 36-45 year ranges. Submissions came from most areas of the country, although there were few responses from northern counties. The greatest response came from Dublin (almost 35% of the total), Cork (13%), Clare (over 9.5%) and Galway (8.5%). The detailed statistics of the response patterns are presented below. Gender of Respondents Female: 304 Male: 256 Total: 560 Age Group of Respondents 16-25: 80 26-35: 167 36-45: 159 46-55: 113 56-65: 37 66+: 4 County of Residence of Respondents Antrim 8 Leitrim 15 Armagh 1 Limerick 11 Carlow 5 Longford 1 Clare 54 Louth 3 Cork 73 Mayo 6 Derry 1 Meath 13 Donegal 3 Monaghan 2 Down 6 Offaly 4 Dublin 194 Roscommon 6 Fermanagh 4 Sligo 17 Galway 48 Tipperary 13 Kerry 8 Waterford 9 Kildare 11 Westmeath 4 Kilkenny 8 Wexford 11 Laois 2 Wicklow 19 58 BioEthics_opinion_Inner 23/11/2005 15:21 Page 59 Working Group on Genetically Modified Organisms Prof. Peter Whittaker (Chairman), Institute of Environment, Philosophy and Public Policy at Lancaster University Mr Matt Dempsey, Irish Farmers’ Journal Prof. Patrick Hannon, St Patrick’s College, National University of Ireland, Maynooth Prof. Tony McGleenan, School of Law, University of Ulster Dr. Nora O’Brien, Department of Food Science, Food Technology and Nutrition, National University of Ireland, Cork Professor Fergal O’Gara, Microbiology Department, National University of Ireland, Cork Dr. Patrick Flanagan, Formerly of Environmental Protection Agency Prof. Seán Strain, Center for Molecular Biosciences, Ulster University Dr. James Burke, Teagasc Dr. Jonathan Hughes, Centre for Professional Ethics, Keele University, UK Dr. Richard Hull, Dept. of Philosophy, National University of Ireland, Galway Dr. Patrick O’ Mahony, Food Safety Authority of Ireland Dr. Tom McLoughlin, Environmental Protection Agency Terms of Reference 1. To discuss the ethical issues surrounding Genetically Modified Organisms (GMOs) in general and also with particular reference to the Irish context. 2. To co-opt appropriate others to the Working Group as deemed necessary. 3. To seek the views of the general public on the ethical issues surrounding GMOs. 4. To prepare a draft report for submission to the Irish Council for Bioethics. 59 BioEthics_opinion_Inner 23/11/2005 15:21 Page 60 The Irish Council for Bioethics Comhairle Bitheitice na hÉireann Mr. Dermot Gleeson, SC, Chairman Professor Peter Whittaker, (Vice Chairman) Institute of Environment, Philosophy and Public Policy at Lancaster University Professor Patrick Cunningham, Department of Genetics, Trinity College Dublin Mr. Matt Dempsey, Irish Farmers’ Journal Dr. Dolores Dooley, Department of Philosophy, National University of Ireland, Cork Dr. Margaret Fitzgerald, Department of Public Health, Eastern Regional Health Authority Dr. Patrick Flanagan, Formerly of Environmental Protection Agency Professor Patrick Hannon, St Patrick’s College, National University of Ireland, Maynooth Canon Kenneth Kearon, Irish School of Ecumenics Professor Cecily Kelleher, Department of Public Health, Medicine and Epidemiology, University College Dublin Professor Mark Lawler, Cancer Molecular Diagnostics Laboratory, St James’ Hospital Professor Tony McGleenan, School of Law, University of Ulster Dr. Peter McKenna, Department of Obstetrics and Gynaecology, Rotunda Hospital Ms. Mary Mulvihill, Science Journalist Dr. Nora O’Brien, Department of Food Science, Food Technology and Nutrition, National University of Ireland, Cork Professor Fergal O’Gara, Department of Microbiology, National University of Ireland, Cork Professor Ronan O’ Regan, Department of Human Anatomy and Physiology, University College Dublin Professor Anne Scott, School of Nursing, Dublin City University Mr. Asim. A. Sheikh, BL, Division of Legal Medicine, University College Dublin Professor Seán Strain, Center for Molecular BioSciences, University of Ulster Secretariat: Dr. Siobhán O’Sullivan Ms. Emily de Grae Dr. Stephanie Dyke Mr. Paul Ivory Terms of Reference of the Council 1. To identify and interpret the ethical questions raised by biological and medical research in order to respond to, and anticipate questions of substantive concern. 2. To investigate and report on such questions in the interests of promoting public understanding informed discussion and education. 3. In the light of the outcome of its work, to stimulate discussion through conferences, workshops, lectures, published reports and where appropriate suggest guidelines. 60 BioEthics_opinion_Inner 23/11/2005 15:21 Page 61 Abbreviations Abbreviations are explained at their first occurrence in the text. They are also shown below for convenient reference. 61 Bt Bacillus thuringiensis DNA Deoxyribonucleic acid EFSA European Food Safety Authority EPA Environmental Protection Agency EC European Commission EU European Union GDP Gross domestic product GM Genetically modified GMO Genetically modified organism HIV Human immunodeficiency virus IPR Intellectual property rights UK United Kingdom US United States WTO World Trade Organisation BioEthics_opinion_Inner 23/11/2005 15:21 Page 62 Regulatory Instruments Available at http://europa.eu.int and http://www.irishstatutebook.ie Directive 98/81/EC – S.I. No. 73 2001 - on the contained use of GMOs, regulates research and industrial work involving the contained use of GMOs. Directive 2001/18/EC – S.I. No. 500 2003 – for the deliberate release of GMOs, regulates experimental releases as well as placing on the market of GMOs and their derived products. Regulation (EC) No 1829/2003 – defines the authorisation procedure for the placing on the market of new GM crops, food, and feed products. Regulation (EC) No 1830/2003 – defines the traceability and labelling requirements necessary for GMOs and their products. Regulation (EC) No 1946/2003 – on the intentional and unintentional movement of GMOs between member states and third countries. This Regulation does not cover the movement of GMOs within the Community. Regulation (EC) No 641/2004 provides detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new GM crops, food products, and feed. Regulation (EC) No 65/2004 provides a system for the assignment of unique identifiers to GMOs. Recommendation 2003/556/EC provides guidelines for the development of national strategies and best practise to ensure the coexistence of GM crops with conventional and organic farming. Recommendation 2004/787/EC provides technical guidance for the sampling and detection of GMOs and material produced from GMOs in seed, food, and feed products. 62 BioEthics_opinion_Inner 23/11/2005 15:21 Page 63 Glossary Note that the terms listed are explained as they apply in the context of the present report. In broader, more general use, some of the terms will have much wider meaning.1 Antibiotic A chemical that can destroy, or inhibit the growth of, a microorganism. Antibiotics are often used to treat bacterial infections. Autonomy See Personal/individual autonomy. Biodiversity The variety of life in all its forms. Includes ecosystem diversity, species diversity, and genetic diversity. Biofortification The process of breeding food crops that are rich in vitamins and minerals. Biotechnology Biotechnology is technology based on biological science and has many applications in agriculture, food science, and medicine. Bt The bacterium Bacillus thuringiensism, which is toxic to some insects such as the European corn borer. Cell The basic structural and functional unit of living organisms. Cells may exist as independent organisms (unicellular bacteria) or as the building blocks of elaborate organisms. Consortium A group of individuals that come together to undertake an activity or project that would be beyond the capabilities of the individual members. Cross-pollination The fertilization of a plant by a plant with a different genetic makeup. DNA DNA (deoxyribonucleic acid) is the biochemical substance that genetic material is made of. Ecosystem An ecosystem can be narrowly or broadly defined. Generally, the term ecosystem encompasses all organisms living in a particular environment as well as the natural resources available to them. Evolution The process by which the genetic structure of organisms changes over time. Exotic plants Non-native species of plants. Field trial An experimental plot of a GM crop allowing tests to be carried out. 1 63 Several definitions were derived from: http://encyclopedia.thefreedictionary.com, and http://www.everythingbio.com BioEthics_opinion_Inner 23/11/2005 Gene 15:21 Page 64 A length of DNA that typically contains the information needed to make a protein. Gene flow The spread of a genetic trait through hybridisation. Genetic modification Genetic modification using GM technology involves modifying the expression of an organism’s gene or adding a new gene (or genes) to the organism’s genome. Genome In general, the genome refers to the whole of an organism’s genetic material (DNA), that is, all of the organism’s genes. GM vector The DNA structure used for genetic modification (typically based on the structure of a bacterial plasmid and containing a new gene or transgene to be inserted into the genome of the organism to be modified). Herbicide A chemical which kills certain types of plants and is used to control weed growth. Herbicide-resistance/ A plant trait (which can be achieved through GM technology or tolerance conventional breeding methods) that allows a crop to tolerate a particular herbicide which would normally kill it. Horizontal gene transfer A transfer of genetic material between two organisms (of the same or different species) other than through reproduction (from parent to offspring). Host The plant or other organism which is receiving the genetic modification. Hybrid (hybridisation) An organism produced by breeding genetically dissimilar parents. Insect resistance A plant trait that makes the plant resistant to an insect that would normally damage it, that is, the plant somehow harms the insect thereby protecting itself from its damage. Insecticide/pesticide A chemical which kills certain types of insect pests. Introgression Infiltration of the genes of one plant variety into the gene pool of another through hybridisation. Landrace A breed that is ideally suited for the land (environment) in which it grows. 64 BioEthics_opinion_Inner 23/11/2005 Marker gene 15:21 Page 65 A marker gene is used in GM technology to select cells that have been successfully modified. The marker gene is inserted into the cell’s genome during the genetic modification and gives it a particular characteristic that allows it to be identified. Antibiotic resistance marker genes, for example, render the modified cells resistant to an antibiotic which would normally kill them. Metabolism Metabolism involves the breakdown of molecules with the liberation of energy, which is required for other processes, and the building of complex substances, which form the material of the tissues and organs. Moratorium A period of time during which a certain activity is not allowed. The European Union moratorium on GM crops and foods was set up to allow scientists and policy makers to reassess the situation and implement the appropriate regulations. Multinational corporation A company that spans multiple nations and is usually quite large. Natural selection Darwin’s proposed mechanism for evolution. Refers to the increased rate of survival of varieties which are well suited to their environment. Non-governmental An NGO is an organisation that is not part of Government. The term organisation is generally used to define social, cultural, health, and environmental interest groups with non-commercial goals. Nutrient Any substance that is needed by an organism to live, reproduce, or grow. Organism An individual form of life, such as a bacterium, a plant, or an animal. Peer review An independent assessment of the quality of research results or proposals, carried out by an expert in the particular field of study. Such reviews are common, for example, when a research proposal is submitted for funding, and when a research paper is considered for publication in an academic journal. 65 Personal/individual The capacity to make decisions and take actions that are in line with autonomy one’s genuine convictions. Policy The decision to adopt a particular set of actions. BioEthics_opinion_Inner 23/11/2005 Precautionary Principle 15:21 Page 66 The idea that if the consequences of an action are unknown, but are judged to have some potential for major or irreversible negative consequences, the action should be avoided. Precursor A molecule that will be converted into another one. Protein Proteins are molecules required for the structure, function, and regulation of the body’s cells. They are coded for in the DNA of an organism’s genome. Refuge An area of crops, which are susceptible to insects, and thus provide a safe haven for them. 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