GM Crop Farm-Scale Evaluations:
Background Papers

The Farm-Scale Evaluations of Genetically Modified Herbicide Tolerant Crops
Rationale and Chronology

A Paper by the Biotechnology Safety Unit, Department of the Environment, Transport and the Regions

1. Summary

This paper sets out the rationale and chronology relating to the decisions to set up the farm scale evaluations of certain herbicide tolerant genetically modified crops (GMHT crops) and the subsequent developments.

• The Government announced the farm-scale evaluations (FSE) in 1998 as part of a set of initiatives to strengthen the process for making decisions on whether or not to allow commercial cultivation of certain GMHT crops grown and managed with their associated herbicide regimes.
• In the event that cultivation were to be permitted the results will also inform decisions on what conditions or restrictions should be applied.
• The evaluations will assess the impact on farmland wildlife of the management of the GMHT crops with their companion herbicide as compared with equivalent plantings of non-GM crops.
• The crops involved, rape, maize and beet, were all on the verge of entering commercial agriculture in the EU. Under the voluntary agreement with industry, they will not now be grown, other than in the evaluations, until the programme is complete.
• The European regulatory authorities and their scientific advisors were content with the safety of the GMHT crops themselves, but questions remained about the impact of the new herbicide regimes on the abundance and diversity of farmland wildlife. The FSE were therefore set up to address this specific remaining area of uncertainty.

Annexed are background papers on the regulatory regime and the evaluations prepared for the AEBC by DETR in August 2000.

• The legal framework for decision making on the release and marketing of GMOs in the EU (1) and
• Risk assessment for releases and marketing of GMOs in the European Union (2)
• The history of the farm scale evaluations (3) and
• The science of the farm scale evaluations (4).

Other relevant documents, including those referred to in these papers, are also attached or referenced (references 5-27).

2. Regulatory background

In the early 1990s the European Community set up a comprehensive system for the assessment and control of GMOs. Under Directive 90/220 no product comprising or containing GMOs can be placed on the market until it had been shown that measures have been taken to avoid adverse affects on human health and the environment (1,2). In addition any GM product to be used as or in food had to be approved under the EU Novel Foods Regulation.

In addition GM crops have to satisfy the same requirements as conventional varieties for addition to the National List of Seeds or the European Common Catalogue. This requires a series of tests to demonstrate distinctiveness, uniformity and stability. Any use of pesticides on the crops also has to be approved.

In 1998, several types of GM crop were working their way through the regulatory process and could have received all the necessary approvals for commercial cultivation by spring 1999. Details of the crops and their regulatory position are at section 9 and Annex A.

3. Concerns

At that time concerns were raised about:

• The environmental impact assessment required under 90/220.
• The safety of GM crops in the food and feed chain.
• Aspects not evaluated as part of the regulatory process, in particular the change in the pattern of use of herbicides on these crops which could lead to adverse affects on farmland wildlife.
• The acceptabilty of GM crops and GM food generally; strong feeling that the move to commercialisation was happening too fast.

Although the environmental and food and feed aspects had been considered by the Advisory Committee on Releases to the Environment (ACRE) and the Advisory Committee on Novel Foods and Processes (ACNFP), many critics felt that there was too much uncertainty in the assessment and that a more precautionary approach should be taken. Others raised concerns which they felt had not been examined by the committees. In 1996 ACRE had itself raised the need to consider the environmental impact of widespread cultivation of GM herbicide tolerant crops (5).

In early 1998 English Nature and the other statutory nature conservation agencies (6) called for a moratorium on the introduction into commercial agriculture of GM crops modified for insect resistance or herbicide tolerance until more was known about the impact of their cropping systems on farmland biodiversity. Many other organisations joined the call for a moratorium. Many went further calling for a halt to import of GM foodstuffs and all outdoor testing of GM crops as well.

During 1998 ministers and officials in DETR and MAFF had a series of meetings with English Nature and NGOs from both sides of the debate. In October 1998 amid mounting pressure (8,9), DETR officials consulted the leading organisations campaigning for a moratorium and separately the industry body SCIMAC. The meetings focussed on the legality and terms of a possible moratorium and the further research and information thought necessary (7).

4. Introduction of the farm scale evaluations

At the same time the House of Lords Agriculture Select Committee was conducting an enquiry into GMOs and had taken evidence from a wide range of organisations and individuals over the summer. Taking this evidence into account together with the other discussions noted above the Government drew up a series of measures to strengthen and improve the assessment of GM crops and the decision making process. Michael Meacher and Jeff Rooker used their appearance before the committee on 21 October to announce the package of measures (11).

The main elements were:

• An agreement with SCIMAC;
• For a programme of managed development of GMHT crops to limit their introduction whilst ecological monitoring was carried out and
• A three year pause on the introduction of insect resistant GM crops;
• The farm scale evaluations to assess the effects of the agricultural management of field scale releases of GMHT crops on farmland wildlife as compared with comparable plantings of conventional crops;
• Consideration of the establishment of a stakeholder forum to discuss and advise on environmental issues raised by biotechnology to work alongside ACRE (This lead to the establishment of the AEBC);
• The setting up of a new Ministerial Group on Biotechnology (MISC6);
• UK action to ensure that the amendment of directive 90/220 had well defined and broad requirements for environmental risk assessment and monitoring;
• A scientific review of pesticides used on GM crops comparing the likely impact on biodiversity of current and possible future practice;
• A reassessment of herbicides to be used on GMHT crops including their effect on non-target species and a requirement for new approvals for the use of the relevant herbicides on GMHT crops;
• Consideration of the introduction of long term monitoring capable of picking up any unexpected effects.

The Ministers made it clear that these measures made a moratorium unnecessary and confirmed the Government's view that:

• The approval under directive 90/220 for cultivation of a GM crop could only be revoked if there was new evidence of harm. If such evidence came to light, action to impose a ban in the UK could be taken using powers in article 16 of the directive.
• The National Seed List Trials are a series of objective tests, so if the GM variety passes the tests there are no grounds for refusal.

The following paragraphs describe how the relevant decisions associated with this announcement were taken forward.

5. Agreement with SCIMAC to limit commercialisation of GM crops

No approvals for products consisting of or containing GMOs have been issued in the European Union since August 1998, when the Europe-wide approval for cultivation of GMHT maize was issued. There is now a backlog of 14 products, listed in Annex A. In light of this and the continuing concern in the UK, the government made a new agreement with SCIMAC in November 1999 (18,19). The terms of the agreement include:

• Renewal of the voluntary agreement on the conduct of the farm scale evaluations through until the end of the evaluations following harvest of the crops planted in 2002;
• No unrestricted cultivation of GM crops in the UK until the FSE are complete;
• None of the produce from GM crop plantings in the UK will be used in a way that is of direct commercial benefit to the consent holders during the FSE period.

At the same time ministers agreed to include GMHT sugar beet and fodder beet in the evaluations on the same terms as the rape and maize.

6. Decisions on setting up the Farm Scale Evaluations

After the announcement in October 1998, DETR scientists had discussions with other government departments, members of ACRE and wildlife and research advisors and then drew up the specification for the ecological studies.

• The hypothesis to be tested was that there are no significant differences between the biodiversity associated with the management of the particular GMHT crop and the comparable non-GM crop at the farm scale.
• The secondary objective was to contribute to an assessment of the wider question of whether the commercial use of GMHT crops will change the management of farming systems and the agricultural landscape.

Fifteen leading research organisations were invited to tender for the work which involved the design and implementation of the monitoring programme, specification of the methodologies to be used and the level of statistical significance which could be obtained. Details of the specification are attached (14). Officials in DETR agreed the practical arrangement with SCIMAC, who were to provide the GM seeds and arrange for suitable farmers to grow and manage both the GM crops and the conventional crops used in the trials (14, Annex A). The ecological studies are funded by DETR with small contributions from MAFF and the Scottish Executive.

During the tendering period, DETR wrote to NGOs and other interested parties inviting comments on the specification for the research. The letter and list of consultees are attached (14). The comments received informed the tender review.

Tenders were received from eight organisations. A tender review panel comprising, Professor John Lawton (then director of the Centre for Population Ecology at Imperial College) and scientists from English Nature, DETR, MAFF, the Scottish Office and the British Society of Plant Breeders considered the various proposals. Ministers announced the decision on the appointment of the successful research consortium on 15 April 1999 (15). Once those involved in carrying out the ecological research had been decided, ministers appointed an independent Scientific Steering Committee (SSC) to oversee the research programme and advise on the outcome (16). The membership, terms of reference and minutes of meetings of the Scientific Steering Committee are published and available on their web site. The research consortium submits half yearly reports to the Committee; these are also published and available on the web site.

The first year of the evaluations was a pilot phase with a small number of fields of each GMHT crop sown in 1999. The full programme started in 2000 and is due to run for 3 years. The SSC will consider the results from the spring-sown crops when they become available in autumn 2002 and the results from the autumn sown crops in autumn 2003. The SSC will supervise the publication of the results. It will then be for ministers, taking the advice of ACRE and others on the interpretation of the outcome, to decide how to go forward.

7. Decisions on the risks to the environment from the farm scale evaluations

Safety of the GM plants. The developers of the four GMHT crops involved in the farm scale evaluations have submitted applications for their approval for EU wide cultivation under Part C of directive 90/220. These dossiers either have been approved (in the case of maize) or are in the late stages of approval by member states (see section on regulatory approval). ACRE had considered these dossiers at various stages of their development and advised ministers; their advice is public.

The Aventis GMHT maize was granted Europe wide approval for cultivation in August 1998 so no specific approval for the FSE was needed. For the GMHT oil seed rape and the sugar and fodder beet to be grown in the evaluations specific Part B, research approvals under directive 90/220 were needed. ACRE and the statutory nature conservation agencies considered the applications and in particular the impact on the environment and advised that there were no grounds relating to safety for human health or the environment for not granting consent for the trials. The relevant regulatory authorities in England, Scotland and Wales have granted consents, these and the applications are available on the public register held at DETR. In advising on these applications ACRE considered the various concerns raised about the safety of the GM plants and voiced by scientists, pressure groups and the public, such as promoters, cross-pollination, horizontal gene transfer and effects on bees.

Safety of the herbicide use. Following advice from the Advisory Committee on Pesticides, ministers have given specific approvals under the pesticides legislation for use of the broad-spectrum herbicides in the farm scale evaluations. The decision on full commercial approval for this use of the herbicides awaits the outcome of the FSE.

Agronomic safety. Through 1998 officials at MAFF had been leading discussions with the industry body SCIMAC on development of a code of practice for the supply and agronomic management of GMHT seeds and crops. The code was published in June 1999 and endorsed by ministers. The voluntary code, which is binding on participants, covers the arrangements that would be necessary to ensure integrity of the supply chain for both GM and non-GM crops should GM crops enter commercial production. The code also includes measures to avoid agronomic problems such as herbicide tolerant volunteers. Ministers and SCIMAC agreed that where relevant the GMHT crops in the FSE will be grown in compliance with the SCIMAC code. This includes separation distances between the GM crops and nearby conventional or organic crops.

Food and feed safety. The rape and beet do not have approval for use in food or feed and the consents require that at harvest they are disposed of by ploughing in or removal to land fill. The maize has Europe wide approval for use in food and feed, however the agreement with SCIMAC requires that at harvest the plants are disposed of by ploughing in or removal to land fill. ACRE and ACNFP have advised that any cross-pollination with neighbouring crops during the trials or volunteers arising in subsequent years do not pose a risk to food or feed safety.

8. Decisions on strengthening the regulatory process

The European Union is in the final stages of agreeing a revised Directive 90/220 to reflect current best practice in member states and to introduce new measures to strengthen the regulatory process. This includes new requirements for risk assessment and monitoring. These are described in annexes 1 and 2 to this paper. The scope of the risk assessment will now include possible impacts of the specific techniques used for the management of GMOs where these are different from those used for non-GMOs. Therefore in future aspects such as changes is the patterns of rotation will be considered in the assessment. European Environment Ministers agreed in December 1998 to adopt these new procedures straight away for new applications, using the powers of the existing directive and without waiting for implementation of the new directive.

In October 1998 Ministers asked ACRE for advice on how the management of the GM crop can be taken into account in the approvals process. An ACRE sub-group under the chairmanship of Sir John Beringer was set up in February 1999 with the publication of ACRE's report on commercialisation of GMHT crops (13) and has been considering these wider environmental issues. The group consulted on a draft guidance note in September 2000 (26) and is currently considering the responses. This ACRE sub-group and the Environment Panel of the Advisory Committee on Pesticides have jointly been considering how the environmental impact of the changed pattern of use of herbicides on GMHT and other crops should be assessed using the powers in both the GMO and pesticides legislation. The minutes of the sub-group are posted on ACRE's web site.

9. The GM crops, information and status

Before a GM crop plant may be placed on the market, ie sold to and grown by farmers commercially, it requires separate approvals:

• under part C of Directive 90/220 to place a GMO product on the market, to ensure the crop plant will not cause harm to human health and the environment;
• under seeds legislation to market the seeds and add them to the National List;
• under pesticides legislation for a new use of the herbicide on a GM crop and
• under novel foods regulations for use of the produce in foods.

In the summer of 1998 no GM crops had all the necessary approvals for commercial cultivation. However several had or were close to getting Part C product approval under directive 90/220. The attached table summarises the position on all these crops. As discussed below it was possible that GMHT rape and maize could have obtained all the necessary approvals in time for sowing in the spring 1999 with beet following in spring 2000.

It is not possible to prevent cultivation of crops which have EU wide approval under Directive 90/220 unless new information is available on the risks to the environment or human health which justifies taking action under Article 16 to impose a temporary local ban.

Oil Seed Rape
Genetically modified herbicide tolerant oil seed rape (GMHT rape) has been grown in trials in Britain and many European Member States since 1988. It is in wide spread cultivation in North America. There are three types of GMHT rape relevant to the FSE.

In 1994 the UK considered type of GMHT rape known as 'MS1RF1' tolerant to the broad spectrum herbicide 'Liberty', glufosinate ammonium, from the company PGS (now Aventis) in an application for a Part C approval under Directive 90/220 for seed production. After due consideration and agreement by Member States, the UK issued consent in 1996. A further application under Part C was made through the French Authorities for general cultivation and animal feed. Approval was given by Member States in 1997 but the French Authorities did not issue the consent because of concerns in France. UK National List seed trials for a variety of this rape were complete and the oil is approved for food use. Therefore this GMHT rape could have had full approval for commercial cultivation at any time.

In October 1998, two more types of GMHT rape from AgrEvo (Aventis) were in the final stages of the Part C process and National List trials. Both are tolerant to 'Liberty' and their details are shown in Annex A. The GMHT rape used in the evaluations is known as MS8RF3, reference C/BE/96/01.

In September 1998 DETR commissioned Prof Alan Grey and his team to review the application for Part C approval for cultivation for GMHT rape. He was asked to identify any new information that had become available on the environmental risks since ACRE had considered the dossier in 1996. Prof Grey was not a member of ACRE when they considered the original application. ACRE considered Prof Grey's review (27) in January 1999 and advised that having taken the new information into account their original advice was unchanged.

Maize
GM insect tolerant maize is grown extensively in the US. For many years research trials have been carried out in other EU member states, notably France, Italy and Spain. Both insect resistant and herbicide tolerant varieties have been developed. Two so-called Bt maize types, giving resistance to the European corn borer have Part C approval for commercial cultivation in the EU. There is no expectation that these particular crops would be grown in the UK as the corn borer is not prevalent.

In 1995 AgrEvo (now Aventis) applied through the French Competent Authorities for EU-wide product (Part C) approval for import, cultivation and animal feed for T25 maize tolerant to the herbicide glufosinate ammonium 'Liberty'. After due consideration by member states consent was granted by the French in August 1998. UK National Seed List trials on a variety of this maize known a Chardon LL were due to be completed in 1999 and novel food approval had been given. Therefore, again there was the prospect of imminent commercial cultivation.

Beet
An application from Monsanto to market GM fodder beet tolerant to the herbicide 'Round-up', glyphosate, was made through Danish Authorities in 1997. Both GMHT sugar beet and fodder beet have been extensively trialed in the UK. A decision on an EU product approval (Part C) for commercial cultivation was expected in early 1999.

10. Extent of governmental, commercial and public consultation

The circumstances surrounding the setting up of the farm scale evaluations and the consultations undertaken have been described in sections 3-6 above and in the background paper the history of the FSE (3). Since then DETR held a seminar for representatives from NGOs in July 1999. DETR, the research consortium, English Nature, SCIMAC and the Scientific Steering Committee made presentations and then answered questions. DETR has published a report of the meeting including the Q&A session (16).

DETR has published information about the evaluations in a leaflet (23) and through the DETR web site. To coincide with the spring sowings in 2000 DETR organised 12 public meetings in the main trial areas (22). Representatives from DETR, the research consortium and SCIMAC gave information about the evaluations with an alternative view presented by Genewatch or Friends of the Earth, followed by a question and answer session. DETR also sent information to each parish council where a trial was being held. The Scottish Executive also held a public meeting.

In the autumn 2000, the publicity concentrated on early notification of parish councils. Mr Meacher invited the chairman of each council to a meeting with him in London to be briefed on the evaluations. DETR also offered to send a representative to a parish meeting should the council wish to organise one. Three out of the 23 councils arranged such meetings.

DETR hosted a meeting for the farmers involved in the evaluations in October 2000.

11. The future

The farm scale evaluations of the spring-sown crops will be complete in the autumn of 2002. The report of the research will be published in 2003 and open to scrutiny. The Government will need to evaluate the findings in the context of public views on acceptability of GM crops. The remit of the AEBC sub-group includes adding value to the future decision-making process. The sub-group might wish to consider providing advice on how the Government might manage the process as regards decisions on possible future commercialisation of GM crops.

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• Annex A (Adobe Acrobat - 18kb)
• Supporting Documentation (Adobe Acrobat - 64kb)

Biotechnology Safety Unit, Department of the Environment, Transport and the Regions: January 200