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GM (Genetic Modifications)

Government Response to "Crops on Trial"

This document sets out Government's response to the recommendations of the Agriculture and Environment Biotechnology Commission's report 'Crops on Trial'. The response is presented on behalf of the UK Government, the Scottish Executive and the Department of the Environment in Northern Ireland.

Introduction:

  1. Government set up the Agriculture and Environment Biotechnology Commission (AEBC) in 2000 to look at social and ethical issues relating to developments in biotechnology which have implications for agriculture and the environment, and to provide strategic advice to government on this important policy area. The AEBC has selected a very significant topic for its first report, the Farm Scale Evaluations (FSE) of Genetically Modified Herbicide Tolerant (GMHT) crops. This topic was chosen by the AEBC as a case study of regulatory decision-making in relation to GM because there has been a high level of public concern about the trials that have become a focus for wider concerns about GM crops and foods.
  2. The Commission includes a range of interests from all sides of the GM debate and has heard evidence over the past year from the public, politicians, farming and industry groups, non-governmental organisations and technical experts. They have produced a detailed analysis of the context in which the FSEs are being conducted as well as a thorough consideration of the issues raised by the intense interest in the evaluations, resulting in a list of recommendations regarding future decision-making.
  3. The Farm Scale Evaluations are a research programme designed to examine whether there are any differences in the diversity and abundance of farmland wildlife associated with the management of GM herbicide tolerant crops when compared with equivalent non-GM crops. The programme involves between 240 and 300 fields in total, across Britain, where half the field is sown with a GM crop and the other half with its conventional equivalent. Biodiversity indicator species are studied in both halves of the field while the crops are grown as they would be if planted commercially. The programme will last until harvest 2002 for spring-sown crops and harvest 2003 for autumn-sown crops.
  4. The crops involved are maize, beet (sugar and fodder varieties) and oilseed rape (spring and autumn sown varieties). The maize being grown in the FSEs has marketing consent under Part C of the European Directive governing GMO releases. This consent was issued at EU level and imposes no restrictions on where or when the crop can be grown. Both the beet and oilseed rape have pending applications for Part C consent but are being grown in the FSEs under research consents for the UK under Part B of the Directive; these impose tight restrictions upon the consent holder. The restrictions vary for individual Part B consents but all consent holders have to notify Defra, the Devolved Administrations and the public of the locations of the trial sites before they are sown. All the crops being grown in the evaluations have been subject to detailed risk assessments as part of the requirements for these consents. The Advisory Committee on Releases to the Environment (ACRE), which is made up of independent experts and scientists, has considered this information and concluded that the crops themselves do not pose risks either to human or animal health and the environment.
  5. The results of the research undertaken at the sites will be peer reviewed and made publicly available at the end of the evaluations. The results will help provide answers to some of the important questions government and the public have about the impact on our environment of the herbicide management practices involved in growing GMHT crops. Under an agreement with the farming and biotechnology industry group SCIMAC there will be no commercial cultivation of GM crops in the UK until the end of the FSEs.
  6. The AEBC have made ten recommendations in their report: two relate to the operation of the Farm Scale Evaluations themselves, seven deal with decision-making on the results and any subsequent commercialisation of the GM crops involved and one deals with the need for a wider public debate about the role of GM crops in UK agriculture in the future. This response deals with each recommendation in turn. Recommendations appear in bold text with government's response set out below.

General response

  1. We welcome the Commission's detailed analysis of the context in which the FSE programme is being conducted as well as the thorough consideration of the broader issues raised by the intense public interest in the evaluations. The report is a positive contribution to the debate surrounding GM crops. We agree with the Commission's view that the report can help illuminate public discussion of the issues surrounding GM crops.
  2. As a result of the report Government asks the AEBC to provide further advice by the end of April 2002. The advice should cover how and when to promote an effective public debate on possible commercialisation of the FSE crops, and how to make best use of the results of such a debate. The advice should also cover how to determine the public acceptability of GM crops, in particular, cross-pollination thresholds and GM presence in organic crops.

Recommendation 1:

The programme of FSEs should be completed subject to:

  • the Government confirming its commitment to no commercial cultivation of GM crops in the UK at least until the trials are complete and the results have been evaluated alongside other factors and other evidence identified below;
  • the Government working with SCIMAC and representatives of the organic farming industry to set adequate separation distances for the remaining trials to ensure that the interests of all parties are accommodated. By "adequate" we mean separation distances that allow current organic standards to continue to be maintained, but recognising that some flexibility will be required to ensure that the trials can be completed;
  • the objectives and limitations of the trials being clearly stated and communicated to the public;
  • effective local consultation taking place on the selection of plots, which, whilst maintaining the scientific basis of site selection, takes into account within the SCIMAC agreement other factors beyond the current regulatory regime, and in particular the interests of local stakeholders.

Government Response:

  1. We welcome the qualified recommendation that the evaluations be completed. As the AEBC explain in their report, the evaluations are an important research programme (the biggest independent study of this type ever) providing new insight for scientists and government into the environmental impact of both GM and non-GM agriculture.
  2. The report records the Commission's concerns about the operation of the evaluations. Paragraph 30 of the report refers to the perceived absence of consultation, the short notification and unfortunate location of some of the chosen sites. These issues are addressed below.

A commitment to no commercialisation until the end of the FSEs and until the results have been considered alongside other factors and evidence.

  1. Government's agreement (dated November 1999) with the farming and biotechnology industry on the Farm Scale Evaluations states that there will be no commercial plantings of GM crops in the UK until the end of the programme in 2002/3. Government remains committed to the undertakings in this agreement. The policy has been restated by government throughout the evaluations. For example, the Defra news release of 23 July 2001 announcing the proposed sites for the autumn 2001 round of Farm Scale Evaluations stated: "There will be no commercial growing of GM crops until the FSEs are completed and only then if the crops and associated farming practices are assessed as causing no unacceptable effects on the environment".
  2. Government takes the position that the scientific results from the Farm Scale Evaluations are only one part of the decision-making framework. In any case the FSEs are a voluntary arrangement and do not form part of the regulatory process governing the release of GM crops. Before a GM crop can be grown commercially it will have to satisfy a number of additional regulatory requirements. These include requirements on safety for human health and the environment under Directive 90/220 (to be replaced by 2001/18 by October 2002) as well as those under the variety listing legislation (to show distinctiveness, uniformity and stability and value for cultivation and use). GMHT crops will also require approval for the commercial use of the pesticide with the crop to which it is specific. Any food products from the GM crops will also have to meet the requirements laid down in the EU Novel Foods Regulations.
  3. Ministers have indicated that decision-making on commercialisation of each of the GMHT crops grown in the FSEs will be as inclusive as possible. Members of the public will have the chance to make known their views on commercialisation through a process of public debate. Government sees the AEBC's fourth recommendation - to have an independent review of the other research and evidence concerning the crops grown in the FSEs - as an important input to the process of public debate and decision-making. Final decisions on commercialisation will be for the UK Government to take in conjunction with the Devolved Administrations and other Member States. Decisions must be taken with reference to the science-based criteria set down in the European legislation, but will be based on more than an analysis of the FSE results. Although general ethical and socio-economic implications of the marketing of GMOs may be taken into account in reviewing the operation of this legislation, the criterion for taking decisions on individual applications is the avoidance of adverse effects on human health and the environment.

Adequate separation distances between GM and non-GM production:

  1. Government is committed to ensuring co-existence between the different types of farming (GM, organic and conventional) both during the remainder of the FSE programme and for any eventual commercialisation that might take place. Separation distances are being kept under review during the evaluations. It is important that the evaluations themselves should not result in any unacceptable cross-pollination.
  2. Organic organisations have pressed for the greatest separation distances. AEBC notes that no organic farmer has lost their accreditation as a result of the 184 evaluations sites that have been sown to date. Upon the recommendation of the AEBC we are working with organic organisations and SCIMAC to ensure that this situation continues in the final year of the evaluations.

Objectives and limitations being clearly stated and communicated:

  1. Ministers are committed to ensuring that the purpose and limitations of the FSEs are communicated clearly. Government hosted a meeting for stakeholders to discuss the evaluations in July 1999 prior to first round of plantings. The Scientific Steering Committee overseeing the evaluations has produced a paper setting out the science involved and its limitations. This has been published on the Defra website at www.defra.gov.uk. In order to improve the communication of these issues the UK Government has recently revised its leaflet on the FSEs ('Genetically Modified Crops - take a closer look') and, together with the Scottish Executive, has made available a new leaflet ('Genetically Modified Organisms - The Regulatory Process') explaining the processes behind the approval of a GMO release. These go further than previous texts to explain what is being studied in the FSEs and why. Copies of the leaflets are distributed at public meetings and can be obtained free of charge from Defra publications (Tel: 08459 556000). They are also available on the Defra website. The Scottish Executive has also prepared up-to-date factual booklets about GM Crops. The research consortium has published a number of papers describing the evaluations in scientific journals and half-yearly progress reports that are available on the website. Further information on the research methods will also become more widely available as the research consortium start the process of submitting them to peer reviewed journals for publication, at the end of the programme.

Effective local consultation on the plots selected, which maintains the scientific basis of the study but takes into account within the SCIMAC agreement other factors beyond the regulatory framework and in particular local stakeholders:

  1. Government agrees with this recommendation and welcomes the commendation of current consultation practices in Scotland. Responsibility for the selection of sites for the evaluations rests with SCIMAC, the independent research consortium and the Scientific Steering Committee. The Scientific Steering Committee approves a distribution of sites that is representative of regional geographical differences and the range of current farming methods, biodiversity and production intensities across Britain. This is necessary to ensure that the FSE results will be scientifically valid.
  2. Government is discussing with interested groups (such as organic accreditation bodies, and farmers) how their interests might be better considered when SCIMAC are compiling the preliminary pool of locations from which the researchers select the proposed sites. Arrangements for the spring 2002 round of the evaluations involve seeking information from the organic bodies about certified organic growers cultivating compatible crops and SCIMAC using the information to inform the selection of potential FSE sites. This process is intended to avoid the most obvious conflicts between local interests and the evaluations.
  3. On the specific issue of notification the AEBC states that there should be no reduction in the government's policy to have four weeks notice. They urge SCIMAC to strive for six weeks notice. Government has asked SCIMAC to operate a six-week notification period in spring 2002 to allow more time for people to make their views known.
  4. Looking broader than FSE site selection, government is currently constrained when taking into account the results of consultation on issuing consents, by Directive 90/220. Under the Directive consents for the release and marketing of GMOs can only be prevented on valid safety grounds supported by sound scientific evidence. This remains the basis for decision-making under the revised Deliberate Release Directive (2001/18). Consultations with the public prior to the issuing of either Part B or Part C consents will be mandatory under the revised Directive, although this does not extend to a requirement for consultations on the planting of crops cleared for commercial cultivation under Part C of the Directive. Government has consulted on the implementation of the revised Deliberate Release Directive. One of the issues on which we have actively sought views is how consultation about release sites can be improved within the context of the European regulatory framework.
  5. Government will continue to meet its obligations under the legislation and will ensure that no releases are allowed unless they are safe and pose no unacceptable risks to the environment. Government will continue to consider any comments from local communities about the safety assessments that have been made on the crops or the proposed sites in their area, as is provided for in the legislation.

Recommendation 2:

Take particular care to ensure that Government press releases and publications are expressed in clear and precise language, so that messages are not distorted and cannot easily be misinterpreted.

Government Response:

  1. Government welcomes this recommendation. Government is constantly seeking to improve its literature on the evaluations. Government is committed to explaining the results of the FSEs, once they are complete, in a clear way that will be easily understood by a non-scientific audience.

Recommendation 3:

Start developing policy now on how to use the results of the FSEs in future decision-making.

Government Response:

  1. We agree with this recommendation. The Scientific Steering Committee overseeing the evaluations has considered what statistical tests and scientific assessments will be needed to present the results in a scientifically robust way. The Advisory Committee on Releases to the Environment (ACRE) and the Advisory Committee on Pesticides (ACP), will advise Ministers on the significance of the FSE results in scientific terms and the degree to which the FSE findings will be applicable to any future risk assessments associated with applications to grow GMHT crops and the use of herbicides. ACRE and ACP will give their advice in the light of the best scientific evidence available at the time. The advice from ACRE and ACP will be made public, as will the raw data produced from the FSEs and the scientific analysis of that data. The wider scientific community and others will have an opportunity to comment on the FSE results and the advisory committees' advice as part of the overall process of public debate on possible commercialisation of the FSE crops. UK Ministers are committed to using all available research and advice in making future decisions regarding commercialisation of GM crops.
  2. In paragraph 47 of the report there is the proposal that the AEBC hold a series of discussions with stakeholders, in conjunction with ACRE. ACRE has expressed a willingness to help in the decision-making process wherever it can within the Committee's strict science-based terms of reference. The Chairman of AEBC and the Chairman of ACRE have met to discuss how best the two advisory bodies can work together synergistically to provide Ministers with a balanced view of the many complex science and societal issues associated with the possible commercialisation of GM crops. The Government supports and encourages this helpful dialogue.

Recommendation 4:

Commission an independent review of all information that will complement the results from the FSEs including:

  • information collated by the Advisory Committee on Pesticides (ACP) on the herbicides in question;
  • information collated by ACRE on any direct and indirect effects of these crops compared to conventional varieties;
  • information from other studies such as BRIGHT and the Brooms Barn trials which have investigated a range of management regimes under which these crops could operate;
  • any relevant information from other countries in which these crops are grown commercially.

Government Response:

  1. This recommendation contributes to the thinking about how the process of an informed debate on the FSE results might work. We believe that it will be very important to set the results of the FSEs, and the decision-making process, in the proper scientific and social context. Much of the evidence considered by the advisory committees named, and their advice to Ministers, is already publicly available and hence open to independent review. ACRE and ACP are responsible for reviewing independently the information with which they are provided about the GM crops and the herbicide. They are already working together on this. There is therefore no need for further independent review of this information. However, the review proposed of the information from other relevant studies and countries could provide a useful component of the background against which to consider the possible commercialisation of the GM crops grown in the FSEs.
  2. Government will consider what further information is needed before decisions are taken. Government will also fund independent researchers to review other studies relating to the crops grown in the FSEs and any relevant information from other countries where the crops are grown commercially. Any review of information from other countries will have to consider carefully the type and representativeness of the information obtained and clearly set out how it relates to UK ecosystems and conditions. The researchers will be asked to present their review to government by spring 2003, before the end of the FSEs. ACRE and ACP will review the researchers' findings and make recommendations to government as appropriate.

Recommendation 5:

Ensure that the level of publicly funded research is such as to secure an objective independent assessment of the potential impacts of both current practices and new technologies on agriculture and the wider environment.

Government Response:

  1. Government agrees with this recommendation and has been trying to achieve it prior to the AEBC's recommendation. To obtain a full picture, it is important that Government draws on a broad range of the best relevant expert sources. These may not all of course be publicly funded, but government recognises the importance of ensuring that research is sufficiently wide-ranging to address all relevant issues and subject to sufficiently questioning review and assessment. The review of studies that we will commission as a result of recommendation 4 above will serve this purpose with respect to the crops being grown in the FSEs.
  2. Government, through its departments and research councils, funds research into the effects of agricultural practices on the environment. The FSEs are just one example of this. The Biotechnology and Biological Sciences Research Council and the Natural Environment Research Council have substantial separate programmes in this area and also have a joint 'Gene Flow in Plants and Micro-organisms Initiative' with a budget of £5.7 million available in grants for research in this area. Defra, the former Ministry of Agriculture, Fisheries and Food and the Scottish Executive has funded research into the risks to the agricultural environment from GM crops since 1991.

Recommendation 6:

Commit to an open and inclusive process of decision-making around whether the GM crops being grown in the FSEs should be commercialised, within a framework, which extends to broader questions.

Government Response:

  1. Ministers will have to decide, within the framework of European legislation, whether the crops grown in the FSEs should be commercialised. Government is committed to taking public opinion into account as far as possible through an open decision-making process. There will be a public debate on the possible commercial growing of GM crops. The debate will cover the FSE results and the wider review of the other information gathered to complement the FSEs outlined under the AEBC's recommendation 4. Members of the public will continue to be able to make their views known on proposed variety listing, on the National Seeds List or EU Common Catalogue, of the crops involved.
  2. Government asks the AEBC to advise, by the end of April 2002, on how and when to promote an effective public debate on possible commercialisation of the FSE crops and how to make the best use of the results of such a debate. The advice should also cover how to determine the public acceptability of GM crops, in particular cross-pollination thresholds and GM presence in organic crops.
  3. The AEBC are asked to be imaginative in the options they consider but to bear in mind that their recommendations must be practical and cost effective. The debate should involve interest groups but also reach beyond them to the wider public. The methods advocated by the Royal Commission on Environmental Pollution in its 1998 report on environmental standards and in the March 2001 report of the Parliamentary Office of Science and Technology (Open channels: public dialogue in science and technology) should be considered. The AEBC will not necessarily be asked to carry out all aspects of its recommendations - Defra, the Devolved Administrations and Government Offices might each participate in different areas of the dialogue with the public. AEBC should advise on which are the most appropriate organisations to carry out the different parts of the process.
  4. The separation distances for the FSEs have been set to ensure that cross-pollination is a maximum of 1%. However, as the AEBC notes in paragraph 65 of the report, there is a case for separation distances to be greater so as to ensure a maximum of, for example, 0.1% cross-pollination.
  5. In paragraph 61 of the report, it is stated that better mechanisms are needed to prevent the upward drift of GM presence in conventional seeds and produce. Such mechanisms are being developed. Given the amount of GM crops grown worldwide it would be very difficult to guarantee that any product or seed is completely GM-free. The presence of GM material should be kept as low as possible and thresholds should continue to reflect the capability of detection methods and the ability of the supply chain to deliver. The European Commission has tabled proposals to amend the Seeds Marketing Directives in order to establish statutory thresholds for adventitious presence of GMs in conventional seeds. These would create a purity standard for conventional seed that would make it illegal to market seed containing levels of GMs that breached the relevant threshold. Further, we believe that the threshold would also apply to GM seed which contained an adventitious presence of an additional modification. These proposals have been the subject of public consultation and are currently under discussion in Brussels. With regard to produce European legislation already requires products containing GM ingredients to be labelled as such. However, Regulation 49/2000/EC contains a threshold, below which labelling is not required, for foods obtained from non-GM sources in which the adventitious presence of GM material is less than 1%. The recently proposed EC regulation on GM food and feed also contains such a threshold and a provision to keep the level under review.
  6. Applications for EU-wide approval for general cultivation are still under consideration for two of the crops involved in the FSEs (the oilseed rape and beet). Any eventual decision on commercialisation will be taken using the criteria in Directive 2001/18, which requires more by way of consultation with the public on applications for approval. However the decision-making process will continue to be evidence based. Government has sought views from the public on how consultation arrangements under the new Directive might work. The procedures in the Directive dictate that, in cases where the competent authority in one or more Member States raises and maintains an objection to another Member State's favourable assessment of an application for a marketing consent, decisions will be taken in conjunction with other European Member States and through a qualified majority voting procedure.
  7. The GM maize involved in the FSEs already has Part C (marketing) approval under the Deliberate Release Directive. The FSE results will provide important information to inform any eventual decision by Ministers on whether to take action under the safeguard clause in the Directive to restrict or prohibit the use of this crop in the UK. The decision would be one for Ministers and the Devolved Administrations to take jointly, with the advice of ACRE and in the light of the informed debate on the FSE results. If action were to be taken, it would have to be notified to the European Commission and other Member States, who would confirm or reject the restriction or prohibition measure by qualified majority vote. An action of this nature has already been taken by the National Assembly for Wales under the safeguard clause, to introduce legally enforceable separation distances. This action has been notified to the European Commission and a proposal from the Commission on the action is awaited.

Recommendation 7:

Give early attention to the framework for post-commercialisation monitoring.

Without prejudging the issue of whether GM crops will be approved for commercialisation in the UK, the Government should be prepared to publish and consult widely on its proposals for the post-commercialisation monitoring which would be needed, and for the action to be taken if adverse effects were discovered.

Government Response:

  1. Government has already made provisions for post-commercialisation monitoring. Post-commercialisation (sometimes called post-market) monitoring is an important addition to the regulatory framework, introduced formally by the new Directive on Deliberate Releases (2001/18). ACRE has a sub-group working on the detailed requirements for post-market monitoring arrangements under the new Directive. Once their proposals are agreed, government will consult on them as part of the implementation process for the new Directive. Any adverse effects detected by monitoring could be tackled by use of the safeguard provisions in the Deliberate Release Directive, which allows Member States to take action to restrict or prohibit cultivation of GM crops where new evidence of risk to the environment comes to light.

Recommendation 8:

Improve understanding of the basis of public views by drawing on the work of social scientists in this field.

Government Response:

  1. We acknowledge the need for improved understanding of public views. This is an objective for which all involved in the GM crops debate should strive. It would be helpful if the AEBC would consider this issue further and take this work forward as part of the advice requested in paragraph 30 of this document, under recommendation 6, as to the best methods of promoting an effective public debate on possible commercialisation.

Recommendation 9:

Improve methods of dealing with risk and uncertainty in relation to the use of biotechnology in agriculture:

  • by ensuring that all the relevant regulatory processes incorporate the principles developed by Phillips and by May, and that the regulators are publicly explicit about where areas of uncertainty occur in their deliberations and how they have tried to take them into account; and
  • by developing and disseminating examples of best practice

Government Response:

  1. We welcome the Commission's recommendation. Government is committed to greater transparency and openness and providing clear information about levels of uncertainty. Government wants to have approaches in place for effective dialogue, which will allow for the views of the public to feed into policy development and ensure that scientific information is presented in an accessible way.
  2. Government will assess, manage and co-ordinate risk as part of its policy-making process, and is committed to better promotion, co-ordination and implementation of risk best practice. In July 2000 the UK Government published Guidelines 2000, a revised and strengthened version of the 1997 guidance from the former Chief Scientific Adviser, Lord May, on the use of scientific advice in policy making. Departments assess how well Guidelines 2000 have been assimilated into their departmental practice, how successful they have been in raising awareness of the principles; and the adequacy of the arrangements for monitoring how well policy makers apply them. The Chief Scientific Adviser reports to Ministers on the implementation of Guidelines 2000 across departments. These reports will be published shortly.
  3. Government also welcomes the Commission's recognition that ACRE is operating in accordance with the principles recommended by Lord Phillips. However we recognise that there are no grounds for complacency and in order to strengthen good practice by scientific advisory committees, government will shortly publish a new Code of Practice for Scientific Advisory Committees that all such committees will be expected to follow.
  4. We believe that an open and consultative approach can lead to better decisions as well as help to build public confidence in the regulatory system. We will be working actively to ensure that progress is maintained to take forward this approach.

Recommendation 10:

Include specific consideration of the future of GM crops in the discussions about the future of agriculture in the UK.

The various strategic reviews of farming and food being undertaken by the UK administrations should explicitly address how to promote the co-existence of different forms of farming in the UK. There should then be a wider public debate involving a series of regional discussion meetings to consider what role GM crops might have in UK agriculture in the future. The AEBC is willing to contribute to this process.

Government Response:

  1. We welcome the recommendation that there be a wider public debate on co-existence between the different farming types. Government acknowledges the suggestions made in paragraph 69 of the report about the form of such a debate and is pleased to note the AEBC's interest in advising on the development of this process. Government is taking up this offer in asking the AEBC to advise further on how a broad public debate might be achieved and how the outcome of such a debate should be used (paragraph 30, under recommendation 6 refers).
  2. The report refers, in paragraphs 57 and 58, to the independent Policy Commission on the Future of Farming and Food that is to report to the Prime Minister and the Secretary of State for Environment, Food and Rural Affairs by 31 January 2002. The Policy Commission's terms of reference are wide-ranging and relate to England only; however similar exercises are being carried out by the Devolved Administrations. We will take into account the AEBC's recommendations in considering our response to the Policy Commission's report.
  3. Defra has been discussing with the various interested parties what measures might be necessary to allow for practical co-existence of GM and non-GM crops. One of the key issues underpinning this process is whether there is public acceptability of the presence of GM material in non-GM produce and if so at what level that might be. Further debate is needed on this issue. Agreement upon this issue could provide a way towards practical measures to preserve consumer choice within the context of commercial GM cultivation, were that to occur. It is against this background that Government has asked (in paragraph 30, under recommendation 6) the AEBC to consider further the issue of public acceptability.

January 2002

Page published 18 January 2002;
Page last modified 10 August, 2002

Department for Environment, Food and Rural Affairs