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

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Post Market Environmental Monitoring Plan for Cultivation of Maize MON 810 in the EU Post Market Environmental Monitoring Plan for cultivation of maize 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 PROTEIN 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 Page 2 of 31 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 Lepidoptera 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 Monsanto. 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
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