House of Commons - Environmental Audit

Select Committee on Environmental Audit Minutes of Evidence

Memorandum from the Department for Environment, Food and Rural Affairs

SUMMARY

1. The Farm Scale Evaluations (FSEs) were announced jointly by DETR and MAFF Ministers in October 1998. Sponsorship was taken over by the Department for Environment, Food and Rural Affairs, on its creation, in 2001. A detailed note setting out the background and development of the FSEs is attached as Annex A to this document.

2. The FSEs are the biggest ecological study ever undertaken on the effect of any farming practice, and are a credit to British science. The work has been internationally recognised and widely applauded. The data collected will serve as a benchmark in the study of agricultural ecosystems for years to come. In Spring 2003 the independent Scientific Steering Committee (SSC) concluded the spring sown FSEs were successfully completed. The quality of the research was endorsed by its publication, after a process of peer review, by the Philosophical Transactions of the Royal Society (Biological Sciences). The researchers and the SSC have done an excellent job and are to be congratulated on their efforts.

3. The farm-scale evaluations are not yet complete. Four crops were entered into the trials and the results so far have been published for three. The fourth crop, winter oilseed rape, was a year behind the others in trials owing to the difference in sowing times (autumn rather than spring). The results of winter oilseed rape will be published later in 2004. We look forward to the publication of these results, not least as winter oilseed rape is arguably the most economically important and most widely grown crop of the four.

4. There are currently no GM crops under cultivation in the UK, either for research or commercial purposes. No GM crop has all the regulatory approvals that are needed to be grown commercially in the UK. Applications to grow GM crops are currently working their way through the EU regulatory process, but final decisions on these will not be taken until later in 2004.

5. The results for the three spring sown crops in the FSEs were published on October 16 2003. The SSC summarised the results on the day as showing that growing conventional beet and spring rape was better for many groups of wildlife than growing GM herbicide-tolerant beet and spring rape. In contrast, growing GM herbicide-tolerant maize was better for many groups of wildlife than conventional maize. Both the best and worst performing crops for biodiversity were conventional crops.

The adequacy of the design on the farm scale trials and their ability to answer the questions posed at the outset of the trials.

6. The FSEs were designed to assess the hypothesis that there is no significant difference between the biodiversity associated with the management of GM herbicide tolerant crops and conventionally managed non-GM equivalent crops. The attached annex (Annex A) sets out the concerns that led to the commissioning of the FSEs, how the hypothesis to be tested was agreed upon, how the specification for the research was drawn up and the process of competitive tender by which the successful research consortium was chosen.

7. The final design of the trials was a matter for deliberation between the independent SSC appointed to oversee the trials and the research consortium. The SSC advised Government that the experimental design adopted after the pilot year studies was suitable to test the chosen hypothesis. The successful completion of the trials for spring sown crops confirmed clearly that the chosen design was appropriate. We refute any suggestion that the design of the trials was flawed.

The conduct and operation of the trials.

8. The conduct and operation of the trials was again an issue for the SSC to oversee and they were given a free hand in this regard.

9. The trials were required to comply with existing legislation, where relevant. The Pesticides Safety Directorate issued experimental approvals to cover the use of the herbicides in the trials. The GM crops were grown under release consents issued under EC Directive 2001/18 which imposed certain conditions. A small number of incidents concerning potential breaches of the consent conditions arose during the trials. These were all investigated by the GM Inspectorate. Details of the incidents and the subsequent investigations are contained in the annual reports of the GM Inspectorate[2] While regrettable we were advised by the SSC that none of these incidents affected the results.

10. SCIMAC, the biotech industry body, developed a code of practice for the supply and agronomic management of GM seeds and crops. This was concerned with ensuring the integrity of the supply chain, for example specifying separation distances to minimize cross-pollination with non-GM crops. The code was endorsed by ministers and it was agreed that the GM crops in the trials would be grown in compliance with the code, where relevant. SCIMAC were responsible for monitoring compliance with this code, and to this end enlisted ADAS Consultancy Ltd to carry out an independent audit of compliance on the trial sites. Their report, which is publicly available[3], concluded that there had been a high level of compliance with the code.

The ways in which the results of the farm scale trials will be integrated with policy and decision-making.

11. The results are directly relevant to the regulatory assessment of the crops in the FSEs under EC Directive 2001/18. A requirement of this directive is that the environmental risk assessment cover the indirect effects of growing GM crops, such as the wider impacts on biodiversity.

12. The results have been passed to the UK Government's statutory advisors on the risks to human health and the environment from the release and marketing of genetically modified organisms, the Advisory Committee on Releases to the Environment (ACRE). ACRE invited stakeholders to submit written comments and held two public meetings to take evidence from other experts and stakeholders, on 25 November in London and 4 December in Edinburgh. ACRE will present their advice in January 2004 and this will inform the regulatory assessment of these crops under EC Directive 2001/18. The statutory nature conservation bodies have also advised on the implications for nature conservation.

13. A summary of the results has also been passed to the Advisory Committee on Pesticides (ACP), which will consider whether there are any implications for the pesticide risk assessment and registration process. The ACP will present its advice in due course.

14. The FSE results will also be taken into account as the Government develops its wider policy on the commercial cultivation of GM crops. We will decide our policy in the light of all the available information, including the reports of the GM public debate and the GM Science Review, the study of the costs and benefits of GM crops produced by the Government's Strategy Unit, and the Agriculture and Environment Biotechnology Commission's report on co-existence and liability. We will set out our conclusions shortly.

The implications of the trial results for Government and other decision-makers.

15. The results of the FSEs add to our knowledge and understanding of the agri-environment and crop management systems and will be used to inform policy development. Specifically the results will inform the regulatory assessment of the impact on the environment of the GM herbicide tolerant crops in these trials.

16. The GM herbicide tolerant maize grown in the trials (Bayer's T25) already holds approval under EC Directive 2001/18 for commercial use, including cultivation, throughout the EU. (Note however that as stated above, neither this nor any other GM crop has the full range of regulatory approvals necessary for actual cultivation in the UK.) There is provision in the regulatory procedure for this approval to be revisited should it be considered necessary in light of the FSE results.

17. The companies which developed both the spring oilseed rape and the beet are currently seeking commercial approval for these crops under EC Directive 2001/18. Belgium and Denmark are the lead member states respectively for these application dossiers.

18. The direct relevance of the results to other EU member states is a matter for debate given that farm conditions vary across the EU. However, we have forwarded copies of the results to each member state and we would expect them to be taken into consideration when the crops are considered for approval at EU level.

19. Current EU legislation requires case-by-case decisions on GM crops on the basis of the scientific evidence. The applicability of the results to other GM herbicide tolerant crops will therefore need to be considered on a case-by-case basis.

20. In addition we recognise that the findings have also raised wider issues of the impact that crop management has on farmland wildlife. They also demonstrate that such effects can be measured. The important lessons to be learned is how to apply the knowledge gained in the FSE to improve environmental protection in all types of agriculture. It is likely that these future applications of the FSE data and methods to wider agriculture will be among the most valuable. We are currently considering what further action is necessary in light of the FSE results.

The costs and benefits of GM food, bearing in mind the potential market, in the light of the farm scale trials and the recent strategy unit report.

21. The Strategy Unit report was a valuable study of the costs and benefits of GM crops. As already noted this is one of the inputs that will feed into the Government's consideration of its policy on GM crops.

22. The Government's primary role is to regulate GM food and crops to ensure they are safe. If a product is assessed as safe then the question of whether it is a success will be up to the market. The Government also supports informed choice through mandatory labeling in order to allow people to decide for themselves. If the benefits of GM products are not seen by consumers, or are outweighed by the costs, then they will not be commercially viable. The supermarkets have also made it clear that they will only stock products that consumers want.

23. However, any potential approval of GM crops, and commercial cultivation by UK farmers, must also be compatible with our other policy goals for the future of farming, including CAP reform, or the Organic Action Plan's aim to increase the market share of UK produced organic produce. As noted earlier the Government is currently considering its policy on GM crops in light of all these considerations and we will set out our conclusions shortly.

January 2004

Annex A

THE FARM SCALE EVALUATIONS OF HERBICIDE TOLERANT GM CROPS

1. SUMMARY

This paper sets out the rationale and chronology relating to the decisions to set up the farm scale evaluations of certain genetically modified herbicide tolerant 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 assessed 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 FSEs were therefore set up to address this specific remaining area of uncertainty.

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 could 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. In addition any GM product to be used as or in food had to be approved under the EU Novel Foods Regulation. Since the beginning of the FSEs Directive 90/220 has been replaced by Directive 2001/18. In addition the Novel Foods Regulation will be replaced by a new Food and Feeds Regulation which comes into force on 18 April 2004.

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 (see Annex D).

3. CONCERNS[4]

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 acceptability 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 (ACRE Annual Report 1996-97).

In early 1998 English Nature and the other statutory nature conservation agencies 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, DETR officials consulted the leading organisations campaigning for a moratorium and separately the industry body SCIMAC. The meetings focused on the legality and terms of a possible moratorium and the further research and information thought necessary.

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. Ministers from DETR and MAFF, Michael Meacher and Jeff Rooker used their appearance before the committee on 21 October to announce the package of measures (Annex B).

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 Agriculture and Environment Biotechnology Commission);

— 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. A number of products were in the process of seeking approval. In light of this and the continuing concern in the UK, the government made a new agreement with SCIMAC in November 1999. 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

Following the announcement of the FSEs in October 1998, DETR officials made the arrangements for setting up and funding the evaluations. It was agreed that the evaluations would be funded from the DETR Environmental Protection Group's existing research budget, with small contributions from MAFF and the Scottish Office. In November scientists in the DETR GM team and MAFF met with experts from English Nature, the Royal Society for the Protection of Birds (RSPB) and the Natural Environment Research Council (NERC) to set the objective for the project and plan the specification for the ecological studies. This was finalised following further meetings discussions by telephone and correspondence. The plans for the project were also discussed with the Advisory Committee on Releases to the Environment (ACRE).

The agreed objective of the project was to assess the effects on farmland wildlife due to the agricultural management GM herbicide tolerant crops as compared with the effects of growing equivalent non-GM crops. This directly addressed the concerns put forward by English Nature and the RSPB. This was expressed as the hypothesis to be tested 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.

Scientists in DETR then drew up the specification for the three research projects to cover forage maize and spring and autumn sown oil seed rape. On 2 February 1999 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. A copy of one of the specifications is attached as part of Annex C (c1). Ministers had agreed the outline of the research programme but as was normal practice in DETR were not involved with setting the detailed specification.

In parallel officials had meetings with SCIMAC to make the practical arrangements for the provision of the fields of crops for the studies. SCIMAC 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.

During the tendering period on 25 February, DETR wrote to NGOs and other interested parties inviting comments on the specification for the research. A copy of the letter is attached (Annex C). The comments received informed the tender review.

During the period from October 1998 to February 1999, ministers in DETR and MAFF had a series of meetings with SCIMAC and relevant NGOs including English Nature, RSPB and FOE at which the progress with setting up the FSE was discussed.

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. 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. 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.

Once they were appointed the SSC took responsibility for oversight of the evaluations and with the research consortium agreeing the final design, methodology and protocols for the conduct of the evaluations. 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.

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 had submitted applications for their approval for EU wide cultivation under Part C of directive 90/220. These dossiers either had been approved (in the case of maize) or were 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 (now Bayer Crop Science) 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 Defra. 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 gave specific approvals under the pesticides legislation for use of the broad-spectrum herbicides in the farm scale evaluations. The ecotoxicological data from the FSE will, alongside other relevant data, be considered in the evaluation of any future applications for a commercial level of approval for these herbicides on GMHT crops.

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

In autumn 1998 negotiations started in earnest to amend Council Directive 90/220/EC. This led to the EU adopting new legislation in February 2001—Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. The UK and other EU Member States were required to transpose the new Directive into national legislation by 17 October 2002; in England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002 were placed before Parliament on 26 September 2002 and entered into force on 17 October 2002.

Among other things, the new regime introduces:

— an explicit requirement for environmental risk assessments to cover indirect and long-term effects of GMOs (eg wider impacts on biodiversity);

— the introduction of mandatory post-market monitoring, to look for unanticipated effects of any GMO that is released commercially;

— mandatory public consultation before decisions are taken on applications for consents to release GMOs; and

— mandatory labelling for all GMOs released commercially in the EU. GMOs must also be traceable throughout the production and supply chain.

European Environment Ministers agreed in December 1998 to adopt these new procedures on risk assessment and post-market monitoring with immediate effect, without waiting for implementation of the new directive.

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 2001/18 (formerly 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;

— In addition approval under pesticides legislation for the associated herbicide may be required.

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. 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 was not possible to prevent cultivation of crops which have EU wide approval under Directive 90/220 unless new information was available on the risks to the environment or human health which justifies taking action under Article 16 to impose a temporary local ban. This principle is carried forward in Directive 2001/18.

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[5] (now Bayer Crop Science) 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 (now Bayer Crop Science) 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 Gray 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 Gray was not a member of ACRE when they considered the original application. ACRE considered Prof Gray's review 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. 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.

To coincide with the spring sowings in 2000 DETR organised 12 public meetings in the main trial areas. 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 RESULTS

The fieldwork for the three spring sown crops ended in 2002, while the fieldwork for the autumn sown oilseed rape continued into the 2003. The SSC supervised the publication of the results. The results for the three spring sown crops were submitted to The Philosophical Transactions of the Royal Society for peer review prior to their publication by the journal on 16 October 2003. The results for the autumn sown oilseed rape will be published in 2004.

The results are being considered by the Advisory Committee on Releases to the Environment (ACRE) who will advise on their implications. As part of its deliberations ACRE invited stakeholders to submit written comments and held two public meetings to take evidence from other experts and stakeholders; on 25 November in London and 4 December in Edinburgh. ACRE's advice will inform the Government's thinking on whether these particular GM crops should be approved for commercial cultivation. A summary of the results will also be passed to the Advisory Committee on Pesticides, who will consider whether there are any implications for the pesticide risk assessment and registration process.

Annex B

GOVERNMENT ANNOUNCES FULLER EVALUATIONS OF GROWING GENETICALLY MODIFIED CROPS

Tough new measures, additional checks and greater transparency about growing genetically modified (GM) crops were announced today by Environment Minister Michael Meacher and Food Safety Minister Jeff Rooker.

Speaking to the House of Lords Select Committee, Michael Meacher and Jeff Rooker highlighted:

farm-scale evaluations

environmental stakeholders forum

Ministerial Group on Biotechnology and Genetic Modification

amendment of Directive 90/220

scientific review of pesticides

re-assessment of herbicides

introducing long term monitoring

The full texts of the Ministers' statements are attached.

Press Enquiries: Env: 0171 890 3041; MAFF 0171 238 5608/5610

(Out of Hours: Env: 0171 873 1966; MAFF: 0171 270 8080)

Public Enquiries: Env: 0171 890 3000; MAFF: 0645 335577

OPENING STATEMENT BY MICHAEL MEACHER TO HOUSE OF LORDS SELECT COMMITTEE: 21 OCTOBER 1998

I am grateful for the opportunity to make this brief opening statement to highlight three issues in this fast moving debate on the introduction of genetically modified organisms. Firstly the negotiations on the amendment of Directive 90/220, the UK welcomed the Commission's proposal, which helps to address some outstanding issues. But we think it can go a little further. Our aim is to strike the right balance between protecting the environment and human health on the one hand, and on the other, maintaining the proper degree of certainty needed by business for the development of new products. I think it right to be cautious at this relatively early stage of the large scale use of the technology in the environment and to make sure that for every product we have practical evidence on safety before we take a decision to move to commercialisation.

For these reasons, the UK is seeking to make sure that the scope of the directive and of the environmental risk assessment are well-defined and broad enough to cover indirect as well as direct effects of GMOs. We want to strengthen the links between this directive and EC product legislation, such as the Novel Foods Regulation, and we are strongly promoting the introduction of mandatory monitoring of the effects of products in use following marketing approval. We shall also press for changes to ensure that member states views are effectively reflected in any decisions on marketing of products. This is crucial in making the best possible judgement on safety and will also help acceptance of the technology. To make the regulatory process predictable, we are asking for sensible, but defined time frames for each of the steps in the decision-making process. We have pressed for maximum disclosure of information and supported consideration of ethical issues at the Community level.

There appears to be considerable support for these ideas and we are hopeful that when the amendment finally comes into force, we shall have an improved regulatory regime. But we must not pin everything on that because it will be a number of years before the amendment is agreed and comes into force. At the same time we are not despondent: there is much that we can do now, even within the framework of the present Directive, and we are trying to exploit every opportunity for improved controls and debate.

Secondly in addition to the important work on revising the Directive, I have been considering how best to respond to calls from groups such as English Nature for a moratorium on the commercial release of certain GM crops and to the great public anxiety that surrounds this whole technology. The concerns of English Nature and others centre on fears that the widespread planting of GM herbicide tolerant crops may lead to changes in agricultural practice that will reduce our already declining biodiversity. I feel strongly that the commercial use of GM crops in agriculture must not put unacceptable pressure on our countryside and wildlife and prejudice our goal of maintaining and where possible enhancing farmland biodiversity.

I am very pleased to be able to announce this morning that we have reached agreement in principle with the plant breeding industry for a programme of managed development of herbicide tolerant GM crops whereby the first farm-scale plantings are strictly limited and monitored for ecological effects along with comparable plantings of conventional crops. This process will be underpinned by the strict guidelines for best practice in using GM crops referred to by Jeff Rooker. The results of these farm-scale evaluations will be carefully assessed before moving further. I feel it is extremely important that we do not travel further down the road to commercialisation of GM crops before we have this information. If, during this process, we find evidence of harm then we can take appropriate action.

The industry has also made the important commitment that no insect resistant GM crops will be introduced into the UK for the next three years. The concept of managed development provides a precautionary way forward to investigate in a proper scientific framework the concerns that some GM crops might be harmful to the environment.

Thirdly I also welcome the announcement of the new cabinet committee. I am acutely aware of the public unease over genetic modification and the widely held belief that these concerns are not being heard or addressed by Government. In my own area of responsibility, I am also aware of the need to look at developments on a generic level in order to take a more strategic approach and ensure that the wider issues are addressed properly. Many from both sides of the debate have proposed an environmental stakeholders forum to discuss and advise on environmental issues raised by biotechnology. Such a forum might include representatives of everyone with an interest, such as farmers, plant breeders, conservation bodies and public interest groups. This group would work in parallel with ACRE, which would remain a scientifically based committee considering applications to release or market genetically modified plants and other organisms on a case by case basis.

I shall of course be happy to elaborate on all these issues in response to your questions.

HOUSE OF LORDS INQUIRY INTO GMOs, 21 OCTOBER

MR ROOKER'S OPENING STATEMENT

If I may, Chairman, I should like to make a short statement about MAFF's approach to the control of GMOs.

Public health and protection of the environment are this Government's first priorities on GMOs. I want to make it clear that we shall apply all the relevant legislation—that on GM foods and GM crops, where we share responsibility with DH and DETR respectively; plus that on seeds and pesticides, where MAFF takes the lead, fully and rigorously. Applications relating to GMOs will be dealt with fairly, but they will not be given any preferential treatment.

We need to recognise however that GM crops are now being grown in considerable quantities in other countries and that the UK's policy towards their use, and that of their products, must be based on a clear analysis of the scientific facts so that it is capable of being fully defended in international fora.

In addition to the statutory requirements, MAFF has been considering what further safeguards need to be introduced to respond to the concerns that organisations and members of the public have expressed about the possible impact of GM crops when grown commercially.

I am aware of concerns that herbicide tolerance, which is one of the main traits being engineered into crops for use in the UK, may cause serious problems as a result of their spreading to neighbouring crops and related wild plants. The best way to avoid such problems is for extra care to be taken when the crops are grown on the farm. MAFF has therefore urged the proponents of GM crops to draw up guidelines on their correct use, on proper identification and on full record-keeping. The industry group dealing with this has made a good deal of progress which I welcome. But we are pressing them further to implement measures to secure compliance with the guidelines. Not until we are fully satisfied will we give our endorsement to this approach.

There is also concern about the impact on biodiversity of the herbicides which would be applied to GM crops. The argument is that their use would interrupt the food supply chain for insects, small mammals and birds. There are differing views as to whether there would be environmental advantages or disadvantages in using a single, broad-spectrum herbicide compared with the current practice of using several different products. I have therefore asked the Pesticides Safety Directorate to prepare for me a scientific review comparing the likely impact on biodiversity of current and possible future practice.

Some people have suggested that the level of herbicide usage on herbicide tolerant crops will rise, while others have suggested it will fall. In order that we are properly informed on this point, I have asked that the scientific review should include an analysis of the likely level of herbicide usage.

A prior review of this kind should be able to make useful forecasts. But there is no substitute for monitoring the actual usage when the crops are eventually grown. I am asking my officials to discuss with the industry an enhancement of the Pesticide Usage Survey to give us specific information on this point.

I am also ensuring that herbicides to be used on GM herbicide tolerant crops will have to be specifically re-assessed for this purpose. Their existing approval will not automatically be transferred to this new use. The assessment will cover their effect on non-target species.

Last, there is the issue of the long term safety of the products of these crops when used as foods. All GM foods are rigorously assessed for safety by the Advisory Committee on Novel Foods & Processes, using internationally recognised procedures endorsed by the World Health Organisation, before being allowed onto the market. However, the Government is currently looking into the possibility of going even further by introducing monitoring arrangements capable of picking up any unexpected effects should they emerge in the future. I hope to be able to make a further announcement about this shortly.

I hope, Chairman, this demonstrates that in MAFF we are not rushing ahead, but thinking ahead on the control of GMOs. Our approach to these matters is of course an integral part of the Government's overall policy towards the use of biotechnology and I very much welcome the announcement yesterday of the new cabinet committee, under the chairmanship of my Rt Hon friend Dr Cunningham, to oversee developments in this area. This will enable us to ensure that the Government's policies in this complex area continue to develop in a fully co-ordinated way.

Annex C

CONSULTATION LETTER TO NGO'S AND OTHER INTERESTED PARTIES

Dr L M Smith

Head of Biotechnology Safety

Chemicals and Biotechnology Division

Department of the Environment

Transport and the Regions

3/F5 Ashdown House

123 Victoria Street

London SW1E 6DE

Direct Line: 0171 890 5240

Divisional Enquiries: 0171 890 5275

Fax: 0171 890 5229

GTN Code: 3533

E-mail: lindam—smith@detr.gsi.gov.uk

25 February 1999

INFORMATION ON THE FARM SCALE EVALUATIONS OF GENETICALLY MODIFIED CROPS AND AN INVITATION TO COMMENT

You will be aware that the Government is taking seriously concerns raised by English Nature and others that the wide-spread introduction of some types of genetically modified crops could bring changes to the agricultural environment which may be damaging to farmland wildlife. There is also concern that such changes may also have other significant impacts on the agricultural landscape.

The Government is examining a small number of GM crops which otherwise might soon have all the necessary approvals for commercial growing. In October, Environment Minister, Michael Meacher and Food Safety Minister, Jeff Rooker announced their agreement with the plant breeding industry for a programme of managed development of these crops. The first farm-scale plantings will be strictly limited and monitored for ecological effects along with comparative plantings of non-GM crops under conventional management.

The Departments are to fund ecological studies of the diversity and abundance of plants and invertebrates associated with the management of the GM and non GM crops to test whether there are any significant differences over a four year period. The results will be reviewed each year and will inform decisions as to whether these crops should enter commercial production as well as contributing vital information to the debate generally on the wider impacts. Fifteen research organisations have been invited to tender and to set out a study protocol with full justification for the methodology and sampling statistics. A copy of the relevant part of the tender specification is attached (see Annex c1). Due to the complexity of this research, a steering committee (including specialists in farmland wildlife) will seek to ensure the work is carried out to the highest scientific standards.

The monitoring of the individual crops in the farm-scale evaluations will provide information to assist the subsequent consideration of what effects there might be on higher species, including birds and mammals, and our agricultural landscape; both of the specific crops in the trials and those under development. If an adverse environmental impact is detected this will be acted upon. If the research proves inconclusive then we will remain open-minded about the issue and investigate other approaches to tackling the questions.

In parallel the Advisory Committee on Releases to the Environment (ACRE), which advises the Government on the risks of GMOs, has set up a sub-group again including specialists in farmland wildlife to consider these issues and advise how they should be tackled both through regulation and research. A background discussion paper, prepared by the ACRE Secretariat, was published on 18 February, entitled The commercial use of GM crops in the UK: the potential wider impact on farmland wildlife. This sets out issues for initial consideration by the sub-group.

As you will know the issue of `gene escape' is already part of the assessment of the environmental impact of GM crops carried out during the regulatory approvals process. In parallel with, but separate from, the ecological studies, the DETR will arrange for monitoring of the crops in the farm-scale evaluations to validate the assumptions in the risk assessment regarding cross pollination and gene transfer.

We would welcome your organisations views on the specific projects to monitor the fields in the farm-scale evaluations by 8 March 1999 and your more general views on the wider implications on farmland wildlife and the agriculture environment of GM crop introduction by 16 April.

The ACRE paper is available on the DETR web site or by post from my office.

Yours sincerely

Dr L M Smith

Head of Biotechnology Safety

Annex c 1

FARM SCALE EVALUATIONS OF GM SPRING OIL SEED RAPE

SPECIFICATION FOR RESEARCH CONTRACT to investigate the effects of the management of field scale releases of genetically modified herbicide tolerant spring oil seed rape on farmland wildlife abundance and diversity.

INTRODUCTION AND BACKGROUND

1. A small number of crop varieties genetically modified to be tolerant to broad spectrum herbicides have almost completed all the necessary approvals to permit them to be grown commercially in the UK. The furthest forward are oil seed rape and maize, with sugar beet and fodder beet close behind. The approvals process includes a comprehensive assessment of the GM plant and the possible risks it may pose to human health and the environment. However a number of bodies including English Nature are concerned that the commercial planting of GM herbicide tolerant crops may lead to changes in agricultural practice which will adversely effect farmland wildlife. This may put pressure on our countryside and wildlife and prejudice the UK commitment to maintain and where possible enhance biodiversity.

2. There are also claims that GM crops which are tolerant to broad spectrum herbicides offer potential advantages both to farmers in terms of improved agronomic control, and may also benefit farmland wildlife. There is no available field monitoring information for these crops on a wider field scale to support either view.

3. In October, Environment Minister, Michael Meacher and Food Safety Minister, Jeff Rooker announced their agreement with the plant breeding industry for a programme of managed development of these crops such that the first farm-scale plantings are strictly limited and monitored for ecological effects along with comparative plantings of conventional crops. The industry body, SCIMAC, will arrange for commercial scale sowings of GM maize and spring and autumn sown oil seed rape to be grown and managed in strict compliance with the SCIMAC guidelines for GM crops alongside comparable non GM crops. DETR in conjunction with MAFF and the Scottish Office will arrange for the abundance and diversity of farmland wildlife to be monitored in both the GM and non GM crops over a period of four years. In the first year we expect two field-scale plantings for each GM crop with between 10-25 farms for each crop participating in subsequent years. Further details of the crops and their management are given at Annex c 2.

4. The ecological studies will be guided by a steering committee, with an independent chairman and comprising representatives from DETR, MAFF, Scottish Office, SCIMAC and the statutory conservation bodies and a number of independent experts. The steering group will peer review the progress of the farm-scale evaluations of maize and spring and winter oil seed rape and other comparable studies of GM crops and ensure that, where appropriate, the approach taken for monitoring the biodiversity in each crop is consistent and is producing data of the appropriate quality. The progress of the studies will be transparent to the public, although the data will only be released at appropriate intervals once analysis has been completed and peer reviewed.

5. This specification invites tenders for the ecological studies on the farm-scale plantings of spring oil seed rape. Tenders for the studies of the other crops are being issued separately.

RESEARCH OBJECTIVES

1. To assess the effects of the agricultural management of field scale releases of GM herbicide tolerant spring oil seed rape on farmland wildlife. The following null hypothesis shall be tested:

That there are no significant differences between the biodiversity associated with the management of GM spring oil seed rape tolerant to the herbicide gluphosinate ammonium and comparable non-GM oil seed rape at the farm scale.

2. The secondary objective is to contribute to an assessment of the wider question of whether the commercial use of GM crops will change the management of farming systems and the agricultural landscape.

TENDER SPECIFICATION

The contractor will:

1. design and implement a monitoring programme to assess accurately the diversity and abundance of farmland wildlife species in the genetically modified (GM) and comparable non-GM spring oil seed rape crops being grown as part of the SCIMAC farm-scale evaluations of GM herbicide tolerant crops. The key plant and invertebrate species associated with spring oil seed rape and those in the following crops shall be identified and monitored. Priority shall be given to detailed monitoring of plants and invertebrates. Species which forage over wide areas and which occupy higher tropic levels, for example birds and mammals do not need to be monitored in these studies, because of the limited usefulness of the data gathered under the trial design described. Where appropriate, rare or endangered species for which Biodiversity Action Plans (BAP) have been prepared should also be monitored, if these species are likely to occur in the near vicinity of the GM crop releases;

2. specify the methodologies to be used for monitoring each selected indicator species, firstly for the assessment of diversity and also for estimating overall biomass or abundance of each selected group. This data will be used to make an estimate of the potential abundance of food and habitats for species higher up the food chain, for example farmland birds which will rely on these species for food, although they may be nesting and foraging from areas outside that monitored in this study. Consideration must be given to intensive monitoring of a selective sub-sample of farms, and how these sub-samples will be selected. Consideration also needs to be given to the scale, frequency and intensity of the monitoring, including field margins and adjacent fields;

3. in carrying out the monitoring allow the farmers to manage each crop in accordance with the SCIMAC guidelines and methods normally used on the farms. Manipulation of the management of the crops shall not be carried out;

4. specify the level of statistical significance that can be obtained for monitoring the plants and invertebrates in 10, 15, 20 and 25 paired comparisons in the second and subsequent years. Paired comparisons will be grown on only two different farms in the first year. The proposal must consider the sample size, that is the number of paired comparisons necessary to obtain statistically relevant comparative data for GM and non-GM crops, for the second and subsequent years. The diversity of farming practices and locations where spring oil seed rape is grown, and natural variations in farmland wildlife abundance and diversity in the UK needs to be taken into account when considering sample size. The tender should specify a separate costing in terms of the monitoring resources required for each. A full explanation of the statistical approach taken should be provided, together with details of how statistical advice will be sought during the studies;

5. explain how the analysis of the results will be handled in terms of identifying the causes of any effects observed. It is emphasised that the comparison will be between the whole management regime for the GM crops and non-GM crops, not just the effects of the crops by themselves. Other factors such as soil types and previous cropping for each field, proximity to semi-natural habitats, hedgerows and other features which may influence the local abundance and diversity of wildlife species will need to be identified for each field so that false conclusions will not be drawn;

6. provide references to published methodologies and statistical analyses. Consideration should also be given to existing national datasets and how appropriate use will be made of them;

7. provide a full explanation of the roles of each participating organisation, where collaboration with other organisations is proposed, (such collaborative bids are welcome) together with proposed costs of sub-contracting, and an explanation of how overall management of the contract will be achieved effectively and economically;

8. provide appropriate staff to attend up to 12 steering committee meetings in London over the period of the contract.

RESEARCH MANAGEMENT

The tender should clearly specify:

how the monitoring will be managed and who shall be responsible for the field monitoring, statistical analysis and provision of expert advice;

proposed methods to ensure consistency in approach and quality of monitoring, and any relevant accreditations for which the participating organisations have qualified;

proposed methods used for compiling, analysing and interpreting the monitoring data;

overall management of the studies to ensure delivery of data and reports to meet deadlines.

THE CONTRACT WILL START ON 1 APRIL 1999 AND FINISH ON 31 DECEMBER 2002

Throughout the period the contractor will provide a written interim report for the steering group two weeks before each steering group meeting, describing progress with the studies, identifying specific issues, and results of statistical analyses of data. It is anticipated that the steering group will meet three times a year for each year of the research contracts and steering group meetings and contract management will be decided after the contract is let.

A final contract report will be submitted on 31 December 2002. This report will include a full description of the ecological studies, methodologies, statistical analyses, results and conclusions of the studies. Raw data will be submitted in an annex to the report. The report and all data will also be provided in electronic form.

Annex c 2

ARRANGEMENTS FOR CULTIVATION AND MANAGEMENT OF THE FIELD SCALE RELEASES OF GM CROPS

The research contractor will not be responsible for the management of the field scale releases. The GM seed will be supplied by the Supply Chain Initiative on Modified Agricultural Crops (SCIMAC), who will also identify the farms who are willing to participate in these studies. At each farm, a field of the GM crop will be grown and managed according to the advice given by the seed suppliers and the SCIMAC code of practice for managing herbicide tolerant crops. On the same farm a similar field of an equivalent non-GM crop will be grown as a comparison to the GM crops, and will managed according to the management practice standard on each participating farm for spring oil seed rape. The farmer will be allowed to grow the appropriate follow on crops in the agricultural rotation on these fields in subsequent years. This set up will enable a comparison between the abundance and diversity of farmland wildlife found under both management regimes.

Each paired comparison will be placed on the same farm to ensure that as many variables as possible are reduced. The degree of spatial separation of the fields with the GM crop and the non-GM crops will be considered with respect to the possible movement of mobile species between the two fields which may affect the statistical validity of the monitoring data. The size of each field is anticipated to be at least 10 ha, and appropriate separation distances between the crops are being considered.

A proportion of farms which implement integrated crop management (ICM) will be selected; reflecting the national proportion of farms which implement ICM for growing spring oil seed rape. LEAF farms will be considered for this purpose. All the farms selected will be in areas where spring oil seed rape is normally grown, eg Northern England and Scotland.

In the first year of the farm scale studies, the number of sites are likely to be limited to two, due to limited GM seed availability and the need for a carefully focused start in order to develop the monitoring protocols before scaling up in the following years. Knowledge of the level of biodiversity at the start of the studies is important. However there may be a problem of limited baseline data for the first year's trials where it will not be possible to collect this information prior to sowing the crops.

It is envisaged that GM crops will be planted for three years and monitoring will follow the rotations adopted by each farmer. Consideration will need to be given to intensively monitoring a selected number of sites during sowing, growth and harvesting and in following crops in each subsequent year of the research contract. If necessary, consideration will be given to extending the contract to follow up specific observations if they occur.

The agricultural rotation in which spring oilseed rape is grown is likely to include the planting of cereals, for example wheat or barley for two consecutive years. Different rotational or break crops may be grown, depending on the area, market forces and farmer's decisions. As each crop in the rotation is likely to influence the diversity and abundance of associated plants and invertebrates to some extent, the contractor will need to monitor representative cropping practices in the areas where spring oilseed rape is likely to be grown.

Annex D

GM CROPS WITH PART C PRODUCT APPROVAL FOR IMPORTATION AND PROCESSING ONLY—NOT TO BE GROWN IN THE EU

Date submitted	Lead CA	Company	Reference	Crop/modification	Consent issued
Dec 94	UK	Monsanto	C/GB/94/M/3/1	Soybeans/ herbicide tolerance	May 96
March 96	UK	Aventis	C/GB/95/M/5/1	Oilseed rape/ herbicide tolerance	June 98
June 96	UK	Northrup King	C/GB/96/M/4/1	Maize/insect and herbicide tolerance	June 98

GM CROPS HOLDING PART C CONSENTS FOR CULTIVATION IN THE EU[6]

Date submitted/ Lead CA	Company	Reference	Crop/modification	Scope	Consent issued
Nov 93 France	SNETA	C/F/93/08/02	Tobacco/herbicide tolerance[7]	Cultivation	June 94
Feb 94 UK	PGS/Aventis	C/GB/94/M1/1	Oilseed rape/ herbicide tolerance[8]	Seed Production	Feb 96
March 95 France	Ciba-Geigy/ Novartis	C/F/4/11-3	Maize/insect and herbicide tolerance	Import and cultivation	Feb 97
April 95 Netherlands	Bejo Zaden BV	C/NL/94/25	Chicory/herbicide tolerancef	Seed production	Aug 96
June 96 France	Monsanto	C/F/95/12/02	Maize/insect resistance	Import and cultivation	Aug 98
June 96 France	AgrEvo/Aventis	C/F/95/12/07	Maize/herbicide tolerance	Import and cultivation	Aug 98
Sept 96 Netherlands	Florigene Europe	C/NL/96/14	Carnation/flower[9] colour	Cultivation	Dec 97
Aug 98 Netherlands	Florigene Europe	C/NL/97/12	Carnation/increased vase-lifeg	Cultivation	Oct 98

Applications for Part C approval for placing on the EU market for GM crops for cultivation in the EU under consideration in Europe in Autumn 1998

GM Crop Reference No Applicant Lead
Competent Authority Stage in the regulatory processb

Herbicide tolerant maize (GA21) C/ES/98/01 Monsanto Spain 5

Insect and herbicide tolerant maize (T25+MON810) C/NL/98/08 Pioneer Netherlands 4

Insect resistant Maize C/F/96/05-10 Novartis France 4

Herbicide tolerant fodder beet C/DK/97/01 Monsanto Denmark 5

Herbicide tolerant oilseed rape C/DE/96/5 Aventis Germany 5

Industrial Starch potato C/SE/96/3501 Amylogene HB Sweden 4

Herbicide tolerant oilseed rape C/BE/96/01 Aventis Belgium 5

Below this line awaiting final consent:

Delayed ripening tomato C/ES/96/01 Zeneca Spain 6[10]

Insect tolerant cotton C/ES/96/02 Monsanto Spain 6c

Herbicide tolerant cotton C/ES/97/01 Monsanto Spain 6c

Insect tolerant Maize C/F/95/12-10/B Pioneer France 6c

Herbicide tolerant oilseed rape C/F/95/05-01 A&B Aventis France 7[11]