Availability and use of general surveillance information for potential changes resulting from GM crop

cultivation

Sarah Hugo, Nigel Boatman, Stéphane Pietravalle, Alistair Murray, James Blackburn, Oliver Wardman

Central Science LaboratorySand Hutton, York YO41 1LZ

Contact: Sarah Hugo

Tel: 01904 462223; email: s.hugo@csl.gov.uk

March 2006

Funded by the Department for Environment, Food and Rural Affairs (Research contract CPEC 44)

Contents

Page

Executive Summary 1

1 Introduction 5

2 Post market monitoring of GM crops in Europe: legislation and guidance 7

3 General surveillance to identify unanticipated effects of growing a GM crop 14

4 Review of environmental monitoring data 18

5 Analysis of selected environmental monitoring data sets 58

6 Gap analysis and recommendations for a general surveillance monitoring programme

68

7 Potential cultivation of GM crops in the UK 81

8 Post market monitoring database 88

9 General conclusions and recommendations 94

Annexes:

1. Regulatory drivers as sources of monitoring data for unanticipated effects of the cultivation of GM crops

2. Statistical review of data

3. Assessment of potential for UK cultivation of GM crops

4. Post market monitoring proposals

5. Database specification and screen shots

AcknowledgementsWe would like to thank the following people at CSL for their assistance with this project: Naomi Jones, Julie Bishop, Emma Clarke and Helen McKay.

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Executive summary

1. Under current EU legislation controlling the deliberate release of genetically modified organisms (GMOs)1,2, post market monitoring (PMM) was introduced to address concerns regarding unknown effects of genetically modified crops and products. Applicants seeking authorisation to release a GM crop in Europe must first submit an application containing a detailed environmental risk assessment (ERA) of the release of the GMO in question. Authorisation will only be given if member states are satisfied that no risks to human or animal health or the environment have been identified, nevertheless, each authorisation will be accompanied by a requirement to undertake a programme of post market monitoring.

2. Marketing authorisations may specify the need for case-specific monitoring to confirm assumptions made in the ERA regarding the occurrence and impact of potential adverse effects of the GMO or its use. Irrespective of this, general surveillance monitoring must be undertaken for all releases to identify any unintended, unanticipated or long-term cumulative effects of the release. The Department for Environment, Food and Rural Affairs (Defra) will be responsible for ensuring, for the UK, that holders of consents to market a GMO in Europe undertake appropriate environmental monitoring in accordance with authorisations and will also be responsible for collating consent holders’ monitoring results. There is currently little consensus on best practice for environmental monitoring in connection with a new agricultural crop/product; the European Commission and the European Food Safety Authority have published guidance to accompany the legislation but this is, as yet, largely untested.

3. This project was commissioned in anticipation of the potential cultivation of GM crops in the UK, with a view to scoping the availability of environmental monitoring data to support consent holders’ post market monitoring duties. The objectives were threefold, firstly to identify existing UK environmental monitoring schemes whose data could feed into post market monitoring programmes for GM crops, secondly to assess the quality of the data and how it might effectively be used in post market monitoring programmes, and thirdly to design a database to collate and integrate monitoring results supplied by companies marketing GM crops in Europe, for both general surveillance and case-specific monitoring. The project is concerned chiefly with GMOs that are released for cultivation in the EU, but also considers live GMOs (i.e. grain) that might be imported and establish via dissemination.

4. A vast quantity of environmental data currently exists, much of which is available via the internet. The primary aims for collecting data vary widely and none are currently collected specifically for monitoring of GMO releases; the components being studied and the way in which the data are held is likewise hugely variable. Given the range of monitoring programmes being undertaken by different bodies and the range of components that could be studied, competent authorities will potentially receive a disparate collection of data and analyses in support of conclusions drawn by consent

1 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration. (Official Journal of the European Communities (OJ) L106, 17/04/2001 p.1 – 39).

2 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance) (OJ L268, 18/10/2003 p.1 – 23).

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holders from their monitoring and/or surveillance programmes. It will be difficult to draw conclusions on clear effects from these. The first step in this project was therefore to accept that it would not be possible to monitor for all possible effects in all compartments and at all levels in the environment, but to try to identify a broad range of key environmental indicators and monitoring schemes that provide robust datasets on these.

5. To ensure that all potential effects were considered, our approach was firstly to consider the crop supply chain in terms of seed/plant production, the growing crop, harvest and utilisation, and general farm management. Within each of these phases of production we considered the pathways by which a GM crop might impact on the environment, such as production of the seed, incidence of pests and diseases, changes to crop management practices, broader effects on on-farm conservation areas for example. Within each of these pathways we then identified indicators which, if monitored, might demonstrate a shift from their normal baseline value, possibly indicating an unexpected effect of the release of a GM crop. Examples of these include weed populations, occurrence and behaviour of grazing mammals, bird populations, soil micro-organism populations and many others. This approach would also be applicable to monitoring effects that may occur as a result of introduction of a new crop type or management practice into UK agriculture.

6. Our approach resulted in a substantial list of potential indicators and web searches were undertaken to identify suitable monitoring schemes. It soon became clear that, for certain indicators, there was an abundance of information while for others there was little or none. To avoid repetition of effort, data types and indicators were classified in terms of agronomic drivers and environmental impacts (agricultural and environmental). A fourth category was also identified whereby data is collected for administrative or regulatory purposes; while these regulatory schemes do not collect environmental monitoring data, they do represent long term data sets that might identify unexpected changes in patterns of cultivation or crop usage.

7. Agronomic drivers identified as being of particular importance were land use, crop varieties and usage of pesticides and fertilisers. To monitor biodiversity in the terrestrial environment, the incidence of pests and diseases, populations of weeds and other terrestrial plants, mammals, birds, invertebrates, soil fauna and flora are identified as important indicators, while in the aquatic environment fish populations and invertebrate populations were identified as being of key importance. Soil chemistry and erosion rates are useful indicators of changes to the soil environment, possibly brought about by changes in agricultural management; the aquatic environment is also an important monitor of change in agricultural management - river chemistry and nutrient levels, silt load and levels of pesticide (and other pollutants) can all be used to monitor the quality of the river environment. In the air, the importance of pollen and spore loads as indicators of air quality has long been recognised.

8. Of the numerous datasets identified, only those that were classed as being either surveys or monitoring schemes carried out on a regular basis, stand-alone surveys repeated at intervals but not part of a regular monitoring scheme, or one-off surveys or large experimental projects which may have been carried out over more than one year were selected for more detailed review. A total of 136 datasets met at least one of these criteria and a meta-data database was developed to hold information pertaining to each of

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these (available to Defra via a password protected web link (http://cpec44.csl.gov.uk/). Each of the datasets was classified in terms of the type of information recorded, frequency, interval, spatial and geographical characteristics and ease of access.

9. Monitoring data also needs to reflect geographical and climatic influences, therefore availability of data at both national and regional levels was also considered important for the purposes of identifying trends. Based on these criteria, a qualitative assessment was made of the usefulness of the dataset to environmental monitoring for provision of baseline data and for identifying trends away from ‘normal’. A statistical review of a sample (six) of these datasets was also undertaken to test the extent to which the datasets allow estimation of trends in the data, and, therefore, deviations from baseline status. Assessment of the biological significance of any persistent deviations from the baseline status would require case-by-case evaluation.

10. On a qualitative basis, major gaps were identified in the availability of monitoring data for weed and other terrestrial plant populations both of which are likely to be valuable indicators of gene flow that might occur as the result of the cultivation or establishment of a GMO; the only annual monitoring of plants is the Common Plants Survey carried out by Plantlife, and as no reports have yet been produced it is difficult to asses the value of this dataset at present. A statistical analysis of the limited data that was available from the Countryside Survey3 for the common agricultural weed Stellaria media, confirmed that very little could be determined about population trends from the available data. In addition, no monitoring data exists for soil flora and fauna, which may also be valuable indicators of possible gene flow or changes in the soil environment as the result of the cultivation or establishment of a GMO. Major gaps in monitoring data have also been identified for terrestrial populations of reptiles and amphibians (for which virtually no regular monitoring data exists), soil chemistry and organic matter, soil erosion rates and silt load in the aquatic environment. The absence of monitoring data in these areas is considered to be a significant gap in the availability of data for post market monitoring of the environment as a result of the release of a GM crop.

11. A similar qualitative assessment of data showed there to be good data availability for agronomic drivers such as land use and crop varieties cultivated, but only moderate availability for usage of fertilisers and pesticides. However, a statistical assessment of the latter confirmed that data available via the Pesticide Usage Survey4 for the use of the herbicide metazachlor on a national and regional basis was sufficient for trend analysis and prediction, although this would be improved if data were collected more frequently. Of the environmental impacts, there is moderate to good availability of data relating to the incidence of pests and diseases, although it should be noted that the long-term security of the source dataset for England (Defra’s ‘Crop Monitor’5 programme) is currently unclear. In the terrestrial environment good quality data is available for bird populations, for example from the British Trust for Ornithology’s Integrated Population Monitoring Programme, while for invertebrates and mammals there is moderate availability with a number of monitoring datasets in existence, however the number of taxa covered is limited and coverage of invertebrate functional groups is also limited. Statistical analysis of data collected for Meadow Brown butterfly populations (The Butterfly Monitoring Scheme6) showed the data to be of limited use for detecting trends

3 http://www.cs2000.org.uk/4 http://www.csl.gov.uk/science/organ/pvm/puskm/pusg.cfm5 http://cropmonitor.co.uk/6 http://bms.ceh.ac.uk/

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and making predictions in the short term. In the aquatic environment good monitoring data is available for fish in England’s watercourses via the Environment Agency’s National Fisheries Monitoring Programme7, while invertebrate populations and the quality of water are also monitored well by the Environment Agency’s General Quality Assessment Scheme8. One dataset for water quality was analysed for the extent to which trends in water quality could be detected and was found to show good potential in this respect.

12. In total seventeen key datasets have been identified that will be useful for the post market monitoring of GM crops. While most of these datasets are available via the internet, access is not always readily provided to the raw data to enable analysis and identification of trends; in these cases access may need to be negotiated on a case-by-case basis, and data may have to be purchased from the owner. In addition, some of the data is collected for a specific purpose and cannot be released for other uses without specific authorisation to do so. These factors may substantially compromise the extent and quality of post market monitoring data that Defra can expect to receive from consent holders and Defra will need to consider how this may be overcome for the key datasets at least. Defra should also consider how performance indicators identified in the government’s Sustainable Food and Farming Strategy, Defra might link with post market monitoring.

13. Post market monitoring data will often be supplemented by questionnaires developed by the consent holder for completion by farmers and/or agronomists. In their current form, these will provide useful feedback to the consent holder for commercial and development purposes and will provide a snapshot of the growing crop for the year of cultivation, readily identifying any immediate on-farm effects. However, unless a farmer cultivates a GM crop for a number of consecutive years, these questionnaires are unlikely to provide much data on longer term unanticipated or cumulative effects of growing a GM crop. Nevertheless, assuming the extent of cultivation of the GM crop increases, they will potentially provide a standard body of data for analysis. We have reviewed one such questionnaire and have made a number of suggestions as to how it could be improved to provide results that can be more readily analysed.

14. A prototype database has been developed for capturing all information relating to authorisations to market GM crops for cultivation in the UK. The database acts as a portal by which Defra and consent holders can access, upload and manage post market monitoring data. The database has been developed as an intuitive web-based tool that would be accessed via the Defra Genetic Modification web pages, with different levels of access described for the general public, Defra and consent holders. All information held on the database is captured as far as possible by the use of pre-determined terms, making it fully searchable within the user’s permitted access level.

15. Seven recommendations have been made regarding future implementation of a general surveillance monitoring programme for GM crops.

7 http://www.environment-agency.gov.uk/subjects/fish/?lang=_e8 http://www.environment-agency.gov.uk/yourenv/eff/1190084/water/213902/river_qual/?lang=_e

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1. Introduction

In the Member States of the European Union (EU) there is strict legislation controlling the deliberate release into the environment of all genetically modified organisms (GMOs). The principal aim of the legislation is to protect human health and the environment, and to ensure the free movement of safe and healthy genetically modified products in the EU. The deliberate release legislation requires that all applicants wishing to place a GMO on the market must first submit a comprehensive dossier, or notification, of prescribed information about the GMO, part of which should include a full environmental risk assessment (ERA). The aim of the ERA is to identify and evaluate, on a case-by-case basis, the potential adverse effects of the GMO, either direct or indirect, immediate or delayed, on human health and the environment arising from its placing on the market. In addition, applicants must elaborate plans for post-market monitoring (PMM) of the GMO.

Monitoring takes two forms, firstly to confirm assertions made in the environmental risk assessment regarding the occurrence and impact of potential adverse effects of the GMO or its use, so called case-specific monitoring, and secondly to identify the occurrence of unanticipated effects of the GMO or its use on human health or the environment, termed general surveillance monitoring. It is important to recognise the distinction between monitoring and surveillance; the purpose of monitoring is defined as the detection of changes and effects related to specific causes (Hellawell, 1991). Surveillance on the other hand is defined as the detection of changes without focussing on a specific cause; various environmental indicators are analysed in order to detect shifts in environmental quality (Hellawell, 1991). Based on this definition, general surveillance is not, therefore, designed to determine the cause of possible environmental changes as a multitude of factors could be involved; it can provide information on unusual environmental events and changes and possibly provide information to forecast the likely development of the environment, but it cannot be linked specifically to the cultivation of a GM crop (Sanvido et al 2005).

The key to identifying and evaluating any changes in the receiving environment as a result of cultivating a GM crop, or indeed any new crop, is to establish the baseline status of the receiving environment for the component being studied. Ideally this should be established before the crop has been placed on the market. There are many programmes already in existence that are being used to monitor components of the environment and which could be harnessed to provide post market monitoring data.

Company plans for general surveillance tend to focus on utilising data gathered by existing monitoring programmes and networks and engaging those who work in the agricultural environment such as farmers, agricultural consultants and grain handlers and requiring them to note any unusual or unexpected occurrences when growing GM crops. The consent holder must establish which networks and other routes they will utilise and to enter into arrangements with the appropriate bodies for gathering the necessary data, they must then critically analyse the findings and report their conclusions to the regulatory authorities on an annual basis.

A vast quantity of environmental data currently exists, much of which is available via the internet. However, the sheer volume of data and the range of methods of access can be barriers to efficient use of data, in addition the form in which data is presented is enormously varied, it may be freely available, or only accessed for a fee. There are also datasets that are

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gathered as part of ongoing research projects and for which little internet-based information is available. Given the range of monitoring programmes being undertaken by different bodies, and the range of components that could be studied, it is easy to see that regulatory authorities could potentially receive a bewildering collection of data and analyses in support of the conclusions drawn by the companies during their monitoring and surveillance programmes. This was project was commissioned to review and clarify the availability and quality of environmental monitoring data that might be of use in the general surveillance of GM crops, with the following aims:

i. To identify all the existing UK environmental monitoring schemes whose data could feed into the post-market monitoring programmes of GM crops.

ii. To assess the quality, quantity and frequency of the data generated in the schemes identified and suggest how data from them could be most effectively used in post-market monitoring programmes to identify unanticipated impacts associated with commercial GM crop releases.

iii. To design a database to collate and integrate monitoring results (from general surveillance and case-specific monitoring) supplied by companies who have released a GM crops(s) onto the European market.

The approach taken was firstly to clarify EU regulatory requirements and guidance with respect to post market monitoring of GM crops. The potential unanticipated effects of the cultivation of GM crops, and identification of environmental parameters that should be monitored were then considered in the context of a generic crop production chain. Environmental monitoring programmes for the identified parameters were then assessed in terms of the characteristics of the data gathered and their suitability for use in PMM programmes, this included an assessment of the statistical power of selected datasets. GM crops currently in the regulatory pipeline were then considered, together with their post market monitoring requirements; crops that are potential candidates for cultivation in the UK were identified. Finally, as requested, we considered how data from post market monitoring programmes for such crops could be collected from consent holders, and how this may be collected in a bespoke database for Defra.

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2. Post Market Monitoring of GM Crops in Europe: Legislation and Guidance

Legal instruments lay down the conditions that must be satisfied before a GMO or a food or feed product derived from GMOs can be developed, used or marketed. The introduction of GMOs into the environment for experimental purposes and for placing on the market for cultivation, importation or processing for industrial use is regulated by EC Directive 2001/18/EC9. The placing on the market of GMO food and feed, or food and feed products containing or consisting of GMOs, is regulated by Regulation (EC) No 1829/200310 on genetically modified food and feed. Under these regulations applicants wishing to place a GMO on the market must first submit a comprehensive dossier, or notification, of prescribed information about the GMO, part of which should include a full environmental risk assessment (ERA). The aim of the ERA is to identify and evaluate, on a case-by-case basis, the potential adverse effects of the GMO, either direct or indirect, immediate or delayed, on human health and the environment arising from its placing on the market.

The deliberate release legislation also stipulates that applicants seeking authorisation to release a GMO must develop detailed plans for monitoring and reporting upon claims made in the ERA in a post-market monitoring (PMM) plan. Monitoring takes two forms, firstly to confirm assertions made in the environmental risk assessment regarding the occurrence and impact of potential adverse effects of the GMO or its use (so called case-specific monitoring), and secondly to identify the occurrence of completely unanticipated effects of the GMO or its use on human health or the environment (termed general surveillance). Whereas case-specific monitoring is only necessary if a specific potential risk has been described, commercial release of all GMOs must be accompanied by a general surveillance plan that extends over the full life of the consent to release the GMO. When consent to place a GMO on the market is granted, the notifier has a legal obligation to ensure that the post market monitoring plan and reporting of its findings are carried out.

Case–specific monitoring versus general surveillance monitoring Case-specific monitoring focuses on potential effects arising from the placing on the market of a GMO that have been highlighted as a result of the conclusions and assumptions of the environmental risk assessment. Case-specific monitoring plans are therefore devised with specific objectives, parameters and timescales in mind and specific data will be collected to assess the potential impact/s of the GMO.

The principle behind general surveillance is to identify the occurrence of unforeseen adverse effects of the GMO or its use on human health and the environment that were not predicted in the risk assessment; it is intended to optimise the chances for early detection of unanticipated or unforeseen adverse effects resulting from marketing the GMO. While it is possible to predict that certain effects may occur based on risk assessments and scientific data, the prediction of unanticipated effects does not lend itself to the formulation of clear scientific hypotheses. General surveillance therefore has its basis in long term observation of the wider receiving environment, often making use of existing monitoring and stewardship programmes 9 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the

environment of genetically modified organisms and repealing Council Directive 90/220/EEC - Commission Declaration. OJ L 106 , 17/04/2001 p.1 – 39).

10 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance) (OJ L 268, 18/10/2003 p.1 – 23).

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that will detect significant changes at the field, farm and landscape levels that may be related to specific GM releases. This may include observing the agricultural/rural environment and assessing biodiversity of weed and feral crop populations, vertebrate and invertebrate populations, changes in behaviour of natural populations (e.g. flowering and seed set, breeding patterns), changes in the soil ecosystem, changes in plant pest and disease incidence, changes in pesticide usage and changes to general land management. When looking for impacts on the cultivated ecosystem as a result of multiple releases of GM crops over a number of years, different approaches to monitoring may be required for assessing e.g. biodiversity and cumulative environmental impacts, as compared to monitoring for surveillance of effects arising as a result of gene flow.

Guidance on post market monitoring plansGuidance on the development of post market monitoring plans has been published by the European Council (e.g. Council Decision of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC11) and by individual member states (e.g. ACRE12 Guidance on Best Practice in the Design of Post-market monitoring Plans). The European Food Safety Authority (EFSA)13 has also produced best practice guidelines for post market monitoring.

Guidance supplementing EU Directive 2001/18/ECThe objectives of the monitoring plan as described in Annex VII of 2001/18/EC are to:

i) confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the environmental risk assessment are correct, and

ii) identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were not anticipated in the environmental risk assessment.

To determine the factors that need to be included in the monitoring programme a case-by-case environmental risk assessment must be carried out prior to a release. This risk assessment should be based on independent scientific advice and current best practice and take due account of potential cumulative long-term effects associated with the interaction with other GMOs and the environment. The types of effects that should be considered are:

‘Direct effects’ refer to primary effects on human health or the environment that are a result of the GMO itself and which do not occur through a causal chain of events.

‘Indirect effects’ refer to effects on human health or the environment occurring through a causal chain of events (e.g. death and changes in the population of target and non-target insects arising as a result of the toxin produced by an insect resistant GMO). Indirect effects may involve interactions between a number of organisms and the environment making it more difficult to predict any potential effect. Observations of indirect effects are likely to be delayed.

‘Immediate effects’ are any effects on human health or the environment that are observed during the period of the release of the GMO. Immediate effects may be direct or indirect.

‘Delayed effects’ refer to effects on human health or the environment which may not be observed during the period of the release of the GMO, but become apparent as a direct or

11 OJ L280 18/10/2002 pages 27-36.12 Advisory Committee on Releases to the Environment, http://www.defra.gov.uk/environment/acre/postmarket/index.htm13 http://www.efsa.eu.int/

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indirect effect either at a later stage or after termination of the release (e.g. the build-up of resistance by insects to the Bt-toxin through continued exposure is an example of a delayed effect).

Monitoring plansThe monitoring strategy put forward by the notifier requires identification of the potential effects that may arise from the placing on the market of a GMO, the degree to which they need to be monitored and an appropriate approach and time-scale over which to monitor. The monitoring strategy should provide the means to detect potential adverse effects at an early stage, thereby allowing for more rapid reassessment and implementation of measures to reduce any consequences to the environment. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the GMO or its use, or due to other factors.

What should be monitored?It is firstly necessary to identify the relevant parameters/elements to be monitored with appropriate justification for their selection; this will depend largely on the conclusions of the environmental risk assessment. Decisions as to which parameters or elements are to be monitored must be taken on a case-by-case basis in line with the modified characteristics of the GMO in question. ‘Sentinel’ species may be used as indicators of the status of the receiving environment, these may include animals, plants and micro-organisms from different groups and ecosystems. Such indicators should be appropriate to the characteristics of the GMO in question and the parameters to be monitored. The monitoring plan may include details as to where the monitoring will be carried out and over what area; this may be at the level of individual Member States, geographical regions, individual sites, plots or any other area(s) deemed appropriate. Relevant areas to monitor would include selected agricultural fields where the crop is commercially grown as well as surrounding habitats. Reference or control areas and/or samples must be sufficiently representative in terms of environment and conditions of use for meaningful conclusions to be drawn, and any sampling methodology should be scientifically and statistically sound.

Environmental baselines and quality parametersDetermination of the baseline status of the receiving environment is a pre-requisite for the identification and evaluation of changes observed via monitoring. The baseline acts as a point of reference against which any effects arising from the placing on the market of a GMO can be compared; it is essential, therefore, that the baseline is established prior to any attempt to detect and monitor possible effects caused by the release of the GMO. In addition, monitoring should be carried out over a time period of sufficient length to detect not only immediate potential effects but also delayed effects. The monitoring plan should indicate the likely frequency of inspections, and may include a timetable to indicate the timing and number of intended visits to a site. Methodology for the subsequent monitoring of the selected parameters/elements should be clearly identified and outlined, including techniques for sampling and analysis. Standard methodology (e.g. European CEN Standards and OECD-methods) should be followed where appropriate and reference to the source of the methodology provided. Statistical analysis should be employed when designing the appropriate sampling and testing methodology, in order to determine optimal sample sizes and minimum monitoring periods for the required power of detection. The monitoring plan should identify how, by whom and how often data is to be collected and collated; notifiers may need to provide standard mechanisms, formats and protocols for data collection and recording in order to ensure consistency.

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Review of data sets and monitoring plansIn addition, the monitoring plan should indicate how often the data is reviewed and discussed in an overall analysis. Evaluation of data should, where appropriate, include statistical analysis to enable subsequent decisions to be taken on a sound basis, including whether evaluations highlighted in the risk assessment are correct. Preliminary findings may need to be examined, especially where potential negative impacts on vulnerable habitats and organism groups are suggested. The evaluation of results from monitoring and surveys may reveal whether other parameters should be monitored. Where changes in the environment are observed, further assessment may be required to establish whether they are a consequence of the GMO or its use, or whether such changes may be unconnected to the placing on the market of the GMO.

Monitoring plans and associated methodology should be reviewed at appropriate intervals and updated or adapted as necessary. The effectiveness and efficiency of data measurements and collection, including sampling and analysis should be reviewed, also the effectiveness of the monitoring measures in addressing the evaluations resulting from the risk assessments. New developments and progress in sampling and analytic techniques should be taken into account where appropriate, and adjustments made as necessary to adapt or upgrade the programme.

Use of existing networks and monitoring programmesFor general surveillance monitoring it may be possible to extend existing monitoring or general surveillance systems to address potential adverse effects arising from the placing on the market of GMOs. These systems may include observation programmes in the field of agriculture, food surveys, nature conservation, and long-term ecological surveys. This project explores the potential for using such systems in UK-based general surveillance monitoring programmes.

European Food Safety Authority Guidance Under EC regulation 1829/2003, the GM food and feed regulation is aimed at providing a harmonised procedure for the scientific assessment and authorisation of GMOs and GM food and feed. The assessment procedure is centralised with the European Food Safety Authority (EFSA) taking responsibility for this process. A ‘one door one key’ approach operates whereby authorisation for the deliberate release of GMOs into the environment can be sought as part of the application for authorisation for GM food and feed. The EFSA GMO Panel established a working group on post market environmental monitoring (WG PMEM) to develop guidance and mutual understanding with the Commission, applicants and others on practical aspects of specific crop/trait related monitoring plans.

A series of consultations and workshops were held in late 2004/early 2005 to discuss general surveillance as a component of post market environmental monitoring, comments to emerge from these included:

Existing networks are considered difficult to harmonise and currently many are not useful for GM crop monitoring. Considerable modification of current environmental networks is needed to make them appropriate for GM crop monitoring.

Farmer questionnaires are a good source of information and should be complemented by other approaches. Further improvements are required in order to cover field sites and the validity of answers. They might also be considered for targeting at agronomists. Specific questionnaire for conservation areas should also be developed.

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There was a consensus on the need for collation and analysis of data from different sites, regions and seasons. It is only once data has been collated and analysed that effective correlation studies can be conducted and the need to trigger further biosafety research determined.

Priorities for further discussion/consideration were also identified, such as methods for monitoring ecosystem function, improvement of farmer questionnaires, identification of types of surveillance networks likely to provide information relevant to PMEM.

EFSA’s final guidance was published in December 200514; it largely reflects that which has already been issued by the European Commission as described above, emphasising the need to ensure that data is collected in a robust fashion that will support statistical analyses and enable clear identification of impacts associated with the release of a GM crop.

Member State guidance In the UK the Advisory Committee on Releases to the Environment (ACRE) has developed best practice guidelines for the design of post market monitoring plans and this guidance broadly reflects that of the European Commission. ACRE defines anticipated and unanticipated effects in three separate categories:

I. Anticipated effects. Potential risks identified in the ERA as worthy of investigation via case-specific monitoring as well as those assessed as being extremely unlikely to occur and to cause harm. These are case-specific and identified in the environmental risk assessment, the need to monitor will be based upon the degree of uncertainty about their potential to cause harm.

II. Interactive or cumulative effects that are difficult or impossible to predict. Potential effects that are difficult to predict or assess fully in a single dossier and its risk assessment, e.g. effects that might arise as a result of an increase in the scale of cultivation and potential effects arising as a result of interactions between the GM crop and future varieties (GM and non-GM) that are released. These effects are more appropriate to general surveillance.

III. Unanticipated effects. Complete unknowns, i.e. potential effects not identified in the ERA, which can only be addressed by general surveillance.

ACRE suggests that general surveillance should be null hypothesis driven, rather than testing whether a particular assumption made in the risk assessment is correct. ACRE also advise that general surveillance should facilitate systematic observation of the effects of the release and interpretation of the results, and that it should be considered as contributing to monitoring the ‘state of the environment’ and therefore make use of existing, established routine surveillance practices, also utilise people who work with and are familiar with the agricultural environment, e.g. by employing the use of farmer questionnaires. ACRE emphasises the importance of establishing reliable baseline data with which to compare monitoring results, and with respect to good monitoring practice, ACRE states that monitoring should be an iterative process with feedback from each round facilitating continual refinements to the programme. ACRE considers that the key to good surveillance is accurate, timely and responsive reporting to ensure that the need for any further investigations can be identified, planned and implemented in a timely fashion.

14 http://www.efsa.eu.int/science/gmo/gmo_guidance/1275_en.html

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In line with EU guidance, ACRE suggest that making appropriate use of existing monitoring for general surveillance reporting will be a key factor for many consent holders and will allow the detection of significant changes at the field, farm and landscape level. ACRE consider that such surveillance data, when integrated and made accessible through open and compatible databases will generate added value, and that to maximise the long-term value, information collected by general surveillance should aim to deliver information in a form that is compatible with the wider UK and EU monitoring programmes. ACRE advises that reports to the regulatory authorities should contain a scientifically rigorous analysis of the results of monitoring, including the power and appropriateness of the data to answer the hypotheses, and should include a mechanism for alerting the regulatory authorities to any unanticipated effects that may have arisen. Further, ACRE recommended that an independent body should undertake data collation and interpretation, and evaluate the information gathered from PMM and national monitoring schemes.

Summary of guidance on development of post market monitoring plansGuidance for general surveillance plans for the placing of a GM crop on the market is less prescriptive than for example assessment of risks to human health and the environment, and to date is also largely untested. There is little in the literature relating to practical guidance of general surveillance of GM crops (Sandivo et al (2005) proposed a conceptual framework for environmental post market monitoring of GM plants but this was largely focussed on case-specific monitoring). As a consequence, general surveillance plans in notifications for authorisation to place a GMO on the market can be of varying scope and quality, often prompting the competent authorities of the EU member states to request further detail and clarification.

Methods and approaches used to identify unanticipated effects of the release of a GM crop should be appropriate, proportional and cost-effective, and where possible, existing data sources and related networks should be identified and utilised. In subsequent sections of the report, we have explored how, for releases of GM crops in the UK, this might be achieved.

Post market monitoring plans Should be hypothesis driven to confirm assertions in the environmental risk

assessment (case-specific) or based on general observation of the wider receiving environment (general surveillance)

Should be cost effective and proportionate to the nature of the release (intended use, scale of release, nature of modification)

Should reflect current scientific insight and practices Should take account of existing environmental conditions and activities to

determine the appropriate baseline status of the receiving environment to enable identification and evaluation of observed changes

Should employ scientifically and statistically sound sampling methodologies to support robust statistical assessment of data

Should identify observed effect/s but generally cannot identify the cause of an effect/s; they may assist in identification of the cause of an effect

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General surveillance monitoring: Should seek to identify and record any indirect, delayed and/or cumulative adverse effects that

have not been anticipated in the GM crop risk assessment Should be carried out over a longer period of time and possibly a wider area Should consider how to identify:

effects on non-target organisms arising from the genetic modification (including development of resistance in wild relatives or pest organisms, change in the host range or in the dispersal of pest organisms and viruses, development of new viruses)

dispersal, establishment and persistence into non-target environments or eco-systems out-crossing/breeding (e.g. occurrence, means and rates of out-crossing/breeding) with

sexually compatible wild relatives in natural populations unintended changes in the basic behaviour of an organism (e.g. changes in reproduction,

number of progeny, growth behaviour and survival ability of the seeds) changes in bio-diversity (e.g. in number or composition of species)

Should, where appropriate, seek to make use of established routine surveillance practices, e.g.: agricultural monitoring – crop selection and productivity management practices – fertiliser, herbicide, fungicide, pesticide application established certification schemes (e.g. OECD & statutory seed certification schemes) long-term ecological monitoring environmental monitoring nature conservation programmes food surveys farmer surveys veterinary surveys and use of veterinary products

Indicator species chosen from the animals, plants and micro-organisms that are prevalent in the local crop ecosystem can provide important information when fitness variables are monitored, such as:

numbersgrowth ratebiomassreproductive effortreproductive successrate of population increase/decreasegenetic diversity

Should consider the appropriate time required to identify any unanticipated effects of the dissemination, reproduction and persistence/survival of a GMO in the environment following the placing of a GM crop on the market

Should cover an area that is sufficiently representative of the environment and conditions of use to enable meaningful conclusions to be drawn, e.g. it may be necessary to extend to adjacent or neighbouring cultivated and non-cultivated land, and should pay particular attention to vulnerable sites

Sampling methodology employed in general surveillance programmes must be scientifically and statistically sound (e.g. CEN, OECD etc), and must be amenable to robust statistical analysis

Are not static documents and can be adjusted to reflect knowledge gained during interim analysis of monitoring data

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3. General surveillance to identify unanticipated effects of growing a GM cropThe fundamental problem presented by the requirement to monitor for effects that have not been anticipated is that, by definition, we do not know what we are looking for; it is an inherently vague concept that does not easily lend itself to the scientific approach. In trying to establish what information is available within the UK to monitor for unanticipated effects we first needed to consider what aspects of the receiving environment that had not specifically been considered in the risk assessment, could potentially be subject to change as a result of cultivation of a GM crop.

Although general surveillance is a not a clearly defined activity it was clear that it was necessary to adopt a structured approach if we were to identify the full suite of surveillance programmes that could be used to monitor for unanticipated effects. Our approach was to consider the crop in terms of the supply chain from seed production through to crop disposal and to consider, for each stage, the key elements that might be affected by growing a GM crop. Similar considerations would apply if a new conventional crop or management practice were to be introduced into UK agriculture.

Generic crop production chain: elements that may be influenced by GM crop cultivationThe supply chain for all agricultural crops exists as a series of discrete but inter-related stages comprising the seed supply chain, the growing crop, crop harvest and utilisation, and disposal of crop wastes. Within each of these stages a number of activities and influences contribute to progressing the crop into the next production stage; some of these are deliberate agricultural operations which may impact upon the environment such as the application of pesticides or changes to standard crop rotations, while others are an integral part of the receiving environment, such as weed populations or the flora and fauna of the rhizosphere. Although the specifics of these will clearly vary from crop to crop, a basic generic framework that is broadly applicable to all crops can be developed on this basis.

The four phases of the supply chain for crop production are listed in table 1 below. Each phase is considered a ‘source’ for the potential effects of a GM crop; for each source, the different ‘pathways’ by which the effects of a GM crop might impact upon the environment are listed; for each of these pathways, the elements that might be influenced by cultivation of a GM crop are identified and are termed ‘indicators’. In this context indicators are those elements of the environment which, if monitored, could identify any indirect, delayed and/or cumulative adverse or beneficial effects of GM crop cultivation. Crop management practices such as pesticide application are included since these could also lead to unanticipated effects on the environment. This framework forms the basis for a review of existing environmental monitoring schemes that collect data relevant to the identified indicators. Availability of existing monitoring data for these indicators will provide baseline data in the absence of the GM crop, and ongoing data as the GM crop is cultivated.

As most authorisations are for a 10-year period and require general surveillance to cover this whole period, it is envisaged that suitable environmental monitoring programmes should, as a minimum, also cover this timescale.

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Table 1. Generic crop production chain and identification of sources, pathways and indicatorsSource Pathway Indicator1. Seed / plant supply chain

Seed production Types of crop cultivated Crop varieties cultivated Controls over pre-packaged seed Feral populations arising from disposal of waste or un-graded

seeds Source of seed (UK, imported or farm saved) Control and assurance of seed quality

Seed transport and distribution

Feral populations arising from: Spillage at point of offloading (docks) Spillage along roadsides Spillage at point of delivery Illegal/inadvertent cultivation Dumping of unsold seed

Illegal disposal to food/feed chainUK seed processing and packaging

Admixture with other seed Admixture with GM seed Altered processing protocols

Seed treatment Changes in chemicals used Adverse effects on operators

2. Growing (GM) crop

Scale and pattern of cultivation

Regional changes (parish, agricultural region, county) National changes (county, E, S, W, NI) Crop yield (increase/decrease) Impact on production of other crops Changes in land area available to grow standard arable crops

(results e.g. of increased drought tolerance in the future)Seed germination Altered rates of establishment (impact on grazing animals)

Effectiveness of seed treatments (impact on soil organisms)Rhizosphere Horizontal gene transfer to soil dwelling organisms

Grazing: root eating vertebrates, soil-dwelling invertebrates

Exudates: soil micro-organismsPlant development rate Development rate

Canopy profile (e.g. affecting effectiveness of agrochemical sprays)

Herbivores (rabbits, deer etc) Target organisms Non-target organisms (including beneficial organisms) Degradation on the ground Volatiles profile Gene transfer to organisms in above-ground receiving

environmentPests and diseases Susceptibility to economically important diseases

Incidence of economically important diseases Susceptibility to economically important pests Incidence of economically important pests Susceptibility to other pests and/or diseases

Weed populations Numbers of weeds Harbours for pests and diseases Altered persistence &/or invasiveness (i.e. as indicator of

gene flow) Balance of species

Invertebrate and vertebrate populations (e.g. diet & food affecting fecundity)

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Pollen release Leading to gene flow: Transfer to sexually compatible wild relatives Transfer to sexually compatible crops

Adding to airborne pollen load: Effects on operators Effects on public

Crop product Seed dissemination &/or longevity altered Volunteers Seed bank

Grazing of crop product: Granivorous birds; mammals

Crop management Pesticide applications: Target organisms Non-target organisms Evidence of tolerance to pesticides

Herbicide applications Target weeds Non-target weeds Evidence of tolerance to herbicides

Fertiliser applications Changes in nutritional requirements Timing of fertiliser application

Mechanical operations: Soil structure Ground nesting birds Foraging birds Mammals (rabbits, deer etc)

Geochemical processes (soil)

Soil productivity: Soil nutrient build up/depletion pH

Geochemical processes (run-off)

Fish Aquatic insects Water-dwelling animals (otters, water birds etc) Water-borne micro-organisms Humans

Field margins Changes in pesticide applications (increase/decrease) Weed populations Non-weed flora population Invertebrate populations Bird and other vertebrate populations

3. Harvest and utilisation

Harvesting Timing Machinery Seed dissemination and longevity Handling by operators (allergic effects)

On-farm storage (grain silos; beet clamps, potato stores etc)

Spillage leading to volunteer populations Feeding by vermin

Distribution of harvested product

Seed spillage & dissemination leading to volunteer populations

Impact on operators (out of scope of this project)Utilization Animal feed

Human consumption Industrial processing By-products and disposal of wastes

Crop disposal Plant stems Desiccated plant parts Discarded tubers, roots etc (feeding by vermin) Ploughed back into the land Landfill

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4. General farm management

Subsequent crop Changes to standard rotation Creation of green bridge effect Changes in timing of on-farm operations

Whole farm effects Impact on: Conservation/protected areas SSSIs Meadows / grasslands Hedgerows Fallow land Bogs, marshes Woodlands

Incidence of de-skilling (outside scope of this review) Impact on neighbouring farms

Landscape effects Visual impact of changes in crop cultivation distribution5. Other production systems

Horticultural environment (commercial greenhouse)

Changes in pesticide applications (increase/decrease) Weed populations Non-weed flora population Invertebrate populations Bird and other vertebrate population

Allotments and private gardens

Incidence of pests and diseases Incidence of weeds Increased persistence of weeds Incidence of novel weeds/plants

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4. Review of Environmental Monitoring DataA vast quantity of environmental data currently exists, much of which is available via the internet. However, the sheer volume of data and the range of methods of access can be barriers to efficient use of data. The information available via the internet can be broadly divided into four categories, although the distinctions between these are not clear-cut and some sites will fall into more than one category:

Web based data portals that enable users to search for and obtain data. Meta-data gateways that have information and links to external sources of data, but

no data provision. Access to data held on the site. Information about data owned by the organisation, but no access to datasets.

The form in which data is presented is enormously varied and data may be freely available, or only accessed for a fee. Sites that present information only rather than datasets may be of limited value, but may be important in terms of highlighting the existence of data which may be either available elsewhere or not freely available. Many organisations make their own data available either on their own websites or held as part of larger collections of data. There are also datasets that are gathered as part of ongoing research projects and for which little internet-based information is available. A review was undertaken to identify all the existing UK environmental monitoring schemes whose data could feed into post-market monitoring programmes of GM crops, and to assess the quality, quantity and frequency of the data generated in these schemes.

MethodologyWeb searches were carried using search terms based on each of the headings listed in the generic crop production chain (table 2), to identify monitoring schemes that could be useful in the surveillance of environmental impacts of GM crops. These were categorised as follows:

i) Surveys or monitoring schemes carried out on a regular basisii) Stand-alone surveys repeated at intervals, but not part of a regular monitoring

schemeiii) One-off surveys or large experimental projects which may be carried out over

more than one year, but are not likely to be repeated, if they were sufficiently extensive to form a useful baseline for future monitoring.

Inevitably some subjectivity was involved in selecting schemes or surveys for inclusion. This applied particularly to category (iii). Factors taken into account included the availability of alternative monitoring data, especially if regularly updated, and the likely speed of change of the parameter being measured. For example, most attributes of soils change relatively slowly, and survey data may therefore be useful for several years after collection. Crop disease data, on the other hand, are ephemeral and are only useful if collected on a regular basis. Most of those selected were national, but surveys covering a more restricted area were occasionally included if they spanned a long time period and/or were particularly relevant. The following meta-data were collected for the selected survey data, and recorded onto a database created for the purpose. In some cases it was not possible to populate all the fields from the information available, in these cases as much information was recorded as was readily available. This database has been made available to Defra via a password protected web link (http://cpec44.csl.gov.uk/).

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Table 2. Meta-data fields included in database

Number Name Description1 Title Name of dataset2 Abstract Brief description of dataset3 Topic category Theme 4 Subject Content of dataset5 Measurement What is measured6 Date Period covered by dataset7 Reference date Publication date8 Extent Geographical extent, e.g. England

9 Spatial reference system Name of Spatial reference system, e.g. National Grid, parish

10 Unit of measure e.g. hectare, km2

11 Sampling regime System for sampling12 Sample number Number of samples per cycle13 Distributor name Name of holding organisation14 Contact Role or position of responsible person 15 Contact name (if known) Name of responsible person16 Address Postal address of distributor17 Tel no Telephone number of distributor18 Fax no Fax number of distributor19 E-mail e-mail address of distributor20 Web address Web address of distributor21 Supply media Type of media in which data is available22 Data format Format is which data is available (if known)23 Update frequency Frequency of update of data24 Access constraints Access restrictions such as copyright, license etc25 Use constraints Restrictions on use

26 Additional information source sources of additional information, including online (e.g. URL)

Classification of data sourcesIt soon became clear that for some aspects there was an abundance of information, whereas for others there was little or none. Also, classification under the indicators identified in the generic crop production chain resulted in frequent repetition of information on the same parameters. In addition, there were a number of indicators identified in the generic crop production chain that are subject to regulatory control and, while they may have indirect environmental impacts, are not appropriate for collation of environmental monitoring data.

While the generic crop production chain provided the essential context for searching for data sources, at this stage it was re-classified into a framework that provided a more coherent structure that encompasses all of the identified indicators. The structure on which data has been classified is outlined in table 3 below.

Table 3. Classification of data types and indicatorsData type Data classified as Pathways and indicators1. Agronomic drivers 1.1 Scale and pattern of cultivation

1.1.1 Land use1.1.2 Land cover

Scale & pattern of cultivation; landscape effects; subsequent crop

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1.2 Crop production1.2.1 Varieties1.2.2 Cultivation, drilling and harvest dates1.2.3 Pesticides: usage1.2.4 Pesticides: application1.2.5 Fertiliser: usage1.2.6 Fertiliser: storage and application1.2.7 Yields

Crop types & varieties cultivated; seed germination; seed treatment; crop management; plant development rate; harvesting; on-farm storage; feeding by vermin; subsequent crop; whole farm effects; horticultural environment

2. Environmental impacts (agricultural)

2.1 Pests, diseases and weeds2.1.1 Pests (invertebrates)2.1.2 Diseases2.1.3 Weeds (including seed banks)

Pests and diseases; pollen release; weed populations; husbandry; seed germination; plant development rate; pollen release leading to gene flow; crop products; volunteer populations; feral populations

2. Environmental impacts (environment)

2.2 Biodiversity (terrestrial)2.2.1 Plants (see also weeds)2.2.2 Mammals (including pest species)2.2.3 Birds (including pest species)2.2.4 Reptiles and amphibians2.2.5 Invertebrates (see also pests)2.2.6 Soil micro-organisms

Seed germination (impact on grazing animals, impact on soil dwelling organisms); rhizosphere (horizontal gene transfer); plant development rate; pollen release leading to gene flow; volunteer populations; feral populations; crop management; crop product; disposal of crop waste; field margins; whole farm effects

2.3 Biodiversity (aquatic)2.3.1 Plants2.3.2 Mammals2.3.2 Birds2.3.4 Fish2.3.5 Amphibians2.3.6 Invertebrates2.3.7 Invertebrates2.3.8 Micro-organisms

Geochemical processes (run-off); whole farm effects.

2.4 Soil2.4.1 Depth and structure2.4.2 Chemistry2.4.3 Organic matter2.4.4 Erosion rates

Geochemical processes (soil); crop management; disposal of crop waste; whole farm effects

2.5 Water2.5.1 Chemistry2.5.2 Silt load2.5.3 Pesticides and other pollutants

Geochemical processes (run-off); crop management; whole farm effects;

2.6 Air2.6.1 Pollen, spores etc

Pollen release adding to airborne pollen load

3. Regulatory drivers 3.1 Seed production and quality

3.2 GM crop cultivation (seed spillage, coexistence; illegal cultivation, crop utilisation)3.3 Disposal of agricultural products

ResultsResults of data searches are presented below. For each headline category, the potential effects of the cultivation of a GM crop on that category are discussed together with background aspects that influence where relevant data may be sourced.

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1. Agronomic drivers

1.1 Scale and pattern of cultivationPotential effects caused by GM crop cultivationThe advent of GM crops could cause changes in the amounts of different crops grown, the extent and patterns of cultivation, at a range of scales from the farm through local, regional to national. Such changes could arise as a result of a shift in the economic returns from growing different crops, or through changes in the way a crop needs to be grown. For example, if a genetic modification reduces the costs of growing a crop substantially, or increases the value of the product, this may result in more of that crop being grown at the expense of other crops. These changes could have a range of environmental impacts on landscape, resource protection, biodiversity and the historic environment. Some of these impacts will arise from the nature of the crop itself, others from its cultivation and crop protection requirements. It should be borne in mind that environmental impacts are not necessarily negative - they can also be beneficial.

Landscape impacts arise from the appearance of the crop itself, diversity of cropping, and its scale, ranging from large blocks of fields to small individual fields or part fields. In the past, the need to achieve economies of scale in operations on broad-acre arable crops (e.g. the use of wide-boom sprayers) has led to field enlargement and the concomitant removal of hedgerows and other field boundaries. This trend has slowed, partly because much of what was considered necessary has already occurred, and partly because of public opinion, which has become opposed to hedgerow loss. This resulted in the passing of the Hedgerow Regulations 1997 under which a farmer or landowner wishing to remove a hedge must first apply to the local planning authority for permission. This may be granted if the hedge is not considered ‘important’; if it is deemed ‘important’ (as assessed according to criteria laid down in the regulations), a ‘Hedgerow Retention notice’ is issued. These major changes in the landscape resulting from hedge removal are unlikely.

Resource protection covers the protection of natural resources, particularly water and air. Impacts are most likely on water pollution, for example crops such as maize which result in bare ground being present late in the year are more likely to give rise to soil erosion through runoff, causing potential pollution of watercourses through sediment deposition and eutrophication caused by phosphate bound to soil particles. Another example is that of oilseed rape, which leaves relatively high levels of soil fertility after harvest compared to other crops such as cereals, which can lead to the leaching of nitrates into watercourses.

Effects on biodiversity arise from the value of the crop as a habitat and/or food source for different forms of wildlife, and the impact of crop management practices such as timing of cultivation, use of pesticides etc. These may also affect adjacent non-crop habitats e.g. through pesticide drift. Thus, increasing acreage of a crop requiring use of a broad-spectrum insecticide could be detrimental, conversely replacement of such a crop with an insect-resistant variety could be beneficial in terms of reducing insecticide use.

Effects on the historic environment are most likely through changes in cultivation practices as depth of cultivation is critical for the protection of archaeological feature under arable land. Any factor that led to an increase in the conversion of grassland to arable would also be detrimental to archaeological interests.

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Background informationThe main factor influencing cropping decisions is predicted economic return; this in turn is largely determined by the balance between variable costs and value of the produce at the predicted level of yield, though other factors such as yield variability and reliability may also be taken into account. Until recently, the level of support payment was an important factor for many crops, but the recent reform of the Common Agricultural Policy resulted in a change to standard area payments (known as ‘Single Farm Payments’), determined by the amount of ‘eligible land’, regardless of what it was used for, provided certain conditions are met such as the requirement to maintain ‘Good Agricultural and Environmental Condition’ (GAEC). This has removed support payments as a factor, and in future cropping decisions are likely to be more responsive to market prices.

Among other factors that can influence cropping decisions are suitability of soil type, rotational considerations, availability of appropriate machinery or other infrastructure and, for some crops, availability of a contract for the product.

Data SourcesData sources fall into two categories: Land Use and Land Cover, though these are not always mutually exclusive.

1.1.1 Land useA number of surveys exist which give data on agricultural land use. The largest and most widely used is the ‘June Agricultural Census’, which was formerly an annual census of all farms in the UK, but since 1995 has been a sample survey, though a full census is carried out every ten years to comply with EU regulations; the last such occasion was 2000. The name ‘June Census’ has continued to be used, but it is now more correctly known as the June Survey. It is one of the longest running continuous data sets, having begun in 186615. Information is collected on the area of land owned and rented, the areas of individual crops grown, numbers of each type of livestock, numbers and categories of people working on the holding, and non-agricultural activities. Data are publicly available on the Internet, though for reasons of confidentiality farm-level data are not supplied. These can be accessed under certain conditions for scientific or policy purposes by arrangement with the Defra Farming Statistics team, under an agreement which protects the confidentiality of contributing individuals. Provisional results are available three months after data collection, and final results after seven months.The June Survey administered by Defra, now covers England only; equivalent surveys for Scotland16, Wales17 and Northern Ireland18 are conducted by the devolved administrations.

The December Survey of Agriculture complements the June survey, with data on major crops, cattle, sheep, pigs, fertiliser stocks, and hay and silage from a smaller sample of farms collected in December. Data are published 3-4 months after collection.

Other Defra surveys of minor crops are: The Vegetables and Flowers Survey19, which records planted areas annually in

England and Wales, in January),

15 http://www.defra.gov.uk/esg/work_htm/publications/cs/farmstats_web/History/history_census.htm16 http://www.scotland.gov.uk/Topics/Statistics/15631/962017http://www.wales.gov.uk/keypubstatisticsforwales/content/publication/agriculture/2005/was2004/was2004-e.htm18 http://www.dardni.gov.uk/econs/spub0010.htm19 http://statistics.defra.gov.uk/esg/statnot/janveg.pdf

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The Orchard Fruit Survey20, an annual survey of area of apples, pears, plums and other fruit orchards in England and Wales in July.

The Glasshouse Survey21, an annual survey in January of protected crops in glasshouses in England and Wales.

The IACS (Integrated Administration and Control System) dataset recorded cropping and forage area for all farms applying for the Area Aid Payment between the 1992 and 2003 reforms of the CAP. The data were collected for administrative reasons, and are not generally available because of confidentiality restrictions. However, they can be made available within Defra and its agencies for specific purposes by arrangement. The information for each field/land parcel is linked spatially to a point within the field. The data are therefore the most spatially accurate available for the period concerned. 2004 was the last year of collection; from 2005 new rules will apply and the IACS database will be superseded by the Rural Land Register.

The Rural Land Register is being created from the IACS database, and new land holdings are being added to comply with the requirements of the most recent reform of the CAP. All land area must be eligible for the Single Payment Scheme (SPS) must be registered in order to receive single Farm Payments under the scheme, also all land entered for the Environmental Stewardship Scheme must be registered. This means that most of the agricultural land in England will be recorded on the register. In contrast to the IACS database, where data are linked to a point location, the RLR will contain digitized maps of all registered land parcels. The RLR will therefore constitute by far the most spatially accurate record of land use available to date. Unfortunately, the land use categories have been greatly simplified, so that from 2005, it will not be possible to distinguish between most crops, though this situation may change in future (S. Langton, pers. comm). As for IACS, the data are not generally available but may be accessed within Defra by special arrangement.

The HGCA Planting Survey provides data on the amounts of the major cereals and oilseed rape planted each year, by taking a sample, comparing it with the previous year to derive a ratio and then multiplying by June Census data to provide national figures for each crop. Regional totals are published on the HGCA website. The Cereals Production Survey provides data on the area of crop grown, for wheat, barley, oats and rye (see section 1.2.7).

LUCAS (Land Use/Cover Area frame Survey) is a pan-European survey co-ordinated by Eurostat to obtain data on land use at points on a grid (European Commission, 2003). It began with a pilot survey in 2001 (2002 in the UK and Ireland because of the Foot and Mouth disease outbreak). A second pilot survey was carried out in 2003 in 15 Member States. Changes to the survey are planned, with a pilot for the new methodology taking place in Poland, Latvia and Lithuania in 2005. A full survey across all Member States is anticipated for 2006. The first two surveys were based upon a grid of 18km x 18km squares and data were collected at the intersections. New surveys will be based on a 1 km2 grid, but only some grid points sampled, using stratified random sampling based on seven land classes and the relative importance of the class, e.g. more samples would be taken from arable areas (McKay et al., 2004). A transect will also be sampled at each point. There will be an annual survey to provide early crop estimates, covering all the strata. Surveys on other topics will be less frequent and are likely to rely on support from interested groups.

20 http://statistics.defra.gov.uk/esg/statnot/orchfrui.pdf21 http://statistics.defra.gov.uk/esg/statnot/janglass.pdf

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1.1.2 Land CoverMajor sources of information on land cover in the UK are the successive Countryside Surveys, carried out in 1978 (Bunce, 1979), 1984 (Barr et al., 1986), 1990 (Barr et al., 1993) and 1998 (Haines-Young et al., 2000), and the Land Cover Maps associated with the last two of these surveys (Fuller et al., 1994; 2000). Separate surveys were carried out in Northern Ireland (Murray et al, 1992; Cooper et al, 2003). The most recent survey, carried out in 1998, reported in 2000 to coincide with the millennium and is known as Countryside Survey 2000 (CS2000). A further Countryside Survey is planned for 2006.

The Countryside Surveys were based on 1km2 sample squares selected at random using an environmental stratification known as the ITE Land Classification. The number of squares surveyed increased each time the survey was carried out, from 256 in 1978 to 384 in 1984, 508 in 1990 and 569 in 1998. In addition to landscape cover and landscape features, additional plots in 1990 and 1998 assessed hedgerows, field boundaries, verges, streams and riversides, and targeted habitats (some of these were also assessed in 1978). Soil data were collected in 1978, 1990 and 1998, and aquatic invertebrates were sampled in 1990 and 1998. River habitats and breeding birds were also added in 1998. The development of the surveys is summarized by Firbank et al. (2003). Although the methodology has developed, continuity has been maintained so that for most parameters measured, comparisons can be made between the surveys (Firbank et al., 2003).

Land Cover maps were created for the whole of Great Britain from satellite images to coincide with the 1990 and 1998 surveys. The first Land Cover Map recorded 25 land cover types on a 25m grid, with a general accuracy of around 80-85%. A number of refinements were made to the methodology for the Land Cover Map 2000, which increased accuracy, added thematic detail and gave closer integration between field and satellite data. The 1990 map was a raster product (pixel-based), whereas the LCM2000 was a vector (parcel-based) database. Although the switch to a parcel based approach gave a number of advantages, it means however that the two maps are not directly comparable, and cannot readily be used to analyse change between the two dates.

The Countryside Survey and Land Cover maps provide the best information available for all habitats, and are the best sources of data for analysing change at the broad Habitat level, however, because they are currently only undertaken at intervals of eight years, they are not very useful for detecting rapid changes. Furthermore, the scale at which they can detect change is limited by the sample size (in the case of the Countryside Surveys), and potentially by image interpretation errors for Land Cover Maps (assuming methodologies for any future maps are compatible with LCM2000). For detecting changes arising from the growing of GM crops, the agricultural datasets described under Land Use surveys above are likely to be more useful.

In Scotland, a census of land cover was carried out by the Macaulay Institute in 1988, at a scale of 1:25,000. Land cover types were classified into 126 categories, as point, line or area features. Mosaics were also identified. Further information is available from the website22

22 .http://www.macaulay.ac.uk/MRCS/gis/gis2_dataset_4a.html

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Table 4. Summary of land use and land cover surveys (N/K = not known; N/A = not applicable)

Survey Sample size Frequency Unit of collection

Smallest spatial reporting unit

June Survey (‘Census’)

48,000 (2004) 75,000 (2005)

annual holding Super Output area (from 2004; formerly Ward).

December Agricultural Survey

32,076 (2004) annual holding Regional

Vegetables and flowers Survey

1,700 annual holding Regional

Orchard Fruit survey 630 (2004) annual holding EnglandGlasshouse Survey 1,360

(2004)annual holding Regional

IACS 88,000 holdings (2004)

annual land parcel N/A

Rural Land Register N/K annual land parcel N/AHGCA Planting Survey

N/K annual holding Regional

LUCAS N/K annual? point + transect on grid frame

Country

Countryside Survey 569 (1998) every 6-8 years

km2 Country

Land Cover Map N/A 1990, 2000 land parcel (2000)

Land parcel (2000)

1.2 Crop productionPotential effects caused by GM crop cultivationMost GM traits introduced into crops are designed to alter some aspect of crop management in such a way as to make the production of the crop easier and/or cheaper. Thus, herbicide tolerant crops allow both the type and timing of herbicide(s) to be changed, whilst insect resistant crops may reduce or eliminate the use of insecticides. Such traits may have both positive and negative environmental effects. For example, the Farm Scale Evaluations identified reductions in the biomass and seed rain of weeds and some invertebrates in GM oilseed rape and beet crops compared with non-GM controls, whereas in GM maize, weed levels were higher than in conventional maize. Other workers have shown that management of GMHT crops can be manipulated to enhance early season weed growth or seed rain compared to conventional management (e.g. May et al., 2005).It is possible that alterations in the management of crops with GM attributes, such as the amount or timing of agrochemical application, could also alter practices with regard to machinery use, such as whether contractors are employed to carry out spraying. This could also have knock-on environmental impacts (e.g. for the example given, contractors might be more or less careful to spray under optimal conditions, avoid spray drift etc.

Background informationPesticides must be approved before sale or use, and users are obliged to comply with the instructions on the label. These may include measures for limiting or mitigating environmental impact, such as the use of no-spray or buffer zones around the outer edge of the field. Nitrogen fertiliser use may also be restricted in Nitrate Vulnerable Zones. These

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cover 55% of England. Within these zones, use of fertilisers is limited to crop requirements, organic manures to 210 kg/ha/year on non-grass areas, and there is an autumn closed period for the application of slurry, poultry manures or liquid digested sludge.In addition to the regulations on the use of crop inputs, there are Codes of Good Agricultural Practice (COGAPs) for the protection of soil, water and air, which set out recommendations for farm management practices to minimise environmental impacts.Fertiliser input is a Government supporting indicator of Sustainable Development23

Data Sources

1.2.0 GeneralThe Defra Farm Practices Survey covers a variety of agri-environmental topics, including some relevant to crop management, though its main theme is waste management, particularly livestock wastes. So far, Farm Practices Surveys have been carried out in 2001, 2004 and 2005. The current intention is to continue the survey annually (S. Langton, pers. comm.).The disadvantage of this survey is that questions are not necessarily consistent from year to year, so it is of limited value for monitoring purposes, though it could be used to provide baseline data. Table 5 shows the information relevant to crop management information recorded in the three surveys carried out so far.

Table 5. Summary of aspects relevant to crop management recorded in Defra Farm Practices Surveys

Topic 2001 2004 2005Inorganic fertilisers Soil type Cultivation equipment Soil analysis Soil erosion by water Waste disposal Codes of Practice Farm management systems LERAPS Pesticide sprayers Conservation management Farm management and water quality

As the survey covers such a wide variety of subjects, specific detail of relevant aspects will be covered under sub-headings below.

1.2.1 VarietiesPotential effects caused by GM crop cultivationThe introduction of GM crops for commercial cultivation will inevitably result in changes to the crop varieties that are cultivated in the UK, not least because new GM lines will be available to UK growers for the first time. However it is also possible that GM crop production will cause more subtle, and unforeseen, changes to the types of varieties that are grown in the UK, including conventional varieties. One area where such a change may manifest itself is in the potential for gene transfer from GM to conventional crops. Cross-pollination between crops of the same species can vary greatly depending on the varieties 23 http://www.sustainable-development.gov.uk/performance/otherinds.htm

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concerned, and a prime example of this variation is to be found in oilseed rape. For example, where the receptor crop is a variety that contains male-sterile plants (e.g. a varietal association) the level of cross-pollination can be significantly increased compared to standard varieties. Concerns about cross-pollination from GM to conventional rape could lead to growers avoiding certain ‘pollen-hungry’ conventional varieties and favouring self-pollinating varieties because of the fear of adventitious GM presence caused by pollen flow from neighbouring GM crops.

Background informationCrop varieties may not be marketed unless they are listed on the National List of a Member State or in the EU Common Catalogue, in accordance with the Seeds (National Lists of Varieties) Regulations 2001 (Statutory Instrument 2001 No. 3510).

Data sourcesMain Agricultural Crops - Certified Seed (England & Wales)Before seed of the main agricultural crops can be marketed for sowing it must be officially certified in accordance with the UK Seed Regulations. In England and Wales NIAB administers seed certification and maintains records relating to individual certified seed lots. The certification process involves seed companies sending details of the particular seed lot they wish to have certified, along with an officially drawn sample, to a Licensed Seed Testing Station. LSTS are administered by NIAB, the Official Seed Testing Station, and it is NIAB therefore that hold records of all officially certified seed lots available for marketing in England and Wales. Although NIAB undertake this work on behalf of Defra Plant Varieties Rights Office and Seeds Division (PVS), it is understood from previous communication with PVS that the data relating to seed certification belong to NIAB, rather than PVS, therefore the accessibility of this data is unclear.

Cereals & Oilseed rape - GB Planting Survey Results:The Home Grown Cereals Authority (HGCA) collects and collates information on the area of the main cereal crops, and oilseed rape, planted in the UK. The basic data (crop type/area) is available on the HGCA’s website. It is not known whether the HGCA compile data based on variety. The HGCA state that their planting survey is the most comprehensive pre-harvest planting survey in the market arena and the methodology used closely resembles DEFRA's June Census. See (http://www.hgca.com/content.output/100/100/Markets/Markets/Survey%20Results.mspx)

Potatoes – area plantedThe British Potato Council collates data on a number of factors relating to the UK potato crop, including the annual area planted, yield and gross returns, grower and purchaser numbers, weekly average prices, areas planted by variety and UK (and European) trend data. Basic data is available from the BPC website in the form of online documents, pdf files and Excel spreadsheets. Additional information is available to BPC levy payers and Corporate Members. (See: http://www.potato.org.uk/include.asp?sec=1064&con=172&lcon=1064)

Main Agricultural Crops - Farm-Saved Seed:The Plant Varieties Act 1997 and The Plant Breeders' Rights Regulations 1998 (Statutory Instrument 1998 No. 1027) makes it an obligation for farmers who save their own seed to pay the holder of variety rights a royalty for the use of that seed (of certain protected varieties). UK Plant Breeders' Rights are administered by Defra Plant Variety Rights Office (PVRO),

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and the British Society of Plant Breeders (BSPB) has legislative authority to collect remuneration on such seed. Eligible varieties include oilseed rape and potatoes (as well as wheat, barley, oats, etc), but do not include maize, soya or beet. Farmers who use farm saved seed of a protected variety are liable to pay the holder of rights ‘equitable’ remuneration under a formula agreed between the national Farmers’ Union and BSPB. BSPB will therefore be in a good position to monitor for any changes in the overall acreage of farm-saved seed and in the proportion of individual varieties. As the administrator, PVS may also hold this information.

1.2.2 Cultivation, sowing and harvest datesThe Farm Practices Survey recorded use of cultivation equipment in all three years in which the survey has been carried out so far. In 2001, respondents were asked to record the area of their farm cultivated using different primary and secondary cultivation equipment and drills, and the number of passes made with each equipment type. Data were reported according to farm and soil type. In 2004 and 2005, data were reported by farm type but not soil type. Unfortunately, different methodologies were used to deal with non-completed forms, so it is not clear how comparable the data are between years. Even if data were comparable, data are not split by crop type, so only gross changes in cultivation on a whole farm basis could be detected.

The Pesticide Usage Survey records sowing date, sowing method (conventional, direct drilled, minimum cultivated, precision, broadcast, other), post-drilling cultivations, drill depth, seed rate and date harvested for each field recorded. These data are not included in standard reports, but can be made available on request. Cultivations (conventional plough/shallow plough/reduced cultivation) and date of sowing are recorded in the winter barley and winter wheat disease surveys carried out as part of the Crop Monitor programme (see under ‘Weeds, pests and diseases’ below). The oilseed rape survey records sowing date and whether the crop was broadcast or drilled.

Sowing and harvest dates were recorded in the Farm Scale Evaluations, but cultivation equipment and method of establishment do not appear to have been recorded (Champion et al., 2003).

1.2.3 Pesticides: UsageOfficial surveys of pesticide usage on a variety of agricultural and horticultural crops were started in 1965, following concerns over the use of organochlorine insecticides. With the introduction of the Food and Environment Protection Act in 1985, the post registration monitoring of pesticides became a legal requirement. The main source of readily available information on pesticide usage in the UK is the Pesticide Usage Survey. This is a rolling programme of surveys covering different crop groups, carried out at varying intervals. In England and Wales it is carried out by the Central Science Laboratory and in Scotland by SASA. In 1990 the government's independent Advisory Committee on Pesticides fixed the programme of surveys such that Arable surveys are conducted every other year, with all other crop groups24 surveyed on a four yearly cycle within England and Wales, though surveys for most crop groups date back at least to the 1970s. A similar team collects usage data in Scotland. Reports for Great Britain, combining data from the England & Wales and Scottish survey teams, are collated and published by the team at CSL.

24 Includes protected crops, vegetables, grassland and fodder crops, outdoor bulbs and flowers, hardy nursery stock, hops, orchards, soft fruit, grain stores and potato stores.

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All holdings are selected from a random sample, stratified by holding size and region. The information is collected on a field-by-field basis for each crop and is then raised using data from the Agricultural Census returns to give national estimates of usage. For arable crops, the sample represents 5% of the total area of crops grown; for other crop groups the proportion is higher. Usage is reported as spray hectares and tonnes of active ingredient for each active ingredient on each crop. In addition, area treated and weight applied for each pesticide group, number of products applied, area treated as percentage of area grown, average application rate, timing of applications, reasons for application and sprayer water volumes are also reported for each crop.

Pesticide usage is also recorded as part of the wheat, barley and oilseed rape surveys carried out for the Crop Monitor programme (see under ‘Pests and diseases and weeds’ below). Product, dose, application date and growth stage are recorded for each pesticide applied to every field recorded. Pesticide usage on cereal fields is recorded in the Game Conservancy Trust’s Sussex Study, an annual survey of 62 km2 covering six large and six small farms on the Sussex Downs, which began in 1970 (see also sections 2.1.3 and 3.1.5). Although it only covers a local area, it is the only survey which also records weeds and insects on an annual basis as well as umbers of the grey partridge, a bird which is dependent on arable farmland in this area, and is therefore a good indicator of management impacts. It has been a key source of data for investigating impacts of pesticides on arable food chains (Ewald and Aebischer, 1999, 2000).

All pesticides used in the Farm Scale Evaluations were recorded (Champion et al., 2003).

1.2.4 Pesticides: applicationCSL carried out a survey of Current Farm Sprayer Practice in 2001 and 2004, commissioned by the CPA and AIC as part of the ‘Voluntary Initiative’. 405 holdings were surveyed in 2004. The surveys were very detailed, covering the following topics: agronomic advice, farm assurance, crop protection management plans, spray operators, operator training, spray equipment – age and numbers, sprayer fittings, nozzles and maintenance, sprayer testing, sprayer filling, sprayer speed, decision making before spraying, water protection and LERAPs, disposal of surplus spray and washings, disposal of containers, PPE and unwanted pesticides, and use of spray contractors on sampled farms. It is not known whether the survey will be repeated again in future. Even if it is not, it could still provide useful baseline data.

In 2004 and 2005 the Farm Practices Survey recorded the number of sprayers on surveyed holdings, and, for holdings without a sprayer, reasons for not having one (in most cases, this was because a contractor did the spraying).

1.2.5 Fertiliser: usageThe main source of information on fertiliser usage in the UK is the British Survey of Fertiliser Practice. This is an annual, nationally representative, survey based on the selection of a random stratified sample of farms from mainland Britain, using the agricultural Census as a sampling framework. The survey is organised and jointly funded by the Fertiliser Manufacturers' Association (FMA), the Department for Environment, Food and Rural Affairs (DEFRA) and the Scottish Executive Rural Affairs. Fieldwork takes place between May and August, the results of which are published the following Spring/Summer. The main purpose of the survey is to estimate average application rates of nitrogen, phosphate and potash used for agricultural crops and grassland. Information is also collected on applications of sulphur fertilisers, organic manures and lime. The survey was first carried out in 1942. Aggregated data have been obtained for Great Britain since 1983, the first year that the existing survey in

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England and Wales was extended to Scotland. Unfortunately, reporting is at a national level only, so can only be used to determine national trends.

Northern Ireland Fertiliser Statistics: In Northern Ireland The Department of Agriculture and Rural Development (DARDNI) compiles fertiliser statistics based on returns from all fertiliser companies in Northern Ireland25. Data are collected on the quantities, nutrient contents and average retail prices of fertilisers delivered to farmers. The survey has been carried out every month since 1979.

Fertiliser usage is also recorded as part of the wheat, barley and oilseed rape surveys carried out for the Crop Monitor programme (see under ‘Pests and diseases and weeds’ below). For wheat and barley, products, formulations, rates of application, dates applied and growth stages are recorded for all fertiliser applications, trace elements and nutrient solutions, including slurries and sewage waste.

1.2.6 Fertiliser: storage and applicationThe December Agricultural Survey (see under ‘Scale and pattern of cultivation’ above) records fertiliser stocks on the surveyed farms.

The Farm Practices Survey 2001 recorded whether inorganic fertiliser was used on each farm, whether it was spread by contractor, how often the spread pattern of the fertiliser spreader was checked, and whether devices were used to avoid spreading into watercourses, ditches and hedgerow bottoms. These questions were not repeated in the 2004 and 2005 surveys.

1.2.7 YieldsThe Defra Cereals Production Survey - England and Wales provides data on the quantity of cereals produced, the yield per hectare and the area of crop grown, for wheat, barley, oats and from 1998, rye. The survey is based on a sample of holdings returning an area of cereals in the most recent June Census or in their administrative return (for area payments). Data are now collected twice a year, in August and April. Results are published within eight weeks of the survey date. The survey covers England and Wales and data are available at standard region level. It has been carried out, in its present form, since 1990 and replaced the annual Estimate of Crop Production Survey which ran from 1951 to 1989.

The Oilseed Rape Production Survey – England is similar to the Cereals Survey, and is carried out annually, in August.

The Minor Crops Yield Survey covered minor cereals (rye, triticale and mixed corn), linseed and minor stockfeeding crops until 1997. From 1998 onwards, the Ministry has run a telephone survey covering linseed and collected area of crop grown, yield per hectare and quantity produced. Rye has been collected within the cereal production survey. Estimates of triticale and mixed corn have been made by ADAS based on their contacts with farmers. In the past, results were published for England & Wales but due to the small Welsh crop areas and concerns about lack of precision, results are now only published for England.

The Dried Pea and Bean Production Survey - England and Wales produces data on the production of peas for harvesting dry and field beans, yield per hectare and the area of crop sown. Data are collected in November and published within ten weeks of collection.

25 http://www.statistics.gov.uk/STATBASE/

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Potato Planting and Production data are collected by the British Potato Council. The annual survey collects data on area planted, yield and gross returns, producer and purchaser numbers, weekly average prices, areas planted by variety and trend data. Access to data is restricted to BPC members.

Similar surveys are run by the Scottish Office (Combinable Crops Production - Scotland) and Dept for Agriculture in Northern Ireland (Crop Yields - Northern Ireland). For Scotland, the production figures are based on initial estimates of crop yields from the agricultural staff of the Scottish Executive Environment and Rural Affairs Department, supplemented by discussions with the trade. Information is collected on total production of wheat, barley, oats, triticale, linseed, oilseed rape and combine peas and beans, and results are published in January. For Northern Ireland, the figures are based on yield estimates from the Department of Agriculture and Rural Development for Northern Ireland. Data are collected each harvest year on the yields, moisture content, patterns of disposal and sources of seed for the various cereals, and published in December.

Table 6. Summary surveys covering aspects of crop management (N/K = not known; N/A = not applicable)

Survey Sample size Frequency Unit of collection

Smallest spatial reporting unit

Farm practices survey

2080 (2005) annual holding Region

Pesticides Usage Survey

Varies with crop (1123 for arable, 2002)

every 2 (arable) or 4 years

holding Region

Crop Monitor 300 wheat200 barley100 oilseed rape

annual holding Country

GCT Sussex study N/K annual field Study areaSprayer Practice Survey

405 (2004) 2001, 2004 holding UK

British Survey of Fertiliser Practice

1,300 (2002) annual holding Country

Northern Ireland Fertiliser Statistics

N/K monthly Fertiliser Manufacturers

Northern Ireland

Cereals production survey (England and Wales)

2450 (2005) twice a year holding Govt. office region and Wales

Oilseed Rape Production Survey – England

Around 750 annual holding England

Minor Crops Yield Survey

Around 190 annual holding England

Dried Pea and Bean Production Survey - England and Wales

Around 1000 annual holding England, England and Wales

Combinable Crops Production – Scotland

Around 350 annual holding Scotland

Crop Yields – Northern Ireland

211 annual holding Northern Ireland

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2. Environmental Impacts (Agricultural)

2.1 Pests, diseases and weedsPotential effects caused by GM crop cultivationThe effects of herbicide tolerant crops on weeds and invertebrates (including pests) have been well studied during the Farm Scale Evaluations and other studies, such as the ‘BRIGHT’ project (Sweet et al., 2004). Direct effects due to herbicide tolerant or insect resistance GM traits are predictable, but indirect effects may also arise through the food chain (e.g. Marshall et al., 2003. Similarly, effects on disease prevalence could arise through a disease resistance trait, or because a GM variety became widely grown and had better or worse disease resistance than the varieties it replaced.

Data sources

2.1.0 GeneralCrop Monitor is a Defra-funded annual programme for monitoring crop health status and crop protection practice in winter wheat, winter barley and winter oilseed rape crops in England and Wales. It incorporates several surveys of pests and diseases in the three target crops. There are three elements to the crop monitoring network:

1. Live Crop Monitoring of 15 wheat and 5 oilseed rape crops and expert interpretation by consultants of weekly data on incidence and severity of disease and effectiveness of control treatments applied.

2. Monitoring of Commercial wheat, barley and oilseed rape crops to gather information on disease and pest levels and crop management practice on farm.

3. Untreated Trials Data: A disease intelligence network of untreated crops from the HGCA Recommended List and TAG Descriptive List trials.

Data gathered are analysed to identify disease and pest risk, and users alerted to emerging threats during the growing season and advised on appropriate courses of action. The programme thus provides ‘real-time’ monitoring of pests and diseases. However, funding for the Crop Monitor programme is currently under review, and its future will depend on its perceived value to policy customers within Defra.

In Scotland, weeds, pests and diseases are monitored by Scottish Agricultural Colleges (SAC). Weed monitoring is qualitative, but summary data are presented for a range of pests and diseases26

Further details of individual surveys are given under the sub-headings below.

2.1.1 PestsPest populations in winter wheat: As part of the Crop Monitor programme, approximately 50 crops are assessed at the early flowering (GS61) and watery ripe (GS71) growth stages for incidence of cereal aphids. Pests assessed include the two main aphid species the grain aphid (Sitobion avenae), the rose-grain aphid (Metopolophium dirhodum), other aphids and the orange wheat blossom midge (Sitodiplosis mosellana).

Pest populations in oilseed rape: Pest assessments are carried out on six occasions during the season; 25 plants from each crop are assessed in the autumn during leaf production and in the spring at stem extension. Three assessments are carried out in the summer on twenty plants in situ in each crop at the green-yellow bud, early flowering and late flowering growth stages. 26 http://www.sac.ac.uk/consultancy/cropclinic/clinic/adoptacrop/

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One hundred crops are included in the monitoring carried out in the autumn and spring and a subset of sixty crops are monitored on the three occasions in summer. Pests monitored in autumn and winter include the peach-potato aphid (Myzus persicae), cabbage aphid (Brevicoryne brassicae), cabbage stem flea beetle (Psylliodes chrysocephala), rape winter stem weevil (Ceutorhynchus picitarsis), plus petiole scarring and slug damage. Pests monitored in spring and summer include the cabbage seed weevil (Ceutorhynchus assimilis), cabbage stem weevil (C. quadridens), and pollen beetle (Meligethes spp.) adults and larvae.

The Rothamsted Insect Survey has kept records of aphid aerial activity using 12.2m suction traps since 1965. Currently, data from a network of sixteen suction traps located throughout Great Britain. The traps are emptied daily during the ‘aphid season’ and the aphids identified to species in most cases. Each trap is representative of what is flying over an area of radius approximately 80 km, but there is considerable local variation in aphid density at ground level. Bulletins giving the number of aphids of each species caught at each site are provided weekly on the survey website.

2.1.2 DiseasesThe Crop Monitor programme incorporates three disease surveys: the Winter Wheat Disease Survey, the Winter Barley Disease Survey, and the Winter Oilseed Rape Disease Survey.

Annual surveys of winter wheat diseases have been conducted since 1975. Approximately 300 Crops are assessed during the early to medium milk development stage (GS73 - 75). Twenty-five tillers from each crop are examined for stem, leaf and ear diseases. The wheat survey records incidence of Take-all, Barley Yellow Dwarf Virus (BYDV), Septoria nodorum, S. tritici, Mildew, Yellow rust, Brown rust, Didymella, Cephalosporium, Tan spot, Eyespot, Sharp Eyespot and Fusarium.

Annual surveys of winter barley diseases have been conducted since 1981. Approximately 200 crops are surveyed; 100 of the crops are assessed at the beginning of stem elongation (GS30), and all crops are assessed during the watery ripe to early milk development stage (GS71 - 73). Twenty-five tillers from each crop are examined for stem and leaf diseases. Diseases recorded on barley are BYDV, Mildew, Rhyncosporium, Yellow rust, Brown rust, Net blotch, Septoria, Selenophoma, Eyespot, Sharp Eyespot and Fusarium.

Oilseed rape diseases have been monitored since 1987. Approximately 100 crops are monitored for diseases at three times throughout the season; 25 plants from each crop are assessed in the autumn during leaf production, in the spring and in the summer during pod ripening. Diseases assessed include Downy mildew, Light leaf spot, White leaf spot, Alternaria leaf spot, Phoma leaf spot, Powdery mildew, Ring spot, Botrytis, and Club root. Roots, stems, leaves and pods are all assessed separately.

In addition to the large scale disease surveys described above, ‘live’ monitoring is carried out at regular intervals throughout the season in winter wheat and oilseed rape, to provide updates and alerts for growers. For wheat, fifteen trials locations throughout England are monitored from March to provide weekly updates on disease severity, growth stage and canopy size. Assessments are carried out on treated and untreated plots of five different cultivars at each site. ADAS and AICC consultants then review the data and provide local and regional summary reports on disease severity, risk and control options. The reports and updates on disease levels across the country are available on the website every Monday. For oilseed

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rape, five crops are monitored weekly from the end of September 2005 until December, and then monthly until harvest, to provide regular updates on disease severity and crop development. The data are reviewed as for wheat and reports posted on the website by each Monday following an assessment. Crop Monitor also produces summary data on disease incidence in untreated plots from the TAG Descriptive List variety trials and the HGCA Recommended List variety trials programmes.The British Potato Council (BPC) provide a potato blight monitoring service known as ‘Fight against Blight.’ BPC has recruited volunteer ‘Blight Scouts’ who regularly have contact with potato crops e.g. Farmers, agronomists, advisers. These scouts report any incidence of blight they find during their normal activities, and then post a sample to the laboratory for confirmation. The information is used to provide maps of blight occurrence on the BPC website, which are updated regularly throughout eh growing season.

2.1.3 Weeds (see also section 3.1.1)There is no regular national monitoring scheme for weeds. One-off surveys have been carried out in the past (e.g. Chancellor, 1977; Froud-Williams & Chancellor 1982; Chancellor & Froud-Williams 1984; Whitehead &Wright, 1989), but often using different methodologies so that they are not generally comparable with each other. The Game Conservancy Trust’s Sussex Study (see section 1.2.3 and 3.1.5) scores the abundance of grass and broad-leaved weeds on a 0-5 scale and notes the presence of individual weed species in each field. This survey has been carried out annually since 1970, and also records insects and pesticide use on the same fields.The best source of repeatable information on weeds at a national scale is the Countryside Survey (see also sections 1.1.2 and 3.1.1). These are recorded with other plant species in five ‘Main plots’, each 200m2 in area, which are randomly positioned in each of the sample 1 km squares. Firbank & Smart (2002) reported changes in arable plants which are important food items for birds using data from these plots. In addition, ‘boundary plots’ (linear plots 1 m wide and 10 m long, outside the crop) were recorded in 1990 and 1998, and arable field margin plots (1 x 100m, at the crop edge) in 1998. These will probably be recorded again in the next Countryside Survey, allowing a measure of change, however the sample size is such that this can only be done for abundant species and at a national scale, and the infrequent nature of the survey means that changes over less than 8-9 years cannot be detected.Weeds are recorded in continuous cereals plots at Environmental Change Network sites (see under ‘Biodiversity: terrestrial, Plants’ below). Ten 40 cm x 40 cm quadrats are assessed in each of two 10 m x 10 m plots per site.The Farm Scale Evaluations (FSEs) recorded numbers of weed plants throughout the growing season and in following crops, during the three years of the experiments, and also sampled biomass prior to harvest. Seed rain was also measured, and seed banks were sampled before crops were sown and in the two subsequent years (Heard et al., 2003). Although the experiments have ended and there are no plans to repeat sampling, the extensive replication over a large number of sites could provide a baseline for possible future surveys. The International Survey of Herbicide Resistant Weeds is not a systematic survey, but maintains records of occurrences of herbicide resistance world-wide, which are available via its website: www.weedscience.org/in.asp. It is a collaborative effort between weed scientists in over 80 countries. Such records could be useful in monitoring multiple resistance in GMHT crops, or the appearance of new herbicide-resistant weeds through gene transfer to wild relatives.

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Table 7. Summary of regular surveys covering pests, diseases and weeds (N/K = not known)Survey Sample size Frequency Unit of

collectionSmallest spatial reporting unit

Crop monitor component surveys:Pest populations in winter wheat

50 Twice per year Crop field Region

Pest populations in oilseed rape

100 Twice per year (autumn & spring

Crop field County

60 Three times per year (summer)

Winter wheat disease surveys

300 Annual Crop field Region

Winter barley disease surveys

200 Annual (100 crops assessed twice)

Crop field Region

Winter oilseed rape disease survey

100 Three times per year

Crop field Region

Rothamsted Insect Survey

16 Daily (reports weekly)

Suction trap

Site

GCT Sussex study N/K Annual Field Study area (62 km2)

Countryside Survey 569 (1998) every 6-8 years km2 Country

3. Environmental Impacts (Environment)

3.1 Biodiversity: terrestrialPotential effects caused by GM crop cultivationA wide range of effects on biodiversity could occur, ranging from direct toxicity (e.g. to herbivorous insects feeding on an insect-resistant crop; Sears et al., 2001; Kelly et al., 2005), to indirect effects arising through food chains (e.g. reduction in food availability for organisms higher in the food chain, (e.g. Boatman et al., 2004; Hawes et al., 2004) or habitat modification resulting from changing management practices. An example of the latter could arise from drift of broad-spectrum herbicides, used on herbicide tolerant crops, into field margin habitats. Changes in amounts of different crops grown could also affect biodiversity, as many species use crops as habitats, and have preferences for certain crops over others. Defra has commissioned a review of research into the effects on farmland biodiversity of the management associated with genetically modified cropping systems27

Background informationThere are several Government policy initiatives linked to biodiversity conservation. The Public Service Agreement (PSA) target 3 is to “care for our natural heritage, make the countryside attractive and enjoyable for all and preserve biological diversity by:

Reversing the long-term decline in the number of farmland birds by 2020, as measured annually against underlying trends;

Bringing into favourable condition by 2010 95% of all nationally important wildlife sites.”28

27 http://www.defra.gov.uk/environment/gm/research/epg-1-5-198.htm28 http://www.defra.gov.uk/corporate/busplan/psa2004.htm

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Bird populations (split into farmland, woodland and coastal) form the subject of a Government Sustainable development Framework Indicator29. A number of species and habitats are the subject of Biodiversity Action Plans, which set conservation targets at national and local level.30. The status of BAP priority species and habitats in England is a Supporting Indicator of Sustainable Development.

Data Sources

3.1.0 GeneralIn addition to the regular survey detailed under separate headings below, information is maintained for a very large number of species by the National Biodiversity Network (NBN), and is available through the NBN Gateway31 (Cooper et al., 2005). This is an internet portal providing a searchable database of occurrence data containing nearly 19 million records from 144 datasets. It can be searched by species or location, at resolutions from 10, km2 down to 100m2 for some datasets. Many of these records are derived from the Biological Records Centre (BRC), which is the national focus in the UK for terrestrial and freshwater species recording (other than birds, for which the British Trust for Ornithology is the main centre). The BRC database contains nearly 13 million records of more than 12,000 species. Whilst the NBN provides a huge resource of biological data, its disadvantage for surveillance purposes is that it is not collected in a systematic fashion, but consists of individual records collected by interested individuals, either amateur naturalists or professional ecologists, on an ad hoc basis. Thus there is no consistency of sampling effort, either spatially or temporally, and the records reflect this. Records are often spatially biased towards centres of population or sites frequently visited by naturalists because of their known biological interest. It is not possible to determine trends through time except in a relatively crude way, by comparing numbers or locations of records over long periods (decades or longer). Even this method implicitly assumes some consistency of sampling effort which is generally not explicitly tested, but such comparisons have frequently been used to indicate changes in abundance and, where such changes are relatively large, the comparisons can provide useful indications of changes in abundance or range. The UK Environmental Change Network (ECN) is a long-term, integrated environmental monitoring and research programme, covering designed to gather information about the pressures on and responses to environmental change in physical, and chemical, as well as biological systems. There are 12 terrestrial sites throughout the UK (see map at http://www.ecn.ac.uk/sites.htm). Terrestrial biological data are collected for vegetation and several vertebrate and invertebrate groups. As the methods vary for different groups, further details are given under separate headings below. All methodology protocols are reproduced on the ECN website.32

Details of specific surveys are given below under the appropriate headings.

3.1.1 Plants (see also section 2.1.3)Until recently three was no annual survey of plants in the UK. In 2000 however, the plant conservation organisation Plantlife began the Common Plants Survey, an annual survey of 65 common species carried out in randomly selected 1 km squares. By 2004, 430 squares were being surveyed. Percentage cover of the target species is recorded in plots in the centre of the square, and in plots of certain habitats. The first report is due in 2006. The other plant

29 http://www.sustainable-development.gov.uk/performance/framework.htm30 http://www.ukbap.org.uk/GenPageText.aspx?id=5431 http://www.searchnbn.net/index_homepage/index.jsp32 http://www.ecn.ac.uk/protocols/index.asp

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monitoring schemes which exist in the UK are generally repeated at intervals of more than one year, and only cover a limited number of sites.

The UK Environmental Change Network (ECN) incorporates the following vegetation measurements, in permanent plots33:

Whole site baseline survey with up to 500 systematic 2 m x 2 m plots (VB); 50 random 2 m x 2 m grid plots surveyed every nine years (VC): species presence

recorded in each of the 25 40 cm x 40 cm cells of the plot. At least 2 10 m x 10 m plots randomly selected within each NVC type surveyed

every three years (VF): species presence recorded in 40cm x 40cm cells. Boundaries and linear features, such as hedgerows, are monitored every three years

(VH). Species presence is recorded in 40 cm x 40 cm plots forming a transect at right angles to the boundary.

Yield of permanent grass in exclusion cages four times a year (VP), Species presence recorded annually in plots of continuous cereals (VA) as for semi-

natural vegetation (VF). Cereal yield is also recorded. Arable areas are excluded from all recording except for the continuous cereals plots, as they are intended to represent semi-natural vegetation.

The Countryside Survey also records vegetation in several different types of permanent plots in each 1 km x 1 km sample square (Haines-Young et al., 2000, Smart et al., 2003):

Five 200 m2 in fields and unenclosed land, located using a restricted randomisation procedure (X plots).

Five 4 m2 plots randomly positioned in plant communities not represented by other plot types (Y plots).

Five 10 m x 1 m linear plots in field boundaries, paired with the nearest X plot (B plots).

Two 10 m x 1 m linear plots along hedgerows (H plots). Five 10 m x 1 m linear samples of road verge vegetation (R and V plots). Five 10 m x 1 m linear samples of river, stream and ditch bank vegetation (S and W

plots). Five 10 m x 1 m linear plots in arable field margins, at the edge of the crop (A plots).

In each plot, all vascular plants and a selection of bryophytes and lichens were listed, and cover estimated for all species covering 5% or more of the plot.

Although it is likely that all these would be carried forward into the next Countryside survey, in 2007, the format has not yet been finally decided.The New Atlas of the British and Irish Flora, published in 2002, was produced from more than 5.5m records made between 1996 and 1999 by 1,600 volunteers from the BSBI, who visited more than 99 per cent of the 3,880 ten kilometre squares in Britain and Ireland. Change indices, indicating the extent of increase or decrease in abundance of species, were calculated by comparison with data from the previous Atlas of the British Flora, published in 1962.The New Atlas could be used as a baseline for future surveys to determine species status in terms of number of squares occupied, or range.

33 http://www.ecn.ac.uk/protocols/Terrestrial/V.pdf

37

3.1.2 MammalsMammals are now among the better monitored groups, though this situation has only come about relatively recently. Mammal monitoring in the UK is co-ordinated by the Tracking Mammals Partnership (TMP)34, which was launched in 2003 as a collaborative initiative, involving 24 organisations with a variety of interests in mammals. Its aims are to improve the quality, quantity and dissemination of information on the status of mammal species in the UK, by standardising survey design, assessing where information is missing, exchanging data and expertise, sharing best practice, information on new technology and data collected.The TMP has a programme of 17 surveillance schemes - nine multi-species schemes in the wider countryside, four schemes collecting data on urban mammal populations and four schemes dedicated to a single species. The majority of schemes engage volunteers, and in some cases those who work in the countryside help to collect the data.The first major report has just been published (Battersby, 2005) and shows that the TMP is currently assessing population change for 34 mammals (including bats), over half of the 65 land mammal species (and sub-species) in the UK. However, for eight native species more years of study are needed before it is possible to assess population change reliably. Plans are underway to introduce surveillance schemes for the remaining mammal species over the next few years.

The schemes which are considered most relevant to GM surveillance (i.e. those which cover farmland and the wider countryside) are described below.The National Bat Monitoring Programme (NBMP), run by the Bat Conservation Trust since 1995, employs three methods to monitor bat populations:

(i) Field surveys, in which volunteers identify and count bats in randomly selected 1 km squares in July and August using ultrasonic detectors;

(ii) Winter counts at hibernation sites;(iii) Summer counts of emerging bats at breeding colonies.Eleven of the 16 UK breeding species are covered by the scheme.Mammal monitoring is carried out by volunteers as part of the British Trust for Ornithology (BTO)’s Breeding Bird Survey (BBS) and Waterways Breeding Bird survey (WBBS) (see section 3.1.3). In the BBS, volunteers make two visits to one of over 2,000 randomly selected 1 km squares and record birds and also sightings and signs of mammals while walking a 2 km transect. In the WBBS, observers walk a 3-5 km length of waterway twice during the breeding season. Mammals on Roads is a pilot project to assess whether road kills can be used to assess population changes. Volunteers count mammals seen on 20 mile long stretches of road in July, August and September.The National Gamebag Census (NGC), run by the Game Conservancy Trust, obtains data from annual questionnaires returned by an average of 636 estates across the UK, detailing numbers of game, pest and predator mammals killed during shoots or game-keeping activities. Although only established in 1961, data for some estates extend back to 1900 or even earlier, thus providing the longest running dataset for the species covered. For some species, such as small mustelids, the NGC provides the only source of information on trends.The Great British Deer Survey, organised by the British Deer Society, assesses deer distribution at a 10km2 level. It has been carried out in 1969, 1998-2000, 2005, with plans for repetition in future at intervals of five years.A pilot Winter Mammal Monitoring survey was run jointly by the Mammal Society and the BTO over the three seasons 2001-2004. Methodology was similar to the Breeding Bird

34 http://www.jncc.gov.uk/page-1757

38

Survey: volunteers were asked to make two visits to randomly selected 1 km squares and record sightings and field signs of mammals along a 2 km transect. The results are currently being assessed, and it is not known whether this survey will be repeated. There are also single species surveys for otter, water vole and water shrew (see section 3.2.2) and dormouse; for further information see Battersby (2005)35.In addition to the above schemes which contribute to the Tracking Mammals Partnership programme, bats, rabbits and deer are recorded at Environmental Change Network (ECN) sites. For bats, a bat detector is used to record bats in 1 km squares, noting the positions along a pre-determined transect of all bats seen or heard. Habitat features along the transect, and changes in those features, are also recorded. The transect is walked four times a year between mid-June and early September. For rabbits and deer, droppings are counted in late March, and again in late September, along two pre-determined transects at each site.

3.1.3 BirdsBirds are without doubt the best monitored group of organisms in the UK at the present time, mainly as a result of the numerous surveys carried out by the British Trust for Ornithology (BTO), with the help of a large number of volunteers. Key annual surveys covering farmland and the wider countryside are described below. A number of other specialist and short-term surveys are also carried out. For further details, see the BTO website http://www.bto.org.uk/.The Breeding Bird Survey (BBS) is an annual survey of widespread breeding birds in the UK. Over 2000 sites are surveyed by more than 1,700 participants, and the scheme monitors population changes of over 100 bird species. It provides the basis of indices of wild bird populations used as a Government indicator of the health of the countryside. Survey sites are randomly selected 1 km squares of the National Grid. Observers make three visits to selected squares, the first to record habitat types and to set up a suitable survey route, and the second and third to record birds that are seen or heard while walking along the route. The Nest Record Scheme records nests of wild birds. The stage of development of the nest, eggs and young are recorded on at least two occasions. The scheme provides data on the breeding success of birds, which is often useful in explaining changes in abundance or distribution. Further information is provided by the Constant Effort Sites (CES) scheme, a standardised ringing programme which has been running since 1983. Ringers set their nets in the same pattern, for the same time period at regular intervals through the breeding season at around 130 sites throughout Britain and Ireland. The scheme provides valuable key information on (1) changes in population size, (2) changes in breeding success and (3) adult survival rates for 28 species of common songbird. The above BTO surveys all contribute to the Integrated Population Monitoring Programme, to monitor the numbers, breeding performance and survival rates of a wide range of bird species. It has the following specific aims:

To establish thresholds that will be used to notify conservation bodies of requirements for further research or conservation action.

To identify the stage of the life cycle at which changes are taking place. To provide data that will assist in identifying the causes of change. To distinguish changes in populations induced by human activities from those that

are natural population fluctuations.Two single species surveys are also carried out annually, the Barn Owl Monitoring programme (BOMP) and the Heronries Census. The BOMP uses Nest Record Scheme methodology to record the location, timing and productivity of Barn Owl nesting attempts. The Heronries Census began in 1928 and is the longest-running breeding-season monitoring

35 http://www.trackingmammals.org/

39

scheme in the world. The aim is to collect annual nest counts of Grey Herons from as many sites as possible in the United Kingdom. Birds are recorded on ECN sites using the BTO BBS methodology, except for moorland areas where a different protocol is used. Here, each square kilometre to be surveyed is divided into four sub-squares each 0.5 km x 0.5 km, which are marked so as to be re-locatable in future surveys. Each sub-square is surveyed twice during spring/summer by a single observer, who walks it in such a way that all parts of the square are approached to within 100 m. Attention is focused on obtaining proof of breeding and on distinguishing individual pairs of birds. Territorial pairs of birds are marked on a map of the site.The Partridge Count Scheme is run by the Game Conservancy Trust (GCT). Farmers, landowners and others with access to land provide annual returns detailing counts of Grey Partridges (a Biodiversity Action Plan species) in the spring and autumn. The spring count is used as a measure of breeding abundance, and the autumn count as a measure of breeding success. Grey Partridges are also counted annually on the GCT’s Sussex Study area, covering 62 square kilometres of the South Downs (Aebischer & Potts, 1998) (see also sections 1.2.3 and 2.1.3).Quarry and pest bird species are recorded in the GCT’s National Gamebag Census (see section 3.1.2)

3.1.4 Reptiles and amphibiansThe phenology of the spawning of the common frog in selected ponds and ditches at ECN sites is recorded by assessing the number of egg masses, as an indicator of the 'health' of frog populations (see section 3.2.5 for further details). No other regular monitoring schemes for reptiles or amphibians have been found.

3.1.5 Invertebrates (see also sections 2.1.1 and 3.1.6)Considering their great diversity, invertebrates are poorly monitored in the UK. Only a few groups of insects are systematically monitored in a regular manner at a national scale.Some of the best long-term datasets are provided by the Rothamsted Insect Survey. Aphids are monitored regularly through a network of suction traps (see section 2.1.1 for further details). Rothamsted Research also runs a national survey of moths, using standardised light traps run by volunteers (Woiwod, & Harrington, 1994; Woiwod et al., in press). This was started at the Rothamsted Research Station in the 1930s, and monitoring was extended to the rest of the UK by 1968. Currently there are more than 80 established monitoring stations across the UK. Traps are run every night throughout the year in a wide range of habitats.The Butterfly Monitoring Scheme (Pollard et al., 1986), run by the Centre for Ecology and Hydrology, started in 1976 and consists of a network of 196 sites throughout the UK, covering 71 species. At each site, weekly counts are made between April and September along a fixed transect, typically 2-4km in length. Each transect is divided into sections which usually vary in length, habitat type and management. Reports and summaries are published on the survey website.36

Insects in cereal fields are recorded annually in the Game Conservancy Trust’s Sussex Study (see also sections 1.2.3 and 2.1.3). Five ten-second samples are taken from each field in the study area along a diagonal transect using a petrol-driven vacuum sampler (‘D-Vac’). Insects are identified to order or family level, and some to genus or species. Although it only covers one area, it is the only long-term dataset available covering a large number of arthropod taxi on arable farmland. Weeds, pesticides and cropping data are also recorded, providing the opportunity for analysis of relationships between these variables Weald and Aebischer, 1999).

36 http://www.bms.ceh.ac.uk/using.htm

40

The ECN records five groups of terrestrial invertebrates: moths, butterflies, tipulids, spittle bugs and ground predators. Moths are recorded using light traps, which form part of the Rothamsted Insect Survey network. Butterflies are recorded using Butterfly Monitoring Scheme methodology. Larvae of tipulids (craneflies) are sampled twice a year, in April and September, from grassland, woodland and upland vegetation, by taking soils cores to 10 cm depth and hand sorting to extract the larvae. This group was chosen because of its importance in food webs, and because they are easier to sample than earthworms37. Larvae of spittle bugs are counted in permanent 0.25cm quadrats in June each year, and adults sampled by sweep-netting in August, in grassland. Two species are sampled, and colour morphs of one, the proportions of which are thought to be environmentally determined, are also distinguished. All these groups are phytophagous, and carabid beetles are also sampled as an example of a predatory group, using transects of pitfall traps. These are emptied fortnightly between May and October. In addition to identifying all species present, leg colour morphs of Pterostichus madidus are recorded, and second femur lengths of Mitopus morio, both of which are thought to be environmentally determined, are measured.

The Farm Scale Evaluations (FSEs) recorded a range of invertebrate groups during the three years of the experiments. These were divided into soil-surface-active invertebrates (Brookes et al., 2003) and aerial and epigeal arthropods (Haughton et al., 2003). Soil–surface-active Carabidae (ground beetles), Staphylinidae (rove beetles), Araneae (spiders) and Collembola (springtails) were sampled by pitfall trapping, and slugs (Gastropoda: Stylommatophora) by baited refuge traps. Aerial arthropods included butterflies and bees, and were counted using a modified version of the line-transect method developed for the Butterfly Monitoring Scheme. Epigeal arthropods, including Araneae, Collembola, Heteroptera (plant bugs), and Carabidae, were sampled using a Vortis suction sampler. Note that some groups were sampled using two methods; the efficiency of these methods however differs between groups and between species within groups according to their size and ecology. Although the experiments have ended and there are no plans to repeat sampling, the extensive replication over a large number of sites could provide a baseline for possible future surveys.

3.1.6 Soil organismsSoil invertebrates were sampled during Countryside Survey 2000 (Black et al., 2003), but it is not yet known whether this will be repeated in the next survey. Tipulid larvae are sampled by the ECN (see 3.1.5). No other regular systematic monitoring schemes for soil biodiversity in the UK have been found. Defra is currently reviewing soil monitoring and indicators for the future, including potential biological indicators38

Table 8. Summary of key regular surveys of terrestrial biodiversity (N/K = not known)Survey Sample size Frequency Unit/method of

collectionSmallest spatial

reporting unit

ECN component surveys (12 sites):Vegetation

Vegetation: NVC types

50 per site Every 9 years 40 cm x 40 cm cells within 2 m x 2 m plots

Site

37 http://www.ecn.ac.uk/protocols/Terrestrial/IT.pdf38 http://www.defra.gov.uk/environment/land/soil/research/indicators/index.htm

41

Vegetation: within NVC types

Min. 2 per site

Every 3 years 10 m x 10 m ‘‘

Boundaries & linear features

Not specified Every 3 years 40 cm x 40 cm cells

‘‘

Permanent grass yield

10 per site 4 times a year 3m2 exclusion cage ‘‘

Vegetation within cereal fields

Min. 2 per site

Annual 10 m x 10 m ‘‘

Vertebrates ‘‘Bats 1 per site 4 times a year Transect ‘‘Rabbits & deer 2 per site Twice a year Transect ‘‘Birds 1 per site Twice a year Km2 ‘‘

Invertebrates ‘‘Moths 1 per site Daily Light trap ‘‘Butterflies 1 per site Weekly during

seasonTransect ‘‘

Tipulids 20 cores Twice a year Soil cores within 50 m x 40 m area

‘‘

Spittle bugs - larvae 20 per site Annual Quadrats ‘‘Spittle bugs - adults Not specified Annual Sweep with net ‘‘Carabid beetles 3 transects x

10 traps2-weekly Apr-Oct

Pitfall trap ‘‘

Countryside Survey (569 km2 in 1998)Vegetation

Main (X) plots 5 per km2 every 6-8 years 200m2 CountryOther (Y) plots ‘‘ ‘‘ 4m2 ‘‘Boundary (B), road verge (R, V), bank (S, W and crop edge (A) plots

‘‘ ‘‘ 10 m x 1 m linear plot

‘‘

Hedgerow (H) plots 2 per km2 ‘‘ ‘‘ ‘‘Soil invertebrates 5 per site ‘‘ Soil core ‘‘Common Plants survey

430 km2 (2004)

Annual plot N/K

National Bat Monitoring Programme

variable Annual Field transectHibernation siteBreeding colony

UK

National Gamebag Census

Average 636 (game), 364 (predators)

Annual Estate County

Great British Deer Survey

All 10km2 5 yearly 10 km2 Country

Breeding bird survey >2,000 Annual Km2 Country/ Region

Nest Record Scheme >30,000 p.a. Annual Nest UKConstant Effort Scheme

>130 Annual Site UK

Rothamsted Insect Survey

16 Daily (reports weekly)

Suction trap Site

Butterfly Monitoring Scheme

196 Weekly during flight season

2-4 km Transect Site

GCT Sussex study N/K Annual Field Study area (62 km2)

42

3.2 Biodiversity: aquaticPotential effects caused by GM crop cultivationAquatic biodiversity could be affected by changes in pesticide or fertiliser use leading to contamination of water ways through drift or via spillage or runoff, or other changes in cropping practices leading to increased soil erosion, as a result of GM crop cultivation.

Background informationFish stocks are the subject of a Government Sustainable Development Framework Indicator, and there is a Supporting Indicator for populations of wintering wetland birds. The EC Freshwater Fish Directive (78/659/EEC) was adopted in 1978, and requires that certain designated stretches of water (rivers, lakes or reservoirs) meet quality standards that should enable fish to live or breed.

Data Sources

3.2.0 GeneralIn addition to the 12 terrestrial sites, the Environmental Change Network has 44 freshwater sites throughout the UK, ranging from small ponds and streams to large rivers and lakes (see map at http://www.ecn.ac.uk/sites.htm). Groups of organisms sampled at these sites include macro-invertebrates, aquatic macrophytes, zooplankton, phytoplankton, and epithilic diatoms. As for terrestrial organisms, details are given under the appropriate sub-heading below. Details of protocols can be found on the ECN website39 Details of specific surveys are given below under the appropriate headings.

3.2.1 PlantsMacrophyte surveys are undertaken at ECN aquatic sampling sites in July or August, annually for rivers (28 sites) and every two years for lakes (16 sites). In lakes, surveys are undertaken of the shoreline and deep water. Shoreline surveys cover an area 100 m long and up to 5 m wide. The 100 m length is divided into ten sub-sections and presence of all emergent, floating and submerged macrophytes is recorded in each sub-section. Deep water surveys record species present at 5 m intervals along a transect at right angles to the shoreline, up to the limit of macrophyte growth.. Methods used to sample the vegetation are (i) an Ekman grab; (ii) a bathyscope or underwater camera; (iii) a macrophyte grapnel. Depth, substrate and a visual estimate of plant cover are also recorded. In rivers, an area 100m long is divided into ten subsections, and percentage cover estimated for each species in each 10 m section of the river channel. Width, depth, substrate, habitats, shading, water clarity and bed stability are also recorded.Aquatic macrophytes are surveyed bi-annually between June and September by the UK Acid Waters Monitoring Network (UKAWMN), which consists of 11 lakes and 11 streams throughout the UK40. For lakes relative species abundance determined on a five point scale following shoreline survey, shore transects and deep water grapnel trawls. For streams, total macrophyte cover estimated for 5m sections of a 50m survey stretch and each then partitioned into proportional species abundance to provide percentage cover for each species.

39 http://www.ecn.ac.uk/protocols/index.asp40 http://www.ukawmn.ucl.ac.uk/info.htm

43

Aquatic and riparian macrophytes (including mosses) were taken during Countryside Survey 2000 sampling, but according to the report of this module, the samples and data have not been analysed41.For phytoplankton see under section 3.2.7 (micro-organisms) below.

3.2.2 MammalsA series of National Otter Surveys was initiated in 1977-8. These have been carried out at approximately seven year intervals at a country level. A range of organizations have been involved (Battersby, 2005, http://www.trackingmammals.org/). Sampling was at the 10km2 level, and sites were not randomly selected, so the data cannot be used to calculate population trends, but give information about distribution at the 10 km2 level. 600m transects were walked along river banks at e-8 km intervals. Details of the most recent English and Welsh surveys are on the Environment Agency website42, and the Northern Ireland survey in the Environment and Heritage Service website43. The most recent Scottish survey is due to report in 2005.44 All reports are listed on the Tracking Mammals Partnership website.Water Voles are surveyed at 14 National Key Sites. At each site, 12-24 100m transects are searched for latrines and other signs of water vole activity.A pilot survey of water shrew distribution (the Mammal Society’s Water Shrew Survey) is taking place between 2004 and 2006. Sites are chosen by volunteers, not randomly, so the survey will provide information on distribution but not population changes.

3.2.3 BirdsThe Waterways Breeding Bird Survey (WBBS) records breeding birds in riparian habitats. Three site visits are made between April and June. Observers walk randomly selected transects along the side of waterways.The Wetland Bird Survey (WeBS) monitors non-breeding water birds in the UK. Monthly counts are made every year at around 2,000 wetland sites of all habitats. The Wildfowl and Wetlands Trust (WWT) carries out a number of surveys which contribute to the Goose & Swan Monitoring Programme (GSMP). The main surveys are summarised in Table 9. Further information is available on the WWT website: http://www.wwt.org.uk/research/monitoring/surveys.asp.

Table 9. Goose and swan surveys carried out by the Wildfowl and Wetland TrustSurvey/census Frequency Species

International Swan Census 5-yearly Bewick’s and Whooper SwanIcelandic-breeding Goose Census

Annual Iceland Greylag Goose and Greenland/Iceland Pink-footed Goose

Greenland White-fronted Goose Census

Annual Greenland White-fronted Goose

NW Scotland Greylag Goose Survey

9-yearly NW Scotland Greylag Goose

UK-breeding Greylag Goose Survey

Annual NW Scotland Greylag Goose and re-established Greylag Goose

Naturalised Goose Survey 9-yearly All non-native goose species in UK and re-established Greylag Goose

International Census of 5-yearly Greenland Barnacle Goose

41 http://www.cs2000.org.uk/Final_reports/M02_Freshwater_final_report.pdf42 http://www.environment-agency.gov.uk/subjects/conservation/483249/?version=1&lang=_e43 http://www.ehsni.gov.uk/pubs/publications/OtterreportNov2004.pdf44 http://www.snh.org.uk/trends/trends_notes/pdf/freshwater%20species/eurasian%20otter.pdf

44

Greenland Barnacle GeeseAll-Ireland Light-bellied Brent Goose Census

Annual East Canadian High Arctic Light-bellied Brent Goose

A Mute Swan Census is also carried out periodically, the most recent being in 2002.

3.2.4 Fish The Environment Agency has recently established a National Fisheries Monitoring Programme, to provide information on fish populations as well as habitats, participation in fishing and catch results. The programme began in 2001, but due to the foot and mouth outbreak in that year, the first comprehensive dataset was collected in 2002. Techniques range from fish traps and automatic fish counters to electric fishing and echosounding. The monitoring network comprises four tiers: index, temporal, spatial and sentinel sites. The information below is extracted from the report ‘Our Nations Fisheries’, which is available on the Environment Agency website45

Index sites are monitored intensively to increase understanding of fish species and their population dynamics, and how environmental and human influences affect them. Fish abundance, age structures and sex ratios are measured at a limited number of locations. So far, a salmon index monitoring programme has been developed on four principal salmon rivers in the North East, North West, Wales and the South West. Equivalent programmes are being designed for other species.Temporal sites are surveyed annually to a lower level of detail than index sites to determine long-term trends in fish populations on all principal river fisheries. There are currently 545 salmonid and 1010 coarse fish sites, which in statistical terms, should be able to detect a 10 per cent change in populations over a ten year period.Spatial sites are monitored to detect differences in fish populations between different locations with similar habitats, for example between neighbouring sub-catchments. There are 4010 salmonid and 825 coarse fish sites, which are surveyed once every five years. However, the geographic coverage is much greater than that of the index and the temporal programme.Finally, 575 salmonid and 495 coarse fish sentinel sites are monitored once every five years to provide information on the distribution of various fish species, including those that are not sought by anglers but which are of general or high conservation value – for example minnows and bullheads.Salmonids are sampled annually in the autumn, by electro-fishing from three 50 m reaches at stream sites and the outflow streams of lake sites which contribute to the UK Acid Waters Monitoring Network (UKAWMN) network (see section 3.2.1).

3.2.5 AmphibiansFrog spawn phenology and abundance is recorded at the 12 terrestrial ECN sites. Recorders check selected pond(s) weekly from about 1 January, and record the date on which male frogs congregate in the spawning areas and begin calling. Thereafter pond(s) are visited daily until the first eggs have hatched. A record is made of the date on which spawn is first seen, and on subsequent daily or weekly visits the number of new spawn masses which have appeared since the last visit are recorded. Samples of water are taken for chemical analysis, and temperature and water depth are measured.

3.2.6 InvertebratesAquatic invertebrates communities are widely used to indicate quality, and are therefore relatively well monitored compared with other groups. The variety of macro-invertebrates differs from site to site and from river to river even when there is no pollution or physical 45 http://www.environment-agency.gov.uk/commondata/acrobat/fisheries_eng_765655.pdf

45

disturbance. Therefore, biological quality is described as the difference between the macro-invertebrate community actually found in the river and that which would be expected under natural conditions. The normal method is to predict the macro-invertebrates that would be found if the river was unpolluted and undamaged using a computer-based system called RIVPACS (River Invertebrate Prediction and Classification System). Reports on websites are usually of derived data on water quality, rather than the invertebrate data.The most comprehensive monitoring of rivers is the General Quality Assessment (GQA) carried out by the Environment Agency in England and Wales, SEPA in Scotland, and the Environment and Heritage Service in Northern Ireland. This comprises a chemical and a biological classification of river water quality, with the biological classification being based on the composition of the macro-invertebrate community. The Environment Agency GQA is carried out at around 8,000 points (over 7,000 sites) representing about 40,000km of rivers and canals and 2,800km of estuaries in England and Wales. Complete national surveys were carried out in 1990, 1995 and 2002. Since 2002, one third of sites have been sampled each year, so that every site is sampled once in three years. Two biological samples are collected, one in spring (March to May) and one in autumn (September to November). The samples are collected by three-minutes of active sampling with a pond net. At some deep sites here this is not possible, the samples are collected by three to five trawls with a dredge or by airlift, followed by a one-minute sweep with a pond net. Every sample is supplemented with a one-minute visual search for individual animals living on the water surface or attached to rocks, logs or vegetation. Identification is mostly to the family level.Macro-invertebrate species presence and abundance is measured 3 times per year at the 28 river and 16 lake sites contributing to the Environmental Change Network. Sampling is carried out using a long-handled pond-net. Sampling tactics include kick-sampling of the streambed or the littoral zone of the lake, hand-searching, and sweep-sampling of any vegetation. Dredge sampling is used in deep rivers or lake margins where it is impossible to sample adequately by other means. Samples are generally identified to species level where possible, where this is not possible identification may be to genus, family etc.Macro-invertebrates are sampled annually at the UK Acid Waters Monitoring Network (UKAWMN) sites (see section 3.2.1). Five kick samples are taken from lake littoral habitats or from riffle areas in streams. Results are expressed as percentage abundance of various taxa, total numbers of individuals, number of individuals at genus level, and as a selection of diversity indices.Aquatic macro-invertebrates were recorded in the Countryside Surveys in 1990 and 1998. A single watercourse was surveyed in each 1 km2 in which an appropriate watercourse was present. In 1998, 404 sites were surveyed, and there were 354 comparable sites from CS 1990.

3.2.7 Micro-organismsThe ECN records zooplankton and phytoplankton fortnightly at lake sites, and epilithic diatoms at river and lake sites 3 times per year. Zooplankton are collected with a net. The animals are counted and biomass is measured. Phytoplankton are counted and also chlorophyll extracted and quantified. Epilithic diatoms grow attached to submerged stones, and are sampled by collecting stones or other suitable substrate. Epilithic diatoms are also sampled from UKAWMN sites; 3-4 samples are taken and used to calculate annual mean percentage frequency of taxa occurring at greater than 2 % abundance in any one sample.

Table 10. Summary of key regular surveys of aquatic biodiversity

46

Survey Sample size Frequency Unit & method of collection

Smallest spatial

reporting unit

ECN Component surveys

Macrophytes 16 lakes Biennial 100m shorelineDeep water - transect

Site

28 rivers Annual 100m sectionMacro-invertebrates 16 lakes

28 rivers3 times a year Lake/river Site

Plankton 16 lakes Fortnightly Lake SiteEpilithic diatoms 16 lakes

28 rivers3 x / year Lake/river Site

National Fisheries Monitoring Programme

Index sites 4 rivers; no. samples varies

Annual Site Region

Temporal sites 545 salmonid1010 coarse

Annual Site Catchment

Spatial sites 4010 salmonid825 coarse

5 yearly Site Catchment

Sentinel sites 575 salmonid495 coarse

5-yearly Site Catchment

UKAWMN 11 lakes11 streams

Annual Lake/stream Site

Countryside Survey 404 (1998) 1990, 1998 One watercourse/km2

Country

Waterways Breeding Bird Survey

N/K Annual 500m transect UK

Wetlands Bird Survey c. 2,000 Monthly Site UKGoose & Swan Monitoring Programme

varies See Table 9 Site Region/ county

General Quality Assessment:

England & WalesScotlandNorthern Ireland

8,000 N/K1250 (2000)

E & W: 2x/year (inverts)

Site Region/ Country

3.3 SoilPotential effects caused by GM crop cultivationThe Soil Ecology Subgroup of the Advisory Committee on Releases to the Environment (ACRE) has produced a ‘Review of the current state of knowledge of soil ecosystems relevant to the potential impacts of GM plants’ (March, 2003). A further review of the relationships between GM crops and soil ecology has recently been produced for Defra (Atkins Environment, 2004). They state that GM crops could affect the soil through altered root architecture, altered decay of plant residues, or altered root exudation. Possible effects on soil organisms could arise through the exudation of toxins such as Bt toxin through root exudates (Evans, 2002).

47

Background informationIn a Better Quality of Life, a strategy for sustainable development for the UK (May 1999) the Government made a commitment to ensure that soil protection received equal priority to that of air and water in the future. The First Soil Action Plan for England was launched on 20 May 2004. The annual report for 2005 is available on the Defra website.46 There is also an EU Thematic Strategy for Soil Protection.47

Data Sources

3.3.0 GeneralThe National Soil Inventory (NSI), produced by the National Soil Resource Institute at Cranfield University, Silsoe, comprises soil, terrain and land use data collected from the intersects of a 5 km grid over the whole of England and Wales. It is part of LandIS, the national soils database for England and Wales, which also contains soils data interpretation (SDI) and the digital National Soil Map (NATMAP), which is linked to a dataset of soil series attribute and function values. Charges are made for the supply of these data, including a one-off preparation & administration fee plus an annual royalty charge. These charges run into many thousands of pounds (e.g. £12,300 for NSI topsoil data), though royalty concessions are available for research. Similar data are held for Scotland by the Macaulay Land Use Research InstituteInitial data were collected during the period 1978-1983. Resampling of selected sites took place in the 1990s to quantify trends in soil chemistry. It is not known whether there are any plans to repeat sampling in the future. The UK Soil Indicators Consortium is currently developing indicators of soil quality, based on the report by Loveland & Thompson (2002).48 This exercise, once completed, will have implications for the future monitoring of the soil resource.In total, the NSI grid has 6800 sample points, of which 5500 fall within rural or open areas and are fully described and sampled. The datasets accessible through the NSRI Soil Data Gateway49 contain 6127 data points. Urban soils are excluded. The Inventory contains three datasets: NSIsite, NSIprofile, and NSIelements. The first two contain site and profile descriptions respectively, whilst NSIelements contains topsoil analytical data on total and available concentrations of 20 elements including heavy metals and plant nutrients.Other sources of information on soils are the Environmental Change Network (ECN) and the Countryside Survey. The ECN carries out fine-grain monitoring from soil cores every five years, and coarse-grain monitoring from soil pits every 20 years. Measurements of soil solution chemistry are also made.Details of data available for different attributes are given under the sub-headings below.

3.3.1 Soil depth and structureSoil structure is included along with related properties in the NSI Profile dataset. There does not seem to be any regularly updated source of information on these properties.

3.3.2 Soil chemistry and organic matterThe Representative Soil Sampling Scheme (RSSS) is a collaboration between ADAS and Rothamsted Research. It has been carried out continuously since 1969. Measurements are made of the pH and nutrient status (Calcium Chloride, available Phosphorus, Potassium and 46 http://www.defra.gov.uk/environment/land/soil/pdf/soilactionplan-annrep05.pdf47 http://www.defra.gov.uk/environment/land/soil/europe/index.htm48 http://www.defra.gov.uk/environment/land/soil/indicators/index.htm49 http://www.silsoe.cranfield.ac.uk/nsri/services/cf/gateway/ooi/about.cfm

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Magnesium) of agricultural soils in England and Wales. It does not measure organic matter. The RSSS is intended to be representative of all agricultural soils, with soil samples taken from four randomly selected fields from each of a stratified random sample of 180 farms. The scheme runs on a five-year sampling cycle, with a subset of the selected farms sampled each year. Trends are identified through comparison of each five-year sampling period; individual years do not provide significant data. The NSI topsoil data contains analytical data for a wide range of elements including nutrients (other than nitrogen), and heavy metals (see Table 11). Organic carbon and pH are also measured.50 Data are available from 1983 and 1995.Soils are sampled at ECN sites at 5 and 20 year intervals. There are six sampling blocks at each site, and each block is divided into 5 m x 5 m cells, of which some are used for five-yearly sampling and others for 20-yearly sampling. Five-yearly samples are extracted with an augur to 30 cm depth. Twenty-year samples are extracted from the side of a soil pit. Chemical elements analysed are listed in Table 11. Moisture, pH and organic carbon are also measured.

Table 11. Analytical data for soil chemistry recorded by the NSI and the ECNElement NSI ECN 5 yearly core ECN 20 yearly

profileAluminium total exchangeable exchangeable &

extractableArsenic total* totalBarium totalCadmium total & extractable totalCalcium total exchangeable exchangeableChromium total totalCobalt total & extractable totalCopper total & extractable totalIron total extractableLead total & extractableMagnesium total & extractable exchangeable exchangeableManganese total & extractableMercury total* totalMolybdenum total* totalNitrogen total totalNickel total & extractable totalPotassium total & extractable exchangeable exchangeablePhosphorus total & extractable total total & extractableSelenium total*Sodium total exchangeable exchangeableStrontium totalVanadium total*Zinc total & extractable total* partial datasets only

Samples were taken from 256 kilometre squares in 1998 as part of Countryside Survey 2000, repeating the soil survey carried out in the first countryside Survey, in 1978. Three soil cores were taken at up to 5 sites associated with main vegetation plots within each 1 km square. In

50 http://www.silsoe.cranfield.ac.uk/nsri/services/cf/gateway/ooi/nsitopsoil.cfm

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addition to soil fauna and microbial activity ((Black et al., 2003; see section 3.1.6), the soil cores were analysed for organic pollutants, heavy metals, pH and loss on ignition (organic matter content).

The Geochemical Baseline Survey of the Environment (G-BASE) is a programme of systematic geochemical mapping across the UK. The survey began in the early 1970s in the northern Highlands of Scotland. The work has progressed southwards ever since and it hopes to be completed by 2012. Data is held on behalf of the Natural Environment Research Council (NERC) by the British Geological Survey (BGS). The overall objective of the project is to support UK environmental sustainability and development. The G-BASE sampling campaign involves the collection and chemical analysis of stream sediment, soil and stream water samples. Each sample is analysed for up to 38 elements. As this is not a regular survey it is not suitable for surveillance monitoring, but could provide useful baseline monitoring.

3.3.3 Erosion rates NSI site data records features caused by erosion and deposition, but as this was only done in the 1980s, it cannot be used to assess erosion rates or changes in these.The Farm Practices Survey (see section 1.2.0) asked questions of participants in 2001 and 2005 relating to soil erosion by water. Questions asked in both years relate to indicators of erosion, actions taken in the last 5 years to prevent soil erosion, and actions taken in a typical year to prevent soil erosion. An additional question asked in 2001 only covered area affected by soil erosion.

Table 12: Summary of surveys providing information on soilsSurvey Sample size Frequency Unit of

collectionSmallest spatial reporting unit

Representative Soil Sampling Scheme

180 farms, 4 fields/farm

5 yearly field

National Soil Inventory

6127 1983, 1995 (partial re-survey)

Grid point Point

Environmental Change Network

12 sites 5 yearly. Soil core Site20 yearly Soil pit

Countryside Survey 256 1978, 1998 Km2 CountryFarm practices survey

2080 (2005) Annual, erosion data from 2001, 2005

Holding Region

3.4 WaterPotential effects caused by GM crop cultivationEffects on water are most likely to occur through changes in soil erosion, pesticide or fertiliser use, arising through changes in cropping practice as a result of growing GM crops (see section 3.2)

Background informationThe Water Framework Directive (WFD) came into force on 22 December 2000, and requires all inland and coastal waters to reach "good status" by 2015. Defra, the Scottish Executive, Welsh Assembly Government and the Department of the Environment Northern Ireland have implemented a major programme of work to implement the Directive, much of which will be undertaken by the Environment Agency in England and Wales; the Scottish

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Environment Protection Agency in Scotland; and the Environment and Heritage Service in Northern Ireland. As part of this programme, monitoring strategies are being reviewed and new ones developed to fulfil the requirements of the WFD.River water quality (biological and chemical) is a Government Sustainable Development Framework Indicator.

Data Sources

3.4.0 GeneralThe Environment Agency General Quality Assessment scheme (GQA) covers chemical quality and nutrient status of rivers, as well as biological quality (see section 3.2.6) and aesthetic quality. Around 8,000 sites are sampled monthly, representing over 40,000 km of rivers and canals. To prevent bias, only data from routine, pre-planned sampling programmes are used in calculating water quality, and data from special surveys or collected in response to pollution incidents are not used. England and Wales data on chemical and biological river water quality and nutrient (nitrate and phosphate) concentrations of monitored rivers are available at regional and local authority level from the River Water Quality Database.51

Similar schemes are administered in Scotland by SEPA52, and in Northern Ireland by the Environment and Heritage Service (EHS)53. Since 1991, the Northern Ireland Environment and Heritage Service has also used the GQA Scheme for classification. The coverage of the Northern Ireland monitoring system was extended considerably from just under 1,700 km of rivers surveyed in 1991 to over 4,300 km in 2003. However, in 1996 the Scottish Environment Protection Agency (SEPA) introduced a new classification scheme which involves an assessment of chemical, biological, nutrient and aesthetic measures of environmental quality. The change in classification means that the scope to look at trends in river quality over the 10 year period is limited. In 2000 Scotland introduced a new system for recording river and stream lengths called the Digitised Rivers Network (DRN). The classification scheme remains the same but the DRN includes rivers on islands and does not include thousands of minor, sometimes seasonally dry, and generally remote headwater tributaries that have never been monitored.

The Harmonised Monitoring Scheme (HMS) was established to provide an archive of water quality data for Great Britain. It is used to provide information for international obligations, including the long-term trends of some determinands and the estimation of river-borne input of selected determinands to the sea. The HMS commenced in 1974 and has been administrated and maintained by the Environment Agency since 1998. The sampling network includes 230 sites, which are mainly located at the tidal limits of major rivers or at the points of confluence of significant tributaries. Parameters measured include oxygen, biochemical oxygen demand (BOD), ammonia, nutrients, metals, and pesticides. The HMS sites are only a small fraction of the total number of monitoring sites in England and Wales. Ground water is also monitored in Northern Ireland.54 The schemes and resulting data are summarized on the Defra website.55 Details are given under the relevant sub-headings below.The 16 lake and 28 river sites contributing to the Environmental Change Network (ECN) (see sections 3.1.0 and 3.2.1) are monitored for a range of attributes, as are the 11 lakes and

51 http://www2.defra.gov.uk/db/rq/index.htm52 http://www.sepa.org.uk/data/classification/river_classification.htm53 http://www.ehsni.gov.uk/pubs/publications/Water_Report_Web.pdf54 http://www.ehsni.gov.uk/pubs/publications/Groundwater_Monitoring_StrategyA_CM.pdf55 http://www.defra.gov.uk/environment/statistics/inlwater/index.htm

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11 streams of the UK Acid Waters Monitoring Network (UKAWMN). See below for further details.

3.4.1 Chemistry and nutrientsSurface watersThree measures of chemical water quality are made in the GQA: biochemical oxygen demand (BOD), ammonia and dissolved oxygen. These are designed to detect the most common types of pollution. Samples are taken 12 times a year at intervals of 6 km. Data are used to classify water quality into one of six grades (A to F). Data are averaged over three years to give the required precision. Where there is a change in classification, a calculation is made to indicate the statistical confidence that the change is real.Two nutrients, nitrate and phosphate, are measured by the Environment Agency as part of the GQA. For phosphorus, total reactive phosphorus is measured using a flow-injection colorimetric method. The results are recorded as measurements of orthophosphate (as mg P/l). Nitrate is recorded as total oxidised nitrogen (mg NO3 /l).ECN river sites are sampled monthly, and lake sites quarterly, and a wide range of chemical analyses carried out, including pH, dissolved oxygen, biological oxygen demand, major nutrients and metals (see website56 for further details). In addition, running surface waters are sampled weekly, and lakes fortnightly, for major cations and anions, along with water flow. Ions measured include: sodium, potassium, calcium, magnesium, chloride, sulphate, ammonium, nitrate, phosphate, aluminium, iron, plus pH and organic carbon.Monthly samples are taken from streams and three-monthly samples from lakes contributing to the (UKAWMN) (see also sections 3.2.1 and 3.2.6). These are analysed for: pH and alkalinity, sulphate, nitrate, and chloride, labile aluminium calcium, magnesium, potassium, sodium, and dissolved organic carbon.Freshwater samples were analysed for pH, total alkalinity, conductivity and soluble reactive phosphorus, as part of the study of freshwater habitats in the Countryside Survey 2000.57

The Geochemical Baseline Survey of the Environment (G-BASE) will provide a one-off map of the chemical status of water samples, but is not a repeated survey (see section 3.3.2).

Ground waterA network of groundwater sites (i.e. aquifers) for England and Wales is in the process of being developed by the Environment Agency (EA) as part of its review of groundwater monitoring. Similar networks are being developed in Scotland and Northern Ireland. At present some information is available for England and Wales nitrates in 17 boreholes which are used for abstraction for public water supplies or other processes. This information, however, relates only to boreholes experiencing nitrate levels close to or above 50mg/l, this level corresponding to that set by the EC Drinking Water Directive for water put into the public supply. Because the selected sites are groundwater monitoring points experiencing elevated nitrate levels they are not representative of all aquifers, either in their immediate region or in England and Wales as a whole.

Northern Ireland has a Groundwater Monitoring Strategy. Between 1992 and 1994, a baseline study of groundwater quality was carried out at 351 sites in Northern Ireland by the British Geological Survey (BGS) on behalf of EHS. In 2000, EHS initiated regular monitoring of 78 sites, representing a subset of sites sampled in the original baseline survey. Sampling for basic chemistry (dissolved oxygen, pH, redox potential, major ion analysis and

56 http://www.ecn.ac.uk/aboutecn/measurements/coremeas/fwcvars.html57 http://www.cs2000.org.uk/Final_reports/M02_Freshwater_final_report.pdf

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nitrates) was carried out four times a year. Additional analysis for pesticides, hydrocarbons and metals was done once a year.

3.4.2 Silt loadSuspended solids are recorded weekly for running waters and fortnightly for standing waters at ECN sites.Sediment cores were taken from all lakes contributing to the UKAWMN network at the start of monitoring, to provide a historical record of pollutant contamination and lake acidity. Recently deposited sediment is collected annually. However, these samples are collected for analysis of acidity and pollutants rather than to measure sedimentation.

Suspended solids are among the parameters measured in the Northern Ireland’s River Monitoring scheme for rivers designated under the Freshwater Fish Directive. The Environment Agency does not appear to monitor sediment on a regular basis. Instead, they are modelled for the purposes of the Water Framework Directive Programme58

3.4.3 Pesticides and other pollutantsSurface watersPesticides and other pollutants are monitored by the Environment Agency. Little information is available on sampling procedures and numbers of samples vary between pesticides. Data summaries are available from the Defra website59. Records of pollution incidents are also maintained. These data are used to produce several indicators (Pesticide detection in fresh water, pesticide trends in fresh water, pesticides in ground water, pesticide incidents). SEPA monitors pollutants in Scotland, as part of the harmonized monitoring scheme (see section 3.4.0), and pollution incidents are also monitored in Northern Ireland.Ground waterInformation covering pesticides detected in groundwater in England and Wales has also been collated by the Environment Agency. Far fewer results are available for groundwater than for surface waters, and the available information does not cover every EA region in every year. Nearly 800 sites are monitored.

Table 13. Summary of key regular surveys of water quality (N/K = not known)Survey Sample

sizeFrequency Unit of

collectionSmallest spatial reporting unit

General Quality Assessment Scheme

c 8,000 monthly Sample Local authority

Harmonised Monitoring scheme

230 variable Sample Region

ECN: chemistry & nutrients

16 lakes every 3 months Sample Site28 rivers monthly

ECN: Silt 16 lakes every 2 weeks Sample Site28 rivers weekly

UKAWMN 11 lakes every 3 months Sample Site11 rivers monthly

Pesticide monitoring variable N/K Sample England & Wales

58 http://www.environment-agency.gov.uk/commondata/acrobat/r_sediment_s_v2_1007996.pdf59 http://www.defra.gov.uk/environment/statistics/inlwater/iwpesticide.htm

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3.5 AirPotential effects caused by GM crop cultivationThe main potential effect of GM crops on air quality is likely to be the production of pollen, which could potentially have impacts on human health.

Background informationGreenhouse gas emissions and ecological impacts of air pollution (acidity and nitrogen) are Government Sustainable Development Framework indicators. Ammonia and methane emissions are components of a Supporting Indicator. Defra has an Air Quality Strategy, which was recently reviewed.60 Agriculture is a relatively small contributor to air pollution compared to manufacturing industry, electricity generation, transport etc.

Data SourcesThere are many sources of data on air pollutants. However, many of these are concerned mainly with pollutants arising principally from non-agricultural sources. Because agriculture is a small contributor to air pollution, it seems most unlikely that GM crops would affect the levels of many air pollutants, so only the key schemes are summarised here and other schemes briefly mentioned. The exception is pollen and spores, to which agriculture is a major contributor, and the monitoring network for these is accordingly described in more detail.

3.5.1 Pollen, spores etc.PollenUK is the pollen and spore monitoring network of the United Kingdom. It has 33 sites covering the whole of the UK (see website for map61). Thirteen of the sites monitor all the main allergenic pollen types throughout the growing season. The other sites monitor grass pollen only and sample in the peak season, June and July. All of the sites use a standard sampling scheme based on Burkard volumetric seven day spore traps located on exposed roof tops. This enables the general ambient airflow to be monitored which contains a good mix of the local and further distant pollen sources gathered on the wind. The sites are run by various Institutions including Universities and Colleges, Hospital allergy clinics and Environmental Health Offices. The sites are co-ordinated by the National Pollen and Aerobiology Research Unit, which produces pollen forecasts daily. Monitoring is continuous during the season, but traps are emptied and grains counted every 24 hours.

3.5.2 Greenhouse gases and other pollutantsGreenhouse gases are the primary causes of climate change. They include Carbon dioxide (CO2), methane (CH4) and nitrous oxide (N2O). UK greenhouse gas emission estimates are updated annually as part of the National Atmospheric Emissions Inventory. Other pollutants include acidifying gases sulphur dioxide, nitrogen oxides, hydrogen chloride and hydrogen fluoride, airborne particulate matter, carbon monoxide, ground level ozone, volatile organic compounds, ammonia, heavy metals and persistent organic pollutants (POPs). Because monitoring schemes cover greenhouse gases and other pollutants, they are treated here together. There are basically two types of monitoring:

continuous automatic monitoring which gives instantaneous measurements of air pollution concentrations

monitoring using non-automatic equipment which provides concentration measurements over longer averaging periods, typically daily, weekly or monthly.

60 http://www.defra.gov.uk/environment/airquality/strategy/evaluation/report-index.htm61 http://www.pollenuk.co.uk/aero/pm/PM2.html

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Automatic monitoringDefra co-ordinates the funding of two automated monitoring networks on behalf of the Government and the devolved administrations: the Automatic Urban and Rural Network (AURN) and the Hydrocarbon Network. The number of sites in the AURN has increased from 74 at the end of 1996 to 120 by March 2004. Sulphur dioxide, nitrogen oxides, carbon monoxide, ozone and particulate matter are measured at a variety of urban locations, while rural sites monitor mainly ozone, but also Sulphur dioxide, nitrogen oxides and particulate matter in some cases. Further information and a map are provided ion the Defra website.62 The Hydrocarbon Network monitors 25 volatile organic compounds including benzene, 1,3-butadiene and ozone precursors at urban roadside, urban background and rural locations across the country. Data are available from the air Quality Archive.63

Non-automatic monitoring schemesMeasurements of daily SO2 and black smoke concentrations in urban areas are currently made through the UK Smoke and Sulphur Dioxide Network. Other networks in operation include the non-automatic Hydrocarbon Network (35 sites monitoring benzene at urban background and roadside locations), the Toxic Organic Micropollutants (TOMPS) Network, the Nitrogen Dioxide Diffusion Tube Network, the Lead, Multi-Element Network, the Acid Deposition Network and the Rural Sulphur Dioxide Network.

4. Regulatory drivers as sources of monitoring dataMany aspects of crop production are subject to regulatory control to ensure certain quality standards are maintained and for compliance with marketing regulations. These include, for example, controls over sources of seed and assurance of seed quality and purity. Any GM crops that are authorised for cultivation in the UK will be subject to the same regulatory requirements plus additional requirements under the GM legislation relating to traceability. Data are collected in relation to these for administrative and economic purposes, often by Defra. In many cases these data have been collected for conventional crops on an annual basis for many years. While these data might seem to have little relevance to monitoring for unintended or unanticipated effects they may, nevertheless, prove a useful resource and may provide good baseline data for comparison purpose. There may be issues of commercial confidentiality associated with accessing this type of data, however, as most are collected by Defra these may be surmountable.

These regulatory drivers have been divided into seed production and quality, GM crop cultivation (including seed spillage, coexistence; illegal cultivation, crop utilisation) and disposal of agricultural products. As they do not provide environmental monitoring data sets per se they are discussed separately in Annex 1 of the report.

Environmental monitoring data: summaryWe have undertaken a comprehensive review of monitoring programmes that are particularly relevant to the arable environment in 2005/06. Data types have been classified according to whether they relate to agronomic factors (e.g. patterns and scale of cultivation, agricultural management practices) or environmental factors; the latter may be monitoring parameters

62 http://www.defra.gov.uk/environment/statistics/airqual/aqmonitoring.htm63 http://www.airquality.co.uk/archive/index.php

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directly related to the agricultural environment (e.g. pests, diseases and weeds), or the wider receiving environment (e.g. terrestrial and aquatic biodiversity, soil, water, air). Of the large number of data sets identified, detailed review has only been undertaken for monitoring programmes that are carried out with some degree of regularity, or which are sufficiently large to contribute baseline data for comparison with future monitoring data. The characteristics of these data sets have been collated in a searchable meta-data database. We have also referred to the useful body of data collected by (or for) Defra to ensure regulatory compliance, for example with the strict requirements surrounding seed certification and marketing.

It is likely to be 2008 before GM crops might be candidates for cultivation in the UK. In the intervening period, environmental monitoring programmes may change and it will be important to keep an overview of developments in this area to ensure that effective post market monitoring of GM crops can be achieved. Of particular interest for its potential value to post market monitoring will be the Defra’s Strategy for Sustainable Farming and Food (SFFS), launched in 200264 in response to recent crises in British agriculture such as BSE and foot and mouth, and the realisation that food chain needed ‘to reconnect with its customers, the world economy, the countryside and the environment’. In the SFFS publication, Defra stated that, environmentally, while agriculture generates significant environmental benefits, it also has significant negative impacts. Damage includes the effects of emissions, water pollution and impacts on biodiversity”. One of the key principles of the SFFS is, therefore, to “respect and operate within the biological limits of natural resources (especially soil, water and biodiversity)”.

A supporting report, “Farming and Food’s Contribution to Sustainable Development: Economic and Statistical Analysis”65, contained proposals for evaluation and monitoring of the Strategy, including the use of performance indicators. A set of indicators is, therefore, currently being developed to enable the progress of the Strategy to be monitored. These will be divided into broad, high-level headline indicators each of which will be supported by a number of core indicators, which will add depth, breadth and detail to measuring change. Although not yet published, the indicators will be selected to reflect current situations and trends in key areas, and enable identification of unforeseen indirect impacts of implementing the Strategy. In accordance with the strategic outcomes of the Strategy, headline indicators are being developed to monitor the environmental costs of the food chain; these will include, for example, indicators of river water quality, greenhouse gas emissions, soil quality, conditions of important wildlife habitats and farmland birds. Defra is currently developing data sheets for each of the headline and core indicators which will include identification of data sources, frequency of updates, methods of collection and analysis and links to the relevant data source.

There are clear parallels with this activity and that undertaken in this report to explore what can be done in support of post market monitoring of GM crops. It is possible that many of the indicators identified to monitor progress of the SFFS could also be utilised for monitoring release of GM crops, but there may also be gaps. Defra has also funded the Agricultural Change and Environmental Observatory project to ‘monitor the potential impacts on the environment of changes in agriculture driven by CAP reform and other key drivers’. To optimise PMM activities, Defra ought also to consider the collective outputs of these activities

64 The Strategy for Sustainable Farming and Food. Facing the Future. Defra 2002. Product code PB 7751A. http://www.defra.gov.uk/farm/sustain/newstrategy/strategy.pdf

65 http://www.defra.gov.uk/farm/sustain/newstrategy/econ/contents.pdf

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and identify what information consent holders could access and utilise, and identify whether there are any gaps in monitoring for GM crops that should additionally be addressed.

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5. Analysis of Selected Environmental Monitoring Data Sets

IntroductionIn the event that marketing of a GM crop commences in the UK, the deliberate release consent holder will be required to identify monitoring networks and other bodies and enter into arrangements for gathering of appropriate environmental monitoring data to support their general surveillance plans. They must then critically analyse the findings and report their conclusions to the competent authority on an annual basis.

The review has identified an extensive body of data, covering a large range of topics. These data sets are not directly comparable among series. Meta-analysis, which is used to combine together various data sets from various sources but on the same variables, is therefore not appropriate for analysis of these datasets. Inevitably, the spatial and temporal scales at which data have been collected vary greatly between data sets. For instance, the temporal scale ranges from weekly measurements for the Rothamsted Insect Survey or Crop Monitor data sets, to yearly measurements for the June Census or IACS data sets, every nine years for the Environmental Change Network (coarse grain monitoring) and twenty years for the Environmental Change Network (soil monitoring). For each data set these scales are the absolute finest resolution at which any change might be detected.

The key to identifying and evaluating any changes in the receiving environment is to establish the baseline status of the receiving environment for the component being studied; ideally this should be established before the GMO has been placed on the market. To be able to identify trends (and therefore deviation from these) the data must be of good quality and in sufficient quantity to provide adequate statistical power for meaningful assessment. Ideally, data would be appropriately described by meta-data and be accessible in a format suitable for direct input to statistical software.

The extent to which changes may be detected and the power of detection of those changes is dependent on what the end-user defines as a ‘change’ and on the variability of these data. Identification of change does not necessarily indicate harm; change may be a beneficial natural process, but identification of change can indicate the need for further investigation of the causal effects. In connection with change, biologists and policy makers define what constitutes harm in the context of prevailing environmental legislation and current policy.

Conclusions have already been drawn at a general level without the use of statistics in terms of the scales of the measurements of each data set. Statistical analysis of the data can only be done if the possible variables of interest are clearly defined, these should be based on biological knowledge and policy objectives, although informed by statistical feasibility. Therefore, such an analysis should be aiming at addressing a series of questions such as “with data collected as they are, can we detect changes of X in variable Y”.

For example, if data were available regarding the total number of a given aphid species at a given time of year throughout the country, and spatial variability of those numbers was also known, it would be possible to derive an estimated number of sites needed to detect a given difference at a given power between two years. The power of detection of differences of counts may vary depending on whether the study is done at a national scale or for an

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individual region, where one might expect less variability. This emphasises the need for a clear and accurate definition of the variable of interest (here, the number of a given aphid species throughout the country or within a given region), and what defines a ‘change’ (in this case, how big a drop or increase in population number will be seen as an indicator of change).

MethodologySix of the monitoring programmes identified in the review of environmental monitoring data were selected for assessment of the extent to which they would enable identification of trends and, therefore, changes that may be associated with the cultivation of a GM crop. To interrogate these datasets, a simple question was addressed to each of them66, appropriate statistical methods were identified to test the data sets and analyses were run in GenStat. Detailed analyses are provided in Annex 2 of the report while summary findings are presented below.

Table 14. Questions devised to test environmental monitoring programmesQuestion Data source

What level of changes can be detected in populations of skylarks both at the national scale and at the regional scale in East Anglia?

Breeding Birds Survey (British Trust for Ornithology)

What change in the area of maize cultivated can be detected at the national scale, and regionally in the south west of England? June Survey (Defra)

Stellaria media (common chickweed) is a common weed on arable farmland across England and Wales, to what extent can we detect change in the prevalence of this weed in England and Wales?

Countryside Survey (Centre for Ecology and Hydrology)

What changes can be detected in the area of oilseed rape treated with metazachlor, nationally and in the south east of England?

Pesticide Usage Survey (Central Science Laboratory)

How accurately can we measure changes in the level of nitrate pollution entering the River Trent in Nottinghamshire over a specified period of time?

River Water Quality Survey (Environment Agency)

What level of change can we detect in the national population of the butterfly species Meadow Brown (Maniola jurtina)?

Butterfly Monitoring Scheme (Centre for Ecology and Hydrology)

1. Bird populations

Question: What level of changes can be detected in populations of skylarks both at the 1. Bird populationsQuestion: What level of changes can be detected in populations of skylarks both at the national (England) scale and at the regional scale in East Anglia?

Data source: British Trust for Ornithology (http://www.bto.org/).

66 Questions were agreed with the customer prior to analyses

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Ease of access to data: Provision of data was negotiated with Census Unit at BTO Headquarters, Thetford. An administrative fee was charged for provision of the data. The source of data must be acknowledged. Data can only be used once in connection with the specified use. BTO requested the opportunity to comment on analyses and results prior to submission to the customer in the final report.

Data format: Yearly counts for skylarks were obtained for 1,927 squares sampled throughout England from 1994 to 2004. The county in which each individual square is located was also provided, which enabled identification of squares in East Anglia (which was defined, throughout this analysis, as the five counties of Cambridgeshire, Essex, Norfolk, Northamptonshire and Suffolk - 308 squares in total). Not all squares were sampled in each year, which meant that just over a third of the data were missing for both England and East Anglia. In this analysis, data were only made available when squares had been surveyed in two or more years between 1994 and 2004.

Statistical approach: For both England as a whole and East Anglia, the data showed a high number of zero counts which made fitting a Poisson distribution inappropriate. Therefore, a generalised linear model with a negative binomial distribution was used in which all surveyed squares were given identical weights. Because of the very large variability in the data and the absence of evidence of any strong non-linear trend in time, only a linear trend in time was assessed. This enabled predictions to be made for populations in the years 2005 – 2010 for both England and East Anglia.

Summary findings: Analyses showed that the population of skylarks has been following a decreasing trend over the past ten years, both at the England level and the more restricted East Anglia level.

Limitations of data for PMM: The analyses show that, as a result of the very large variability in the number of skylarks observed between squares, the predictive power of any model derived from these data is going to be limited. Estimates of future values had large standard errors and confidence intervals and limited predictive power, however estimation of past observations were fairly accurate (shown by smaller standard errors) as a result of the large number of observations for this period (details in Annex 2).

2. Crop cultivation areasQuestion: What change in the area of maize cultivated can be detected at the national scale, and regionally in the south west of England?NOTE: although this is monitoring a direct effect, it is being used as an indicator; if significant increase is detected in the south west and this is found to be due to the cultivation of the GM maize, this could be an indicator that other environmental indicators that may be affected indirectly in this area (e.g. soil erosion leading to pollution of watercourses) should be monitored.

Data source: June Census data (Defra) at: http://www.defra.gov.uk/esg/work_htm/publications/cs/farmstats_web/datamap_links/search_menu.asp

Ease of access to data: Data were available and collected from the Defra website.

Data format: Yearly data were obtained for the total area grown with maize from 1987 until 2004. Data from individual County Parish Holding numbers (CPH) were obtained and the county and region of the farms were derived from those. From these, overall total farming area for the regions and counties was not available since the data (including total farming

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area) were only provided for farms where maize was grown. A second, more complete, set of data was available from Defra website but for a limited number of years (1990, 1995 and from 2000 to 2004). These were summary data per region and for the whole of England and contained both the total maize area and the total farming area. The missing years from 1987 were requested but were not provided in time for analysis.

Statistical approach: A logistic curve was fitted to the data and a linear regression was fitted to the restricted data from 1995 onwards for both England and south west England data to derive predictions and their confidence intervals for future years.

Summary findings: Over the full time period, the area grown with maize in England was found to follow a logistic growth as a function of time: first, the total area grown with maize was constant, followed by a rapid increase in the early 1990s, followed by a plateau since the mid to late-1990s. The plateau from the late 1990s was then analysed in detail with regard to the variability of the observed data since then. It was, therefore, assumed that the total area grown with maize was approximately constant from 1995 and predictions of areas of maize and confidence intervals for future years could be based on this. A similar approach was taken in analysis of data for the south west of England.

This analysis showed that, although a rapid increase in the area grown with maize was observed in the early 1990s, this stabilised to a plateau around 105,102 ha for England as a whole and 47,661 ha for the south west of England. Assuming that the assumption of recent stability is true, a mean estimate of the area grown with maize (with standard error and confidence interval) was obtained for both England and south west England data.

Limitations of data for PMM: No account has been taken of a possible change in the total farming area. It is therefore possible that observed changes in the area grown with maize are merely reflecting changes in the total farming area or do not show the full extent of the change in farmers’ preference for maize. However, because data on the proportion of the farming area grown with maize were not available on time, results in this analysis may underestimate slightly the extent of some of the changes observed.

3. Agricultural weed populationQuestion: Stellaria media (common chickweed) is a common weed on arable farmland across England and Wales, to what extent can we detect change in the prevalence of this weed in England and Wales?Data source: Countryside Survey at: (http://www.cs2000.org.uk/M01_tables/reports/CS_Mod1_veg_index.htm#Individualspecies)

Ease of access to data: Data could be downloaded directly from website link above; raw data was provided directly by the Centre for Ecology and Hydrology. Permission for use for this purpose was not required.

Data format: The data obtained for this analysis were extremely limited. For plots of type X (aerial features) in aggregate class 1 (crops/weed communities)67, numbers of plots with reports of Stellaria media were obtained together with the percentage coverage for those plots. The data had been collected twice, once in 1990 and once in 1998. In addition, plot identifiers were only available for plots where the weed was observed and, for those, only 28 (out of 153 and 130 in 1990 and 1998 respectively) were present in both years.

67 See “National-scale vegetation change across Britain; an analysis of sample-based surveillance data from the Countryside Surveys of 1990 and 1998”. Smart S.M. et al, Journal of Environmental Management (67) 2003 pp 239-254.

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Statistical approach: The statistical analysis showed that there was no significant difference (p=0.07) in prevalence of S. media (proportion of squares sampled where the weed was observed) between 1990 (32.7%) and 1998 (27.3%), given the number of squares sampled. The proportion of plots (amongst the plots where the weed was observed) where the coverage was of 1% (versus plots with over 1% coverage) was found to be significantly different between the two years where observations were made and conclusions about the chance of detecting “unexpected” changes in the proportion of plots with low coverage (1%) against plots with high coverage (> 1%) could not be drawn from this analysis.

Summary findings: Limited availability of data meant that no conclusion could be drawn about trends in Stellaria media populations.

Limitations of data for PMM: The limitation of the S. media data set was apparent because only two years of data were available and only at the national scale, therefore making it impossible to derive any reliable trend in time. Plant populations are identified as being key indicators of environmental change with respect to the possible cultivation of GM crops; the Countryside Survey has been identified as the most comprehensive national survey for plants. However, the available data are collected so infrequently that they do not support identification of trends in populations of this common farm weed. The Common Plants Survey initiated by Plantlife in 2000 may remedy this, but data is not yet available.

4. Herbicide usageQuestion: What changes can be detected in the area treated with metazachlor, nationally and in the south east of England?Note: although this is monitoring a direct effect, it is being used as an indicator. If significant change in the range of herbicides used or an increase in levels of herbicide/s being applied is identified and this is found to be due to cultivation of e.g. GM sugar beet, this will indicate that we should also look at other environmental indicators that may be affected indirectly. This could also be linked with June Census data to see if regional changes correspond with changes in where the crop is being grown.

Note: Before doing any analysis it was established that any trend in increased use of metazachlor would not be simply due to an increase in the number of times fields were treated rather than an increase in area treated; data from the PUS website showed that the vast majority of fields only received one application.

Data source: Pesticide Usage Survey statistics (http://pusstats.csl.gov.uk/)

Ease of access to data: Downloaded from website. No prior permission for use was required.

Data format: Data were available from the Pesticide Usage Survey every two years starting in 1990 and up to 2004. Data were collected at the national level and for the south east of England.

Statistical approach: A linear regression was fitted between the total area treated with metazachlor and time; this showed that there was a clear increase with time in the total area treated throughout Great Britain. The model was used to predict areas treated with metazachlor in Great Britain together with 95% confidence intervals (CI) for 2006, 2008 and 2010.

Looking at data from earlier years, although the number of years that would have been used to derive the model would have been unsatisfactory, a similar linear regression approach would have led to a predicted value for 1998 of 148,287 hectares treated with metazachlor with a 95% confidence interval of which suggests that 1998 deviated from the

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previously derived trend in total area treated. However, the same model would have predicted a value of 165,881 ha for 2000, with a 95% confidence interval of , which would have then included the observed value of 157,130 ha for that year, this would have led to 1998 being considered as an outlier rather than a change from the linear trend derived.

The overall picture for south east England data was very similar to that described for Great Britain. Although still satisfactory, the fit of a linear model to the south east was not as good as the data for Great Britain as a whole, the slightly increased variability of the data was apparent in the increased standard error of the predicted value (19% of the mean for data from the south east versus 16% for data from overall Great Britain). However, similar conclusions could be drawn with regard to the goodness of fit of the model. As with the Great Britain data, 1998 can also be considered as an outlier when looking at use of metazachlor in the south east, again this would have appeared in the analysis had a linear model been derived from early years (but note, the lack of data points to derive the prediction in 1998 would have been unsatisfactory). The predicted area treated in the south east would have been (from data prior to 1998) 29,786 with a 95% confidence interval of , therefore showing 1998, with an observed value of 52,310, to depart from the linear trend. As with the national trend, the prediction for 2000 (from data prior to 1998) would have been 32,423 with a 95% confidence interval of , in which the observed area for 2000 would have fallen.

Summary findings: The analysis outlines a general (significant increasing) trend in the total area treated with metazachlor as a function of time and therefore allows for predictions to be made for future years, together with associated confidence intervals. However, it must be noted that although this approach allows identification of changes in trends, it relies on the assumption that the hypothesized initial trend is correct. Although no evidence of deviation from the linear trend was detected in the above data, a large part of the variability of those data remained unexplained by the model used.

Limitations of data for PMM: Although raw data on area treated with metazachlor are available, they were not made available at the time the analysis was done and data on total areas treated were used. However, summary data were available both at the national scale and local scale (south east of England). Despite the absence of raw data, an increasing trend was detected and the uncertainty associated with predictions was a result of the inherent variability of those data.

5. River water qualityQuestion: How accurately can we measure changes in the level of nitrate pollution entering the River Trent in Nottinghamshire over a specified period of time?

Source of data: Environment Agency at http://www.environment-agency.gov.uk/yourenv/eff/1190084/water/213902/river_qual/?version=1&lang=_e

Ease of access to data: Raw data provided on request by the Environment Agency. No cost to CSL was involved in obtaining this data.

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Data format: Data were obtained for both the lower and upper river Trent in Nottinghamshire on a yearly basis. In total there were 16 sites measured over eight years (from 1998 to 2005 inclusive) on the upper river and nine sites over 17 years (in 1976 and between 1990 and 2005 inclusive) on the lower river. Not all sites were measured every year. In both cases measurements were made throughout the year and, when present, the number of measurements per site per year varied from 1 to 14 for the upper river and from 1 to 77 for the lower river. In the case of the lower river, 1976 had much higher numbers of measurements overall. As a result, this set of data was highly unbalanced. In both the lower and upper river, two factors were present and analysed: the site of the observation and the year.

Statistical approach: Because not enough observations were available for all months within a year, only the overall variability between years (rather than between months and years) was analysed. Further, because there was much more variability between sites for the upper river than for the lower river, it was decided to run the analysis for each of the two sets of data separately. In this work, the site variability was considered as noise (i.e. not a factor of interest) and therefore a REML (residual (or restricted) maximum likelihood) approach was used, using site as a random effect.

Analysis of data for the upper riverUsing this approach, a significant decreasing trend in the nitrate levels in the upper river was found and predictions were made for future years with 95% confidence intervals. The residuals plots showed that the assumption of normality of the residuals in the model was acceptable.

Analysis of data for the lower riverThe same approach was taken for the lower river and enabled similar conclusions to be drawn, with a significant decrease in the levels of nitrate with time. The results showed that, unlike the upper river, because of the smaller variability observed between sites, standard errors and confidence intervals for predicted nitrate levels for future years were much smaller than for the upper river. Finally, and similarly to the upper river analysis, the residuals plots showed that the assumption of normality of the residuals in the model was acceptable.

Summary findings: These data demonstrate good potential for detecting changes in nitrate levels in river water. Data sets for the upper and lower river Trent both showed a similar trend of a significant decrease of nitrate level with time. However, it was also apparent (and not unexpected) that the spatial variability of nitrate levels was much larger in the upper river than in the lower river, hence making the lower river more appropriate for robust predictions. The analysis also showed that nitrate levels are higher lower down in the river.

Limitations of data for PMM: The data were analysed in two parts (lower and upper river) separately. Although levels of nitrate were found to be higher in the lower river, the variability between observation sites in this part of the river was much lower than in the other part, therefore making it more useful for detecting changes.

6. Butterfly populationsQuestion: What level of change can we detect in the national population of the butterfly species Meadow Brown (Maniola jurtina)?

Data source: Butterfly Monitoring Scheme (http://www.bms.ceh.ac.uk/default.htm).

Ease of access to data: Downloaded from the Butterfly Monitoring Scheme (BMS) website. No prior permission was required.

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Data format: Although weekly counts were available for all sites, the data used in this analysis are overall indices calculated on each site. These are derived from log-linear Poisson regressions (full detail available on the Internet). Indices were collected for all sites every year (between 1976 and 2004) across sites and those means were used to fit a linear regression and obtain predictions of indices for future years

Statistical approach: Indices were collected for all sites every year (between 1976 and 2004) across sites and those means were used to fit a linear regression and obtain predictions of indices for future years. A straightforward linear regression was fitted to log-transformed indices. The indices were re-scaled to be consistent with the work done for the BMS so that they average to two over the whole period (this does not affect any of the output and results), this is defined as the log collated index (LCI). It is thought that the BMS took this approach to detect a general (linear) trend – by testing the slope of the fitted line against zero – ignoring seasonality and assuming normally distributed residuals.

The variability explained by the model was very low and led to extremely large uncertainty in predicted values. This model may be suitable to detect a general underlying trend in Meadow Brown population over the past 29 years, but it is not suitable for predictive purposes as a result of the very poor fit.

A time series approach was then fitted to the log-transformed data over the 29 years available. In order to stay as close as possible to the first analysis, the model used here was a linear trend and the residuals were specified as an autoregressive model which takes into consideration the relation between two and up to three points in time respectively. Similarly to what was observed when using the linear regression approach, the standard errors around the predicted values from the autoregressive model were also fairly large. This can be explained by the fairly low number of cycles around 2000 (three, although there seems to be some deviation from the approximately ten year cycle originally observed).

Summary findings: Although a significant increasing trend in the log collated index for Meadow Brown butterflies could be detected both when using a simple linear regression or incorporating autocorrelation in the model, the high variability and cycle observed between years limit the extent to which changes in trend may be identified in the future.

Limitations of data for PMM: this study was only done at the national scale since data on the spatial location of the observing sites were not readily available. Therefore, data for all sites were pooled together and analysed as a whole. A model was fitted and an increasing linear trend was detected. However, it also appeared that the variability in the population level from year to year –although following a cyclical trend– was quite large, hence making prediction fairly uncertain.

Summary of statistical analysisThis statistical review has examined the ability of a small subset of the monitoring programmes identified to estimate trends and the forming of predictions in parameters of interest. Where this is possible, predictions can be made for future observed values of the parameter in a certain situation (e.g. within a particular region) with appropriate confidence limits, assuming no substantial changes to the method of monitoring and reporting. The ability to predict, with statistical confidence, observed values of a parameter of interest enables identification of deviations from these predicted values and, where this is observed, a causal link can be investigated.

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The relative importance and extent of any detectable change, and therefore the usefulness of any data set in detecting such changes, can only be assessed against what is biologically meaningful. In advance of devising a monitoring programme for general surveillance purposes, it will therefore be necessary to establish what parameters are to be measured, and for each to determine the level of change that would be considered sufficiently significant to justify further investigation. It would then be necessary to identify the appropriate monitoring programme and establish if it would be capable of identifying change at that level.

Of the analyses undertaken here, trends could be identified with a high level of confidence for one of the six datasets (river water quality). Herbicide usage and maize cultivation data also supported identification of trends and predictions, the latter would be more powerful if linked with the total farming area. The skylark data identified a trend, but power is limited by the large spatial variability observed throughout England, and the non-continuous sampling of squares from year to year; analysis at a more local level (e.g. county) may reduce the spatial variability and therefore lead to more accurate predictions. Long-term changes in Meadow Brown butterfly populations could be identified but the cyclical nature of the population means that a relatively long time is needed to do so. The data for the agricultural weed would not support identification of population change due to the inadequacy of the data collection characteristics for this purpose.

If this review is a reasonable representation of the range of analyses that would be supported by other datasets, this illustrates that it may not be possible to identify trends for a number of the parameters of interest.

Farmer questionnaires

Farmer questionnaires are often proposed as key elements of companies’ post market monitoring (PMM) programmes. These will provide useful feedback to the consent holder for commercial and development purposes and will provide a snapshot of the growing crop for the year of cultivation, readily identifying any immediate on-farm effects. However, unless a farmer completes these for a number of consecutive years and/or cultivates a GM crop for a number of consecutive years, these questionnaires are unlikely to provide much data on longer term unanticipated or cumulative effects of growing a GM crop. Nevertheless, assuming the extent of cultivation of the GM crop increases, they can potentially provide a useful body of data for analysis.

Data gathered at the farm level will be more sensitive to impacts than data collected at the regional or national level. Farmers have detailed knowledge of their land including its biodiversity and any species of special interest or value that occur. They also keep a close watch on the use of expensive pesticides and will quickly notice any changes. It would, therefore, seem sensible to maximise on the value of these questionnaires. A database has been designed to hold PMM data and, if data is collected in an appropriate format, this information management tool could also be used to support meta-analysis of data gathered via farmer questionnaires.

To date we have seen one example of a farmer questionnaire, relating to maize modified for resistance to corn borer (Ostrinia nubilalis) 68. This document poses a comprehensive range of questions in a number of areas:

68 Syngenta Seeds SAS notification C/F/96/05.10 concerning Bt11 maize. Annex I: farmer questionnaire document.

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the farm – personal details, type of farm/holding agricultural practices - soil type and quality, rainfall, crop rotation (4 years), use of

pesticides, herbicides and fertiliser, irrigation, cultivation and management methods general observations - crop development, weed presence, volunteer control, pests and

diseases, occurrence of beneficial organism and other wild animals Corn borer infestation – corn borer infestation in the region of cultivation and yield loss

in grain maize and silage maize, pest control measures used.

Much of this data is already being collected for other surveys. Data is requested for the modified variety and the comparable conventional variety. Note though, the farmer may chose only to grow the modified variety and will therefore only have data from previous years to rely on, hence direct comparison will not always be possible. Additionally, for this example, if corn borer has been a problem in the area, maize may not have been cultivated for a few years.

Improving the value of farmer questionnaires for the competent authority:Defra would derive considerable benefits from designing a pro-forma questionnaire for use by consent holders for on-farm surveys. The pro-forma would gather similar basic information to the farmer questionnaire but, where data is already being gathered, would ensure that the format is compatible with existing data. This would ensure that all data is collected in a consistent and comparable format and would introduce the possibility of doing meta-analysis for similar crops and/or traits between companies. For example, it would make good sense to collect data on farm holdings in a format consistent with Defra’s ‘Agricultural and Farm Classification in the United Kingdom’69. This would enable meta-analyses and comparison with existing Defra data sets (the June Agricultural and Horticultural Census, the Farm Business Survey and the Pesticide Usage Survey use this classification). Additionally, where possible, questions should be phrased to elicit a quantitative answer or at least an ordered score e.g. 1 to 5.

It would not be the intention to make the questionnaire more complex or lengthy. The pro-forma could be made available on the PMM database and companies would be encouraged, but not compelled, to use it. Companies could collate the data themselves and submit to Defra via the PMM database or enter all data directly, or farmers could enter the data through the Whole Farm Appraisal http://www.defra.gov.uk/farm/wholefarm/default.htm – the latter two options would provide Defra with greater opportunities for analysis. The database could be modified to accommodate this functionality or questionnaires devised for the WFA.

The approach suggested here would be a positive step towards establishing good practice in on-farm post market monitoring and would be building on and maximising the use of, the farmer questionnaire approach that many companies have already proposed.

69 http://statistics.defra.gov.uk/esg/pdf/farmclass.pdf.

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6. Gap Analysis and Recommendations for a General Surveillance Monitoring Programme

General surveillance is designed to detect unanticipated effects of growing GM crops that would not be detected by case-specific monitoring. More specifically, general surveillance plans “should seek to identify and record any indirect, delayed and/or cumulative adverse effects that have not been anticipated in the GM crop risk assessment”. As the effects are unanticipated, it appears difficult to prioritise the types of data that may be required. However, further consideration of the monitoring guidelines, provides some pointers to assist in the construction of a monitoring framework. Taking these into account, monitoring programmes contributing to such a framework should have the following characteristics:

They should provide a pre-release record of the baseline status of the environmental parameter being monitored. Ideally, it should be possible to establish a trend pre-release, so that any change in this trend can be detected post-release. This requires a minimum of five, and preferably ten, years (or record points if not annual) prior to release.

They should be constructed using scientifically and statistically sound sampling methodologies. They should be carried out over a sufficient period of time. As release consents are for ten-years, it is reasonable to assume that monitoring schemes should provide data over at least this time period. Unfortunately, funding for monitoring schemes is often linked to a specific policy driver, and those who make funding decisions frequently fail to consider the wider implications of reducing or ceasing to fund a monitoring programme. It is therefore difficult to predict the future of most monitoring schemes, and unwise to assume that even long-established schemes will continue indefinitely. However, users of data from long-term monitoring schemes can help to safeguard their future by making funding bodies and policy decision makers aware of the wider value of the data concerned.

They should cover a sufficiently wide area, extending beyond cultivated land, though it seems reasonable to assume that effects will be greatest within cropped fields and decline with distance from them, and the importance of monitoring datasets can be considered in relation to their relevance to arable agriculture.

Other factors to be taken into consideration are:

Indicators: It is not possible or desirable to measure everything, therefore indicators should be chosen to represent the key drivers and environmental variables likely to be affected. In chapter 2, reference is made to the use of indicator species that are prevalent in the crop ecosystem. For biodiversity, these should ideally include key functional groups (primary producers, herbivores, detritivores & saprophytes, pollinators, parasites, predators etc.). In practice, data are only available on a subset of these, but it is often assumed (though rarely tested) that selecting indicator species near the top of the food chain provides effective monitoring of the whole ecosystem.

Data type: chapter 2 also refers to fitness variables such as numbers, growth rate, biomass, reproductive effort, reproductive success, rate of population increase/decrease, and genetic diversity. In practice, most monitoring schemes only provide information on numbers and population changes. For birds, information is also available on reproductive effort and reproductive success for a range of species.

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Frequency: Effects which occur rapidly (e.g. changes in insect populations or disease pressure) require frequent monitoring, while impacts which occur over a longer period of time (e.g. soil attributes) may be adequately monitored by less frequent schemes.

The available datasets have been assessed according to these criteria. Each heading identified in the review of datasets, has been assigned a level of importance (high, medium, low) for GM crop monitoring, on the basis of its relevance to crop production and the likely environmental impacts of crop production practices. This has been used to judge the significance of data gaps, where they occur. For each of the categories assigned a high level of importance, data availability is assessed as good, moderate or poor, and key datasets are identified. A summary is then presented of the availability and characteristics of datasets for attributes in the ‘high’ category.

Analysis of data availability and identification of gapsKey datasets for categories of high importance in the following analysis are identified in bold italics. Additional datasets with potential to provide useful information are also noted.

1. Agronomic drivers

1.1 Scale and pattern of cultivation

1.1.1 Land use Importance: highAgricultural land use is considered to be of high importance because it provides a measure of amounts of different types of crops grown and changes in crop area. Data availability: goodKey datasets:The June Survey (Census): provides information at farm level (though availability at this level is controlled by confidentiality restrictions). Formerly a census, this is now a sample survey, so data for some farms are not current. In future, the Rural Land Registry will provide information at a parcel level. The digitised maps are linked to data from single Farm Payment database. At present, many individual crops are not distinguished, but this may change in future.The HGCA Planting Survey is based on a much smaller sample but provides early warning of substantial changes in crop areas.

1.1.2 Land coverImportance: mediumLand cover monitoring is concerned with all habitats. It provides information on changes in both agricultural and non-agricultural land, with respect to vegetation and features. However, cropping information is provided by the June Survey, and changes in the area of other habitats and features are potentially of lower importance in the context of GM surveillance.

1.2 Crop production

1.2.1 VarietiesImportance: highIf consents for releases are given, it will be important to monitor the extent of cultivation of GM varieties.

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Data availability: moderateKey datasets: NIAB Seed Statistics provide seed production data for different varieties. Crop Monitor provides information on amounts of varieties grown for winter wheat, barley and oilseed rape.

1.2.2 Cultivation, drilling and harvest datesImportance: mediumAlthough changes in the timing of field operations resulting from the growing of GM crops could have environmental impacts, these are likely to be less significant than changes in crop types grown, hence they are considered to be of medium importance.

1.2.3 Pesticides: usageImportance: highGM crops likely to be released in the foreseeable future have traits which are highly likely to influence the types and amounts of pesticides used, and such changes could have significant environmental impacts.Data availability: moderateKey datasets:The Pesticides Usage Survey provides statistically robust estimates for all types of pesticide usage on all major crops at a regional level. Unfortunately, surveys are not carried out every year. For arable crops, surveys are conducted every two years. Statistical analysis undertaken in this project indicated that these data sets will be useful in identifying trends in the changing use of pesticides on the farm.Crop Monitor records pesticide use on survey farms, and is an annual survey, but only wheat, barley and oilseed rape are covered.

1.2.4 Pesticides: applicationImportance: lowIt is unlikely that GM crops will have a major impact on pesticide application practice.

1.2.5 Fertiliser: usageImportance: highFertiliser usage has major environmental impacts. It increases the fertility of terrestrial habitats, with resulting detrimental impacts on plant communities and diversity in semi-natural habitats. Perhaps more importantly, nutrients reaching surface and ground waters reduce water quality and affect biodiversity, including fish stocks. Any effects of GM crops on fertiliser usage (e.g. by stimulating greater cultivation of nutrient-demanding crop types) are therefore likely to be important.Data availability: moderateKey datasets:The British Survey of Fertiliser Practice provides annual, statistically robust, estimates of fertiliser use at a national scale. Unfortunately, data at a lower spatial scale are not readily available.Fertiliser usage is also recorded for wheat, barley and oilseed rape crops contributing to the crop monitor survey.

1.2.6 Fertiliser: storage and applicationImportance: lowGM crops are unlikely to have major impacts on fertiliser application practice.

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1.2.7 YieldsImportance: lowAlthough it is quite probable that GM crops will affect crop yields, the environmental impact is likely to be small compared to cropping practices such as pesticide use.

2. Environmental impacts (agricultural)

2.1 Pests, diseases and weeds

2.1.1 PestsImportance: highPests may be influenced directly through pest resistance traits of GM crops, or indirectly through other mechanisms (see section 3.1.5 below).Data availability: moderateKey datasets:Surveys of pests in wheat and oilseed rape form part of the Crop Monitor programme. Although carried out in a statistically robust manner, the number of crops assessed is relatively small, so that and only these two crops are included.The Rothamsted Insect Survey is a long-term dataset which provides weekly data on aphid numbers in traps located throughout the UK. The traps are located where there are facilities to operate them rather than through a statistically determined procedure. Although not ideal, the high and frequent labour requirement of surveys such as this means that situating sample sites in locations requiring significant travel would almost certainly render them unviable.

2.1.2 DiseasesImportance: highThe introduction of new varieties may well affect disease levels, either through GM traits or other characteristics of the GM varieties, or stimulated by changes in the amount of a crop type grown. Data availability: moderate-goodKey datasets:Crop Monitor surveys provide good, statistically robust national data on disease prevalence, but only for a limited range of crops (winter wheat, winter barley and oilseed rape).

2.1.3 WeedsImportance: highGM crops are very likely to impact on weed populations, either through herbicide tolerant traits or other traits of the GM variety.Data availability: poorKey datasets:There are no regular national surveys of weed populations. This is a major gap in data availability.The best data available national data come from the Countryside Survey, but as this is only carried out every 6-8 years, it is not suitable for detecting rapid changes. Also, the recording methods are not particularly well suited to monitoring weed populations. The Game Conservancy Sussex Study provides a long term annually surveyed dataset from commercial arable farms, but covers a limited area and weed data are only semi-quantitative. It is however, the best annual data available. The Environmental Change Network records weeds, but these are in continuous cereal crops which are not managed commercially.

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3. Environmental Impacts (Environment)

3.1 Biodiversity (terrestrial)

3.1.1 PlantsImportance: highGM crops could affect vegetation in a number of ways, e.g. GM tolerant crops could invade semi-natural plant communities; GM traits could transfer to wild relatives through introgression; changing agricultural practices (e.g. widespread use of non-selective herbicides) could affect the natural flora.Data availability: poorKey datasets:The Countryside Survey is the most comprehensive national survey, but is too infrequent. Plantlife began the Common Plants Survey (covering 65 species) in 2000; this is an annual survey which may prove valuable in future, but no detailed reports have yet been produced so its value is difficult to assess at the time of writing. Cereal plots in the Environmental Change Network are monitored annually, but from only a limited number of sites and they are not commercially managed. Other plots are monitored every three or nine years. Statistical analysis undertaken in this project indicted that data available from the Countryside Survey would not be adequate to identify trends in populations of a common weed.

3.1.2 MammalsImportance: highAlthough there is little direct evidence of arable cropping practices having significant impacts on mammal populations, this may be partly because until recently there was little regular structured mammal monitoring at a national scale. Any such impacts resulting from the cultivation of GM crops would be likely to have a high profile due to public interest in mammalian species, so it would be important to ensure that adequate data were available to detect changes. Data availability: moderateKey datasets:Unlike most other groups, there is a number of mammal surveys each of which contributes to the overall picture, and co-ordinated by the recently formed Tracking Mammals Partnership. Selecting key datasets is therefore less easy for this group. However, the National Bat Monitoring Programme and the Breeding Bird Survey currently provide the best data at a national scale. Other useful programmes are the National Gamebag Census, the Great British Deer Survey, and the Environmental Change Network.

3.1.3 BirdsImportance: highMany species of farmland birds have declined, due to lack of food availability. GM crops are likely to affect food resources, as demonstrated by the Farm Scale Evaluations. Birds are high profile and reversing the farmland bird decline is part of the Government’s Public Service Agreement.Data availability: goodKey datasets:Birds have by far the best monitoring network of any wildlife taxon, with thousands of volunteers as well as professionals contributing to a wide range of surveys. For the purposes of GM surveillance, the key programmes are the Breeding Birds Survey, the Nest Record Scheme, and Constant Effort sites. These plus the Waterways Breeding Bird Survey all

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contribute to the Integrated Population Monitoring Programme, which provides annual reports of numbers, breeding performance and survival rates. Birds are the only group for which good data on breeding performance are available.

3.1.4 Reptiles and amphibiansImportance: mediumSome reptiles and amphibians are widely distributed on farmland, and could be affected by releases of GM crops. Little is known at present about the influences of farming practices on this group, and the only regular monitoring is ECN recording of frog spawning. Whilst reptiles and amphibians are not as high profile as mammals and birds, the lack of monitoring of this group does represent a significant gap in wildlife recording. However, the Herpetological Conservation Trust has plans for a National Amphibian and Reptile Recording Scheme, with national monitoring possibly starting in 200770

3.1.5 InvertebratesImportance: highThere is a wide diversity of invertebrates inhabiting crop fields. Although some are pests, others provide ecological services such as pollination or predation of pests. They are also key components of the food chain. They are highly likely to be affected by GM crop releases, either directly as a result of insect resistance traits, or indirectly, as demonstrated by the Farm Scale Evaluations. Data availability: moderateAlthough high quality datasets are available, these only cover a few taxa, and coverage of the range of functional groups is limited and inadequate. Key datasets:In addition to the aphid monitoring network (section 2.1.1), the Rothamsted Insect Survey has a network of moth traps. The same caveats apply with regard to location as for the aphid traps, nevertheless this network of over 80 sites, monitored daily, provides a level of information unrivalled for any other group.The Butterfly Monitoring Scheme provides good national data on butterfly populations, though like the Rothamsted Insect Survey, sites are not selected randomly. This means that the surveys cannot be used to estimate populations as they are not representative of the country as a whole, but temporal trends are still likely to be indicative of national changes, especially as the Butterfly Monitoring scheme now has a larger number of farmland transects than previously. Statistical analysis undertaken in this project indicated that this dataset would provide sufficient data to detect trends in populations at the national scale. Data are available for regional scale analysis but were not readily available.The GCT Sussex study, while limited geographically, provides the only long-term monitoring data for a wide range of invertebrates sampled directly from crops.The ECN records a range of groups on its 11 terrestrial sites, but as these are not particularly representative of commercially cropped environments, the data are considered to be of lower value for the present purpose than the surveys described above.

3.1.6 Soil organismsImportance: highData availability: poorApart from monitoring of tipulid larvae in the ECN, and sampling of soil invertebrates in Countryside Survey 2000, there appears to be no regular monitoring of soil fauna. These are important in maintaining soil fertility, and this therefore constitutes a significant data gap.70 http://www.herpconstrust.org.uk/

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Key datasets:No key datasets have been identified for this group.

3.2 Biodiversity: aquatic

3.2.1 PlantsImportance: mediumAlthough aquatic plants may be affected by nutrient, pesticide or sediment pollution of waterways arising from changes in cropping practices, such pollution is more effectively monitored through invertebrate communities and analysis of water chemistry. Aquatic flora has not therefore been identified as a monitoring priority for GM crop surveillance.

3.2.2 MammalsImportance: lowAlthough it is possible that aquatic mammals could be affected by changes arising from the cultivation of GM crops, such changes would probably be detected more rapidly and effectively through monitoring of other groups, e.g. terrestrial species occurring in cropped environments, which would probably be more exposed to whatever impacts might occur, and aquatic invertebrates, whose sensitivity to water quality and use as an indicator is well established.

3.2.3 BirdsImportance: mediumFor most aquatic birds, the same comments apply as for mammals. However, swans and several species of goose may graze crops, and so potentially stand at greater risk of exposure to e.g. toxins in GM crops.

3.2.4 FishImportance: highFish are an important resource as well as being an important part of our national biodiversity. Fishing is one of the most popular leisure pursuits, and fish populations also provide an important indicator of the health of UK waterways.Data availability: goodKey datasets:The National Fisheries Monitoring Programme is the main source of information on inland fish populations. Whilst it is geographically comprehensive and covers a large number of sites, some smaller streams are not covered, so it is possible that some pollution arising from farms might go undetected. The current programme only started to produce comprehensive data in 2002, so the time series is not yet long enough to detect trends.

3.2.5 AmphibiansImportance: lowThese may be affected in their aquatic phase, as eggs or tadpoles, or in their adult, terrestrial phase (see section 3.1.4). Although any effects on amphibians would be important in conservation terms, as far as the aquatic phases are concerned, other monitoring schemes are more effective for detecting effects on water quality.

3.2.6 InvertebratesImportance: high

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The communities of invertebrates found in fresh water are very responsive to changes in water quality. The characteristics of these communities in relation tot the prevailing conditions are well understood, and they are widely used as indicators of the quality of both still and running freshwater. Invertebrates are also key components of aquatic food chains.Data availability: goodKey datasets:The Environment Agency’s General Quality Assessment, and its equivalents in the devolved administrations, provide the major source of information on aquatic invertebrates. Annual monitoring only commenced in 2002, but earlier data exist allowing the establishment of trends. The Environmental Change Network and UK Acid Waters Monitoring Network also collect records annually, but are less relevant in a wider countryside context.

3.2.7 Micro-organismsImportance: mediumAlthough micro-organisms are important constituents of aquatic food chains, the availability of alternative methods of monitoring water quality means that monitoring of this group is not considered a top priority.

3.3 Soil

3.3.1 Soil depth and structureImportance: lowSoil depth could be affected by erosion, and structure is affected by traffic, cultivation techniques and soil condition during cultivations. Changes in choice of crops could affect these factors, and a GM trait that increased profitability could bring about such changes, but the likelihood of significant impacts is low and so these aspects are not considered a priority.

3.3.2 Soil chemistry and organic matterImportance: highSoil fertility is vital to the continued ability to produce crops from the land. The mechanisms by which GM crops might affect soil chemistry and organic matter are not obvious, but could be mediated through impacts on soil ecology (see chapter 4, section 3.3) or changes in cropping patterns. In view of the importance of this factor it is felt that it should form part of a monitoring programme. Data availability: poorKey datasets:The only regular monitoring of agricultural soils at present is the Representative Soil Sampling Scheme (RSSS). Whilst this provides a valuable time series, the range of measurements is limited. National Soil Inventory (NSI) data are available from 1983 and 1995, but it is not known whether or when repeat sampling will take place, and they have to be purchased at considerable cost compared to most other national monitoring datasets, which are either free of charge or available at a modest cost to cover processing time. ECN sites are sampled every 5 years for some parameters and 20 years for others, but the number is limited and they do not represent the generality of agricultural soils.A recent review (Archer et al., 2003) made recommendations for extending and improving the RSSS, and integrating it with the NSI. Defra is currently reviewing its soil strategy and developing indicators of soil quality71, so the situation may change in the near future.

71 http://www.defra.gov.uk/environment/land/soil/research/indicators/index.htm

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3.3.3 Erosion ratesImportance: highSoil erosion is important because it reduces soil fertility and pollutes watercourses. Changes in cropping due to the adoption of GM varieties (e.g. an increase in maize cultivation) could increase soil erosion.Data availability: poorKey datasets:There is no direct regular monitoring of soil erosion at a national scale. The Farm Practices Survey asked questions about soil erosion in 2001 and 2005, but this only provides indirect evidence and does not constitute a time series.

3.4 Water

3.4.1 Chemistry and nutrientsImportance: highWater quality is important because it is extracted for drinking water, and it provides the habitat for fish and other aquatic organisms. Agriculture can be a major polluter of water if appropriate safeguards are not in place and good practice is not followed.Data availability: goodKey datasets:The General Quality Assessment and its equivalents in Scotland and Northern Ireland are key sources of data on chemical quality and nutrient status of surface waters. Other sources of data are the ECN and the UKAWMN. Groundwater only seems to be regularly monitored in Northern Ireland. Statistical analysis undertaken in this project indicated that this monitoring programme provides useful datasets with which to identify trends, and therefore changes, in nitrate levels of UK river water.

3.4.2 Silt loadImportance: highSediment is an important pollutant of watercourses. It prevents successful spawning of salmonids and lowers the quality of the habitat for a range of species.Data availability: poorKey datasets: Sediment is recorded at ECN sites and in Northern Ireland’s river Monitoring Scheme. However, neither of these is likely to detect any changes caused by the uptake of GM crops.

3.4.3 Pesticides and other pollutantsImportance: highPesticide pollution can have serious consequences for the aquatic fauna and flora. It is also one of the most likely factors to be influenced by the cultivation of GM crops.Data availability: good?Key datasets: Pesticides and other pollutants are monitored by the Environment Agency in England and Wales, and also by equivalents in Scotland and Northern Ireland. However, little information on sampling regimes is available.

3.5 Air

3.5.1 Pollen, spores etc.Importance: high

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Pollen is an important allergen; it is the cause of hay fever and can stimulate asthma. Chemicals present in GM pollen could exacerbate health effects.Data availability: moderateKey datasets: PollenUK is the key dataset, based on 33 sites across the UK. Sites are located where facilities are available to maintain the labour-intensive daily sampling regime. Although not statistically ideal, the programmes would doubtless be unviable if site locations were chosen at random (cf. Rothamsted Insect Survey, section 2.1.1).

Summary of gap analysisData gaps can be of several types:

(i) no data, or data totally inadequate(ii) Survey data available, but not regularly repeated, or not repeated sufficiently

frequently(iii) Survey data available, but sampling regime spatially inadequate(iv) Survey data available, but sampling regime not statistically robust(v) Survey data available, but time series insufficiently long to assess trends.

One or more of these may occur in combination. The last point may be remedied by the passage of time if the monitoring programme is only recently established. The following significant gaps have been identified in the monitoring of factors considered to be important in the foregoing analysis.

(i) No data, or data totally inadequate: Soil organisms Soil erosion Sediment in watercourses

(ii) Survey data available, but not regularly repeated, or not repeated sufficiently frequently:

Pesticides usage: ideally data collection by the Pesticides Usage Survey would be annual, rather than biennial. Crop Monitor provides information for intervening years, but only for wheat, barley and rape.

Weeds: the Countryside Survey is inadequate as a source of weed data. A regular representative survey should be a high priority, possibly incorporated into the Crop Monitor programme.

Terrestrial plants: the Countryside Survey is too infrequent. Whilst it forms a valid framework for vegetation sampling, additional intermediate samples would allow a more regular assessment of status. For the purposes of GM surveillance, this could be targeted at arable farmland. The Common Plant Survey is currently carried out annually and may be a valuable additional source of information for plants, but a full assessment of its potential must await the appearance of the first report.

Soil chemistry and organic matter: the RSSS does not record organic matter, and only a limited range of nutrients. The NSI is not a regular survey, and the ECN covers only a limited number of sites and is not representative of agricultural soils. Defra is currently reviewing soil monitoring policy.

(iii) Survey data available, but sampling regime spatially inadequate:

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Most sampling regimes are adequate to provide robust national or regional data. The GGCT Sussex Study only covers a limited area but is nevertheless the best time series data available for many invertebrate taxa on arable land.

(vi) Survey data available, but sampling regime not statistically robust:

Most surveys have a relatively robust design, with sites selected randomly or using a stratified random selection procedure. Those that do not usually select sites where the resources are available for labour-intensive sampling, and a strictly random location of sample sites is therefore not feasible (Rothamsted Insect Survey, Butterfly Monitoring Scheme, PollenUK).

(v) Survey data available, but time series insufficiently long to assess trends: The Countryside Survey has a maximum of four repeats for some variables, for

many there are fewer, and for some only one. Fish: The National Fisheries Monitoring Programme only began in 2002, but with

time will provide adequate trend data.

Table 15 summarises the data available for monitoring the indicators identified as being of high importance. The datasets included in Table 15 are those recommended as a basis for a general surveillance monitoring framework. The Environmental Change Network has been included because of the wide range of variables monitored and hence the potential for relating changes in different parameters to each other. The disadvantage of the ECN is the small number of terrestrial sites, and the fact that in general they are not particularly representative of arable land.

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Table 15. Data availability for key indicators, considered to be of high importance for general surveillance of GM crop impacts

Indicator Key DatasetTime series

adequate for trends?

Timing Spatial scale at which results applicable Statistical

designFrequency Adequate? Level Adequate?

Land use June survey Yes Annual Yes Sub-regional Yes Good

Crop varieties NIAB seedstats Yes Annual Yes National Yes N/A (census)Crop Monitor Yes Annual Yes Regional No Good

Pesticide usage Pesticides Usage Survey Yes Biennial No Regional Yes GoodFertiliser usage British Survey of Fertiliser

Practice Yes Annual Yes National No Good

PestsCrop Monitor Yes Annual Yes Regional Yes1 GoodRothamsted Insect Survey (aphids)

Yes Weekly Yes Regional Yes Moderate

Crop Diseases Crop Monitor Yes Weekly/Annual

Yes Regional Yes Good

Weeds Countryside Survey No 6-8 years No National No Good2

GCT Sussex study Yes Annual Yes N/A3 No Moderate3

Terrestrial Plants

Countryside Survey No 6-8 years No National Yes Good

Terrestrial Mammal

National Bat monitoring Programme

Yes Annual Yes National Yes Good

Breeding Bird Survey Yes Annual Yes National Yes GoodTerrestrial Birds Integrated Population

Monitoring Programme4Yes Annual Yes Regional (BBS) /

National (others)Yes Good

Terrestrial Invertebrates

Rothamsted Insect Survey (moths)

Yes Daily Yes Sub-regional Yes Moderate

Butterfly Monitoring Scheme

Yes Weekly Yes Sub-regional Yes Moderate

GCT Sussex Study Yes Annual Yes N/A3 No Moderate3

Soil organisms None N/A N/A N/A N/A N/A N/A

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Table 15 continued

Indicator Key DatasetTime series

adequate for trends?

Timing Spatial scale at which results applicable

Statistical design

Frequency Adequate? Level Adequate?Fish National Fisheries

Monitoring ProgrammeNo Annual/

5 yearlyYes Catchment Yes Good

Aquatic Invertebrates

General Quality Assessment

Yes Annual Yes Catchment Yes Good

Soil chemistry, organic matter

National Soil Inventory No Not regular No Sub-regional Yes YesRepresentative Soil Sampling Scheme

Yes 5 yearly No Region No Good

Soil erosion None N/A N/A N/A N/A N/A N/AWater chemistry General Quality

AssessmentYes Monthly Yes Catchment Yes Good

Sediment None N/A N/A N/A N/A N/A N/APesticides etc EA monitoring Yes N/K N/K N/K N/K N/KPollen, spores PollenUK Yes Daily Yes National Yes ModerateVarious Environmental Change

NetworkYes varies Yes National No Moderate

1. Could be improved to provide regional estimates. 2. The overall design is robust, but because it covers all habitats it is not particularly well suited to weed sampling.3. Unlike most other monitoring schemes which are sample surveys, it is a census of a local area.4. See chapter 3, section 3.1.3 for component surveys

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7. Potential Cultivation of GM Crops in the UK

7.1 Candidate cropsThe types of GM crops that will be grown in the UK are predominantly influenced by the UK climate, the physiology of the crop species and the type of authorization sought by the notifier. In Annex 3, tables 32 to36 show the different notifications pending or already approved for GM crops in the EU, with an assessment of the likelihood of cultivation, dissemination or establishment. This assessment is based on the biology of the crop (including the suitability of the crop to the UK climate, mode of reproduction, pollen dispersal, etc.), the type of marketing approval sought (e.g. import for processing only, or for cultivation) and any legislative restrictions such as crop quotas. The tables are divided into notifications approved and pending under the various pieces of EU GMO legislation (90/220/EC72, 2001/18 and 1829/2003), with use either including cultivation or not including cultivation. A summary of these assessments is presented in tables 16-17 below. Three GM crops are identified as potential candidates for cultivation in the UK - maize, sugar beet, and potato (table 16), but note these are all dependent on specific conditions being met before they would be grown.

Table 16. Summary of GM crops currently in the EU regulatory pipeline assessed to be potential candidates for cultivation in the UK73

Crop GM lines Trait Use CommentsMaize C/ES/03/01

(NK603)Glyphosate tolerance

In EU as any other maize, including cultivation

APPROVED IN EU (2001/18/EC).Cultivation is considered possible, but will depend on yield potential as is primarily for grain maize.

Sugar beet C/DE/00/8 (H7-1) Glyphosate tolerance

For use in EU as any other sugar beet, including cultivation

PENDING APPROVAL IN EU (1829/2003).Cultivation would depend on adoption of GM varieties by British Sugar

Potato C/SE/96/3501 (EH92-527-1)

Modified starch content

In EU for industrial starch production, including cultivation

PENDING APPROVAL IN EU (2001/18/EC).Cultivation would depend on UK gaining a quota for production of industrial starch, or abolishment of the EC quota system.

72 Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms. (OJ L 117 , 08/05/1990 P. 15 – 27). Superseded by EU Directive 2001/18/EC.

73 Carnation crops C/NL/96/12 (extended vase life and tolerance to sulphonylurea herbicides), C/NL/96/13 and C/NL/96/14 (modified flower colour plus tolerance to sulphonylurea herbicides) and C/NL/96/14 (modified flower colour) have been authorised in the EU since 1997 (intended for cultivation by cutflower growers, flower auctions, flower wholesalers, retailers and breeders). There have been no reports of their cultivation in that time and as the consents expire in October 2006, they have not been considered as candidates for cultivation in the UK.

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Potential cultivation of GM crops in the UK: summary of authorisations and notifications originally received under EU Directive 90/220/EC and 2001/18/EC

Table 17a. GMO Products already approved for placing on the market under Directive 90/220/EC1

Crop Type & Notification

Company Product name and trait Scope of use within EU Date consent issued

Date consent expires

Candidate for establishment in UK?

1 SoyaC/UK/94/M3/1

Monsanto Roundup Ready soya line 40-3-2.

Import & processing. Not for cultivation in the EU

May 1996 Oct 2006

2 MaizeC/F/94/11-03

CIBA-GEIGY Limited (now Syngenta)

Insect resistant maize line CG00526-176 (Bt 176). Note: Bt176 also possesses herbicide tolerance but the scope of the notification has been limited to use without the application of glufosinate ammonium herbicides.

Intended for cultivation for seed production & the production of silage & grain for animal feed, & grain for industrial processing.

Feb 1997 Oct 2006

3 CarnationC/NL/96/14

Florigene Europe BV

Carnation (Dianthus caryophyllus L.) lines with a modified flower colour

Intended for cultivation by cutflower growers, flower auctions, flower wholesalers, retailers and breeders. The cut flowers will be purchased by consumers. Plants are sold as flowers, cuttings or plants.

Dec 1997 Oct 2006Possible (but no reports to date)

4 Oilseed rape C/UK/95/M5/1

AgrEvo UK Crop Protection Limited (now Bayer)

Herbicide tolerant (glufosinate ammonium) oilseed rape Topas line 19/2

Import & processing to non-viable products. Not for cultivation in the EU

Jun 1998 Oct 2006 Possible via dissemination

5 MaizeC/F/95/12/07

AgrEvo UK Crop Protection Limited (now Bayer)

Herbicide tolerant (glufosinate ammonium) fodder maize line T25

Intended for cultivation within the EU, and the importation of grain and maize for processing for feed, food and industrial products

Aug 1998 Oct 2006

6 MaizeC/F/95/12/02

Monsanto Insect resistant maize line MON 810, genetically modified to express the cryIA(b) insect control protein.

Intended for cultivation within the EU, and the importation of grain and maize products into the EU, and their storage and processing for feed, food and industrial products.

Aug 1998 Oct 2006

7 Maize C/GB/96/M4/1

Northrup King Company (now Syngenta)

Herbicide tolerant and insect resistant maize line Bt-11.

Importation of maize seed into the EU, for animal feed and industrial processing to non-viable products, including those for human consumption. Not for cultivation in the EU

Jun 1998 Oct 2006

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8 CarnationC/NL/97/12

Florigene Europe BV

Carnation (Dianthus caryophyllus L.) line 66 with improved vase life (and tolerance to sulphonylurea herbicides).

Intended for cultivation by cutflower growers, flower auctions, flower wholesalers, retailers and breeders. The cut flowers will be purchased by consumers. Plants are sold as flowers, cuttings or plants.

Oct 1998 Oct 2006 Possible (but no reports to date)

9 CarnationC/NL/97/13

Florigene Europe BV

Carnation (Dianthus caryophyllus L.) lines 959A, 988A, 1226A, 1351A, 1363A, and 1400A modified for altered flower colour (and tolerance to sulphonylurea herbicides)

Intended for cultivation by cutflower growers, flower auctions, flower wholesalers, retailers and breeders. The cut flowers will be purchased by consumers. Plants are sold as flowers, cuttings or plants.

Oct 1998 Oct 2006 Possible (but no reports to date)

1 http://gmoinfo.jrc.it/gmc_browse.asp

Table 17b. Notifications authorised under Directive 2001/18/EC (DG ENV)1Crop Type & Notification

Company Product name & trait Scope of use within EU Date consent issued

Date consent expires

Candidate for establishment in UK?

10 MaizeC/ES/00/01

Monsanto NK603 Roundup Ready maizeTolerance to glyphosate herbicide.

Use as for any other maize, but not for cultivation in the EU

Oct 2004 Oct 2014

11 MaizeC/DE/02/9

Monsanto Maize line MON 863 and maize hybrid MON 863 x MON 810Insect-protected maize

Uses as for any other maize but not for cultivation in the EU

Commission decision 8 August 2005

Consent not yet issued

12 Oilseed rapeC/NL/98/11

Monsanto Roundup Ready oilseed rape, event GT73

As for any other oilseed rape, but not for cultivation in the EU

Commission decision 31 August 2005

Consent not yet issued

Possible via dissemination

13 MaizeC/NL/00/10

Mycogen Seeds; Pioneer Hi-Bred

1507 MaizeLepidopteran resistant and glufosinate tolerant

Import of products derived from 1507 maize seed, including import of 1507 maize grain produced outside the EU, but not for cultivation in the EU

Commission decision 3 November 2005

Consent not yet issued

1 http://gmoinfo.jrc.it/gmc_browse.asp

Table 17c. Notifications pending under Directive 2001/18/EC (DG ENV)1

Crop Type & Notification

Company Product name & trait Scope of use within EU Date consent issued

Date consent expires

Candidate for establishment in UK?

14 MaizeC/ES/04/01

Monsanto NK603 × MON810Tolerance to glyphosate & Lepidopteran insect resistance.

For import and use including cultivation.

15 Maize Syngenta Seeds Bt11 maize (field or sweet For import and use including cultivation.

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C/FR/96/05/10 SAS maize).Resistance to corn borers using the Cry1Ab gene

16 MaizeC/ES/01/01

Dow AgroSciences; Mycogen Seeds; Pioneer Hi-Bred

1507 MaizeResistance to Lepidopteran insects and tolerance to glufosinate

For import of grain and grain products for storage and processing into food, animal feed and industrial uses, including cultivation.

17 PotatoC/SE/96/3501

Amylogene HBSweden

Potato line EH92-527-1. Modified starch content.

For industrial use including cultivation.

18 CarnationC/NL/04/02

Florigene Limited “Florigene Moonlight”. Modified flower colour and tolerance to sulphonylurea herbicides

Import and use as cut flowers; not for cultivation in the EU

Possible via dissemination

19 CottonC/NL/04/01

Dow AgroSciences; Agrigenetics

Insect resistant cotton events 281-24-236 and 3006-210-23.

For import and use; not for cultivation in the EU

20 Oilseed rapeC/BE/96/01

Bayer BioScience Oilseed rape Ms8xRf3 (developed from the spring variety Drakkar)Tolerance to glufosinate ammonium

Import and use as any other oilseed rape; not for cultivation in the EU

Possible via dissemination

21 MaizeC/GB/02/M3/03

Monsanto Maize NK603 × MON 810 Tolerance to glyphosate, and lepidopteran resistance

For import and use, not for cultivation in the EU

1 http://gmoinfo.jrc.it/gmc_browse.asp

Table 17d. Notifications pending under Directive 1829/2003 (DG SANCO), having been transferred from 2001/18/EC1

Crop Type & Notification

Company Product name & trait Scope of use within EU Date consent issued

Date consent expires

Candidate for establishment in UK?

22 MaizeC/ES/03/01

Monsanto Roundup Ready maize NK603Herbicide (glyphosate) tolerance.

For use as any other maize including cultivation.

23 Fodder beetC/DK/97/01

Danisco Seed; DLF Trifolium A/S; Monsanto

Roundup Ready fodder beet derived from line A5/15

For use as any other fodder beet, including cultivation

Withdrawn

24 CottonC/ES/97/01

Monsanto Roundup Ready cotton line derived from Event 1445

For use as any other cotton including cultivation Withdrawn

25 CottonC/ES/96/02

Monsanto Insect-Protected cotton line derived from Event 531

For use as any other cotton including cultivation Withdrawn

26 Cotton Bayer LLCotton25 For import only. Not for cultivation in the EU

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C/ES/04/02 CropScience Glufosinate tolerant cotton27 Oilseed rape

C/GB/04/M5/4Bayer CropScience

Oilseed rape T45Glufosinate tolerance

For import only. Not for cultivation in the EU Possible via dissemination

28 RiceC/GB/03/M5/3

Bayer CropScience

Glufosinate-tolerant Rice, LLRICE62

For import only. Not for cultivation in the EU

29 Sugar BeetC/DE/00/8

Monsanto Roundup Ready Sugar Beet derived from Event H7-1

For use as any other sugar beet, including cultivation

30 CottonC/ES/99/01

Stoneville Pedigreed Seed Company

Herbicide tolerant BXN cotton lines 10215 and 10222.

For import only. Not for cultivation in the EU Withdrawn

31 Oilseed RapeC/DE/96/5

Bayer CropScience

Glufosinate tolerant winter oilseed rape Falcon GS40/90 pHoe6/Ac

For use as any other OSR, including cultivation. Note: as of Dec 2004 the scope of the application was reduced to no longer include cultivation.

Withdrawn

32 Oilseed RapeC/DE/98/6

Bayer CropScience

Glufosinate tolerant Oilseed Rape Liberator pHoe6/Ac

For use as any other OSR, including cultivation. Note: as of Dec 2004 the scope of the application was reduced to no longer include cultivation.

Withdrawn

1 http://gmoinfo.jrc.it/gmc_browse.asp

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7.2 Case-specific monitoring for GM crops with potential for cultivation in the UKFour crops have been authorised under 2001/18/EC but none of these have been identified as requiring a case-specific monitoring programme; of the crops pending authorisation under 2001/18/EC, three have been identified as requiring a case-specific monitoring programme. All notifications have submitted proposed general surveillance programmes. This project is concerned with design of a database to hold all case-specific and general surveillance post market monitoring data that will be submitted by consent holders when a GM crop is cultivated. To assist development of this facility, it is important to be aware of the type of monitoring that will be undertaken, and the data that need to be held and analysed. At the present time these exact details are not known.

C/FR/96/05/10, Bt11 maize (Syngenta Seeds SAS)Based on the environmental risk assessment the notifier has concluded that no case-specific monitoring is recommended. However, in order to delay insect resistance to Bt11, an insect resistance management plan will accompany Bt11. The monitoring plan is divided into four parts:

Maintenance of refuges (20% in the case of holdings with over 5 ha of maize); Monitoring of Bt resistance; Action plan in the event of resistance being detected; Training for producers. If authorised, it is possible that further case-specific monitoring may be requested

Anticipated data: it is thought unlikely that Bt11 maize will be cultivated in the UK because corn borers are not a pest in the UK. However, if it is cultivated, the numbers of Bt resistant lepidopterans collected from plantings in the UK will be provided.

C/ES/01/01, 1507 Maize (Dow AgroSciences; Mycogen Seeds; Pioneer Hi-Bred)The case-specific monitoring programme for 1507 maize will form part of the insect resistance management (IRM) plan. The IRM proposal has been developed in order to maintain the efficacy of the CRY1F protein in 1507 maize and is based on the following five principles: (i) deploying products with an effective dose of Bt protein; (ii) maintaining adequate refuges; (iii) monitoring product performance; (iv) educating seed distributors and farmers; and, (v) continuing to conduct research. In order to monitor for the potential development of resistance to CRY1F protein, the following measures will be used:

Field collections of target pests to determine baseline susceptibility and contribute to monitoring of its variation;

Monitoring of target pests to detect variation in baseline susceptibility; Sampling of plant tissue of maize infested with target pest; Sampling of the insect population; Use of discriminating dose assay (when available) to determine resistant pest

phenotype.

Anticipated data: the scope of the authorisation does not include cultivation in Europe. If feral populations were to develop they would be removed and would not be subject to post market

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monitoring. The UK is, therefore, unlikely to receive any case-specific monitoring data in connection with this consent.

C/SE/96/3501 Potato line EH92-527-1 (Amylogene HB)The case-specific monitoring will focus on (1) any significant detrimental changes in the composition of the tubers and (2) a change in the presence of the bleomycin resistant protein associated with open reading frame 4 (ORF4). Monitoring will comprise verification of the following assumptions of the risk assessment:

the genes of interest remain stably inserted, the ORF 4 is not expressed at the protein level, and the starch composition and the glycoalkaloid content are stable.

The assessment report of the Swedish Competent Authority states that the notifier has developed methods and accounted for sampling and analysis. The suggested case-specific monitoring will continue for five years, after which the monitoring plan will be evaluated and may be extended or altered. The Swedish Board of Agriculture (SBA) concluded that in particular it is important to study how the glycoalkaloid content may vary depending on the place of cultivation or weather conditions. In addition, the SBA state there is very little reason to expect that the possible expression of a protein from ORF4 would result in negative health effects in animals that will eat the by-products of the potato. The SBA conclude that it is reasonable that monitoring is designed to fulfil the most important criterion in this context, that is to detect and avoid the unlikely scenario that ORF 4 causes a protein to occur in a significant share of the potatoes.

Anticipated data: it is possible that this crop may be cultivated in the UK, although this would depend on changes to the current EU industrial starch quota system. Data provided will relate to the levels and type of glycoalkaloids found in potatoes grown under a range of different conditions. If the competent authority were to be notified by Amylogene HB of the intention to market these potatoes in the UK, a standard format for collation of data would need to be agreed between the competent authority and the consent holder, ideally in a format that could be directly uploaded into the competent authority’s PMM database.

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8. Post Market Monitoring DatabaseWe have reviewed environmental monitoring programmes currently being undertaken in the UK and considered their potential value to general surveillance monitoring programmes in terms of availability, quality, complexity and format of available data. A pilot database has been developed to collate and integrate monitoring results from general surveillance and case-specific monitoring supplied by companies who have released a GM crops(s) in the UK. One of the key considerations in developing this facility was to provide a tool that could be easily and intuitively used by Defra personnel, deliberate release consent holders and the general public alike with a clean and outwardly simple format, while at the same time maximising the ability to capture post market monitoring information. Defra personnel have been provided with a link to the pilot database (http://cpec44.csl.gov.uk/) and a secure username and password. Screenshots of the pilot database are provided in Annex 5.

Database specification

Customer specification for the database:The following criteria were specified for the database:

The database will be for use by Defra personnel and GM deliberate release consent holders as an information management tool. It should be flexible and be able to accept revisions/enhancements in the future. The database will hold data from general surveillance and case-specific monitoring.

The database must be able to provide links to Defra-nominated environmental monitoring data sets, but will not necessarily hold raw data from these data sets.

Defra cannot be prescriptive about the information that consent holders should submit as part of their PMM activities. Data analyses will therefore be provided in a range of formats and from a range of sources. Defra does not anticipate that companies will enter raw monitoring data directly into the database.

The database will need to hold data gathered in farmer questionnaires. It is possible that templates can be developed on a case-by-case for entry of farmer questionnaire data, which would enable analysis of findings.

The database will only be required to hold data that are relevant to the UK. The database will be accessed via the Genetic Modification pages on the Defra

website.

Database characteristics as defined by customer specification The database will serve as a portal via which Defra will provide links to monitoring

programmes that deliberate release consent holders could use to support PMM activities. Consent holders will submit their monitoring reports to Defra via this portal.

To extend the utility of the database it has been designed to hold, for Defra, all information relating to deliberate release consents for placing on the market. In the future it could be extended to perform a similar function for experimental GM releases, should this be needed.

Three levels of access are proposed:i) Defra and/or the database administrator will have full administrator status and

have access to all areas.ii) All consent holders will be issued a username and password; this will provide

access to all Defra-nominated monitoring programmes/monitoring data sets

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and will enable them to upload monitoring reports each year. Consent holders will only be able to view their own monitoring reports, but to maximise the utility of the database for consent holders, they will be able to search their own data extensively within their own password-protected area.

iii) Public access to general information about deliberate release consents will be provided via the Defra website, but access will not be provided to monitoring information or reports (unless Defra wish to provide this).

To make consent holders’ use of the database as straightforward as possible, all data entry stages have been designed to capture generic information about monitoring reports that are submitted using pre-set drop down menus and yes/no buttons. Administrators can add new terms to drop down menus as necessary.

The design of the database is such that analysis of the types of reports that have been submitted to Defra will be possible. As raw monitoring data in a pre-determined format will not be supplied, the database will not support any analysis of the information submitted in these reports.

Case-specific monitoring dataA standard template for consents with a requirement for case-specific monitoring will be developed on a case-by-case basis in collaboration between the consent holder and Defra. The format of data collection and storage will depend on the nature of the monitoring that is requested by the European Commission. The database will need to be updated case-by-case to accommodate new requirements as they arise.

Farmer questionnairesFarmer questionnaires are considered to be a very useful way of capturing practical information about the use of a GM crop on the farm and within the supply chain. In chapter 5 we have reviewed an example that was submitted as part of the authorisation process; this was a fairly comprehensive document, and we have made a few suggestions as to how it could be improved to make the data gathered more amenable to analysis. Under the current specification for post market monitoring, the competent authority will not specify to consent holders how data collected from farmer questionnaires is submitted; it will therefore only be possible to request that results from questionnaires are uploaded to the database as pre-prepared reports, as for general surveillance monitoring reports. If a more standardised format were to be developed, a template for entry of data to the database could be developed that would enable more flexible analysis and interrogation of the data provided. Alternatively, templates could be developed on a case-by-case basis for each consent holder, as with case-specific monitoring. Under the current arrangement, analysis will only be possible by accessing consent holder reports and extracting the data manually.

Meta-data databaseWeb searches were used to identify monitoring schemes that could be useful in the surveillance of environmental impacts of GM crops. Many monitoring schemes were identified; of these, schemes that met one of the three criteria outlined below were recorded into the ‘Meta-data database’ created for the purpose:

i) Surveys or monitoring schemes carried out on a regular basisii) Stand-alone surveys repeated at intervals, but not part of a regular monitoring

scheme

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iii) One-off surveys or large experimental projects which may be carried out over more than one year, but are not likely to be repeated, if they were sufficiently extensive to form a useful baseline for future monitoring.

This database is accessible from the CPEC44 pilot database via the ‘Search meta-data’ facility. The meta-data fields included in the database are listed in Table 2 of this report. The database can be searched by title, abstract, topic category, subject and/or survey category to identify monitoring schemes that may be of interest. Summary results are presented in a table, full details of individual monitoring schemes can then be viewed by selecting one of the displayed results. The database contains details of 136 monitoring schemes, with key schemes discussed in more detail in the report.

Limitations of the databaseUntil data is collected and submitted to Defra according to a pre-specified format, database-driven analysis of monitoring data will not be possible. The database is capable of storing this sort of data, and could be modified to undertake basic analyses if required. Under the current specification, analysis will only be possible by reviewing hard data submitted in individual consent holder monitoring reports.

Pilot database technical specificationRelational database management system: MySQL 4.1Web software: ColdFusion: 7.1

Pilot database structureThe database has four main functional areas, each of which are linked:

Area 1: AdministrationFunction: Storage of specific details of deliberate release consents.

Operation: Each time a new consent is issued the competent authority will create the consent in the database in terms of consent holder name, product name, crop and notification number. These key details of each individual consent (e.g. Amylogene HB Sweden EH92-527-1 potato, C/SE96/3501) will then be integrated into all other areas of the database and appear in pre-formatted drop-down menus at all subsequent data entry stages. The ‘Add New Consent Details’ facility enables addition of further detail for each consent such as the issuing competent authority, scope of the authorisation and unique identifier; relevant electronic documents can be uploaded and case-specific and general surveillance monitoring requirements can be entered in free text boxes. The ‘search consent details’ facility enables the user to search for consents that have been issued according to the criteria of their choice.

Access: Uploading of data by the competent authority and/or the database administrator only.

Visibility: Visitors to the Genetic Modification pages on the Defra website will be able to view all the consents and relevant documents without the need for a username or password.

Area 2: Data sets for general surveillance monitoringFunction: This area provides consent holders with access to the datasets that Defra has identified as being suitable to support general surveillance monitoring activities. In the pilot database details of just four data sets are provided, however in the final product a

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comprehensive list of the data sets that have been identified by Defra as providing good data for use in general surveillance monitoring would be available.

Operation: The database administrator will provide each consent holder with a username and password that will create access to the area called “General surveillance data sets” where direct links are provided to Defra-nominated data sets. In the final product this may be a simple web link to the data source, such as pesticide usage statistics on the Pesticide Usage Survey website (http://pusstats.csl.gov.uk/) where the data can be accessed, or in other cases, where a web link cannot be provided, the actual data set can be made available. For example, on the pilot database, actual data on maize cultivation, meadow brown butterflies and nitrate levels in the River Trent have been provided. Consent holders could elect to download maize data on a regional basis - the database will bring up the area of maize grown (hectares) as a percentage of the total area grown by county in the region of interest in the year of cultivation. A summary of each data set is provided, the source of the data is specified and a web-link is provided to enable the consent holder to access other related data. Data can be presented in graphical or tabular format and tables can be exported to Excel.

Access: Each consent holder will be issued a username and password enabling downloading of data and/or linking to data. Defra and database administrators will be able to update information held in these pages.

Visibility: Visible only to database administrators and persons with username and password. Not visible to the general public without username and password.

Area 3: Upload monitoring dataFunction: This area is to enable consent holders to submit their monitoring reports to the competent authority. Consent holders will not be entering raw monitoring data to the database, therefore, this area has been designed to capture generic details about each monitoring report and thereby create a searchable record for Defra of the monitoring that has been undertaken.

Operation: The consent holder is asked to provide information about the following by selecting answers from drop-down menus:

crop notification number county of cultivation trait sowing and harvest dates monitoring data sets used if some datasets were not used, why not (this gives Defra feedback on availability and

accessibility of the suggested data sets) whether a significant effect was noticed for any of the datasets used Monitoring reports (farmer questionnaire, case-specific and/or general surveillance

reports) can be uploaded as word documents, pdf files, excel files or plain text files

Access: Defra and database administrators (e.g. to upload data sent directly to the competent authority as hard copy). Consent holders with username and password.

Visibility: Visible only to database administrators and persons with username and password. Not visible to the general public without username and password.

Area 4: Search consent holder dataFunction: This area has been designed to enable the competent authority to interrogate the database for monitoring reports. For example, Defra may wish to review monitoring that has

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been undertaken in connection with sugar beet crops with a herbicide tolerant trait; the use of drop down menus will enable the user to specify exactly what data they wish to review and to download the relevant reports. Similarly, if they wish to identify all monitoring reports for GM crops grown in a specific region of the country, or for reports in which a specific effect was recorded, this will also be possible.

Operation: The reports of interest can be identified by selecting criteria from drop-down menus; thus reports can be identified on the basis of notification number, county of cultivation, trait, sowing and harvest dates, the monitoring datasets used, and whether any significant effects were noticed for any of these datasets. The search can be as detailed or as general as the user wishes it to be for their purpose. Results are provided in tabular form providing notification data (e.g. Amylogene HB Sweden EH92-527-1 potato, C/SE96/3501), trait, county/s of cultivation and the reports that are held within the database for each result that meets the criteria of the search. To undertake any further analysis the user must download the report of interest and review it.

Access: Competent authority (Defra) only (and database administrator if not at Defra).

Visibility: Competent authority (Defra) only.

Development to a usable productThe database presented is a pilot intended to demonstrate the level of functionality that can be expected, given the customer specification. Before the database could be used on a routine basis, further work would be required to ensure it meets fully the requirements of Defra and that consent holders are able to use it for the purpose envisaged, these are listed below:

No major technical requirements (such as investments in hardware) are anticipated; further coding and basic development work would be sufficient to make the transition from a pilot database to a usable, web-based product.

It will be necessary to establish whether there is anything that the database does not do that Defra and/or the consent holder would like it to do, and vice versa. To do this, we strongly recommend that the database developer should spend time with the customer when the database is being tested.

Acceptance by the consent holders will be key to the success of the database. As the use of the facility by consent holders would to some extent be voluntary, it would be very important for the database developer to spend time with a consent holder (or, preferably, a few consent holders) to establish whether the database performs the necessary functions for them and whether there are any modifications that would improve its utility for them.

The ‘Data sets for general surveillance’ area should be a very useful area for the consent holders, and should also maximise the likelihood for Defra that good quality post market monitoring data will be submitted. It will be essential, therefore, for Defra to decide exactly which datasets would be made available via this facility. Defra will need to establish the basis on which the information will be provided, i.e. whether as a simple link to a website or whether provision of raw data sets will be necessary, and to ensure that access rights to the relevant data sets has been negotiated where this is needed.

A decision will have to be taken regarding who would run the database, i.e. Defra (IBM) or CSL. CSL currently hosts a number of databases for Defra, this is easily done using templates provided by Defra Communications Division to ensure outward presentation meets Defra website specifications. The domain name for the database would indicate that the database is hosted at CSL, but otherwise the post market monitoring pages would

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appear identical to all other Defra web pages. Current examples are Animal Health and Welfare Division’s FMD data Archive at http://footandmouth.csl.gov.uk/ and Defra Sustainable Farming and Food Science programme website at http://defrafarmingandfoodscience.csl.gov.uk/.

Development of the pilot facility has concentrated only on functionality; the database has not benefited from any cosmetic design input and Defra may wish to address this. Making changes to the general appearance of database outputs would be relatively straightforward to address.

It would be possible to increase the power of the database if data were to be collected from consent holders in a systematic, pre-determined way.

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8. General conclusions and recommendations

This report has focussed on general surveillance aspects of the post market monitoring of genetically modified crops. This activity is a legal requirement of all authorisations to release a GM crop, and seeks to identify unanticipated effects of the cultivation of the crop. By nature general surveillance is broad and ill defined in scope. It is, as yet, largely untested within the European Union, particularly in connection with the cultivation of GM crops, because of the limited number of crops currently authorised for this purpose.

General surveillance will rely heavily on existing environmental monitoring programmes to identify changes within a receiving environment; questionnaires have also been proposed to provide additional specific information relating to the use of the GM crop on the farm and within the supply chain. We consider it unlikely that general surveillance monitoring will identify any small impacts associated with the cultivation of a GM crop, although it is possible that farmer questionnaires could identify persistent effects at the farm level, which would lead to wider investigations.

In the UK there are many monitoring programmes for consent holders to choose from although surprisingly few of these provide statistically robust data for the general surveillance of annual arable crops. This is often due to spatial and/or sampling inadequacies. Access to data and ownership of data may also potentially limit the usefulness of good datasets where general access for consent holders cannot be negotiated (or can only be negotiated at a price). Significant data gaps have been identified in relation to arable weed and terrestrial plant populations, soil organism populations and populations of reptiles and amphibians on arable land. For a monitoring programme to be of use for general surveillance purposes assured long term funding will be necessary for gathering of baseline data that is likely to register impacts potentially associated with the cultivation of a GM crop. Unfortunately such funding is rarely assured in the long term. It will, therefore, make good sense for the competent authority to examine the extent to which indicators identified for the Strategy for Sustainable Farming and Food can be linked with indicators for GM cultivation, this is likely to assure greater consistency in provision of data in the long term. Nevertheless, there may still be gaps in data provision and Defra will need to consider how these gaps can be remedied.

We have developed a prototype database for management of post market monitoring data that maximises the utility of data that will be collected in the UK. It has been developed on the basis that competent authorities cannot, at present, be prescriptive about the information that consent holders must provide. However, if consistent and comparable results are to be gained from these activities, it will be desirable for consent holders to be required to run their PMM programmes according to a more standardised framework. If this were to be extended EU-wide it would further strengthen the value of the activity. Consent holders may also welcome such an approach if it helps to ‘de-mystify’ general surveillance.

General surveillance monitoring is discussed in this report in connection with GM crops. Comparable monitoring activities are not carried out for conventional crops. However, the same principles could be extended to any new agricultural introduction (e.g. a crop introduced on a large scale for non-food or energy uses) or alteration to established management practice.

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Recommendations

1) There are significant gaps in monitoring for arable weeds, terrestrial plant communities and populations of soil organisms. These are considered important indicators for monitoring impacts of the cultivation of GM crops. Defra should consider how this can be addressed, either by extension of an existing programme, such as the ‘Crop Monitor’ programme, support for independent monitoring such as Plantlife’s ‘Common Plants Survey’ (if adequate/appropriate), or commissioning a new monitoring programme.

2) There are significant gaps in monitoring reptile and amphibian populations on arable land; these are considered medium importance for monitoring for potential impacts of GM crops. The Herpetological Conservation Trust is currently developing a monitoring scheme, which may remedy this deficiency, but Defra should keep this under review.

3) Defra should select up to 20 indicators that are important for the identification of potential unintended impacts of the cultivation of GM crops, and identify the key environmental monitoring programmes for these. Investigate the funding basis for each programme and the availability of data.

4) For each of the identified indicators, ensure that baseline data is available, and establish what level of ‘change’ would be necessary to trigger further investigation into the cause of the change.

5) Farmer questionnaires offer a potentially very useful source of data regarding effects of cultivating a GM crop. Defra should consider establishing best practice in this area by developing a pro-forma questionnaire for gathering farming data in connection with cultivation of GM crops. This would give the opportunity of obtaining consistent data, and possibly of doing meta-analysis of similar GM crops and/or traits across companies.

6) Review the headline and core indicators that are identified as part of the Strategy for Sustainable Farming and Food, and consider how these might be linked to those for general surveillance of GM crops. Review also outputs from the Defra funded ‘Agricultural Change and Environmental Observatory’ project and consider how these may be utilised in implementing a strategy for general surveillance of GM crops.

7) Consult potential consent holders on the proposed approach for capturing post market monitoring data via the ‘pilot database’, including provision of links to key nominated datasets.

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