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Efficacy Regulation Where Do We Go?

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Efficacy Regulation Where Do We Go? Efficacy regulation Where do we go? Udo Heimbach JKI, Institute for Plant Protection in Field Crops and Grassland 1 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland www.jki.bund.de Efficacy regulation Why Efficacy regulation? Effective pest control should be ensured neutrally to secure farmers No problems should arise from product use - direct phytotoxicity - yield - quality (including transformation processes, taint) - plants or plant parts used for propagation - succeeding crops including substitute crops - adjacent crops - technical problems with application technique or sowing 2 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Efficacy regulation Why Efficacy regulation? Pest control should be sustainable (possible also in future) - e.g. resistance issues - no other unacceptable effects on crop production (e.g. pollinators and natural enemies Minimum risk for humans and environment should arise from any use, Minimum effective dose, maximum dose rate /ha, correct timing, etc. Regulatory requirements are in line with the aims of companies, if companies feel responsible for a safe and sustainable use of their PPP 3 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Efficacy regulation Why Efficacy regulation? Risk - Benefit (Efficacy) analysis is a coming issue! Legal requirements EU regulatory demands National regulatory demands EU zonal approach aims to improve harmonisation between countries 4 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Zonal Efficacy regulation, why? Presentation W. Reinert, EU Com, EPPO Workshop Oct . 2013 in Sofia 5 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Zonal Efficacy regulation Scientific approach? 6 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grasslandhttp://bdj.pensoft.net//showimg.php?filename=oo_9169.jpg 3 EU Zones, political 4 EPPO Zones, scientific 7 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland 3 EU Zones 4 EPPO Zones Problems for Efficacy Evaluation Pests and pest problems do not follow any zones, they react species specific according to their biology e.g. European Corn Borer (Ostrinia nubilabilis) Damage mainly in the south of Europe (and south Germany) but also in northern parts of east Europe including east Germany, Neither following EPPO nor EU zones Pests may adapt to changes of climate and agricultural use patterns faster than political decisions 8 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland 3 EU Zones 4 EPPO Zones Problems for Efficacy Evaluation Agricultural patterns do not follow zonal systems Cropping intensity often affects pest pressure and - may be historically high (e.g. for linseed in BE or for potato and bulb production in NL) - may be driven by industrial processing nearby (sugar beet) - may change over time due to policy (e.g. subsidising bioenergy) and market price (e.g. monoculture and expanding area of maize to north Europe and of oil seed rape to south and east Europe) 9 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland 3 EU Zones 4 EPPO Zones Problems for Efficacy Evaluation How to solve problems? Product development and regulation should be based on scientific knowledge to support sustainable farming and sustainable PPP marketing Trial location and No. of trials should generally be based on EPPO zones and not on EU zones and in addition - should be aware of variable pest damage (and PPP use) in EPPO and EU zones - regions with high damages (and PPP use) with more trials than low damage regions 10 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Distribution of Colorado Potato Beetle trials in EU Central Zone EPPO Zones Maritime East, South East All 3 zones 11 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Basis of Harmonisation: EPPO Standards More than 20 general standards on www.eppo.int More than 200 crop and pest specific EPPO Standards PP1/181 Conduct and reporting of efficacy evaluation trials incl. GEP PP1/152 Design and analysis of efficacy evaluation trials PP1/135 Phytotoxicity assessment PP1/214 Principles of acceptable efficacy PP1/241 Guidance on comparable climate PP1/226 Number of efficacy trials, PP1/225 Minimum effective dose PP1/213 Resistance risk analysis PP1/256 Adjacent crops, PP1/207 Succeeding crops PP1/224 Principles of efficacy evaluation for minor uses PP1/240 Harmonized basic information for databases on PPP PP1/248 Harmonized classification and coding of the uses of PPP PP 1/278 Principles of zonal data production and evaluation Not a complete list! 12 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation Reports and dRR with sufficient detail to allow zRMS evaluation cMS need to understand the basis of zRMS evaluation Most aspects of efficacy should be covered in a core doc. for each zone, allowing easy evaluation and decision To speed up evaluation a well prepared detailed BAD as well as a separate shorter dRR are needed. dRRs need to be specific for the intended zone A national addenda is needed only for some regional specific aspects 13 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Example of a dRR summary table on Oil Seed Rape pests, how to use this?? Test Product Test Product Rating 0,2 l/ha 0,3 l/ha Reference Standard Pest Code Type Unit Mean Trials Min Max Mean Trials Min Max Mean Trials Min Max ALL PESINC %UNCK 74,4 a 27 52,1 100 77,3 a 27 33,3 100 77,5 a 25 41,3 100 ALL PESSEV %UNCK 65,9 a 12 31,1 100 69,2 a 12 29,3 100 73,2 a 11 39,4 100 CEUTAS PESINC %UNCK 75,9 a 10 52,1 100 78,4 a 10 53,9 100 75,9 a 10 51,4 100 CEUTAS PESSEV %UNCK 31,1 a 1 29,3 a 1 39,4 a 1 CEUTNA PESINC %UNCK 76,5 a 10 53,9 88,8 80,6 a 10 50 96,4 77,8 a 8 41,3 93,6 CEUTNA PESSEV %UNCK 68,7 a 5 54,3 92,5 71,4 a 5 54,7 100 74,5 a 5 53,4 100 CEUTQU PESINC %UNCK 81,5 a 4 68,5 95 74,0 a 4 33,3 95 80,2 a 2 80 80,4 CEUTQU PESSEV %UNCK 72,8 a 4 47,9 100 74,5 a 4 47,9 100 76,9 a 3 69,9 85,9 CEUTSP PESINC %UNCK 64,4 b 5 53,9 79,2 73,9 a 5 61 87,5 79,2 a 5 65,8 100 CEUTSP PESSEV %UNCK 62,3 c 2 45,3 79,2 73,1 b 2 54,5 91,7 81,2 a 2 62,4 100 Yield %UNCK 115,8 a 5 104,3 139,2 113,6 a 5 105,2 132,9 112,8 a 3 101,4 122,4 Mean separation test: SNK 0,05 PESSEV= damage severity, PESINC= Number of insects, % UNCK versus check 14 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation Clear Intended Uses (showing deviatons for spec. countries) The applicant should describe all details (EPPO PP1/240, esp. no 15 - 34) of his recommended use for each country, e.g.: • area of use (e.g. outdoor) • name of crop/product/object or group of these (EPPO code!) • restriction to certain uses (e.g. only for seed production) • name of pest/target or group of these (EPPO code!) stages of pest • type of treatment – e.g. seed treatment • time of treatment incl. restrictions (e.g. not during flowering) and BBCH • maximum dose rate per application • any dose changes according to e.g. crop stage, soil type, pest stage • maximum dose rate /crop or /season for all crop/pest combinations and total rate /crop or maximum no. of seeds/ha • Minimum / maximum intervals between treatments • any necessary mixing partner with detailed information • resistance phrases • IPM suitability claims Not a complete list! 15 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Europe as 1 zone only for seed treatment /glasshouses, stored products Reasoning (??): in house treatment Effects in the field should be provided for each EPPO zone as for spray applications 20 – 30 trials from relevant EPPO zones representative for different soil types No. of trials higher if insufficient persistence or high variability of efficacy Dose may differ between major pests and vary between regions (e.g. higher dose for regions with high pest damage pressure) Minimum effective dose should be provided for major pests Different sowing density, row distance or planting technology may affect efficiency For regional cultivars consider phytotoxicity Free transportation and use of treated seeds in all Europe! 16 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Maximum sowing rate per ha draft EU Seed Guidance Document Crop Max. seed sowing rate Max. seed sowing rate (kg/ha) (no. seeds/ha) Maize 100,000 Winter oil seed rape 700,000 Summer Oilseed rape 1,200,000 Sunflower 75,000 Wheat 240 Barley 180 Barley hybrid cultivars 120 Rye 180 Rye hybrid cultivars 120 Triticale 180 Oat 160 Sugar beet 100,000 Linseed, flax 150 17 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Maximum sowing rate per ha draft EU Seed Guidance Document Crop Max. seed sowing rate Max. seed sowing rate (kg/ha) (no. seeds/ha) Broad Bean (Vicia) 300 Pea 280 Garden Beans 350,000 Lupin 250 Onion 2,500,000 Carrot 3,000,000 Cabbage 100,000 Leek 500,000 Spinach 7,000,000 Broad Bean (Vicia) 300 Pea 280 Garden Beans 350,000 Lupin 250 18 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation Example seed treatment Recommendations Applicants should aim to apply - for different rates (different uses!) depending on pest pressure (supported by trials with different rates) - for different pests - for worst case sowing rates for all regions applied for (take at least plus 20% of the values given in the tables before) - for a harmonised dose expression (per seed or per weight) 19 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation RMS evaluators need to understand the agricultural and pest situation for all countries a product is applied for! Be aware of differences in crop and pest groupings between countries! Groups are not harmonised yet and may differ to residue groupings.
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