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. EPPO is working on this Also English common names are not clearly defined Sometimes we get meaningless applications!
Do not use automatically translation: Rape may mean a crop or something less nice (which once was applied for in DE)
Groups need to be explained clearly presenting species or crop names using solely EPPO codes
20 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation
Applicants and Evaluators need Information on pest biology and pest damage and regional cropping intensity for different relevant regions within the zone Differences have to be expected between areas even within a zone e.g. more generations of a pest, other pest species composition in warm climate. More appl. or higher doses may be necessary Differences in the regional way of crop production (e.g. crop rotation, application technique) should be described, which allow regulators in other regions to understand the way and need for the intensity of control
21 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation
Efficacy at intended dose rate, Trial No. and distribution Climatic and agricultural situation differ within zones influencing trial No. and distribution Extrapolation of data between pest, crops and regions is often possible (e.g. EPPO extrapolation tables)
Example Colorado Potato Beetle in the central zone: At least 10 trials from southern and northern continental areas (e.g. Poland, Czech Republic, Hungary) plus at least 10 trials from southern and northern maritime climate areas (e.g. Netherland, Belgium, Germany) using dose rates foreseen for the specific regions More data may be needed from areas with high summer temperature. Most trials should come from regions with high potato production and CPB pressure. No registration and no data are needed from northern countries where CPB is not considered to be a pest problem
22 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation
Efficacy at intended dose rate, Trial No. and distribution Trials from other EU zones esp. of bordering areas may reduce trial No. All data should be presented - separately for regions with similar conditions - additionally in a combined form in case the same rate is intended Scientifically sound summary tables are needed (EPPO) Minor uses do not need trial data in the EU regulation but may be extrapolated, some trials be may be carried out in different EPPO zones A minor of a single country might not be a minor use any more of an EU zone! Minor use harmonisation is urgently needed
23 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation
Minimum effective dose
Minimum effective dose trials should be carried out taking EPPO zones in mind Dose applied needs to be correct for different circumstances (e.g. temperature, pest pressure, soil type, etc.) Trials have to carried out on major crops and pests intended A need for different dosing between countries of a zone is likely depending on chemistry and pest biology, 3 doses in most trials recommended allowing use for multiple purpose The number and timing of applications has to be explained 24 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation
Unwanted direct effects on the crop Phytotoxicity data with higher rates for herbicides, growth regulators and seed treatments In all PPP trials phytotoxic effect occurring on the crop should be scored If indication of phytotoxic effects, more detailed trials are needed clarifying when such effects may occur (e.g. under which distinct climatic of agricultural conditions (EPPO) Yield data may be needed where phytotoxicity occurs in trials of insecticides and fungicides, some specific EPPO Standards ask for it New actives with unknown properties may require yield data If applicable taint and other unintended effects have to be
25checked Oct 14 Heimbach Institute for(EPPO) Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation
Unwanted effects on adjacent plants or succeeding crops
For herbicides and growth regulators specific data needed Usually not needed for other PPP, if there are no phytotoxic effects For new insecticidal or fungicidal actives with little experience and information some data may needed
Unwanted effects on beneficial organisms
Usually no special trials needed, but observations in efficacy field trials should be reported Depending on country specific regulations, information on specific beneficial organisms may be needed
26 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland What is needed for a zonal evaluation Resistance If resistance likely (pest biology, historical knowledge, type of PPP activity) sensitivity data needed, allowing to follow any resistance development Samples from different areas of the zone (similar to efficacy data), the majority from regions with high need for control or known resistance to other actives, some samples from areas with low control need Data of other EU zones support evaluation of resistance risk Cross resistance checks with samples from areas with and without resistance Data No. depend on efforts needed to produce them. E.g. for actives with no information and CPB at least 15 populations each for the central and southern zone Resistance strategies may differ between regions with different resistance likelihood
27 OctResistance 14 Heimbach Institute for Plant monitoring Protection in Field Crops and Grassland might be needed if a shift is expected National addenda Specific Resistance management strategies are generally country specific - taking into account other PPP registered, - regional pest situation, - regional resistance status, - regional agricultural (and political!) conditions Succeeding /adjacent crop restrictions depend on regional agricultural condition IPM – different national requirements (e.g. IPM labels) Convenience tank mixtures, obligatory mixtures Specific regional targets / uses Dose expression adjustment in 3-dim. crops may be necessary
28Bee Oct 14 Heimbach protection Institute for Plant Protection strategies in Field Crops and Grassland and claims are often country specific Zonal Efficacy regulation, why?
Praesentation W. Reinert, EU Com, EPPO Workshop Oct . 2013 in Sofia
29 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Zonal Efficacy regulation
Why intermediate? The same capacity of experts in each of the EU countries impossible, this results in different decisions between countries Workload high, many countries can not keep timelines and reject applications Competition between countries for fees Applicants may select countries with low demands even if fees are higher, applicants failing in country A may try again and succeed in country B Influence of national politics on regulators - e.g. different approach between countries to use old trial data and conclude on generic products - e.g. countries with pest control problems easily approve a PPP 30 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Zonal Efficacy regulation
Alternatively a central evaluation? No regional knowledge if centralised evaluation and regulation, Decisions taken like from a drawing board neglecting real life Workload will be very high, regulators will concentrate on formal aspects and models (see ecotox, e.g. EFSA Bee Guidance Doc.) Evaluation reports and data will be even more useless for IPM and will not support the political wish of PPP reduction
Or improve the current situation? About 50 country evaluators have an annual meeting just now in Italy and try to harmonise with no support by the EU Com EPPO works hard on harmonisation since several years
31 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland Thanks for listening
New systems demand
more learning from all of us (learning is said to be healthy and keeps us young!)
more meetings like this here are necessary (supporting social life!)
more work (creating jobs!)
32 Oct 14 Heimbach Institute for Plant Protection in Field Crops and Grassland