第 1 层和第 2A 层情景参数化和示例计算 - 支持根据理事会指令 91414EEC 和议会和理事会条例 (EC) 11072009 修订土壤持久性指导文件（SANCO 9188VI97 rev. 8, 12.07.2000).pdf

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1、 EFSA Journal 2012;10(1):2433 Suggested citation: European Food Safety Authority; Tier-1 and Tier-2A Scenario Parameterisation and Example Calculations. EFSA Journal 2012;10(1):2433 64 pp. doi:10.2903/j.efsa.2012.2433. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority,

2、2012 1 SCIENTIFIC REPORT OF EFSA Tier-1 and Tier-2A Scenario Parameterisation and Example Calculations 1 In Support of the Revision of the Guidance Document on Persistence in Soil under Council Directive 91/414/EEC and Parliament and Council Regulation (EC) 1107/2009 (SANCO/9188/VI/97 rev. 8, 12.07.

3、2000) European Food Safety Authority2, 3 European Food Safety Authority (EFSA), Parma, Italy 1 On request of EFSA, Question No EFSA-Q-2011-00113, issued on 16/12/2011. 2 Correspondence: pesticides.pprefsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the experts for the preparation of this EFSA

4、scientific output: Aaldrik Tiktak, Jan Vanderborght, Michael Klein, Jos Boesten, Richard Bromilow and EFSA staff members Mark Egsmose, Maria Sodani and Judith Ricketts for the support provided to this scientific output. EFSA wishes to thank Tony Hardy, Paulo Sousa, Andreas Schffer and Theo Brock for

5、 reviewing this scientific output. Parameterisation of scenarios for exposure of soil organisms EFSA Journal 2012;10(1):2433 2 ABSTRACT European scenarios for exposure of soil organisms to Plant Protection Products are currently not available (EFSA Panel on Plant Protection Products and their Residu

6、es (PPR), 2010). In this document, the parameterisation of realistic worst-case scenarios for Tier-1 and Tier-2A simulations is described which are part of a tiered approach. The aim of this scheme is to assess such Predicted Environmental Concentrations (PEC), chosen to be the 90th spatial percenti

7、le, resulting from the use of the plant protection product. In order to account for the uncertainty in substance and soil properties, the Tier-2A scenarios are combinations of soil and climatic properties within a zone, for which the predicted concentration is equal to the 95th percentile of all con

8、centrations within the area of annual crops. The selected soil profiles are based on digitised information from topsoil (organic matter and texture) combined with calculated average soil profiles available in the SPADE-1 database. The daily weather information for the scenarios is taken from the MAR

9、S database using the period 1990-2009. In order to have a sufficient overview on the differences between simulations performed with the analytical Tier-1 model and the numerical Tier-2A models, PEARL and PELMO test runs are performed covering all relevant substance properties and all evaluation dept

10、hs. For each of the total-soil scenarios, both models simulate nearly the same concentration. Small differences between PEARL and PELMO can be found for the pore-water scenarios due to differences in the calculation of soil moisture contents. The comparison with the analytical model shows that Tier-

11、1 concentrations are usually above the respective Tier-2A concentrations in accordance with the philosophy of the tiered assessment scheme. However, due to the different handling of soil moisture, Tier-1 simulations may occasionally give concentrations below those of Tier 2A, which occurrence necess

12、itates additional calibration using special model-adjustment factors. European Food Safety Authority, 2012 KEY WORDS Exposure assessment, exposure scenarios, scenario development, soil, parameter uncertainty, scenario uncertainty, plant protection product, PEARL, PELMO Parameterisation of scenarios

13、for exposure of soil organisms EFSA Journal 2012;10(1):2433 3 SUMMARY European scenarios for exposure of soil organisms to Plant Protection Products are currently not available (EFSA Panel on Plant Protection Products and their Residues (PPR), 2010). There is, however, a need for such scenarios at t

14、he EU level in view of ongoing discussions in PRAPeR experts groups4 on PECSOIL. Therefore, the PPR Panel has started a revision of the existing Guidance Document on Persistence in Soil (SANCO/9188/VI/97 rev. 8, 12.07.2000) by developing tiered exposure-assessment approaches for soil organisms in wh

15、ich European exposure scenarios play an important role. The assessment scheme comprises five tiers, each with realistic worst-case scenarios. The tiered scheme applies to spray applications to annual crops under conventional or reduced tillage but may also be useful for other types of application or

16、 other tillage systems. In this document, the parameterisation of realistic worst-case scenarios for Tier-1 and Tier-2A simulations is described. Here, a realistic worst-case scenario is defined as a combination of soil and climate properties within a certain region for which predicted concentration

17、s (PECs) are equal to a certain percentile of the distribution of concentrations for all climate and soil-property combinations within the region. The scenarios are part of a tiered approach. The aim of this tiered approach is to assess this spatial percentile, chosen to be the 90th, resulting from

18、the use of the plant protection product (assuming a market share of 100%) and considering the population of agricultural fields (in one of the three regulatory zones) where the crop is grown and in which this plant protection product is applied. Tier 1, Tier 2 B and Tier 2C are proposed to be based

19、on a simple analytical mode, whereas Tier 2A, Tier 3 and Tier 4 will utilise numerical fate models. The scenarios are combinations of soil and climatic properties within a zone, for which the predicted concentration is equal to the 90th percentile of all concentrations within the area of annual crop

20、s. The end-point for the exposure assessment is, however, the 90th percentile of the exposure concentration within the intended area of use of a plant protection product. The area of the selected crop (or combination of crops) will have an effect on the 90th percentile exposure concentration, and so

21、 the Tier-2A scenarios as such may not be conservative enough; this problem is handled by introducing crop extrapolation factors. Furthermore, the overall 90th percentile of the substance concentration is shifted towards higher values if uncertainty in substance properties and soil properties is con

22、sidered. As a consequence the selected scenario may not be sufficiently conservative if scenarios are selected without consideration of uncertainty about substance and soil properties; such uncertainty has therefore explicitly been incorporated in the scenario-selection procedure. It was found that

23、for the soil exposure end-points (peak concentration in total soil and concentration in the liquid phase), the 90th overall percentile corresponds to the 95th percentile of the cumulative probability density function (cpdf) resulting from median substance properties and deterministic soil properties

24、. The scenario selection was based on properties of the topsoil (organic matter and texture). However, the fate models also need information about subsoil properties. As the spatial coverage of European soil-profile databases is less than 100%, it was not possible to extract this information from th

25、e databases. Instead, average soil profiles, based on all arable soil profiles available in the SPADE-1 database, were calculated. The use of average soil profiles was judged to be acceptable because the evaluation depth for the exposure assessment is only the top 20 cm. The MARS climate database pr

26、ovides daily weather data for the entire EU-27 in a 25x25 km2 grid. Therefore, daily weather data as needed by the fate models can be directly extracted for the selected scenario locations from the appropriate MARS grid. The MARS database contains all the parameters required for simulation runs with

27、 the current fate models, such as minimum and maximum 4 Now replaced by Pesticides Unit Parameterisation of scenarios for exposure of soil organisms EFSA Journal 2012;10(1):2433 4 temperature, rainfall, potential evapotranspiration and global radiation. A quality check was performed to see if the da

28、taset contains unrealistic data (see EFSA, 2010 for details). The MARS weather data for the period 1990-2009 were used, converting these to a 66-year time-series using the rules described in FOCUS (2000). Tier-2A scenarios have been developed for a range of annual crops. Crop emergence and harvest d

29、ates for these crops were taken from FOCUS (2010). The corresponding FOCUS scenario was selected from a map of FOCUS climatic zones. A crop that is irrigated in the corresponding FOCUS scenario in the same climatic zone was assumed also to be irrigated in the EFSA soil scenario. Ploughing was assume

30、d to occur one month before crop emergence for all locations and all crops because all scenario soils have medium to coarse soil texture. Early ploughing in the preceding winter is assumed to occur only for heavy clay soils. The same crop extrapolation factors were considered for Tier 2A as for Tier

31、 1. Different safety factors were made available for major and minor crops. In order to have a sufficient overview on the differences between Tier-1 and Tier-2A simulations, test runs were performed that covered all relevant substance properties and all evaluation depths. In most of the comparisons,

32、 Tier-1 concentrations were found to be above the respective Tier-2A concentrations in accordance with the philosophy of the tiered assessment scheme. However, due to different handling of soil moisture, Tier-1 simulations can occasionally give concentrations below those of Tier 2A, which occurrence

33、 necessitates additional calibration using special model adjustment factors which are provided. Parameterisation of scenarios for exposure of soil organisms EFSA Journal 2012;10(1):2433 5 TABLE OF CONTENTS Abstract . 2Summary . 3Table of contents . 5Background as provided by EFSA . 6Terms of referen

34、ce as provided by EFSA . 61.Introduction . 71.1. Aim of the study . 71.2. Targets for the exposure assessment . 72.Description of the scenarios . 102.1. General characterisation of the scenarios . 102.1.1 Location of the scenarios . 112.1.2 Basic parameters of the scenarios . 112.2. Description and

35、parameterisation of Tier-1 scenarios . 122.3. Parameterisation of Tier-2A scenarios . 132.3.1.Soil input data . 132.3.2.Weather input data and irrigation . 182.3.3.Crop data. 242.3.4.Runoff and soil erosion . 302.3.5.Crop extrapolation factors . 303.Results of test runs using the scenarios to compar

36、e PELMO and PEARL . 323.1. Pesticide input data and application pattern . 323.2. Endpoints considered in the comparison . 333.3. Results of Tier-2A simulations calculated with PEARL and PELMO . 344.Test calculations to calibrate Tier 1 . 534.1. Input data and application pattern . 534.2. Calibration

37、 procedure . 534.3. Results of the simulations . 534.4. Possible model adjustment factors . 59References . 61Appendices . 62A.Description of the Tier-1 model . 62B.PEARL documentation . 63C.PELMO documentation . 63Glossary and abbreviations . 64 Parameterisation of scenarios for exposure of soil org

38、anisms EFSA Journal 2012;10(1):2433 6 BACKGROUND AS PROVIDED BY EFSA During the review process of the substances of the second list, several concerns were raised regarding the Guidance Document on persistence in soil. A number of Member states have expressed interest in a revision of the current Gui

39、dance Document on persistence in soil during the general consultation of Member States on Guidance Documents in answer to the request by the Director of Sciences of EFSA in a letter of 3rd July 2006 sent via the Standing Committee on the Food Chain and Animal Health. Further the former EFSA PRAPeR U

40、nit has noted that Guidance Document needs to be brought in line with the FOCUS degradation kinetics report (SANCO/100058/2005, version 2.0, June 2006). FOCUS (1997) developed the first guidance at EU level for exposure assessment in soil. This included a simple approach for estimating PECSOIL but F

41、OCUS (1997) did not develop first-tier scenarios (in contrast to subsequent FOCUS workgroups that developed such scenarios for surface water and groundwater as development of soil scenarios was a lower priority at that time). FOCUS (2006) developed detailed guidance on estimating degradation rate pa

42、rameters from laboratory and field studies, but did not develop exposure scenarios. Nevertheless there is need for such scenarios in view of ongoing discussions in the peer review expert group regarding PECSOIL as current approaches at EU level just represent the range of climatic conditions covered

43、 by available field dissipation and or accumulation studies and member states would like tools to be able to extrapolate to a wider range of climates present in the EU. The existing Guidance Document on Persistence in Soil (9188/VI/97 rev 8) published in 2000 did not include scenarios. The intention

44、 with the new guidance document is to update the existing Guidance Document on Persistence in Soil to include European exposure scenarios for soil and to provide guidance on best practice for using the results of field experiments and soil accumulation studies in the exposure assessment. TERMS OF RE

45、FERENCE AS PROVIDED BY EFSA The intention with this report is to provide the scientific methodology for the parameterisation and calibration of the EU soil scenarios for estimating exposure of pesticides to soil organisms. The report will provide scientific input to address the terms of references t

46、asked by EFSA to the PPR Panel and approved on the 7th February 2011 by the EFSA Executive Director. The Scientific Panel on Plant Protection Products and their Residues (PPR Panel) of EFSA is asked to prepare a revision of the Guidance Document on persistence in soil (SANCO/9188VI/1997 of 12 July 2

47、000). Parameterisation of scenarios for exposure of soil organisms EFSA Journal 2012;10(1):2433 7 1. INTRODUCTION 1.1. Aim of the study European scenarios for exposure of soil organisms to Plant Protection Products are currently not available (EFSA panel on Plant Protection Products and their Residu

48、es (PPR), 2010). There is, however, a need for such scenarios at the EU level in view of ongoing discussions in PRAPeR experts groups on PECSOIL. Therefore, the PPR Panel has started a revision of the existing Guidance Document on Persistence in Soil (SANCO/9188/VI/97 rev. 8, 12.07.2000) by developi

49、ng tiered exposure-assessment approaches for soil organisms in which European exposure scenarios play an important role. The assessment scheme comprises five tiers, each with realistic worst-case scenarios. The tiered scheme applies to spray applications to annual crops under conventional or reduced

50、 tillage but may also be useful for other types of application or other tillage systems. In this document, the parameterisation of realistic worst-case scenarios for Tier-1 and Tier-2A simulations is described. Here, a realistic worst-case scenario is defined as a combination of soil and climate pro