Post Market Environmental Monitoring Plan for cultivation of MON 810 in the EU

Table of contents

1 INTRODUCTION ...... 3 2 RESPONSIBILITIES ...... 4 3 CASE-SPECIFIC MONITORING ...... 4 3.1 APPROACH ...... 4 3.2 MONITORING FOR RESISTANCE EVOLUTION OF LEPIDOPTERAN TARGET PESTS TO THE CRY1AB 5 3.2.1 Time period ...... 5 3.2.2 Monitoring strategy ...... 5 3.2.2.1 Establishment of baseline to implement the monitoring strategy ...... 5 3.2.2.2 Measurement of changes in susceptibility ...... 5 3.2.2.3 Detection limit of resistance allele frequency ...... 5 3.2.2.4 Field sampling of target pests ...... 6 3.2.2.5 Farmers' alert system for the performance of maize MON 810 ...... 7 3.2.3 Remedial plan...... 8 4 GENERAL SURVEILLANCE ...... 9 4.1 APPROACH ...... 9 4.2 TIME PERIOD ...... 9 4.3 MONITORING STRATEGY ...... 9 4.3.1 Farmer questionnaire ...... 9 4.3.1.1 Design of the farmer questionnaire ...... 9 4.3.1.2 Reference for comparison between GM maize MON 810 and conventional maize ...... 9 4.3.1.3 Sampling ...... 9 4.3.1.4 Collecting information via questionnaires ...... 10 4.3.1.5 Quality control ...... 11 4.3.1.6 Data analysis ...... 11 4.3.2 Existing environmental surveillance networks ...... 11 4.3.2.1 Identification and selection and suitability of existing environmental networks ...... 12 4.3.2.2 Baseline ...... 13 4.3.2.3 Collecting information ...... 13 4.3.2.4 Analysis ...... 13 4.3.2.5 Quality control ...... 13 4.3.3 Review of relevant scientific publications ...... 13 4.3.3.1 Approach ...... 13 4.3.3.2 Baseline ...... 13 4.3.3.3 Timeline ...... 14 4.3.3.4 Assessment of relevant scientific publications ...... 14 4.3.3.5 Quality control ...... 14 4.3.3.6 Reporting requirements ...... 14 4.3.4 Companies' stewardship programmes ...... 15 4.3.4.1 Approach ...... 15 4.3.4.2 Timeline ...... 15 5 REPORTING AND REVIEW ...... 15 5.1 SUBMISSION OF REPORTS ...... 15 5.2 REPORTING ADVERSE EFFECTS ...... 16 5.3 REVIEW AND ADAPTATION ...... 16 FARMER QUESTIONNAIRE ...... 18

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1 Introduction

EFSA has carried out and has updated the environmental risk assessment (ERA) of genetically modified (GM) maize MON 810 and has concluded that, subject to appropriate management measures, maize MON 810 cultivation is unlikely to raise safety concerns for the environment. (1) (2) (3) (4). EFSA has recommended, that cultivation of maize MON 810 should be accompanied by appropriate risk management strategies to minimise exposure of both target(5) and non-target to the Cry1Ab protein expressed in maize MON 810. Therefore, non-Bt maize refugia should be put in place for the target and non-target Lepidoptera. In addition, isolation distances from protected habitats should be imposed to limit exposure to maize MON 810 pollen of non-target lepidopteran species of conservation concern. Instructions should also be provided to farmers in order to ensure the implementation of these required measures. EFSA has also recommended that, in addition to the general surveillance for unanticipated adverse effects, case-specific monitoring should be undertaken to monitor Cry1Ab resistance evolution in target Lepidoptera. The Post Market Environmental Monitoring (PMEM) plan shall consist of two parts: 1. Case-Specific Monitoring which sets out the requirements for monitoring for resistance evolution of lepidopteran target pests to the Cry1Ab protein; 2. General Surveillance (GS) which sets out the requirements for monitoring for unanticipated adverse effects. The GS plan shall be based on the following four pillars: (1) farmer questionnaire; (2) existing surveillance networks; (3) review of relevant scientific publications; and (4) company stewardship programmes.

(1) Scientific Opinion of the Panel on Genetically Modified Organisms on applications (EFSA-GMO-RX- MON810) for the renewal of authorisation for the continued marketing of (1) existing food and food ingredients produced from genetically modified insect resistant maize MON810; (2) feed consisting of and/or containing maize MON810, including the use of seed for cultivation; and of (3) food and feed additives, and feed materials produced from maize MON810, all under Regulation (EC) No 1829/2003 from . The EFSA Journal (2009) 1149, 1-85. (2) EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion supplementing the conclusions of the environmental risk assessment and risk management recommendations for the cultivation of the genetically modified insect resistant maize Bt11 and MON 810. EFSA Journal 2012;10(12):3016. [32 pp.] doi:10.2903/j.efsa.2012.3016. (3) EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion updating the risk assessment conclusions and risk management recommendations on the genetically modified insect resistant maize MON 810. EFSA Journal 2012; 10(12):3017. [98 pp.] doi:10.2903/j.efsa.2012.3017. (4) EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2015. Scientific Opinion updating risk management recommendations to limit exposure of non-target Lepidoptera of conservation concern in protected habitats to Bt-maize pollen. EFSA Journal 2015;13(7):4127, 31 pp. doi:10.2903/j.efsa.2015.4127. (5) Certain lepidopteran insect pests, including the European Corn Borer (ECB) (Ostrinia nubilalis) and pink borers (Sesamia spp)

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2 Responsibilities

In accordance with Regulation [Enter Number of authorisation Regulation], the authorisation holder and the other companies breeding or producing maize MON 810 and marketing it shall ensure that the PMEM plan described herein is put in place and implemented. The authorisation holder shall, in addition, submit to the competent authorities of the Member States a single annual monitoring report which shall include in a consolidated form the implementation and the results of the activities set out in the PMEM plan as carried out by all relevant companies. An independent third party designated by the authorisation holder shall prepare the annual report. Companies breeding or producing maize MON 810 and marketing it, including the authorisation holder, shall communicate the results of their monitoring activities to that third party so that the annual report contains a comprehensive and statistically relevant analysis of the monitoring results. The third party may also be delegated other activities outlined in this PMEM plan, to be carried on behalf of the companies concerned. This option should be considered in particular with regard to general surveillance, where certain activities could give rise to unnecessary duplications of work or where a coordination by the third party would be beneficial (farmers' interviews, review of scientific literature, networks etc.). In order to facilitate the overall work of the third party, in particular the identification of the other companies than the authorisation holder that are concerned by the monitoring obligations, the authorisation holder and the other companies breeding or producing maize MON 810 and marketing it shall inform that third party of the first certification of MON810 seeds they have obtained in the Union pursuant to Council Directive No 66/402/EEC6. The contract(s) and/or arrangements between the companies concerned and the third party, in particular at the moment of the designation of that third party by the authorisation holder, shall ensure:  An equitable repartition of the costs of the recourse of that third party between the companies concerned  The protection of confidential business information communicated by the companies concerned. The main elements of the contract(s) and/or arrangements between the companies concerned and the third party shall be described in the annual report.

3 Case-Specific Monitoring

3.1 Approach

EFSA has recommended case-specific monitoring (CSM) to address resistance evolution to the Cry1Ab protein in lepidopteran target pests.

(6) Council Directive No 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ 125, 11.7.1966, p. 2309

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The results of CSM shall also be used to assess the efficacy of the mitigation measures, taking also into account other available relevant evidence.

3.2 Monitoring for resistance evolution of lepidopteran target pests to the Cry1Ab protein

3.2.1 Time period

CSM for resistance evolution of lepidopteran target pests to the Cry1Ab protein shall be undertaken in areas where maize MON 810 is cultivated for as long as there is cultivation during its authorisation period and according to the monitoring conditions outlined herein (e.g. adoption rates etc.).

3.2.2 Monitoring strategy

The aim of monitoring for resistance evolution is to detect resistance far enough in advance of building up of population resistance to allow adequate time for the confirmation and characterisation of resistance and to take steps to reduce the likelihood or extent of resistance. To achieve this, the monitoring strategy for resistance evolution of the target pests to Cry1Ab protein shall be based on the susceptibility of lepidopteran target pests to Cry1Ab protein. Monitoring for resistance evolution shall also include monitoring and reporting of unexpected damage through GS.

3.2.2.1 Establishment of baseline to implement the monitoring strategy

For Cry1Ab protein the already established diagnostic dose, baseline susceptibility and initial allele frequency shall be used in order to implement the monitoring strategy and to monitor the changes in the susceptibility of lepidopteran target pest populations to Cry1Ab protein, from year to year. Regarding the initial resistance allele frequency of the target pest populations, it is important to improve the already estimated ones with the aim to obtain even more accurate data that will feed the mathematical models. Therefore, if possible, the initial resistance allele frequency shall be re-estimated in relevant geographical areas in accordance with appropriate protocols (e.g. F2 screen).

3.2.2.2 Measurement of changes in susceptibility

Insects shall be collected according to the sampling strategy described in Section 3.2.6 and dose-response and/or diagnostic dose bioassays shall be conducted in the laboratory in accordance with standardized protocols in order to detect changes in susceptibility of lepidopteran target pest populations to the Cry1Ab protein. Samples from each sampling zone as determined in Section 3.2.6.1 shall be analysed separately. At least the MIC shall be measured.

3.2.2.3 Detection limit of resistance allele frequency

Given that a population is considered resistant when the frequency of resistant alleles reaches 50%, and to allow adequate time for measures to be taken, the level of sensitivity of the monitoring plan for resistance evolution, and of the respective sampling strategy and bioassays shall be of such that allows a detection limit of resistance allele frequency of maximum 3%. If achievable, a lower detection limit should be aimed at.

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3.2.2.4 Field sampling of target pests

The sampling strategy (i.e., sampling frequency, sampling areas) for monitoring resistance evolution in a given geographical area(7) shall be dependent on the ecology of the pests (based on current knowledge) and adoption rates of Bt-maize (i.e. all Bt-maize events that are cultivated), covering the lepidopteran-active expressing maize events. Adoption rates of Bt- maize shall be determined using data published by Competent Authorities, seed sales information, and information recorded by other relevant authorities. The principles of the sampling strategy as outlined in relevant EFSA scientific opinions (e.g. EFSA scientific opinion on the annual PMEM report on the cultivation of MON810 in 2014(8)) shall be taken into account in developing the sampling strategy for maize MON 810.

(i) Sampling areas and zones

Three independent samples of the relevant target pest larvae shall be collected before the end of the cultivation season from each geographical area. The collection of the target pest individuals shall focus on three ''sampling zones''(9) of approximately 10km x 10km within that given geographical area. There might be cases where the collection of sufficient number of larvae in sampling zones of 10 km x 10 km is not feasible. In those cases, samples can be collected from larger zones, provided that justification is given for this deviation. Sample site (i.e. field) selection within a sampling zone shall be determined by the target pest population. In situations where the Bt-maize adoption rates and/or the target pest pressure are very high or increasing over time, or where farmers have indications (see section 3.2.7) of possible resistance evolution, repeated sampling of the same sampling zones over time shall be conducted for resistance monitoring. Target pest collections shall be made in refugia or non-Bt-maize fields in close vicinity of Bt- maize field. Applicants shall specify the precise distance between the sampling sites and the nearest Bt-maize field.

(ii) Sampling frequency

The frequency of sampling for each type of target pests (Monovoltine, Bi-/Multivoltine) is dependent on the adoption rate of Bt-maize in a given geographical area. Considering that the recommended size of the non-Bt-maize refuge in the EU is 20%, the maximum adoption rate should not exceed 80%.

(7) A geographical area is defined as an area where maize is typically grown following similar agronomic practices and isolated from other maize areas by barriers that might impair an easy exchange of target pests between those areas. In accordance with EFSA's recommendations, the aim is to identify large geographical areas (e.g. Ebro valley in ) where Bt-maize adoption rate and target pest pressure are high. (8) EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2016. Scientific opinion on the annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A. EFSA Journal 2016;14(4):4446, 26 pp. doi:10.2903/j.efsa.2016.4446. (9) A sampling zone is defined by an area of approximately 10 km x 10 km within a geographical area where the Bt-maize adoption rate and the target pest pressure are high to very high.

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The sampling frequency is outlined in Table 1. Bt-maize adoption levels can vary from year to year. The sampling methodology shall be adapted to these variations.

Table 1: Sampling frequency for monitoring for resistance evolution of Lepidopteran target pests based on their ecology and Bt-maize adoption rates.

Bt-maize adoption rate(a) Monovoltine Bi-/Multivoltine populations(c) populations(b)

< 20% None None

20%-60% Biennial Biennial

> 60%- 80% Biennial Annual

> 80%(d) Annual Annual

(a) The Bt-maize (i.e. both Cry 1Ab and Cry1F maize) adoption rate is expressed as a fraction of total maize cultivation in the same area, which is based on the data available for this area. (b) A monovoltine population is a population producing one generation in a year. (c) A bivoltine population is a population having two generations in a year. A multivoltine population is a population having several generations in a year. (d) In circumstances in which non-Bt-maize refugia have not been fully implemented.

(iii) Sample size

To conclude that the detection limit of resistance allele frequency is 3% or below, at least 1000 larvae will be collected within a geographical area, through sampling of three sampling zones.

3.2.2.5 Farmers' alert system for the performance of maize MON 810

In addition to field sampling and laboratory assays, the reported cases of unexpected damage of maize MON 810 plants as reported through the “Farmers' alert system for the performance of the product” shall be followed-up in a timely manner. Purchasers of maize MON 810 seeds shall be instructed by distributors to report unexpected levels of damage caused by target pests as and when they occur. The information gathered through this channel shall be such that it complements the information obtained through laboratory assays.

In case of reported unexpected damage the following shall be implemented to confirm that the unexpected damage was attributed to resistance evolution: 1. The cause of the reported unexpected damage shall be investigated, using available methods to confirm that the damaged plants express Cry1Ab protein, the damage resulted from a target pest and the damage is unexpected. 2. Insects shall be collected for the purpose of further evaluation.

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3. The collected insects shall be tested in a laboratory according to standardised protocols with the aim being to: a. Confirm field resistance; b. Confirm that resistance is heritable; c. Use crosses to determine the nature of resistance (i.e. recessive or dominant, and level of functional dominance); d. Estimate resistant allele frequency; e. Estimate whether resistant allele frequency is increasing by analysing field collections in subsequent years sampled from the same site where the resistant allele(s) was originally collected; f. Determine the geographic distribution of the resistant-allele by analysing field collections in subsequent years sampled from the same site where the resistant allele(s) was originally collected; 4. Conclude on the link between the unexpected damage and the potential resistance evolution.

3.2.3 Remedial plan

If the resistant allele frequency exceeds 3% or if it is confirmed that the reported unexpected damage was attributed to resistance evolution the Commission shall be informed immediately, irrespective of the regular scheduled PMEM reports. A remedial action plan shall be implemented as soon as resistance is identified in collaboration with the relevant competent authorities. Components of an appropriate remedial action plan may include: a. Informing customers and extension agents in the affected areas of confirmed resistance; b. Increasing monitoring in affected areas; c. Implementing alternative means to reduce or control target pest populations in affected areas; d. Modifying and amending the refuge strategy accordingly; e. If the above measures are not sufficient, then cessation of sales in the affected and bordering areas may be necessary until an effective local management plan, approved by the pertinent Member State and the European Commission, has been put in place; If interrupted, the cultivation of maize MON 810 in the affected area shall restart when an effective management plan has been implemented.

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4 General surveillance

4.1 Approach

GS has been designed to detect any unanticipated adverse effects on the environment that may be due to the cultivation of maize MON 810, including biodiversity and ecosystem services and functions. By nature, the prediction of unanticipated effects does not lend itself to the formulation of specific scientific hypotheses. The GS plan shall focus on the geographical regions within the EU where maize MON 810 may be grown, and take place in representative environments, reflecting the range and distribution of farming practices and environments exposed to maize MON 810 plants and their cultivation. GS shall comprise the following elements:  Farmer questionnaire.  Existing monitoring networks.  Review of relevant scientific publications.  Company stewardship programme.

4.2 Time period

The time period for GS shall be in line with the period of authorisation, i.e. 10 years, in areas where maize MON 810 is cultivated during the monitoring season.

4.3 Monitoring strategy

4.3.1 Farmer questionnaire

4.3.1.1 Design of the farmer questionnaire

The farmer questionnaire provided in Annex of this PMEM plan has been designed to seek specific information on previous and current cropping and management practices, and tenable comparisons between maize MON 810 and conventional maize. The farmer questionnaire shall be made available in the farmers’ local language for each region.

4.3.1.2 Reference for comparison between GM maize MON 810 and conventional maize

The reference for comparison can be:  Simultaneous growing of conventional maize by the same farmer.  Historical experience of growing conventional maize on the same farm.

4.3.1.3 Sampling

Based on the overall cultivation of maize MON 810 (i.e. on the basis of all the varieties being cultivated), a minimum sample size of 2500 questionnaires over the 10-year period of authorisation is required (i.e., 250 questionnaires for each cultivation year of maize MON

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810). The questionnaires shall be collected after every growing season. If, due to low uptake of maize MON 810, fewer than 250 farmers per year are identified, then the maximum possible number of farmers shall be surveyed. If at the end of the authorisation period less than 2500 questionnaires are completed, then the test statistics shall be evaluated for power. The sampling frame shall be clearly specified and described (total population included, characteristics of the population etc). National registers would be the optimum sampling frame. Customer lists or lists developed by local associations might also be used. The sampling method to select sampling units from the sampling frame shall be described. The sampling procedure shall ensure that the monitored area is proportionate to and representative of the total regional area under MON810 cultivation. It shall also ensure the representativeness of the varieties of maize MON 810 on the market. Monitoring shall focus on cultivation areas with a high uptake of maize MON 810. The area of cultivation (ratio of country and total area) shall be the first subdivision factor. The product situation(10) within the countries shall also be taken into consideration and the number of questionnaires per country adjusted accordingly. Within each stratum (per year and country), the determined number of farmers shall be selected randomly, and the method or the software used for this purpose shall be described. The proportion of new farmers and farmers with previous experience in maize MON 810 cultivation selected for each region shall be presented The losses to sampling shall be fully documented.

4.3.1.4 Collecting information via questionnaires

Reliable infrastructure shall be identified, in order to support the collection of information integrating: a. The breeders' own organisation, particularly when acting as seed suppliers; b. Seed distributors; c. Sales representatives and promoters; d. Growers of or other users of maize MON 810; e. Identification of interviewers. Farmers shall be interviewed by qualified, specially trained independent interviewers either in person or by phone, but in the same way within a season for all farmers. The personal data of farmers shall be handled in accordance with applicable data protection legislation such as Directive 95/46/EC11 on the protection of individuals with regard to the processing of personal data. The questionnaires shall be encoded to protect farmers’ identity in the survey, and confidentiality agreements shall be put in place between the different parties. The response rate of the survey and reasons for non-completion shall be specified yearly.

(10) Product situation takes into account the GM adoption rate of the different countries. (11) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31–50)

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4.3.1.5 Quality control

Before the data are analysed, they shall be subject to:  Completeness check: Certain database fields are defined as mandatory because they are indispensable for the analysis.  Validity check: Quantitative values have to vary within a plausible min-max range, qualitative values have to meet only acceptable parameter values.  Plausibility check: Data values have to be logical (e.g. the harvest date has to be after the sowing date) and to conform with European agricultural practices. Possible logical connections between the questions have to be identified and inquired. In case of missing or wrong data, queries shall be sent to the farmer in order to complete the database. Missing values shall be reported. If a questionnaire is excluded it shall be conserved in the raw data and reported as such.

4.3.1.6 Data analysis

Each monitoring characteristic shall be analysed according to the following scheme: 5. Calculation of the frequencies of the farmers’ answers for the three categories (''As usual'', ''More'', ''Less'') and the corresponding confidence intervals (CI). 6. Comparison of the frequencies ''More'' and/or ''Less'' answers and their corresponding 99% upper confidence bounds with the threshold of 10% (binomial test). 7. Interpretation of the test result (effect/ adverse/ beneficial) 8. In case of identified effects: review possible causes 9. In case of maize MON810 being identified as the cause of the effect: further explanation of possible mechanism, as far as supported by the collected information. A statistical analysis shall be conducted with all pooled data at intermediate periods depending on the level of uptake and at the end of the authorisation period. EFSA recommendations on methodologies of data analysis, clearly provided for similar GM crops should be taken into account.

4.3.2 Existing environmental surveillance networks

GS shall make use of established routine surveillance practices such as monitoring of agricultural plants, variety/seed registration, plant protection, plant health and soil surveys as well as ecological monitoring and environmental observations, where appropriate. Four categories of existing networks shall be considered: governmental networks that are official initiatives focused on particular policy areas; academic networks providing platforms for scientific communications on particular projects or research; trade networks that address specific professional issues; and environmental networks that educate, promote and collect information on observations of diverse components of nature. National routine surveillance programmes and networks can also provide relevant information.

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4.3.2.1 Identification and selection and suitability of existing environmental networks

The following steps shall be implemented for identification, selection and suitability appraisal of existing networks:  Identifing for existing networks that address relevant protection goals and areas of risk of interest,  Selecting and keeping an up-to-date database of existing networks that may be relevant for PMEM.  Cross checking with existing networks in case of an indication of an adverse effect relating to maize MON 810 and its cultivation. Existing inventories of environmental monitoring networks at the European level and/or any other relevant sources shall be used to identify existing environmental networks suitable for the purposes of monitoring maize MON 810. The initially identified networks shall be further evaluated in the following selection procedure. Step 1 The first screening shall be based on the information collected from the initially identified networks. In particular the following aspects should be taken into account:  Relevance for GS: Networks are selected to cover the environmental protection goals in the geographic regions in which maize MON 810 will be introduced. The information on networks shall be collected as early as possible following the entry into force of the authorisation, and shall be kept up-to-date throughout the authorisation period, with annual updates.  Availability of and level of accessibility to information. Step 2 For networks that pass step 1, suitability shall be further assessed, taking into account the following criteria:  Type (eg raw data) and quality of the data recorded  Statistical power and effect sizes detected by the monitoring networks  Track record and past performance of the networks  Methodologies used by the networks.(eg sampling and statistical approach)  Spatial scale of data collection (eg local, regional, national, zonal/ focusing in agricultural areas cultivating maize MON 810)  Temporal scale of data collection (eg frequency of data collection and reporting) A database with all the information collected on environmental existing networks, considered in step2 shall be made available as part of the annual PMEM report. The surveillance programmes that are relevant and develop reporting systems shall be identified so that all parties shall be fully informed about maize MON810, any specific management requirements, the importance of the monitoring programme and the importance of reporting of any unanticipated adverse effects during and after the cultivation of maize MON810.

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4.3.2.2 Baseline

The data provided by selected existing networks will serve as baseline for comparison of maize MON 810 cultivation with conventional maize cultivation, in case there are indications of an unexpected adverse effect. Related methodologies shall form part of the baseline.

4.3.2.3 Collecting information

Information shall be collected, as it becomes publicly available. This includes publications, journals, reports, information on websites and other communications. On a regular basis, the information on each network shall be verified in order to keep the listing up-to-date. Whenever new networks are identified, the same documentation and selection process as described above shall be followed.

4.3.2.4 Analysis

In case there are indications of an unexpected adverse effect reported via any other GS source of information (i.e., farmer questionnaire, literature, etc.), the information of the existing networks covering the specific protection goal or risk shall be reviewed, and the existing network may be contacted to investigate if there is any indication of the adverse effect occurring in the environment where maize MON 810 has been cultivated. The results of this analysis shall be communicated in the annual PMEM reports.

4.3.2.5 Quality control

The existing network selection shall be performed in a standardised way and all actions shall be properly recorded. Only data collected and published from existing surveillance networks shall be used. Records of these data shall be made available upon request.

4.3.3 Review of relevant scientific publications

4.3.3.1 Approach

A review of any study (scientific publications, studies, reports etc.) shall be performed based on a systematic literature search in generally recognised high quality online/electronic bibliographic databases. At least two such databases shall be used to allow some consideration of complementarity and redundancy. The search strategies shall be designed to retrieve a broad range of studies relevant to the cultivation of maize MON 810.

4.3.3.2 Baseline

The selection of a study shall be based on the level of relevance to the verification of an adverse effect according to the assumptions underlying the ERA. In addition the quality, validity and reference of each individual publication shall form part of the baseline.

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4.3.3.3 Timeline

The literature search shall be conducted annually throughout the authorisation period during the reporting period.

4.3.3.4 Assessment of relevant scientific publications

The full text of each publication shall be examined to determine whether it is relevant, according to criteria defined a priori. For each relevant publication, the authorisation holder shall:  List, summarise and provide details on the scientific content, including an assessment of its reliability  Put the results into the context of the original ERA by relating each study to the respective area of risk to be addressed in the ERA, and  Consider the implications of the results; in particular if this literature indicates any potential adverse environmental impacts associated with the cultivation of maize MON 810 and whether these findings alter the ERA conclusions, and risk management requirements including PMEM.

4.3.3.5 Quality control

Each stage of the study selection process shall be well documented, in order to make it assessable and reproducible.

4.3.3.6 Reporting requirements

The results of the review of relevant scientific publications shall be presented in a table as per the Appendix of the Commission Decision 2009/770/EC12. The selected publications shall be sorted by their relevance to each area of risk (e.g. human and animal health). The following information shall be provided in the annual PMEM report:  The complete search strategy or syntax used, including all the search terms and the logical association between the search terms (Boolean operators and parentheses).  The time span of the search (e.g. yearly basis or through weekly/monthly alerts).  Any limits applied to the search (e.g. publication types or language).  If the document is not in one of the official EU languages, a summary of the relevant parts shall be provided in English.  List of criteria for relevance and inclusion of the publications.  Date of the search, last update of each database use, whether the search strategy was adapted for each database use.  Full list of retrieved publications

(12) Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9).

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 Full-text documents of the relevant publications in electronic format.

4.3.4 Companies' stewardship programmes

4.3.4.1 Approach

Stewardship programmes for farmers are based on good agricultural practices to:  Facilitate compliance with the authorisation conditions,  Ensure that the products are used responsibly in a way that has similar or less environmental impacts compared to conventional crop cultivation, and  Ensure the sustainable use of the technology. To ensure the efficiency of the stewardship programme, the following shall be implemented:  Development of a leaflet for the farmers including the conditions of the Regulation, that will inform growers, seed suppliers, processors and other stakeholders about maize MON810 and its management and in particular the importance of the implementation of the measure to delay insect resistance.  Promoting the networks of the sales and technical organisations, through their routine visits to the farmers, ensuring a continuous and efficient communication link from the grower to the technology provider, especially in relation to complaints about product performance, difficulties with product management, compliance implementation and unexpected effects.  Establishment of a Farmers' Alert System for the Performance of the Product Performance, via which farmers can report any unexpected field damage resulting from lepidopteran target species control failure.  Providing farmers with contact details and directions on where they can obtain more information and instructions on how to make use of the Farmers' Alert System for the Performance of the Product.

4.3.4.2 Timeline

The stewardship programme shall continue throughout the life cycle of the product. Any information that may have an impact on the ERA or that is relevant for PMEM shall be included in the regular reporting.

5 Reporting and review

5.1 Submission of reports The authorisation holder shall submit single annual monitoring reports to the Commission and to the Competent Authorities of Member States in accordance with the conditions laid down in the Regulation. The report shall be submitted in electronic form (and in paper form upon request). Raw data shall be made available whenever requested by the European Commission and/or EFSA in order to allow different analyses and interrogation of the data. The results shall be presented in accordance with the standard reporting formats established by Commission Decision 2009/770/EC.

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Further to any specific reporting requirements mentioned herein, in general, reporting shall be conducted to the fullest detail possible, in accordance with EFSA guidance document on PMEM(13) as well as on the basis of EFSA opinions already issued on PMEM reports for the cultivation of MON810 in previous years. If compliance with EFSA recommendations on reporting details is not possible it shall be justified.

5.2 Reporting adverse effects

When new information becomes available from the users or other sources, with regard to the risks of maize MON 810 cultivation to human health or the environment after the authorisation has been given, the following shall be implemented:  Immediately take the measures necessary to protect human health and the environment,  Inform the competent authority thereof, and  Revise the information and conditions specified in the notification. Any indication of a possible adverse effect shall be immediately reported to the Commission irrespective of the regular scheduled PMEM reports. In addition, it shall be ensured that information, documentation, technical guides are provided to breeders, seed companies, agronomic advisers, farmers and other users, pointing to the need to report unexpected and/or adverse effects. Where an unusual effect linked with the cultivation of the maize MON 810 is observed, for which it is not certain that it should be classified as adverse; it shall be ensured that the Commission and the competent authority are informed in order to establish the most appropriate course of action.

5.3 Review and adaptation

The PMEM plan and associated methodology, the farmers' questionnaires and any accompanying documentation, may be developed and adapted by the authorisation holder in light of experience gained by all breeders or seed producers of maize MON 810 and in response to recommendations. Any adaptation shall be subject to the approval of the Commission.

(13) EFSA Panel on GMO; Scientific Opinion on guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants. EFSA Journal 2011;9(8):2316. [40 pp.] doi:10.2903/j.efsa.2011.2316.

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Annex - Farmer Questionnaire

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------Year Event Partner Country - Interviewer- Farmer - Area

Farmer Questionnaire Product: Farmer personal and confidential data Name of farmer: ______Address of farmer: ______City: ______Postal code: ______Country: ______Name of interviewer: ______Date of interview (DD / MM / YYYY): ______/ ______/

 The personal data of the farmer will be handled in accordance with applicable data protection legislation. The personal data of the farmers may be used for the purpose of interviews necessary for the survey if the farmers have authorised this use as per the data protection legislation.

 The questionnaires will be encoded to protect farmers' identity in the survey and confidentiality agreements will be put in place between the different parties (i.e. authorisation holder, licensees, interviewers and analyst) to further enforce this. The identity of a farmer will only be revealed to the authorisation holder if an adverse effect linked to their trait has been identified and needs to be investigated.

 Furthermore, the agreements between the different parties will also ensure that any information collected in the questionnaires will not be improperly shared or used.

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Code: Year □□□□ Event □□ Partner □□□ Country □□ Interviewer □□ Farmer □□ Area □□ Coding explanations:

2 0 1 3 - 0 1 - M A R - E S - 0 1 - 0 1 - 0 1

Year Event Partner Country Interviewer Farmer Area code code code code code Codes: Event: 01 MON810 02 …

Partner(14): MON Monsanto … … … … Country ES Spain … …

Interviewer(15): 01 A 02 B 03 …

Farmer: incremental counter within the interviewer. Area: Incremental counter within the farmer.

The information recorded here should be sufficient to enable the farm questionnaire to be identified with the corresponding entry for the same farm on the GMO Register held by the competent authority.

(14) Partner is the organization that implements the survey. (15) Interviewer is the employee from the Partner that is contacting the farmers.

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1 Maize grown area

1.1 Location:

Country/Region:

County:

How would you describe your farm type? O Arable O Dairy O Poultry O Orchard/Fruit O Mixed/other (please specify) ______

1.2 Surrounding environment: Which of the following would best describe the land usage in the surrounding of the areas planted with maize MON810 O Farmland O Forest or wild habitat O Residential or industrial O Mixed (please describe) ______

1.3 Size and number of fields of the maize cultivated area:

Total area of all maize cultivated on farm (ha) ______Total area of maize MON810 cultivated on farm (ha) ______Number of fields cultivated with maize MON810 ______

1.4 Maize varieties grown:

List up to five maize MON810 varieties planted this season:

1.

2.

3.

4.

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5.

List up to five conventional varieties planted this season:

1.

2.

3.

4.

5.

Are you growing any other GM maize varieties this season? O Yes O No

1.5 Soil characteristics of the maize grown area:

Mark the predominant soil type of the maize grown area (soil texture):

O very fine (clay) O fine (clay, sandy clay, silty clay) O medium (sandy clay loam, clay loam, sandy silt) O medium-fine (silty clay loam, silt loam)loam) O coarse (sand, loamy sand, sandy loam) O no predominant soil type (too variable across the maize grown area on the farm)

O I do not know

Characterize soil quality of the maize grown area (fertility): O below average - poor O average - normal O above average -good

Organic carbon content (%): ______

1.6 Local pest and disease pressure in maize:

Characterize this season's general pest pressure on the maize cultivated area:

Diseases (e.g., fungal, viral) O Lower O Same O Higher

Pests (e.g., insects, mites, nematodes) O Lower O Same O Higher

Weeds O Lower O Same O Higher

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2 Typical agronomic practices to grow maize on your farm

2.1 Irrigation of maize grown area:

O Yes O No

If yes, which type of irrigation technique do you apply:

O Gravity O Sprinkler O Pivot O Other

2.2 Major rotation of the maize grown area:

previous year: two years ago:

2.3 Soil tillage practices:

O No O Yes (mark the time of tillage: O Winter O Spring)

2.4 Maize planting technique:

O Conventional planting O Mulch O Direct sowing

2.5 Mark all typical weed and pest control practices in maize at your farm:

Number of applications Applied pre or post Practice Number of treatments compared to previous years emergence (more, less, same)

MCB & ECB insecticides

Insecticides for other pests

Bio control treatments

Herbicides

Mechanical weed control

Fertiliser

Manure

Fungicides

2.6 Application of fertilizer to maize grown area:

O Yes O No

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2.7 Typical time of maize sowing range (DD:MM - DD:MM):

2.8 Typical time of maize harvest range (DD:MM - DD:MM):

Grain maize: ______/______--______/

Forage maize: ______/______--______/

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3 Observations of maize MON810

3.1 Agricultural practices in maize MON810 (compared to conventional maize)

Did you change your agricultural practices in maize MON810 compared to conventional maize? If any of the answers is different from «As usual», please specify the change.

How did you perform your crop rotate for maize MON810 compared with conventional maize?

O As usual O Changed, because (describe the rotation): ______

Did you plant maize MON810 earlier or later than conventional maize?

O As usual O Earlier O Later, because:

Did you change your soil tillage or maize planting techniques to plant maize MON810?

O As usual O Changed, because ______

Full commercial name of insecticides you applied in maize MON810 field, including seed treatments:

1.______2.______3.______4.______

Full commercial name of herbicides you applied in maize MON810 field:

1.______2.______3.______4.______

Full commercial name of fungicides you applied in maize MON810 field:

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1.______2.______3.______4.______

In YYYY, how were the weed and pest control practices in maize MON810 when compared to conventional maize?

Insecticides: O As usual O Changed, because______

Herbicides: O As usual O Changed, because______

Fungicides: O As usual O Changed, because______

In YYYY, did you change maize borer control practices in maize MON810 when compared to conventional maize?

O Similar O Changed, because______

In YYYY, how were the fertilizer application practices in maize MON810 when compared to conventional maize?

O Similar O Changed, because______

In YYYY, how were the irrigation practices in maize MON810 when compared to conventional maize?

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O Similar O Changed, because______

Did you harvest maize MON810 earlier or later than conventional maize?

O Similar O Earlier O Later because ______

3.2 Characteristics of maize MON810 in the field (compared to conventional maize)

Germination vigour O As usual O More vigourous O Less vigourous

Time to emergence O As usual O Accelerated O Delayed

Time to male flowering O As usual O Accelerated O Delayed

Plant growth and development O As usual O Accelerated O Delayed

Incidence of stalk/root lodging O As usual O More often O Less often

Time to maturity O As usual O Accelerated O Delayed

Yield O As usual O Higher yield O Lower yield

Occurrence of volunteers from previous year planting O As usual O More often Less often (if relevant)

If any of the answers above is different from «As usual», please specify:

Please detail any additional unusual observations regarding the crop maize MON810 during its growth:

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3.3 Characterise the maize MON810 susceptibility to disease (compared to conventional maize)

Overall assessment of disease susceptibility of maize MON810 compared to conventional maize (fungal, viral diseases):

O As usual O More susceptible(16) O Less susceptible(17)

If the above answer is different from «As usual», please specify the difference in disease susceptibility in the list and the commentary section below:

1. Fusarium spp. O More O Less

2. Ustilago maydis = U. zeae. O More O Less

3. XXXXX. O More O Less

4. XXXXX. O More O Less

5. XXXXX. O More O Less

6. Other O More O Less

Additional comments:

3.4 Characterise the INSECT pest control in maize MON810 fields (compared to conventional maize)

On the two insects controlled by maize MON810, overall efficacy of the GM varieties on:

1. European corn borer (Ostrinia nubilalis):

O Very good O Good O Weak O Don't know

(16) More susceptible than conventional maize (17) Less susceptible than conventional maize

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2. Pink borer (Sesamia spp.):

O Very good O Good O Weak O Don't know

3.5 Characterise the maize MON810 susceptibility to OTHER pests susceptibility (compared to conventional maize)

Except the two insects mentioned above, overall assessment of pest susceptibility of maize MON810 compared to conventional maize (insect, mite, nematode pests):

O As usual O More susceptible O Less susceptible

If the above answer is different from «As usual», please specify the difference in pest susceptibility in the list and the commentary section below:

1.______O More O Less 2.______O More O Less 3.______O More O Less 4.______O More O Less 5.______O More O Less

Additional comments:

3.6 Characterise the weed pressure in maize MON810 fields (compared to conventional maize)

Overall assessment of the weed pressure in maize MON810 compared to conventional maize:

O As usual O More weeds O Less weeds

List the three most abundant weeds in your maize MON810 field:

1.______2.______3.______

Were there any unusual observations regarding the occurrence of weeds in maize MON810?

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3.7 Occurrence of wildlife in maize MON810 fields (compared to conventional maize)

General impression of the occurrence of wildlife (insects, birds, and mammals) in maize MON810 compared to conventional maize fields:

Occurrence of insects (arthropods):

O As usual O More O Less O Do not know

If the answer above is «More» or «Less», please specify your observation:

Occurrence of birds:

O As usual O More O Less O Do not know

If the answer above is «More» or «Less», please specify your observation:

Occurrence of mammals:

O As usual O More O Less O Do not know

If the answer above is «More» or «Less», please specify your observation:

3.8 Feed use of maize MON810 (if previous year experience with this event)

Did you use the maize MON810 harvest for animal feed on your farm?

O Yes O No

If "Yes", please give your general impression of the performance of the animals fed maize MON810 compared to animals fed conventional maize.

O As usual O Different O Do not know

If the answer above is «Different», please specify your observation:

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3.9 Any additional remarks or observations [e.g. from fields planted with event xxxx that were not selected for the survey]

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4 Implementation of Bt-maize specific measures

4.1 Have you been informed on good agricultural practices for maize MON810?

O Yes O No

Only if you answered "Yes", would you evaluate these technical sessions as:

O Very useful O Useful O Not useful

4.2 Seed

Was the seed bag labelled with accompanying specific documentation indicating that the product is genetically modified maize MON810?

O Yes O No

Did you comply with the label recommendations on seed bags?

O Yes O No, because:______

4.3 Prevention of insect resistance

Did you plant a refuge in accordance to the technical guidelines?

O Yes O No, because:______

4.4 Isolation distances from protected habitats

Is your farm the closest to a protected habitat?

O Yes O No

If you answered "Yes", did you apply 5 meters isolation distance between that farm and the protected habitat?

O Yes O No, because:______

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