AGRICULTURE AND ENVIRONNMNNEN T BIOTECHNOLOGY COMMISSION 25510 AVILA 22503526422 AGRICULTURE AND ENVIRONMENT BIOTECHNOLOGY COMNMISSION CROPS ON TRIAL A REPORT BY THE AEBC . : \ September 2004 CROPS ON TRIAL A REPORT BY THE AEBC CONTENTS PART 1 INTRODUCTION AND CONTEXT PART 1.1 INTRODUCTION PART 1.2 THE CONTEXT: THE FARM-SCALE EVALUATIONS AND THE LEGAL FRAMEWORK PART 2 CONCLUSIONS AND RECOMMENDATIONS PART 3: OUR THOUGHTS PART 3.1 THE BROAD ISSUES PART 3.2 IMPLICATIONS OF THE FARM-SCALE EVALUATIONS PART 4: THE BACKGROUND PART 4.1 THE SCIENCE, ITS APPLICATION, AND PUBLIC OPINION PART 4.2 THE LEGAL AND REGULATORY FRAMEWORK PART 4.3 THE FARM-SCALE EVALUATIONS: MORE INFORMATION PART 4.4 WHO WE ARE PART 4.5 WHAT PEOPLE TOLD US PART 4.6 WHAT THE WORDS MEAN ANNEX A Case Study of the regulatory process for Genetically Modified crops ANNEX B Letter of 14 June 2000 from the Minister for the Cabinet Office to the Chair of AEBC, and the Chair's reply of 20 July 2000 ANNEX C Letter of 22 February 2001 from the Chair of AEBC to the Minister for the Environment, and the Minister's reply of 21 May 2001 CROPS ON TRIAL A REPORT BY THE AEBC 3 4c) q AUDJAVS fel, ‘aA 5-2 “1! WHOM “Se Es 9 1a nT ARteY yer wa am 20 Api ‘gen yor we = mye v greg tagenert ane j 2 engi } =r stint aS sup ch Recstt, nNkU ooh Ae ~ yatiad a ESA to Watt? wt J. OS 7w y te zs a 2 ‘eft . = ‘ — ; : A a ww: sol wen“t td rialS S ie vetted gay a yiegurs eta pi wis b thorwitns vind orthY eh ae at PART 1 INTRODUCTION AND CONTEXT CROPS ON TRIAL A REPORT BY THE AEBC PART 1.1 INTRODUCTION 1. The issues thrown up by genetic modification (GM) technology are hugely challenging, but two facts at least seem clear. The first is that the remarkable advances in our understanding of molecular biology are here to stay. They have created the possibility of GM products of many kinds. Many of these — like the use of genetically modified bacteria to produce insulin for diabetics, or chymosin (used in the making of cheese) have attracted little criticism, or indeed have been positively welcomed. GM products may deliver demonstrable environmental benefits, as with the significant reductions in the use by farmers of chemical pesticides that has followed the introduction of insect resistant cotton in the USA. But this and other possible uses have nonetheless given rise to intense discussion in many countries as well as our own as to the terms and conditions on which they might now be developed in useful and socially acceptable ways. This highlights a second clear fact — that the political arrangements needed to deal legitimately with these issues in countries like the UK are immature, and in immediate need of further development. This report makes some proposals for how these may start to be improved. 2. The Agriculture and Environment Biotechnology Commission (AEBC) is a new and distinctive kind of independent body. We were set up in June 2000 with a brief to look at current and future developments in biotechnology which have implications for agriculture and the environment, and to advise the Government on their ethical and social implications and their public acceptability. Our remit requires us, amongst other things: e to advise the Government on the ethical and social implications arising from developments in biotechnology and on their public acceptability; e to consider the wider implications of the lessons to be learnt from individual cases requiring regulatory decision: e to make recommendations as to changes in the current structure of regulatory and advisory bodies. 3. Our terms of reference specify that in the context of the work of the Commission, the term “Government” comprises the UK Government and the devolved administrations. We use the term in that sense in this report. 4. The AEBC’s twenty members come from different backgrounds. Some work in agriculture, in ecological research, in academia or in biotechnology, while others are involved in non-Governmental organisations (NGOs), social research and consumer matters. And they cover all shades of opinion on GMs. Some came into these discussions as sceptics, others were cautiously optimistic about the potential benefits GM crops may bring, while still others were undecided. In this sense, the membership of the AEBC reflects the spread of public attitudes towards GM in the country at large. 5. At our first meeting, in July 2000, we noted that the Government’s Farm-Scale Evaluations (FSEs) of genetically modified herbicide-tolerant (GMHT) crops had caused considerable controversy since they were first announced in late 1998. Looking closely at these trials seemed likely to be a good way of getting to grips with some of the issues. The intensity of public interest and concern which they aroused seemed to have CROPS ON TRIAL A REPORT BY THE AEBC 6 surprised and puzzled the Government, the industry and the scientists most directly involved. The trials had become the focus both of local resentments and of wider national concerns about possible GM crops and foods. So we decided to evaluate the role of the trials in the regulatory process, looking at the reasons for setting them up, their objectives (and the extent of consultation in agreeing those objectives), the data they were expected to produce and the gaps which might still remain — and, in particular, to try to understand and explain the evident public concern. As a result of this study, we hoped to be able to provide advice which, in accordance with our remit, would assist in future decision-making in the sphere of biotechnology and its implications for agriculture and the environment. 6. This is a report of the whole Commission. It is based on work by a sub-group of seven AEBC members, with a spread of interests and backgrounds reflecting that of the Commission as a whole. Over six;months, the group held discussions with local people in areas affected by the trials and took evidence from both national and local organisations and institutions. The whole Commission deliberated at two separate meetings on the group’s proposals, held public meetings and took evidence formally in public. 7. Coming from such different backgrounds, members of the Commission have debated intensely among themselves. In the process, we have learnt a lot about how best to air and examine varying beliefs, assumptions and attitudes. There are many matters on which we have agreed — more than some of us might have expected. The fact that there are other issues on which we disagree has not prevented us from reaching a number of shared conclusions on how these matters might be handled better by Government in the future. We trust that this report, benefiting from the diversity of opinions and values which the Commission’s membership embraces, can help illuminate public discussion of what is now at stake for society. And we trust that Government too will benefit from our recommendations. 8. Our report is structured so as to provide first a brief summary of the context of the FSEs (Part 1.2), then our conclusions and recommendations (Part 2). Our thoughts which led to those conclusions and recommendations are in Part 3, and Part 4 presents more detailed background information. CROPS ON TRIAL A REPORT BY THE AEBC 7 PART 1.2 THE CONTEXT: THE FARM-SCALE EVALUATIONS AND THE LEGAL FRAMEWORK 9 To set the context for our conclusions and recommendations in the next Part, we give here a brief outline first of the Farm-Scale Evaluations, and then of the legal framework governing the commercial cultivation of GM crops. The Farm-Scale Evaluations’ 10.The Farm-Scale Evaluations (FSEs: “the trials’) are a programme of scientific investigations at field level which are being undertaken in the UK on the basis of an agreement between the Government. and the body representing the farming and biotechnology industry, SCIMAC (the Supply Chain Initiative on Modified Agricultural Crops). After a pilot project in 1999, the main project started in spring 2000, and will end at harvest 2002 for spring sown crops and harvest 2003 for winter sown crops. Four genetically modified herbicide-tolerant (GMHT) crops are involved in the trials: winter and spring varieties of oilseed rape, beet (fodder and sugar) and forage maize. In all, between 60 and 75 fields, varying in size from 4 to 30 hectares, are to be planted for each of the four crops. Each field is split into two, one half being sown with a GMHT crop and the other with an equivalent non-GM variety. 11.The objective of the FSEs is not to evaluate the effects of the GMHT crops themselves, whose safety has already been evaluated in the laboratory and in small- scale field trials and approved by the regulatory authorities. It is to find out whether the herbicide management associated with these GM crops, as compared with that used on the non-GM equivalents, has any effects on some aspects of farmland biodiversity — that is to say, on the number and diversity of plants and animals. Some key indicators of biodiversity will be measured to check if there are differences between the two halves of each field. The legal framework” 12. The regulatory arrangements for GM crops are more rigorous than has been the case in the past for the introduction of technological and agronomic changes in farming. They are based primarily upon case-by-case assessments of new seed varieties. This involves securing approval for each new GM crop/food under several separate processes that are governed by EU rules (with supporting UK legislation): e the EU Directive on the deliberate release of GMOs (implemented in the UK via the Environmental Protection Act 1990 and subordinate legislation); e the EU Novel Foods Regulations (for decisions on whether GM crops are safe as food): :F or more detail and a critical analysis, see Parts 3.2 and 4.3. For more detail, see Part 4.2. CROPS ON TRIAL A REPORT BY THE AEBC 8