comparison of national approaches for pesticide exposure...

Comparison of National Approaches for

Pesticide Exposure Assessment in the EU

Central Zone

Abdul Abu, Wendy van Beinum & Sabine Beulke

FINAL REPORT

Defra Project PS2253

The Food and Environment Research Agency

Sand Hutton, York, YO41 1LZ, UK

Tel: 01904 462000 Fax: 01904 462111

Web: http://www.defra.gov.uk/fera

OCTOBER 2013

FERA Project No.: Y6FW

Client Project No.: PS2253

Report Status: Final

Dissemination: External

Report prepared by: A Abu, W van Beinum & S Beulke

Date: 24 October 2013

Executive Summary

A major goal of the new European Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market is harmonisation of the criteria, procedures and conditions for authorisation among Member States (MS). To avoid duplication of work, reduce the burden on industry and on MS, and to provide for more harmonised availability of plant protection products, authorisations granted by one MS should be accepted by other MS where agricultural and environmental conditions are comparable under the principle of mutual recognition set out in Regulation (EC) No 1107/2009. To this end, the EU community was divided into three regulatory zones—Northern, Central and Southern Zone.

In this project, a review was undertaken of the procedures requested by the MS in the Central Zone to calculate predicted environmental concentrations (PECs) in groundwater and surface water. Nine dummy substances with a range of sorption (Koc) and degradation (DT50) properties were assessed with FOCUS models and scenarios commonly used at EU level, and according to MS requirements. The results were evaluated according to those that passed at EU and MS levels and those that failed the risk assessment only at specific MS level. Key elements of exposure assessment were analysed to identify effects of differences or similarities in MS approaches such as scenarios, model parameterisation, regulatory endpoints, pH-dependent properties and decision criteria on the regulatory outcome and implications for harmonisation of the authorisation procedures. Comparisons were made between MS that use FOCUS procedures and Germany, Netherlands and the UK that apply their own specific national approaches.

Four test substances (compounds 1—4) were variations of the same substance with only soil DT50 and Koc changed, and each had the same metabolite. These were applied to winter cereals in spring as ground spray. An additional set of four test substances (compounds 5—8) were variations of a different substance with only soil DT50 and Koc changed and no metabolites formed. These were applied to apples as air blast. Compound 9 was selected to evaluate effects of pH-dependent degradation and sorption on the regulatory outcome at EU and MS level. This substance was applied to winter cereals as pre-emergence ground spray.

Mitigation options for drift and runoff/erosion considered by the various MS were reviewed and their effect on the PEC in surface water and the regulatory outcome was assessed for two of the compounds.

Groundwater Assessment

Most MS accept the current version of the model FOCUS PEARL for groundwater assessment. Key model parameters such as DT50, Koc and 1/n are derived according to FOCUS guidelines and agreed endpoints in the Review Report. Poland requires current versions of PEARL and PELMO and the results from both models are used in decision making. Germany uses the current version of PELMO but with volatilisation and plant uptake set to zero. The Netherlands requires PEARL 3.3.3 at tier 1 and GeoPEARL 3.3.3 for tier 2 groundwater assessment. Current practice among MS, except Poland, is to accept PEC groundwater based on one model as recommended by FOCUS (2009). However, EFSA (2004, 2013c) recommended that PEC groundwater calculations should be based on more than one leaching model. The UK requires an additional calculation with the MACRO model and the Châteaudun scenario for compounds with Koc > 100 L kg

-1.

Although the active substances would potentially be eligible for inclusion in the EU pesticides database, all products evaluated in this work failed the national tier 1 groundwater assessment for all MS in the Central Zone. Assessment at tier 2 for the Netherlands which involves spatially distributed modelling resulted in compounds 5-7 passing the groundwater assessment. Most MS surveyed by Fera indicated that they accept the tiered approach for assessing the risk of active substances to groundwater provided by FOCUS (2009).

Common practice for substances with pH-dependent degradation and/or sorption at EU level are separate assessments under acidic and alkaline conditions based on agreed endpoints in the review report. A survey by Fera including information obtained from personal communication indicated that, whilst most MS adopt the common practice, others such as Belgium use worst-case DT50 and Koc values; and Germany uses the Input-Decision tool to determine input values that give conservative groundwater concentrations.

Regardless of the DT50 and Koc values of the test substance and the crop or application timing, the largest PEC groundwater calculated with PEARL was always predicted for the FOCUS Hamburg or Okehampton scenario. Although further testing would be required, the use of these scenarios as a simplified tier 1 for standard groundwater assessment in the Central Zone could be a potential area to explore for harmonisation.

Surface Water Assessment

The FOCUS scenarios used by most MS for their national assessment include two or more of the following: drainage scenarios D3, D4 and D5 and/or runoff scenarios R1, R3 and R4. All representative scenarios must be passed at MS level in order to obtain authorisation of the plant protection product. Germany, Netherlands, Slovenia and the UK use different methodologies for surface water assessment.

Unlike at EU level (FOCUS Steps 1—3) where spray drift is added to losses from runoff/erosion or drainage, Germany, Netherlands, Slovenia and the UK assess spray drift separately from other routes of exposure. Calculation of PEC surface water from spray drift is based on the Rautmann drift values at the EU level and for most MS. The Netherlands uses drift values that are lower than the Rautmann data (1% for field crops and 17% for fruit crops) and does not differentiate between single and multiple applications. Germany and the UK deviate from the FOCUS approach in that drift deposit is not integrated over the width of the water body to derive an areic mean percentage deposition.

Germany is the only MS that considers volatilisation of plant protection products from plant and soil surfaces and subsequent dry deposition onto surface water at tier 1 of the national assessment. Germany uses the EXPOSIT model to calculate losses via runoff and erosion where a maximum of 0.45% of the applied substance is assumed to be transferred to surface water via runoff/erosion and up to 0.25% via drainage following a rainfall event 3 days after application. The UK is the only MS that considers drainflow from soils with high clay content that are prone to preferential flow as part of tier 1 national assessment. Up to 1.9% of applied amount per 10 mm drain water is assumed to be lost via drainflow.

Most MS that apply FOCUS procedures use at least one drainage and one runoff scenario for their national assessment. However, Hungary does not consider drainage entries as relevant and only runoff scenarios are assessed. Slovenia requires assessment of surface water exposure via spray drift only and not via runoff/erosion or drainage. Although runoff is regarded as relevant in Slovenia, the FOCUS scenarios are considered to be not representative and this MS has not yet developed its own scenarios. In the Netherlands, runoff/erosion is not included as an entry route to surface water and drainage scenario D3 is currently used as starting point for calculation with the drinking water assessment tool DROPLET. The Netherlands is the only country to consider drinking water abstraction points or Water Framework Directive (WFD) water bodies in their national assessment.

Compounds 1—4 and associated metabolites passed surface water assessment in all MS that use FOCUS procedures. For compound 5, mass loading to surface water was dominated by drift with predicted concentrations exceeding the RAC in the ditch and stream scenarios. Compound 9 failed most scenarios under alkaline conditions but only few under acidic conditions. For all active substances assessed in this work, the highest concentrations were consistently calculated for FOCUS stream R3 which is used by only Austria, Hungary and Ireland for their national authorisation. All active substances assessed passed the runoff/erosion and drainage scenarios for Germany at tier 1. By contrast, all active substances, except compound 2, failed the tier 1 drainflow assessment for the UK. Tier 1 drainflow calculation for the UK produced results that were similar to those obtained for FOCUS stream D2 at EU level which is based on heavy clay soil data from Brimstone Farm, UK.

Spray drift and runoff/erosion mitigation considered by most MS include: (i) no-spray buffer zones up to 50 m, (ii) drift reducing nozzles by up to 95%, and (iii) vegetative buffer strip up to 20 m. Implementation of up to 20 m no-spray buffer zone or 75% drift reduction would result in compound 5 passing all FOCUS surface water scenarios relevant to MS. Because the entry of compound 9 into surface waters was dominated by drainage in the drainage scenarios, application of no-spray buffer zones, drift reducing nozzles and the various combinations of vegetative buffer strips as well runoff/erosion reduction efficiencies as mitigation measures did not reduce the surface water concentrations in any of the scenarios below the Step 3 levels.

The differences in agro-environmental conditions across MS have lead to disparities in the approach applied for surface water assessment in the national authorisation procedures. Harmonisation of the assessment of drainage and runoff/erosion inputs into surface waters across Europe does not appear appropriate as the discrepancies are justified and based on MS specific conditions. There could be some potential for the harmonisation of the drift calculations. Continued efforts should also be made to developing harmonised approaches for application of pre and post-registration mitigation measures among MS across the EU.

TABLE OF CONTENTS

EXECUTIVE SUMMARY .................................................................................................................................... 3

TABLE OF CONTENTS ...................................................................................................................................... 5

1 BACKGROUND ............................................................................................................................................. 8

2 OBJECTIVES ................................................................................................................................................ 8

3 OVERVIEW OF NATIONAL APPROACHES ................................................................................................ 8

4 SELECTION OF TEST COMPOUNDS AND APPLICATION SCENARIO ................................................. 11

4.1 Compounds 1—4 Application Scenario ............................................................................................ 12

4.2 Compounds 5—8 Application Scenario ............................................................................................ 12

4.3 Compound 9 Application Scenario .................................................................................................... 13

5 MODEL PARAMETERISATION .................................................................................................................. 13

6 REGULATORY ENDPOINTS ...................................................................................................................... 14

6.1 Groundwater Assessment ................................................................................................................. 14

6.2 Surface Water Assessment ............................................................................................................... 14

7 STANDARD EXPOSURE ASSESSMENT FOR COMPOUNDS 1—4 ........................................................ 15

7.1 PEC Groundwater ............................................................................................................................. 15

7.1.1 FOCUS Groundwater Assessment of Compounds 1—4 at EU Level ................................. 15

7.1.2 Assessment of Compound 1 for MS that use FOCUS Scenarios ........................................ 15




7.1.6 Tier 2 Groundwater Assessment at MS Level ...................................................................... 17

7.1.6.1 Tier 2 Groundwater Assessment for the Netherlands ........................................... 18

7.1.7 Conclusions of FOCUS PEC Groundwater Assessment ..................................................... 18

7.2 PEC Surface Water and Sediment .................................................................................................... 19

7.2.1 Surface Water Assessment of Compounds 1—4 at EU Level ............................................. 19





7.2.6 Standard Assessment for Germany, Netherlands and the UK ............................................ 22

7.2.6.1 Standard Surface Water Assessment for Germany .............................................. 23

7.2.6.2 Standard Surface Water Assessment for Netherlands ......................................... 23

7.2.6.3 Standard Surface Water Assessment for the UK ................................................. 24

7.2.7 Conclusions of FOCUS PEC Surface Water Assessment ................................................... 24

8 STANDARD EXPOSURE ASSESSMENT FOR COMPOUNDS 5—8 ........................................................ 26

8.1 PEC Groundwater ............................................................................................................................. 26

8.1.1 FOCUS Groundwater Assessment of Compounds 5—8 at EU Level ................................. 26


8.1.3 Tier 2 Groundwater Assessment of Compounds 5—8 for the Netherlands ......................... 27

8.1.4 Conclusions of FOCUS PEC Groundwater Assessment ..................................................... 27


8.2.1 Surface Water Assessment of Compounds 5—8 at EU Level ............................................. 28


8.2.3 Standard Assessment for Germany, Netherlands and the UK ............................................ 29

8.2.3.1 Standard Surface Water Assessment for Germany .............................................. 29

8.2.3.2 Standard Surface Water Assessment for Netherlands ......................................... 30

8.2.3.3 Standard Surface Water Assessment for the UK ................................................. 31

8.2.4 Conclusions of FOCUS PEC Surface Water Assessment ................................................... 31

9 STANDARD EXPOSURE ASSESSMENT FOR COMPOUND 9 ................................................................ 33

9.1 PEC Groundwater ............................................................................................................................. 34

9.1.1 FOCUS Groundwater Assessment of Compound 9 at EU Level ......................................... 34

9.1.2 Assessment of Compound 9 for MS that Apply FOCUS Procedures .................................. 37

9.1.3 Groundwater Assessment of Compound 9 for Belgium ....................................................... 37

9.1.4 Groundwater Assessment of Compound 9 for Czech Republic ........................................... 37

9.1.5 Groundwater Assessment of Compound 9 for Germany ..................................................... 38

9.1.6 Groundwater Assessment of Compound 9 for Netherlands ................................................ 42

9.1.7 Conclusions of PEC Groundwater Assessment ................................................................... 44


9.2.1 FOCUS Surface Water Assessment of Compound 9 at EU Level ....................................... 44

9.2.2 Assessment of Compound 9 for MS that Apply FOCUS Procedures .................................. 45

9.2.3 Surface Water Assessment of Compound 9 for Belgium ..................................................... 45

9.2.4 Surface Water Assessment of Compound 9 for Czech Republic ........................................ 46

9.2.5 Surface Water Assessment of Compound 9 for Germany ................................................... 46

9.2.6 Surface Water Assessment of Compound 9 for Netherlands .............................................. 46

9.2.6.1 Edge-of-Field Water Body ..................................................................................... 46

9.2.6.2 Drinking Water Abstraction Points ........................................................................ 47

9.2.7 Surface Water Assessment of Compound 9 for the UK ....................................................... 47

9.2.8 Conclusions of PEC Surface Water Assessment ................................................................. 47

10 APPLICATION OF MITIGATION MEASURES ........................................................................................... 48

10.1 Refinement of FOCUS Step 3 PEC Surface Water Using SWAN .................................................... 48

10.2 Step 4 Assessment of Compound 5 .................................................................................................. 48

10.3 Step 4 Assessment of Compound 9 .................................................................................................. 51

11 DISCUSSION .............................................................................................................................................. 53


11.1.1 Groundwater Assessment for MS that Apply Different Procedures ..................................... 54


11.2.1 Spray Drift Deposition .......................................................................................................... 56

11.2.2 Volatilisation and Dry Deposition .......................................................................................... 57

11.2.3 Runoff/Erosion and Drainage ............................................................................................... 57

11.2.4 Spray Drift and Runoff/Erosion Mitigation ............................................................................ 58

11.3 Implications for Harmonisation .......................................................................................................... 58

11.3.1 Groundwater Assessment .................................................................................................... 58

11.3.2 Surface Water Assessment .................................................................................................. 60

12 CONCLUSIONS .......................................................................................................................................... 61



13 REFERENCES ............................................................................................................................................ 64

APPENDIX A Tables of Predicted Environmental Concentrations (PECs)

APPENDIX B Summary of National Approaches for Pesticide Exposure Assessment in the Central Zone

1 Background

In order to facilitate authorisation of plant protection products, the European Community has been divided into three zones with comparable pedo-climatic conditions: Northern, Central and Southern zones. Following approval of the active substance at EU level, assessments for the authorisation of plant protection products takes place at the zonal levels. In addition to the core assessment at zonal level, several Member States (MS) require assessments based on their national approaches and have also developed specific models and national scenarios for the calculations of predicted environmental concentrations (PECs) in groundwater, surface water, soil and sediment. Model parameterisation, regulatory endpoints and decision criteria as well as mitigation measures prescribed to reduce environmental exposure of plant protection products also differ among some MS.

To compare authorisation procedures among MS in the Central Zone, nine dummy substances with a range of sorption and degradation properties as well as two application scenarios were assessed: (i) ground spray to winter cereals with or without interception, and (ii) air blast application to apples. Groundwater and surface water exposure assessments were first undertaken according to FOCUS procedures to provide a baseline for comparison with assessments based on individual national protocols. Results were evaluated according to those that passed at EU and MS levels and those that failed the risk assessment only at specific MS level. Key elements of the exposure assessment were analysed to identify the effect of differences or similarities in MS approaches on the regulatory outcome. Lastly, implications for zonal harmonisation of the authorisation procedures for plant protection products according to Regulation (EC) 1107/2009 were evaluated.

2 Objectives

This work aims to provide a comparative evaluation of various national approaches for exposure assessment of plant protection products in the authorisation procedures of MS in the Central Zone. It only considers the standard assessments recommended by FOCUS and MS including, where possible, application of mitigation measures for surface water exposure. The report does not consider higher tier assessments. The objectives of the work include:

Review MS national approaches for calculating PEC of plant protection products in groundwater and surface water as well as their use in the authorisation procedures in the Central Zone.

Undertake standard groundwater and surface water exposure assessments for selected substances at both EU and individual MS level in the Central Zone;

For substances that failed the tier 1 assessment, undertake tier 2 assessment or apply the mitigation measures recommended by individual MS in their national authorisation procedures where possible.

Analyse effects of key elements of exposure modelling and risk assessment at individual MS level on the regulatory outcome.

Identify differences or similarities in the decision process for national authorisation of plant protection products at MS level, and evaluate the implications for zonal harmonisation of authorisation.

3 Overview of National Approaches

Fera has completed a survey of national pesticide exposure assessments for groundwater and surface water across the EU within a Fera Innovation Fund project. The information from the survey was combined with information compiled by the Chemicals Regulation Directorate (CRD) who previously requested MS within the Central Zone to provide information on country-specific approaches to pesticide exposure assessments. In preparing this report, additional enquiries were also made by e-mail to representatives of the MS in order to clarify details.

An Excel spreadsheet was populated containing information from all MS on:

The models, soil, climate and cropping scenarios used to calculate PECs at individual MS level;

Methodology for selecting and/or calculating model input parameter values from the substance data package;

Regulatory endpoints and decision making criteria in the MS national authorisation procedures;

Options for risk mitigation strategies considered by individual MS.

Detailed review of groundwater and surface water assessment procedures in Germany, Netherlands and the UK were also undertaken. A summary of MS procedures and requirements can be found in Appendix B.

The EU level exposure assessment involved calculation of concentrations in groundwater and surface water as recommended by FOCUS (2000, 2009 and 2011) for a number of soil-climate scenarios. The procedures followed by many MS were found to be similar to the EU procedure. These MS select FOCUS scenarios that are considered to be representative of their soil-climatic conditions. Groundwater assessment among MS in the Central Zone is generally based on 2 to 5 FOCUS scenarios which include: Châteaudun, Hamburg, Kremsmünster, Okehampton, Piacenza and Porto (Table 1). Hamburg scenario is used by all MS except the Netherlands and Romania. Germany, Netherlands and the UK use some of the groundwater scenarios, but the assessment methodologies differ from the EU level procedure. These differences are explained below.

For surface water assessment, MS in the Central Zone use a combination of drainage scenarios D3, D4, D5, and/or runoff scenarios R1, R3 and R4. Drainage scenarios D1, D2, D6 and runoff scenario R2 are not used by any of the MS. Hungary requires predicted concentrations for the runoff scenarios only as drainage is not considered a relevant exposure route.

Germany, Slovenia and the UK do not use any FOCUS scenarios for surface water assessment but have developed tier 1 methods for calculating predicted concentrations. The Netherlands uses the D3 scenario as starting point for tier 1 prediction of surface water concentration. A summary of the requirements of these MS can be found in Appendix B.

It should be noted that at least one of the FOCUS scenarios must be passed at EU level for inclusion of the active substance in the EU pesticides database, whereas all the representative scenarios must be passed in order to obtain authorisation for products containing the active substance at MS level. No information was available on the national authorisation procedures for Luxemburg.

Table 1. FOCUS scenarios used by each MS in the Central Zone1

1Shaded cells indicate relevant FOCUS scenarios.

Some MS have specific requirements for which type and version of the FOCUS groundwater models must be used, while other MS allow some flexibility (see Table 2). Most MS use the current version of PEARL for groundwater assessment. Poland requires the use of current versions of PEARL and PELMO and the results from both are used in decision making. Czech Republic and the UK require simulations with current versions of PEARL, PRZM or PELMO.

EU Level Aust ria Belg ium Czech R Germany Hungary Netherlands Poland R Ireland Romania Slovakia Slovenia UKGroundwater Scenarios

Châteaudun X X X X X X X XHamburg X X X X X X X X X X XJokioinen X

Kremsmunster X X X X X X X X X XOkehampton X X X X X X X

Piacenza X X X XPorto X X

Sevilla XThiva X

Surface Water Scenarios

D1 XD2 XD3 X X XD4 X X X X X X XD5 X X X XD6 XR1 X X X X X X X X XR2 XR3 X X X XR4 X X X

In order to compare differences between simulations with and without macropore flow, FOCUS developed parameters for the Châteaudun scenario because soils at this site are heavier than at most other sites. In the UK, if Koc of the substance is >100 L kg

-1, additional simulation must be performed with the FOCUS

parameterisation of MACRO 4.4.2 for Châteaudun to account for preferential flow. This specific procedure was agreed by the UK Advisory Committee on Pesticides following an independent assessment of the relevance of the FOCUS groundwater scenarios to the UK for pesticides regulatory risk assessment purposes.

For the tier 1 groundwater assessment, Germany requires the use of PELMO which has to be parameterised to meet specific national requirements for plant uptake and volatilisation. Netherlands use PEARL 3.3.3 and Kremsmünster for groundwater assessment at tier 1, and GeoPEARL, a spatially-distributed model, for tier 2. For substances with pH-dependent properties, Germany and the Netherlands have specific requirements for model parameterisation.

Table 2. Models currently used for groundwater and surface water assessment by MS in the Central Zone1

1Shaded cells indicate models currently used by MS.

aCurrent versions of FOCUS groundwater models.

bCurrent versions of FOCUS surface water models (STEPS 1—2 in FOCUS, SWASH, MACRO, PRZM).

For aquatic risk assessment, most MS use the current versions of FOCUS models: STEPS 1—2 in FOCUS for Steps 1—2 assessment; and SWASH, MACRO, PRZM, TOXSWA for Step 3 assessment. In current practice, Steps 1—3 are generally considered as tier 1 or lower tier surface water assessment. For higher tier assessment, FOCUS (2007) has published guidance on a number of options for consideration including the use of SWAN 3.0.0 to assist in the application of mitigation measures for spray drift and runoff entries at Step 4. Step 4 is considered as higher tier and can include any refinement of exposure. But it should be noted that higher tier aquatic risk assessments have not been considered in this report except mitigation of spray drift and runoff using SWAN 3.0.0 for substances that failed the Step 3 assessment.

Germany requires EVA for simulations of drift and atmospheric deposition and EXPOSIT for runoff/erosion and drainage due to bank infiltration at tier 1. The Netherlands uses the D3 scenario (with Dutch drift values) and subsequent calculations with DROPLET for assessment of surface water concentration at drinking water abstraction points; TOXSWA for assessment of exposure via drift at tier 1; and a simple calculation for the assessment of Water Framework Directive (WFD) water bodies at tier 2. Slovenia uses the UK method for calculating exposure via spray drift which is based on the Rautmann drift values with some modification for 4 or more applications to fruit crops. Tier 1 calculation of concentration in drainflow is also required in the UK. The CRD have published guidance on higher tier drainflow assessment in cases where there is failure of the risk assessment at tier 1 (CRD, 2009), but this is not addressed in this report.

EU Level Aust ria Belg ium Czech R Germany Hungary Netherlands Poland R Ireland Romania Slovakia Slovenia UKGroundwater Models

PEARL 3.3.3 XPEARL 4.4.4 X X X X X XPELMO 4.4.3 X X

PEARL or PELMOa X

PEARL, PELMO or PRZMa X X X X

MACRO 5.5.3 XMACRO 4.4.2 X XEXPOSIT 3.0 X

GeoPEARL 3.3.3 XSurface Water Models

FOCUS Modelsb X X X X X X X X X X

TOXSWA 1.2 XDROPLET 1.1 X

Input-Decision Tool 3.3 XEVA 2.1 X

EXPOSIT 3.0 XSpray Drift Calculation X XDrainflow Calculation X

Other Calculations XSWAN 3.0.0 X X X X X X X X X

4 Selection of Test Compounds and Application Scenario

To compare the procedures for groundwater and surface water exposure assessments set out in the FOCUS guidance with approaches in different MS, several test compounds with a range of degradation and sorption properties were identified and one crop and application scenario was assessed for each test compound. The following procedure was followed in identifying and selecting test compounds for exposure assessment:

Initial simulation of PEC groundwater were performed with several dummy compounds, crops, rates, timing and methods of application and ecotoxicological endpoints as presented in FOCUS (2012) using FOCUS PEARL 4.4.4. These dummy compounds are listed in Table G.1-2 of FOCUS (2012).

After evaluation of the calculated PEC groundwater, compound 6_sw (and the metabolite) which was applied as post-emergence ground-spay herbicide to cereals, and compound 7_sw applied as an air blast fungicide to vines were selected for further evaluation.

Variations of less than one order of magnitude for sorption (Koc) and degradation (DT50) values for compounds 6_sw and 7_sw were implemented to give a total of 50 dummy compounds, including the original dummy compound Koc and DT50 values taken from Table G.1-2 of FOCUS (2012).

For PEC groundwater, crop interception was set to 50% for compound 6_sw and 70% for compound 7_sw. The formation fraction of metabolite of compound 6_sw was set to 70%. Other compound properties (including those of metabolite of compound 6_sw), ecotoxicological endpoints, application timing and methods remained as specified in Table G.1-2 of FOCUS (2012). However, crops and application rates were changed.

Simulations of PEC groundwater were performed for all 50 dummy compounds with FOCUS PEARL 4.4.4. From the calculated PEC groundwater, four (4) variations of compound 6_sw and associated metabolites and four (4) variations of compound 7_sw were selected based on the PEC groundwater passing at least one FOCUS scenario, in addition to considerations of realistic variations in Koc and DT50 values of the selected compounds. These selected compounds were designated compounds 1—4 (and associated metabolites) and compounds 5—8, respectively.

In order to evaluate effect of pH-dependent sorption and degradation on the exposure assessment of plant protection products, and hence on the regulatory outcome at individual MS level, an additional compound with pH-dependent properties was identified from a search of the publicly available Draft Assessment Reports (DAR) on the European Food Safety Authority (EFSA) website. The selected compound was designated compound 9. Certain properties of the selected compound, including Koc and DT50 values for acidic and alkaline conditions, ecotoxicological endpoints and application rate were changed or modified for the purpose of this assessment.

Properties of the selected compounds, ecotoxicological endpoints, selected crops, application rates, timing and application methods used for tier 1 groundwater and Steps 1—3 surface water exposure assessment are listed in Table A1 for compounds 1—4 and Table A2 for compounds 5—9.

Tier 1 groundwater and Steps 1—3 surface water simulations were performed with compounds 1—9 using FOCUS PEARL 4.4.4, FOCUS PELMO 4.4.3 for simulation of PEC groundwater; and SWASH 3.1 (including a Drift Calculator, MACRO 4.4.2, PRZM 3.1.1 and TOXSWA 3.3.1 for the simulation of PEC surface water.

Groundwater and surface water assessments were undertaken for individual MS in the Central Zone which include: Austria, Belgium, Czech Republic, Germany, Hungary, Ireland, Netherlands, Poland, Romania, Slovenia, Slovakia, and UK following procedures outlined for the national authorisation of pesticides. No information was available on the national requirements for Luxemburg.

Most MS use the FOCUS procedures, models and a selection of FOCUS scenarios for their national assessment of groundwater and surface water. However different procedures, models and scenarios are applied in Germany, Netherlands and the UK. A summary of the specific requirements of these MS can be found in Appendix B.

4.1 Compounds 1—4 Application Scenario

Parent compounds: 1, 2, 3 and 4. One metabolite each with a formation fraction of 70%.

Crop: winter cereals

Application rate and method: 0.2 kg ha-1

as post-emergence ground spray to cereals every year.

Number of applications: 1

Application interval: not applicable.

Application timing:

Surface water assessment: Steps 1—2, North Europe (March to May) and South Europe (March to May)

1, Step 3, first possible date of application on 1 March and last possible date of application on

31 March based on 30 day window (spring application). The actual application date is calculated with the pesticide application timer (PAT).

Groundwater assessment: absolute application date on 1 March (spring application).

Crop interception:

Surface water assessment: Step 2 average crop cover; Step 3, application to foliage with the fraction intercepted by crop canopy simulated by MACRO and PRZM models. Therefore, the application rate was set to 0.2 kg ha

-1 in the SWASH shell.

Groundwater assessment: 50% during the tillering stage of winter cereals occurring until after March (Table 1.5 of FOCUS (2011); Tables 2.4.2-1 and 7.2.5-1 of FOCUS (2012); effective application rate for the PEC groundwater simulations = 0.1 kg ha

-1.

4.2 Compounds 5—8 Application Scenario

Parent compounds: 5, 6, 7 and 8. No metabolite formed.

Crop: apples (pome/stone fruits used in surface water simulations).


as air blast to apples every year (early application).


Application interval: minimum 14 days

Application timing:

Surface water assessment: Steps 1—2, North Europe (March to May) and South Europe (March to May)

1; Step 3, first possible date of application on 1 April and last possible application day on 15

June (spring and summer application). The actual application dates are calculated with the pesticide application timer (PAT). The surface water simulations were undertaken for both single and multiple applications of the compounds.

Groundwater assessment: absolute application dates from 1 April (spring and summer application).

Crop interception:

Surface water assessment: Steps 2, full canopy; Step 3, foliar application with fraction intercepted by the crop canopy simulated by MACRO and PRZM models. Therefore, the application rate was set to 2.5 kg ha

-1in the SWASH shell.

Groundwater assessment: 70% during the foliage development stage of apples occurring after April (Table 1.4 of FOCUS (2011); Tables 2.4.2-1 and 7.2.5-1 of FOCUS (2012); effective application rate for the PEC groundwater simulations = 0.75 kg ha

-1.

1The EU level assessment (Step 2) was undertaken for North Europe, which is applicable to 10 of the 13 countries in the

Central Zone, and for South Europe which is applicable to Romania, Bulgaria and Slovenia according to the definitions given for crop residue zones in the SANCO Document 7525/VI/95-rev.7, SANCO, 2001.

4.3 Compound 9 Application Scenario

Parent compound: 9. No metabolite formed.

Crop: winter cereals


as pre-emergence ground spray to cereals every year.


Application interval: not applicable.

Application timing:

Surface water assessment: Steps 1—2, North Europe (October to February); South Europe (October to February)

1. Step 3, first possible date of application: 2 weeks pre-emergence based on a 30 day

window (autumn application). Actual application date is calculated with the pesticide application timer (PAT).

Groundwater assessment: 2 weeks before emergence (autumn application).

Crop interception:

Surface water assessment: Step 2 no interception; Step 3, application to soil with fraction intercepted by crop canopy (if at all) simulated by MACRO and PRZM models. Therefore, the application rate was set to 0.02 kg ha

-1 in the SWASH shell.

Groundwater assessment: application to soil surface 2 weeks pre-emergence; effective application rate for PEC groundwater simulations = 0.02 kg ha

-1.

5 Model Parameterisation

In addition to guidance on selection of input parameters provided by FOCUS for exposure assessment at tier 1 or Steps 1—3, some MS also require specific parameterisation such as use of arithmetic mean or median DT50 values rather than geometric mean, investigating pH dependence of Koc etc. The available information is summarised in Appendix B. Except for compound 9, model parameterisation at tier 1 or Steps 1—3 at EU and national levels was assumed to meet MS national requirements and so the same input parameter values have been applied for surface water and groundwater assessment at both EU and individual MS level. Other model parameters were generally based on standard default values, including:

Q10 Factor = 2.58 (PRZM, PELMO); Alpha Factor = 0.0948 (MACRO);

Molar Activation Energy = 65,400 joules mol-1

(PEARL, TOXSWA);

Exponent for effect of moisture = 0.7;

Plant uptake factor: 0.5 (except for Germany where plant uptake factor = 0 at tier 1);

Reference diffusion coefficient in water = 4.30E-05 m2 d

-1; and air = 4.30E-01 m

2 d

-1.

Model parameterisation for the assessment of compound 9 was based on MS guidance for substances with pH-dependent sorption and degradation. Details are given in Section 9.

The formation fraction of the metabolites of compounds 1—4 was set to 0.7. This value was used as input in PEARL and SWASH. In PELMO, the degradation rate of the parent was split into the two fractions—one for formation of the metabolite and the other for complete degradation or mineralisation of the parent compound. The correction for molecular weight differences between parent and metabolite is done within these models. MACRO requires the fraction of parent converted to metabolite on a mass basis, this was calculated as 0.7 x (molecular weight of the metabolite ÷ molecular weight of the parent) = 0.541.

For PEC surface water calculations at Steps 1 and 2 and some of MS national assessments, the maximum occurrence of metabolite in soil and water-sediment is needed. The maximum occurrence is always lower than the formation fraction when degradation of the metabolite occurs. This was calculated with ModelMaker using the formation fraction and DT50 values for the parent and metabolite. The results are given in Table 3 below.

Table 3. Maximum occurrence of metabolites of compounds 1—4 used for PEC calculations

Metabolite of Test Compound Water-Sediment (%) Soil (%)

Metabolite of Compound 1 29.98 35.50




6 Regulatory Endpoints

6.1 Groundwater Assessment

For groundwater assessment, the limit value of 0.1 µg L-1

laid down in Council Directive 98/83/EC (Drinking Water Directive) for active substances and relevant metabolites is generally applied by MS. Hungary accepts concentrations in groundwater up to 0.2 µg L

-1 for FOCUS scenarios except Châteaudun where the 0.1 µg L

-1

limit is still applied.

The Netherlands uses 0.1 µg L-1

for comparison with the 80th percentile concentration in leachate at a depth

of 1 m for the Kremsmünster scenario at tier 1. At tier 2, the 90th percentile in space of the median annual

average concentrations simulated with GeoPEARL is considered. An extra safety factor of 10 is applied for groundwater protection zones where the calculated concentration for the 90

th percentile of the area must be

<0.01 µg L-1

. Where the 90th percentile is >0.01 but <0.1 µg L

-1 it should be indicated on the plant protection

product in question that application in groundwater protection areas is prohibited, unless supplementary data show that in practice the 90

th percentile is <0.1 µg L

-1 in groundwater protection areas.

According to SANCO (2003), metabolites must be included in groundwater assessment if any one of the following conditions applies: (i) metabolites which account for more than 10% of the amount of active substance added in soil at any time during the studies; or (ii) metabolites which accounts for more than 5% of the amount of active substance added in soil at least two sequential measurements during the study; or (iii) metabolites for which a maximum formation is not reached at the end the studies; or (iv) metabolites identified at >0.1 µg/l annual average concentration in a lysimeter or similar study. Moreover, metabolites included in groundwater assessment and predicted to occur at annual average concentrations exceeding 0.1 µg l

-1 at the 1 m depth should be subject to assessment of relevance.

A 5—step process is proposed for assessing the relevance of metabolites: (1) exclusion of metabolites of no concern; (2) quantification of potential groundwater contamination; (3) hazard assessment—identification of relevant metabolites, (4) exposure assessment—threshold of no concern approach, and (5) refined risk assessments for non-relevant metabolites. Although a 70% formation fraction and a maximum occurrence in soil and water-sediment system of 26—35.5% and 29.98%, respectively was reported for the metabolites of compounds 1—4, not enough information on the properties of these metabolites was available to enable application of the above 5—step evaluation procedure. Therefore, the assessment of metabolites was based on the limit of 0.1 µg L

-1 for relevant metabolites and 0.75—10 µg L

-1 for non-relevant metabolites according

to SANCO (2003).

6.2 Surface Water Assessment

A standard toxicity-exposure ratio (TER) or regulatory acceptable concentration (RAC) approach involving each aquatic organism in turn can be used for the aquatic risk assessment. In determining concentrations of active substances or their metabolites in surface water that will result in acceptable risk, the RAC approach was used. RACs were calculated by dividing the ecotoxicological endpoint by the appropriate Annex VI (or TER) trigger for acute or chronic exposure of the aquatic organism. The lowest RAC was used in this report.

For the Netherlands, the RAC derived above was used to assess the edge-of-field water body. A limit value of 0.1 µg L

-1 was applied for the assessment of active substances and relevant metabolites at surface water

abstraction points, and a maximum permissible concentration (MPC) assumed equal to the RAC was used to assess the Water Framework Directive (WFD) water body.

7 Standard Exposure Assessment for Compounds 1—4

7.1 PEC Groundwater

The results of the PEC groundwater calculations are presented in Appendix A. It was assumed that applicants submit only the PEC calculated with FOCUS PEARL to the MS unless there is a specific requirement for an alternative or additional model. But in reality, MS are likely to take into account all data if results for more than one model are submitted in the Central zone assessment. The concentrations shown in Appendix A for PELMO would not be ignored if they are larger than those calculated with PEARL.

7.1.1 FOCUS Groundwater Assessment of Compounds 1—4 at EU Level

80th percentile annual average PEC groundwater for compounds 1—4 and associated metabolites are shown

in Figure 1 below, and also presented in Table A1 of Appendix A. Exposure assessment for the nine FOCUS groundwater scenarios indicated that PEC groundwater was below the limit value of 0.1 µg L

-1 for at least

one of the FOCUS groundwater scenarios. Compounds 1—4 would therefore be eligible for inclusion in the EU pesticides database according to Regulation (EC) No 1107/2009.

Figure 1. Tier 1 PEC groundwater for compounds 1—4 and associated metabolites simulated with PEARL 4.4.4

7.1.2 Assessment of Compound 1 for MS that use FOCUS Scenarios

Table A3 of Appendix A shows the 80th percentile annual average PEC groundwater for compound 1 and

associated metabolite for FOCUS scenarios relevant to MS in the Central Zone. Except for Châteaudun, the PEC groundwater for the parent compound exceeded the limit of 0.1 µg L

-1 for all other scenarios of interest

to Central Zone MS.

Exposure assessment for Hungary, where a limit value of 0.2 µg L-1

is acceptable (except for Châteaudun), indicated that calculated PEC groundwater also exceeded this threshold for the relevant national scenarios.

For the metabolite of compound 1, calculated PEC groundwater exceeded the limit of 0.1 µg L-1

for Hamburg, Kremsmünster, Okehampton and Piacenza but was below 0.75 µg L

-1 for all relevant MS scenarios. Since

the Koc of metabolite 1 is >100 L kg-1

(580 L kg-1

), additional simulation with MACRO 4.4.2 is required in the UK for Châteaudun scenario. This gave a concentration of 0.125 µg L

-1 for the parent which exceeded the

limit, and 0.042 µg L-1

for the metabolite. If metabolite 1 passed the initial assessment for relevance at step 3 (hazard assessment) according to SANCO (2003), then it would also be expected to pass at individual MS level based on a threshold of no concern approach or refined risk assessment for non-relevant metabolites.

Groundwater concentration calculated with PELMO for compound 1 and metabolite in accordance with tier 1 procedures for Germany were higher than the concentration derived with PEARL most likely due to the plant uptake and volatilisation set to zero.

0.00.51.01.52.02.53.0

Ch at eaud un H amb urg J ok i oi nen K remsmuenst er Ok eh ampt on Pi acenza P ort o S evill a Th i vaPEC ground wat er( ug/l)Compd 1 Compd 2 Compd 3 Compd 4

0.000.050.100.150.200.250.300.35Ch at eaud un H amb urg J ok i oi nen K remsmuenst er Ok eh ampt on Pi acenza P ort o S evill a Th i vaPEC ground wat er( ug/l)

Metab 1 Metab 2 Metab 3 Metab 4 0.1 µg l

-1

Calculation with EXPOSIT resulted in PEC groundwater of 0.014 µg L-1

from runoff/erosion and 0.018 µg L-1

from drainage due to bank infiltration for the parent compound. EXPOSIT treats the metabolite as an applied substance, therefore an equivalent application rate of 0.0274 kg ha

-1 was calculated within the model using

the mass of parent reaching the soil accounting for 50% interception (0.1 kg ha-1

), the maximum percentage of the metabolite formed in soil (35.5%) and the molecular weight ratio (197/255 g mol

-1). This gave a PEC

groundwater of 0.004 µg L-1

from runoff/erosion and 0.005 µg L-1

from drainage due to bank infiltration for the metabolite. Since calculation with PELMO gave concentrations of parent and metabolite that exceeded the limit value of 0.1 µg L

-1, compound 1 would not be eligible for authorisation in Germany based on the tier 1

groundwater assessment.

Calculation of PEC groundwater with PEARL 3.3.3 for Kremsmünster as required in the Netherlands gave a value that was slightly higher than that derived with PEARL 4.4.4 used for EU level assessment and which exceeded the limit of 0.1 µg L

-1. A tier 2 groundwater assessment using the spatially distributed model

GeoPEARL would therefore be required in the Netherlands (see Section 7.1.6.1).

Based on standard tier 1 assessment, compound 1 would not be eligible for authorisation in any of the MS in the Central Zone unless higher tier assessment including monitoring can be used to demonstrate leaching to groundwater below the limit value of 0.1 µg L

-1.



associated metabolite for FOCUS scenarios relevant to each MS in the Central Zone. The PEC groundwater for the parent compound exceeded the limit value of 0.1 µg L

-1 for MS representative scenarios except in the

case of Châteaudun (for all MS excluding additional UK simulation with MACRO), and Piacenza where a limit value of 0.2 µg L

-1 is acceptable in Hungary.

Additional simulation with MACRO for Châteaudun accordance to UK requirements gave higher groundwater concentrations of 0.11 µg L

-1 compared to 0.042 µg L

-1 calculated with PEARL or 0.03 µg L

-1 with PELMO.

For the metabolite of compound 2, calculated PEC groundwater exceeded 0.1 µg L-1

for Hamburg (Germany) and Okehampton (for all other MS). However, predicted concentrations for all scenarios relevant to MS were below 0.75 µg L

-1. If the metabolite of compound 2 passed the initial assessment for relevance at step 3

according to SANCO (2003), then it would be expected to pass at all MS level based on the threshold of no concern approach or refined risk assessment for non-relevant metabolites.

Groundwater concentration calculated with PELMO for compound 2 and metabolite in accordance with tier 1 procedure for Germany (no plant uptake and volatilisation) were higher than the values derived with PEARL. Additional calculation with EXPOSIT gave PEC groundwater of 0.018 µg L

-1 from runoff/erosion/drainage due

to bank infiltration for the parent compound. The PECs for the metabolite were 0.003 µg L-1

from runoff/ erosion and 0.004 µg L

-1 from drainage. Since calculations with PELMO gave concentrations of parent and

metabolite that exceeded the limit value of 0.1 µg L-1

, compound 2 would not be eligible for authorisation in Germany based on tier 1 groundwater assessment.

Calculation of PEC groundwater with PEARL 3.3.3 for Kremsmünster as required in the Netherlands gave a value for the parent compound similar to that derived with PEARL 4.4.4 used for EU level assessment which exceeded the limit value of 0.1 µg L

-1. A tier 2 groundwater assessment using the spatially distributed model

GeoPEARL would therefore be required in the Netherlands (see Section 7.1.6.1).

Based on standard tier 1 assessment, compound 2 would not be eligible for authorisation in any of the MS in the Central Zone unless higher tier assessment including monitoring can be used to demonstrate leaching to groundwater at concentrations below the limit value of 0.1 µg L

-1.



associated metabolite for all FOCUS scenarios relevant to MS in the Central Zone. The PEC groundwater for parent compound exceeded the limit of 0.1 µg L

-1 or 0.2 µg L

-1 (Hungary) for all scenarios relevant to the MS.

For the metabolite, predicted concentrations were below 0.75 µg L-1

. If the metabolite of compound 3 passed initial assessment for relevance at step 3 according to SANCO (2003), then it would be expected to pass at individual MS level based on a threshold of no concern approach or refined risk assessment for non-relevant metabolites.

Groundwater concentration calculated with PELMO for compound 3 and metabolite in accordance with tier 1 procedure for Germany (no plant uptake and volatilisation) were higher than values derived using PEARL for the Hamburg scenario. Calculation with EXPOSIT gave PEC groundwater of 0.015 µg L

-1 from runoff/erosion

and 0.019 µg L-1

from drainage due to bank infiltration. PECs for the metabolite were 0.003 µg L-1


-1 from drainage. Since calculation with PELMO gave predicted concentrations for the

parent compound and metabolite that exceeded the limit of 0.1 µg L-1


Calculation of PEC groundwater with PEARL 3.3.3 for Kremsmünster as required in the Netherlands gave a value similar to that derived with PEARL 4.4.4 which exceeded the limit of 0.1 µg L

-1. A tier 2 groundwater

assessment using the spatially distributed model GeoPEARL would therefore be required in the Netherlands (see Section 7.1.6.1).


-1.



associated metabolite for FOCUS scenarios relevant to MS in the Central Zone. The PEC groundwater for parent compound exceeded the limit value of 0.1 µg L

-1 for all scenarios used by MS. Parent compound 4

would also fail in Hungary where a limit of 0.2 µg L-1

is acceptable for most relevant scenarios.

For the metabolite, predicted groundwater concentrations exceeded the limit for all scenarios relevant to MS (except Châteaudun), but were below 0.75 µg L

-1. If the metabolite of compound 4 passed initial assessment

for relevance at step 3 according to SANCO (2003), then it would be expected to pass at individual MS level based on the threshold of no concern approach or refined risk assessment for non-relevant metabolites.

Groundwater concentration calculated with PELMO for compound 4 and metabolite in accordance with the tier 1 procedure for Germany (no plant uptake and volatilisation) were higher than value derived with PEARL for Hamburg. Additional calculation with EXPOSIT gave PEC groundwater of 0.01 µg L

-1 from runoff/erosion

and 0.02 µg L-1

from drainage due to bank infiltration. PECs calculated for metabolite were 0.004 µg L-1

from runoff/erosion and 0.005 µg L

-1 from drainage. Since the calculation with PELMO resulted in concentrations

of parent and metabolite that exceeded the limit value of 0.1 µg L-1


Calculation of PEC groundwater using PEARL 3.3.3 for Kremsmünster as required in the Netherlands were similar to the values obtained with PEARL 4.4.4 which exceeded the limit of 0.1 µg L

-1. A tier 2 groundwater

assessment using the spatially distributed model GeoPEARL would therefore be required in the Netherlands (see Section 7.1.6.1).


-1.

7.1.6 Tier 2 Groundwater Assessment at MS Level

Groundwater assessment objectives are different for EU approval of the active substance (inclusion in the EU database of pesticides) and product authorisation at MS level. Current practice is to demonstrate at least one safe use on a representative crop in a significant area of Europe which is represented by the FOCUS groundwater scenarios. For national assessments, however, all crops and the entire potential use area must be considered. The objective is to demonstrate that a compound can be used safely for most of the relevant

environmental conditions. If this conclusion cannot be reached, unfavourable conditions should be identified and risk management measures considered.

FOCUS (2009) and a recent survey by Fera identified that most MS consider the use of refined model input values, field data and lysimeter studies in the leaching assessment of plant protection products at higher tier. Monitoring data are also taken into account by many MS. In addition, spatially distributed modelling with GeoPEARL has been operational in the Netherlands as part of the authorisation procedures at tier 2. Austria is understood to be considering spatially distributed modelling for groundwater assessment in their national authorisation procedure. EFSA (2013a) have noted that spatially distributed modelling is more important at MS level where the groundwater protection goal is likely to account for the entire crop area instead of a safe use area, as required at the EU level.

7.1.6.1 Tier 2 Groundwater Assessment for the Netherlands

The GeoPEARL model calculates the drainage of pesticides into local surface waters and their leaching into the regional groundwater for the area within the Netherlands relevant for the cultivation of a particular crop. It can simulate the fate and behaviour of volatile substances and substances showing soil-dependent sorption and transformation. The tier 2 assessment determines whether the 90

th areal percentile of the median annual

concentration in leachate is below the threshold limit of 0.1 µg L-1

. An additional safety factor of 10 is applied for groundwater protection areas, i.e. a threshold limit of 0.01 µg L

-1 is applicable.

Tier 2 90th percentile PEC groundwater for compounds 1—4 and associated metabolites calculated with the

GeoPEARL model are given in Table A3—A12 of Appendix A. Compounds 1—4 failed the assessment for the Netherlands with predicted concentrations of 0.101—1.181 µg L

-1 which represent reduction of 40—65%

from calculated tier 1 PEC groundwater for Kremsmünster. The metabolites of compounds 1, 2 and 4 passed with predicted concentrations of 0.04—0.09 µg L

-1. However, the metabolite of compound 3 failed the tier 2

groundwater assessment.

For groundwater protection areas, the calculated 90th percentile spatial concentrations of compounds 1—4

and associated metabolites exceeded 0.01 µg L-1

which indicated that these substances would be prohibited in groundwater protection areas, unless supplementary data can be used to demonstrate that in practice the 90

th percentile concentrations are <0.1 µg L

-1.

7.1.7 Conclusions of FOCUS PEC Groundwater Assessment

Based on standard tier 1 groundwater assessment for individual MS national scenarios in the Central Zone, predicted concentrations of compounds 1—4 following a single application at 200 g a.s ha

-1 to winter cereals

(assuming ~50% interception) would exceed the regulatory endpoint for protection of groundwater for most FOCUS scenarios relevant to MS. Assessment at tier 2 or higher, options for which including refinement of substance parameters, use of field data and lysimeter studies would be required to demonstrate safe uses for these compounds in accordance with individual MS authorisation procedures.

In general, calculated PEC groundwater for metabolites of compounds 1—4 were below 0.75 µg L-1

based on the threshold of no concern approach or refined risk assessment for non-relevant metabolites according to SANCO (2003) for those scenarios relevant to MS. If the metabolites of compounds 1—4 passed initial assessment for relevance at step 3 of the evaluation process, then the metabolites would also be expected to pass the assessment of leaching to groundwater at individual MS level in the Central Zone.

Tier 2 groundwater assessment using GeoPEARL, a spatially distributed model for the Netherlands indicated that compound 2 which has the largest Koc of 200 L kg

-1 and DT50 of 56 days and the associated metabolite

gave the lowest PEC groundwater of 0.101 µg L-1

because of stronger adsorption in soil and less potential for leaching to groundwater, and marginally exceeded the threshold. Compounds 1, 3 and 4 which have Koc of 34—66 L kg

-1 and DT50 of 28—56 days failed at tier 1 for all MS and also at tier 2 for the Netherlands

because of comparatively weaker adsorption to soil and hence greater potential for leaching to groundwater.

Use of compounds 1—4 would be prohibited in the groundwater protection areas of the Netherlands unless supplementary data can be used to demonstrate safe uses.

7.2 PEC Surface Water and Sediment

7.2.1 Surface Water Assessment of Compounds 1—4 at EU Level

FOCUS Steps 1—3 global maximum PEC surface water for compounds 1—4 and associated metabolites are presented in Table A1 of Appendix A. The Step 3 global maximum PEC surface water for compounds 1—4 and metabolites are also shown in Figure 2 below. The RAC for the parent compounds was 10 µg L

-1

based on aquatic invertebrate chronic NOEC; and 390 µg L-1

for the metabolites based on fish acute LC50.

The global maximum PEC surface water for compounds 1—4 failed the assessment at Steps 1 and 2 (south Europe and spring application). Compounds 1, 3 and 4 also failed drainage scenarios D1 and D2 at Step 3, but compound 2 only failed the D2 ditch scenario. All other compound-scenarios combinations passed the FOCUS surface water assessment at Step 3. Calculated global maximum PEC surface water for metabolites of compounds 1—4 were significantly below the RAC at Steps 1—3. Mass loading of compounds 1—4 to surface water was dominated by drainage inputs for drainage scenarios and runoff inputs for the runoff scenarios, with inputs from drift deposits on the day of application. However, except for scenarios D1 and D2, the concentrations in surface water are unlikely to pose unacceptable risk to aquatic organisms.

It should be noted that MS in the Central Zone do not use drainage scenarios D1 or D2 as representative scenarios, although in the UK, assessment of drainage losses is based on the Denchworth clay soil which also forms the basis for the FOCUS D2 scenario. Therefore, failure of these scenarios would not be of any significance for MS that apply FOCUS methodology for their national surface water assessment.

Figure 2. Calculated maximum surface water concentrations of compounds 1—4 and associated metabolites at FOCUS Step 3

Based on Steps 1—3 FOCUS surface water assessment, safe uses were identified for compounds 1—4 with respect to potential impact on surface waters (assuming also no unacceptable risks to sediment organisms) for the drainage scenarios D3, D4, D5 and D6 as well as runoff scenarios R1, R3 and R4, which collectively represent the majority of surface water scenarios in the EU. Scenario R2 is not applicable for winter cereals.

No potential risks to surface waters were identified from associated metabolites. Therefore, compounds 1—4 would be eligible for inclusion in the EU pesticides database accordance to Regulation (EC) No 1107/ 2009.


The global maximum PEC surface water and PEC sediment for compound 1 and associated metabolite are shown in Figure 3 below for all representative scenarios except D1, D2, D6 and R2 which are not relevant to MS in the Central Zone. Global maximum PEC surface water for FOCUS scenarios relevant to each MS are also presented in Tables A4 (parent compound) and A5 (metabolite) of Appendix A.

The global maximum PEC surface water for compound 1 passed the surface water assessment at Step 3 for all relevant MS scenarios including drainage scenarios D3, D4 and D5 as well as runoff scenarios R1, R3 and R4. The calculated global maximum concentrations of associated metabolite were also significantly less than the RAC for all representative MS scenarios.

05101520253035

Dit ch D1 St reamD1 Dit ch D2 St reamD2 Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al M axi mumPEC( Ug/l) RAC= 10 ug/lCompd 1 Compd 2 Compd 3 Compd 4

0.00.20.40.60.81.01.2

Dit ch D1 St reamD1 Dit ch D2 St reamD2 Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al M axi mumPEC( ug/l) RAC = 390 ug/lMetab 1 Metab 2 Metab 3 Metab 4

The highest sediment concentrations of compound 1 (0.95 µg kg-1

dw) and associated metabolite (0.46 µg

kg-1

dw) were predicted for stream R3 and pond D4 scenarios, respectively. Predicted sediment concentrations for all other scenarios ranged from 0.003—0.58 µg kg

-1 dw for both parent compound and

metabolite.

Germany, Netherlands, Slovenia and the UK apply their own methodologies, models and scenarios for tier 1 surface water assessment which are presented in Section 7.2.6. As can be seen from Tables A4 and A5 of Appendix A, compound 1 and associated metabolite also passed the aquatic risk assessment for these MS except for the UK where the predicted tier 1 concentration of the parent compound resulting from drainflow exceeded the RAC of 10 µg L

-1.

Based on results of Step 3 assessment for MS that apply FOCUS methodology as well as the standard tier 1 assessments for Germany, Netherlands and the UK (see section 7.2.6 below), compound 1 would be eligible for authorisation by Central Zone MS (assuming also no unacceptable risks to sediment organisms) except in the UK.

Figure 3. Calculated maximum surface water and sediment concentrations of compound 1 and associated metabolite at FOCUS Step 3


Global maximum PEC surface water and sediment for compound 2 and associated metabolite are shown in Figure 4 below. The global maximum PEC surface water results for FOCUS scenarios representative for MS in the Central Zone are also presented in Tables A7 (parent compound) and A8 (metabolite) of Appendix A.


02468

Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconcent rati on Compound 1 (Parent)SurfaceWater RAC = 10 ug/l Sediment (ug/kg dw)

0.00.10.20.30.40.5Di t ch D3 P ond D4 S t reamD4 P ond D5 S t reamD5 Di t ch D6 P ond R1 S t reamR1 S t r eamR2 S t reamR3 S t reamR4Gl ob al maxi mumconc

ent rati onCompound 1 (Metabolite)SurfaceWater RAC = 390 ug/l Sediment (ug/kg dw)

0246

Di t ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Di t ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconcent rati on

Compound 2 (Parent)SurfaceWater RAC = 10 ug/l Sediment (ug/kg dw)0.00.20.40.60.8

Di t ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Di t ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconcent rati on Compound 2 (Metabolite)SurfaceWater RAC = 390 ug/l Sediment (ug/kg dw)

The calculated maximum PEC surface water for compound 2 passed the surface water assessment at Step 3 for all representative MS scenarios including drainage scenarios D3, D4 and D5 as well as runoff scenarios R1, R3 and R4. Calculated concentrations of associated metabolite were also significantly less than the RAC for all representative MS scenarios.


dw) and associated metabolite (0.62 µg kg

-

1dw) were predicted for stream R3 and pond D4 scenarios, respectively. Predicted sediment concentrations

for all other scenarios ranged from 0.004—0.91 µg kg-1

dw for both parent compound and metabolite.

Based on results of Step 3 assessment for MS that apply FOCUS methodology as well as the standard tier 1 assessment for Germany, Netherlands and the UK (see section 7.2.6 below), compound 2 would be eligible for authorisation by all Central Zone MS (assuming also no unacceptable risks to sediment organisms). The compound does fail FOCUS scenario D2 ditch, but this is of no significance for any of the MS using the FOCUSsw methodology for national assessments, because this scenario is not considered relevant.


Global maximum PEC surface water and sediment for compound 3 and associated metabolite are shown in Figure 5 below. The global maximum PEC surface water results for FOCUS scenarios representative for MS in the Central Zone are also presented in Tables A10 and A11 of Appendix A.




-

1dw) were predicted for pond D4 scenario. Predicted sediment concentrations for all other scenarios ranged

from 0.002—0.98 µg kg-1


As can be seen from Tables A10 and A11 of Appendix A, compound 3 and associated metabolite passed the aquatic risk assessment for all Central Zone MS except for the UK where predicted tier 1 concentration of the parent compound resulting from drainflow exceeded the RAC of 10 µg L

-1.



02468

Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 S t reamR2 St reamR3 S t r eamR4Gl ob al maxi mumconcent rati on

Compound 3 (Parent)Surface Water RAC = 10 ug/l Sediment (ug/kg dw)0.00.20.40.60.8

Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconcent rati on

Compound 3 (Metabolite)SurfaceWater RAC = 390 ug/l Sediment (ug/kg dw)


Global maximum PEC surface water and sediment for compound 4 and associated metabolite are shown in Figure 6 below. The global maximum PEC surface water results for FOCUS scenarios representative for MS in the Central Zone are also presented in Tables A13 and A14 of Appendix A.




-

1dw) were predicted for stream R3 and pond D4 scenarios, respectively. Predicted sediment concentrations

for all other scenarios ranged from 0.003—0.49 µg kg-1


As can be seen from Tables A13 and A14 of Appendix A, compound 4 and associated metabolite passed the aquatic risk assessment for all Central Zone MS except for the UK where predicted tier 1 concentration of the parent compound resulting from drainflow exceeded the RAC of 10 µg L

-1.



7.2.6 Standard Assessment for Germany, Netherlands and the UK

Information from the survey undertaken by Fera as part of the evaluation of national approaches for pesticide exposure assessment in the EU identified Germany, Netherlands, Slovenia and the UK as MS in the Central Zone that do not apply the FOCUS protocol for surface water assessment. Therefore, tier 1 assessment was performed separately for these MS as outlined in their national approaches. A summary of MS requirements in the authorisation procedures for pesticides have been provided in Appendix B.

Calculated tier 1 PECs for compounds 1—4 based on national surface water assessments for Germany, the Netherlands and the UK are presented in Tables A4—A14 of Appendix A for each compound. Slovenia only considers exposure via spray drift which is calculated following the UK method based on the Rautmann drift values. Therefore, assessment of surface water exposure via spray drift for the UK would apply to Slovenia.

0246810

Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconcent rati on Compound 4 (Parent)SurfaceWater RAC = 10 ug/l Sediment (ug/kg dw)

0.00.10.20.30.40.5Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconc

ent rati onCompound 4 (Metabolite)SurfaceWater RAC = 390 ug/l Sediment (ug/kg dw)

7.2.6.1 Standard Surface Water Assessment for Germany

The initial PEC surface water based on drift deposit at a distance of 1 m was 1.85 µg L-1

for compounds 1—4. Because the vapour pressure of these compounds were significantly below the trigger value of 1E-04 Pa for volatilisation from soil and 1E-05 Pa from plant surface, volatilisation and subsequent dry deposition to surface water as an entry route was not considered to be relevant. Predictions of PEC surface water from runoff/erosion and drainage using EXPOSIT gave concentrations which ranged between 0.54—0.93 µg L

-1

for the parent compounds.

EVA 2.1 model which is used to calculate concentrations in surface waters from spray drift and volatilisation does not simulate the formation, fate and concentration of metabolites from the parent compounds in surface water systems. No guidance was identified for Germany on how to calculate the metabolite concentrations in surface water exposed via spray drift and volatilisation deposits. Thus, unlike the EU level, Netherlands and UK procedures, assessment of surface water concentrations of metabolites formed in the water column was not performed at tier 1 of the German national assessment.

Assessment of runoff/erosion/drainage loadings for metabolites involved initial calculation of the equivalent metabolite application rate using the application rate of the parent compound corrected for interception (100 g ha

-1), maximum occurrence in soil from Table 3 and correcting for differences in molecular weight between

the parent and metabolite. PEC surface water were then calculated as for parent compounds with EXPOSIT. Predicted concentrations in surface water due to runoff/erosion and drainage ranged from 0.14—0.25 µg L

-1

for the metabolites of compound 1—4.

Tier 1 surface water assessment indicated that predicted concentrations of compounds 1—4 and associated metabolites were below the RAC. Therefore, these compounds would be eligible for product authorisation in Germany.

7.2.6.2 Standard Surface Water Assessment for Netherlands

Assessment of drinking water abstraction points in the Netherlands indicated that the calculated PEC surface water were below the standard of 0.1 µg L

-1 for compounds 1—4. A maximum PEC surface water of

0.952 µg L-1

was calculated for the edge-of-field water body for the parent compounds.

DROPLET and TOXSWA do not simulate formation and fate of metabolites from parent compound in surface water systems. However, based on personal communication with CTGB staff, metabolites can be assessed as if they were parent compounds by calculating the equivalent metabolite application rate using maximum occurrence in soil or water-sediment system and multiplying by the molecular weight ratio. For TOXSWA calculations of PEC arising from drift only, a maximum occurrence of 29.98% in water-sediment was used to give an equivalent application rate of 46.3 g ha

-1 corresponding to PEC surface water of 0.219 µg L

-1 for the

metabolites resulting from spray drift. It should be noted that metabolites of compounds 1—4 have the same Koc and DT50 values.

In the drinking water tool DROPLET, an initial simulation for the D3 scenario was performed. The substance concentrations at abstraction points were then calculated with DROPLET on the basis of the edge-of-field concentrations for all crops in the intake area on which the pesticide can be used by accounting for factors such as: (1) relative crop area (2) market share default factor = 0.4; (3) difference in timing of applications in the area of use, default factor = 0.5; (4) degradation and volatilisation from the edge-of-field watercourse to the abstraction point, and (5) additional dilution by lake or incoming river, default factor = 1 (except Andijk = 1/6).

For metabolites, CTGB staff informed us that the metabolites should be assessed as if they were parent compounds but indicated that metabolite assessments are not common. A complication arises because the D3 simulation with TOXSWA combines inputs via drainage and spray drift. Entry via drainage should be calculated using the equivalent application rate of the metabolite based on the maximum occurrence in soil. By contrast, the maximum occurrence in water-sediment studies is relevant for drift input. This complication was acknowledged by CTGB but no further guidance was given.

A simulation was performed as if the metabolite were the parent substance by using a maximum occurrence of 35.5% in soil to give an equivalent application rate of 54.9 g ha

-1 for drainage simulations (adjustment for

interception was done within the model) and 29.98% in water-sediment to give an equivalent application rate of 46.3 g ha

-1 for simulation of concentrations in surface water resulting from drift deposit. The drift deposition

was edited manually in the TOXSWA interface applying the Dutch drift value of 1% for arable crops. Adjustment of the application rate for drift simulation was achieved by editing the .m2t. The maximum PEC surface water was then input into DROPLET for calculation of concentrations at drinking water abstraction points. The results are shown in Table A4—A14 of Appendix A.

Tier 1 surface water assessment indicated that predicted concentrations of compounds 1—4 and associated metabolites were below the RAC. Therefore, these compounds would be eligible for product authorisation in the Netherlands.

7.2.6.3 Standard Surface Water Assessment for the UK

Soils with high clay content are under agricultural use in the UK and losses of pesticides to drainage systems via preferential flow can occur in these soils. An assessment of drainage losses, based on experimental data for a Denchworth clay soil at Brimstone Farm, is required as a first tier in the UK. It should be noted that the data from the Brimstone Farm experimental work also forms the basis for the FOCUS D2 scenario. Moreover the Defra R&D project PS2214 “Establishing the Representativeness of FOCUS Surface Water Scenarios for Pesticide Risk Assessment in the UK Landscape” indicated that scenario D2 is directly relevant to the UK in terms of soil and weather and would therefore be of importance if the UK were to use FOCUS framework for surface water exposure assessment and consequent ecotoxicological risk assessment.

In the UK, calculated PEC surface water based on drift deposit was 1.85 µg L-1

, but separate calculation for drainflow resulted in a PEC surface water of 14.6 µg L

-1 which exceeded the RAC for compounds 1, 3 and 4.

For these compounds with the Koc ranging from 15—74 L kg-1

(classed as mobile), an estimated 1.9% of the applied amount per 10 mm of drain water would result in drainage loading into surface water. The calculated drainflow concentration of compound 2 with Koc of 200 L kg

-1 (classed as moderately mobile with estimated

0.7% of the applied amount per 10 mm of drain water) was below the RAC.

For metabolites, the PEC surface water can be calculated based on application rate of the active substance adjusted for observed maximum occurrence of metabolite in water-sediment systems and further corrected for molecular weight differences as appropriate. For the UK drainflow calculations, the application rate of the metabolite was calculated as 200 g ha

-1 x 50% interception x (maximum occurrence in soil / 100) x molecular

weight ratio. Using this method, calculated concentrations of the metabolites in surface water were 0.43 µg L-

1 from drift deposit and 0.77—1.05 µg L

-1 from drainflow.

The tier 1 surface water assessment of compounds 1, 3 and 4 indicated that predicted concentrations of the parent compounds in surface water from drainflow exceeded the RAC. Therefore, these compounds would not be eligible for authorisation in the UK. However, compound 2 passed the tier 1 surface water assessment for drift deposit and drainflow and would be eligible for product authorisation in the UK.

7.2.7 Conclusions of FOCUS PEC Surface Water Assessment

In general, assessment of potential impact of compounds 1—4 on aquatic organisms following single ground application at 200 g a.s ha

-1 to winter cereals in the spring (assuming ~50% interception) identified potentially

unacceptable risks for FOCUS scenarios D1 and D2 where the highest concentrations in surface water and sediment were predicted. However, none of the Central Zone MS currently use drainage scenarios D1 or D2 as representative national scenarios. Therefore, failure of these scenarios would not be of any significance for MS that apply FOCUS methodology for their national surface water assessment.

The calculated PEC surface water for all other FOCUS scenarios were below the RAC of 10 µg L-1

for parent compounds. In addition, calculated global maximum concentrations of metabolites of compounds 1—4 were significantly less than the RAC of 390 µg L

-1 for all representative MS scenarios.

Tier 1 surface water assessment indicated that compounds 1—4 would pass the authorisation procedures in Germany, Netherlands and Slovenia. However, compounds 1, 3 and 4 which have Koc of 34—66 L kg

-1 and

classed as mobile, exceeded the RAC for entries to surface water via drainflow as required in the UK.

Except for the Netherlands, calculation of PEC surface water resulting from spray drift deposit was based on the Rautmann drift values at the EU level and for all MS in the Central Zone including Germany and the UK.

For FOCUS ditch, stream and pond, the nominal concentration in water resulting from drift event calculated with the SWASH drift calculator was 1.285 µg L

-1, 0.954 µg L

-1 and 0.044 µg L

-1, respectively. For Germany

and the UK, a nominal concentration of 1.85 µg L-1

was calculated; while for the Netherlands, a value of 0.952 µg L

-1 was calculated similar to the FOCUS stream. The assessment of surface water exposure to drift

deposit, thus, seems to be more conservative in Germany and the UK.

Based on standard surface water assessment of FOCUS scenarios representative for some MS, compounds 1—4 (and associated metabolites) would be eligible for authorisation in: Austria, Belgium, Czech Republic, Ireland, Hungary, Poland, Romania and Slovakia. The assessment based on specific national requirements also indicated that compounds 1—4 would be eligible for product authorisation in Germany, Netherlands and Slovenia.

However for the UK, only compound 2 (and associated metabolite) would be eligible for authorisation based on the tier 1 assessment. Compounds 1, 3 and 4 would not meet the authorisation requirements at tier 1 due to the occurrence of high concentrations in surface water from drainage losses or preferential flow that result in exceedance of the RAC.

It should be noted that compounds 1—4 failed groundwater assessment for all MS at tier 1 and also for the Netherlands at tier 2. Overall, these compounds would not be eligible for product authorisation unless higher tier assessment, including groundwater monitoring, can be used to establish safe uses in accordance with individual MS authorisation requirements.

8 Standard Exposure Assessment for Compounds 5—8

Initial assessment indicated that impact of compounds 5–8 on groundwater following 4 applications to apples at 2500 g a.s ha

-1 (assuming ~70% interception) and intervals of 14 days between applications would result

in potentially unacceptable risk for most FOCUS groundwater scenarios. However, at least one scenario was passed by compounds 5—8, with the lowest concentrations predicted for compound 5 which had a Koc of 500 L kg

-1 and DT50 of 50 days, and highest concentrations predicted for compound 8 with Koc of 840 L kg

-1

and DT50 of 120 days.

A close inspection of the FOCUS Step 3 results for compounds 5—8 presented in Table A2 of Appendix A indicated that the global maximum PEC surface water for all four compounds were approximately the same for the relevant scenarios. This is likely due to surface water exposure being dominated by drift deposits with minimal effects from differences in the soil DT50 and Koc values of the compounds. It should also be noted that the DT50 water (2.5 days) and sediment (28 days) were the same for all four compounds.

Therefore, in addition to EU level exposure assessment for compounds 5—8, only the MS level assessment for compound 5, which is considered representative of the group has been presented in this report.

8.1 PEC Groundwater

8.1.1 FOCUS Groundwater Assessment of Compounds 5—8 at EU Level

The 80th percentile annual average PEC groundwater for compounds 5—8 are shown in Figure 7 below and

presented in Table A2 of Appendix A. PEARL exposure assessments for FOCUS scenarios indicated that PEC groundwater was below the limit of 0.1 µg L

-1 for at least one of the FOCUS scenarios. Compounds 5—

8 are therefore considered eligible for inclusion in the EU pesticides database according to Regulation (EC) No 1107/2009.

Figure 7. Tier 1 calculated PEC groundwater for compounds 5—8

It is interesting to note that the EU level simulation with PELMO with plant uptake and volatilisation switched on gave a much lower 80

th percentile concentrations for the Hamburg scenario (0.045 µg L

-1) than simulation

with PEARL (0.225 µg L-1

). The fact that PELMO simulated a much greater loss of the pesticide mass via volatilisation (42—86% of applied) than PEARL (0.08—0.4% of applied) contributed to these differences. Results for the Piacenza scenario are reversed—PELMO gave a slightly larger 80

th percentile concentration

in leachate (0.144 µg L-1

) than PEARL (0.113 µg L-1

) despite greater volatilisation losses. The scenario is irrigated. The irrigation volumes used in PELMO are larger than those calculated in PEARL. This enhances losses in percolation.

0 .00 .20 .40 .60 .81.01.2Ch at eaud un H amb urg J oki oi nen K remsmuenst er Ok eh ampt on Pi acenza P ort o S evill a Thi vaPEC ground wat er( ug/ l)

Compd 5 Compd 6 Compd 7 Compd 80.1 µg l

-1


Tables A15 of Appendix A show tier 1 80th percentile annual average PEC groundwater for compound 5 for

those FOCUS scenarios relevant to MS in the Central Zone.

Except for Châteaudun, PEC groundwater exceeded the limit value of 0.1 µg L-1

for other scenarios relevant to MS. For Hungary, only predicted concentrations for the Hamburg scenario exceeded the limit of 0.2 µg l

-1.

PEC groundwater calculated with PELMO for the Hamburg scenario in accordance with tier 1 procedures for Germany (0.152 µg L

-1) was much higher than the value derived with PELMO (0.045 µg l

-1) at EU level. This

is because Germany requires tier 1 leaching assessment with plant uptake and volatilisation set to zero to give a worst-case leaching scenario. As compound 5 is a volatile substance (vapour pressure = 1.30E-04 pa), the effect of switching off losses via volatilisation in PELMO was more significant compared to compounds 1—4.

Additional calculation with EXPOSIT for the assessment of bank infiltration resulted in PEC groundwater of 0.379 µg L

-1 from runoff/erosion and 0.138 µg L

-1 from drainage.

Calculation of PEC groundwater with PEARL 3.3.3 for Kremsmünster as required in the Netherlands gave a value of 0.14 µg L

-1 that was slightly higher than that derived with PEARL 4.4.4 (0.105 µg L

-1) currently used

for EU level assessment. Since tier 1 groundwater assessment failed for Kremsmünster, tier 2 assessment with the spatially distributed model GeoPEARL would be required in the Netherlands for compound 5.

Additional simulation with MACRO 4.4.2 in accordance with UK requirements for compounds with Koc >100 resulted in predicted groundwater concentrations of 0.09 µg L

-1 compared to a value of 0.08 µg L

-1 calculated

with PEARL or 0.045 µg L-1

calculated with PELMO.

8.1.3 Tier 2 Groundwater Assessment of Compounds 5—8 for the Netherlands

The tier 2 90th percentile PEC groundwater for compound 5 calculated with GeoPEARL is given in Table A15

of Appendix A, corresponding to 0.013 µg L-1

for the area of use in the Netherlands. The calculated values for compounds 6—8 were 0.019 µg L

-1, 0.018 µg L

-1 and 0.142 µg L

-1, respectively (data not shown in Table

A15). It should be noted that spatially distributed modelling at tier 2 resulted in a reduction of PEC groundwater by 91% for compound 5 compared to tier 1 value calculated for Kremsmünster. However, while compounds 5—7 passed tier 2 assessment, compound 8 with the largest Koc of 840 L kg

-1 and DT50 of 120

days still failed the assessment at tier 2.

8.1.4 Conclusions of FOCUS PEC Groundwater Assessment

Based on standard tier 1 assessment for individual MS national scenarios, the predicted concentrations of compounds 5—8 in groundwater following multiple applications at 2500 g a.s ha

-1 to apples (assuming ~70%

interception) would exceed the regulatory endpoint for protection of groundwater for most MS representative scenarios. Therefore, assessment at tier 2 or higher tier, options for which include refinement of substance parameters, use of field data and lysimeter studies or monitoring data would be required to demonstrate safe uses in accordance with individual MS authorisation procedures.

Tier 2 assessment with GeoPEARL indicated that compounds 5—7 with Koc of 120—500 L kg-1

and DT50 of 16—50 days passed the regulatory trigger of 0.1 µg L

-1. However, compound 8 failed the tier 2 assessment

because of relatively slower degradation in soil, and hence greater potential for leaching to groundwater. All compounds exceeded 0.01 µg L

-1 which indicates that these substances would be prohibited in groundwater

protection areas, unless supplementary data can be used to demonstrate that in practice the 90th percentile

concentrations are <0.1 µg L-1

.

Based on the tier 2 groundwater assessment, compounds 5—7 would be eligible for product authorisation in the Netherlands. Compound 8 would, however, require further assessment including model refinement using lysimeter or field data, shallow groundwater monitoring, transformation studies or monitoring data for deeper groundwater in order to demonstrate safe uses in this MS.


8.2.1 Surface Water Assessment of Compounds 5—8 at EU Level

Global maximum PEC surface water for compounds 5—8 calculated at FOCUS Step 3 are shown in Figure 8 and also in Table A2 of Appendix A. A RAC of 50 µg L

-1 was used based on fish chronic NOEC. For multiple

applications where peak PEC surface water is mainly caused by drift deposit, FOCUS (2012) recommend repeating PEC calculations for the respective single application and selecting the highest PEC to perform the aquatic risk assessment.

The global maximum PEC surface water calculated for compounds 5—8 failed the surface water assessment at Steps 1—2 for multiple and single application. Of the drainage scenarios assessed at Step 3, pond D4 and D5 passed. Similarly, of the runoff scenarios assessed, only pond R1 passed surface water assessment. It should be noted that drainage scenarios D1, D2 and D6 are not relevant for apples and runoff scenario R2 is not used by any of the MS.

Mass loading of compounds 5—8 to surface waters was dominated by drift deposits for all FOCUS scenarios with nominal inputs from drainage and runoff.

In general, the maximum PEC surface water predicted after 4 applications was lower than the corresponding value after single application. This is because the peak concentrations are dominated by drift deposits and compounds 5—8 have a short half-life of 2.5 days in water which results in rapid degradation within the 14 days interval between applications. The fraction of the applied amount lost via drift is larger for a single application than for each multiple application because a higher percentile drift loss is used for the calculation.

Based on Steps 1—3 FOCUS surface water assessment, predicted concentrations of compounds 5—8 were found to be below the RAC for several relevant scenarios which implies that safe uses can be identified in the EU. Therefore, compounds 5—8 would be considered eligible for inclusion in the EU pesticides database in accordance with Regulation (EC) No 1107/2009.

Figure 8. Calculated maximum surface water concentrations of compounds 5—8 after single and multiple applications at FOCUS Step 3

050100150200250Dit chD3 P ondD4 St reamD4 P ondD5 St reamD5 Dit chD6 P ondR1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob alM axi mumPEC( ug

/ l) RAC = 50 ug/ lCompd 5 S ing le A ppl. Compd 6 Compd 7 Compd 8


The global maximum PEC surface water and sediment for compound 5 are shown in Figure 9 for all relevant Step 3 FOCUS scenarios. Global maximum PEC surface water results for individual MS in the Central Zone are also presented in Tables A16 (multiple applications) — A17 (single application) of Appendix A.

Figure 9. Calculated maximum surface water concentrations of compound 5 after single and multiple applications at FOCUS Step 3

The global maximum PEC surface water was below the RAC of 50 µg L-1

for single and multiple applications in pond D4, D5 (only Austria) and pond R1 scenarios which are used by Austria, Belgium, Hungary, Poland, Ireland, Romania and Slovakia for their national authorisation.

However, all other FOCUS scenarios relevant to MS including ditch D3, stream D4 and D5, stream R1, R3 and R4 failed surface water assessment. In general, the maximum PEC surface water calculated for multiple applications was lower than the corresponding values for single application. The results imply that all MS using FOCUS scenarios would need to consider risk mitigation measures before authorising products containing compound 5.

For multiple applications, maximum PEC sediment ranged from 14.9 µg kg-1

dw in pond D4 to 69.4 µg kg-1

dw in ditch D3. These values are lower than the corresponding maximum PEC sediment for a single application which ranged from 5.28 µg kg

-1dw in stream D5 to 61.7 µg kg

-1dw in ditch D3.

Germany, Netherlands, Slovenia and the UK apply specific national approaches for standard surface water assessment and separate exposure assessments based on the national authorisation requirements for these MS have been provided in Section 8.2.3 below.

8.2.3 Standard Assessment for Germany, Netherlands and the UK

Tables A16—A17 of Appendix A show calculated tier 1 PECs for compound 5 based on the national surface water assessments for Germany, Netherlands and the UK following multiple and single application. Slovenia only considers exposure via drift which is calculated following the UK method. Therefore, the assessment of surface water exposure via spray drift for the UK would also be applicable to Slovenia.

8.2.3.1 Standard Surface Water Assessment for Germany

In the German national assessment, actual PEC surface water based on drift deposit and volatilisation was 203 µg L

-1 for multiple applications and 246 µg L

-1 for the corresponding single application. These values are

higher and more conservative than those calculated following FOCUS procedures for EU level assessment which does not consider additional input from atmospheric dry deposition, and integrates drift over the width of the water body to derive an areic mean deposition.

Separate calculations of maximum PEC surface water in the ditch resulting from runoff/erosion and drainage gave 6.2—18.6 µg L

-1 and 2.25—6.8 µg L

-1 for single and multiple applications which are well below the RAC

of 50 µg L-1

.

050100150200250Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconc

ent rati on Compound 5 (Multiple Application)SurfaceWater RAC = 50 ug/l Sediment (ug/kg dw)050100150200250

Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob al maxi mumconcent rati on Compound 5 (Single Application)SurfaceWater RAC = 50 ug/l Sediment (ug/kg dw)

8.2.3.2 Standard Surface Water Assessment for Netherlands

The standard water body in the Netherlands is a ditch with length of 320 m, depth of 0.3 m, border slope of 45

0 and bottom width of 0.4 m, and is divided into 80 segments of 4 m length. The sediment thickness is

0.1 m and divided into 14 segments. Flow velocity is 10 m day-1

. Simulations of concentrations in surface water and sediment were performed with TOXSWA 1.2 and the maximum exposure concentrations at 318 m were used for the aquatic risk assessment. The results are presented in Table A16—A17 of Appendix A.

Figure 10 Distribution of compound 5 in the edge-of-field water body after multiple and single application.

The predictions of surface water concentrations in the edge-of-field water body gave a maximum of 245 µg L

-1 following multiple applications and 202 µg L

-1 after single application, both of which exceeded the

RAC of 50 µg L-1

(Figure 10). Therefore, a tier 2 evaluation was performed to estimate PECmax in the Water Framework Directive (WFD) water body based on the predicted maximum concentration in the edge-of-field ditch taking account of dilution and degradation during travelling time from the ditch to the water body as follows:

PECmax, WFD = PECmax, edge-of-field ditch * e (-residence time * k)

/ dilution factor

With a dilution factor = 3 (for multiple applications) or 5 (for single application) and residence time of 5 days; k, degradation rate in water = 0.28 d

-1, the calculated PECmax was 20.14 µg L

-1 for multiple applications and

9.96 µg L-1

for single application. In addition to higher input, the lower dilution factor for multiple applications also contributed to calculated higher concentrations compared to single application. For the tier 2 aquatic risk assessment, the RAC of 50 µg L

-1 was taken as the MPC for the WFD water body. The results indicated that

compound 5 would pass this scenario in the Netherlands.

The assessment of potential impact on drinking water abstraction points indicated that PEC surface water exceeded the limit of 0.1 µg L

-1 at several abstraction points following multiple and single application based

on calculated D3 PEC surface water of 140 µg L-1

and 139.72 µg L-1

, respectively. It should be noted that the D3 PECs were calculated using the Dutch drift value of 17% for fruit crops. These results are also presented in Table A16—A17 of Appendix A.

Refinements of tier 1 calculations are further discussed in Adriaanse et al. (2008) and in the DROPLET user manual (van Leerdam et al. 2010). The assessment of pesticides moves to tier 2 if the concentration in one of the nine abstraction points calculated at the first tier (including possible refinements), has a value in the range 0.1—Y*0.1 µg L

-1. The factor Y represents a safety factor the size of which is determined by the Dutch

Authorities.

At tier 2, monitoring data from all nine drinking water abstraction points are evaluated. The recommended minimal frequency of monitoring is 13 times a year and a 90

th percentile is calculated for each abstraction

point as well as an overall 90th percentile. If insufficient data (<13 per year) are available for an individual

water abstraction point, the maximum value is taken for that particular year instead of a 90th percentile. The

drinking water standard of 0.1 µg L-1

should be met in all nine surface water abstraction points.

8.2.3.3 Standard Surface Water Assessment for the UK

For the UK national assessment, 90th percentile spray drift values according to Rautmann et al. (2000) were

used to calculate PEC surface water via drift. The substance mass is deposited in a water body of 100 m x 1 m x 0.30 m. There is no sorption in the water body, but the model accounts for degradation in the water column between applications by using the DT50 in water. Unlike at the EU level with FOCUS surface water drift calculator, spray drift is not integrated across the width of the water body.

Drainage inputs are given as a percentage of the applied dose and dependent on the Koc. The inputs from drainage are then diluted in 130,000 litres water. This additional calculation is intended as a first tier in the assessment of the potential exposure via drainflow.

The predicted maximum PEC surface water based on drift deposits was 204 µg L-1

after multiple applications and 243 µg l

-1 after single application based on 3 m distance to the surface water body.

The loss of pesticides to surface water in drainflow is considered most likely in the months of October—April. Early application of compound 5 to apples, with the first application on 1 April and a 14-day interval between applications means that there are potentially 3 applications during the period of drainflow in the UK up to 30

th

April. The method used for tier 1 drainflow calculation was to first estimate the PEC soil after 3 applications at 2500 g ha

-1 and 70% interception which gave a PEC soil of 1876 g ha

-1 based on a 14-day interval and a

DT50 of 50 days. The losses to drains were assumed to occur immediately following the third application, with the fourth application occurring outside the period of drainflow. The calculated PEC surface water via drainflow was 72 µg L

-1 after 3 applications (1876 g ha

-1) and 29 µg L

-1 after a single application (750 g ha

-1)

(Table A16—A17). Further higher tier drainflow simulation would therefore be required to demonstrate safe uses of compound 5 in the UK.

8.2.4 Conclusions of FOCUS PEC Surface Water Assessment

The assessment of potential impact of compound 5 on aquatic organisms following multiple applications to apples at 2500 g a.s ha

-1 (assuming 70% interception) has identified potentially unacceptable risk for most

FOCUS surface water scenarios used by MS in the Central Zone in their national authorisation procedures. Based on FOCUS Steps 1—3 surface water assessment, compound 5 (and by implication compounds 6—8) would not meet national authorisation requirements in the following MS: Austria, Belgium, Czech Republic, Ireland, Hungary, Poland, Romania and Slovakia. Higher tier assessment or application of drift mitigation measures, would therefore be required to demonstrate safe uses in these MS.

At EU level and for those MS that use FOCUS scenarios in their national assessment, only pond D4, D5 and R1 scenarios passed the standard surface water assessment. The nominal concentrations in water resulting from drift deposit calculated with SWASH drift calculator for FOCUS ditch, stream and pond was 155—197 µg L

-1, 141—180 µg L

-1 and 9.2—11.8 µg L

-1, respectively for the multiple and single application. The

calculated values are much lower for the FOCUS pond compared to the FOCUS ditch and stream scenarios. Hence, all the pond scenarios passed the surface water assessment while all the ditch and stream scenarios failed at tier 1.

If substances are applied as spray and have a high potential for adsorption to soil particles like compound 5, the spray drift route of entry usually dominates. For several reasons the initial PEC surface water in the pond is lower than in the streams and ditches because: (i) the edge of the pond is further away from the edge of the treated area (6m), (ii) drift is integrated over a greater width (30m), (iii) drift deposition from a smaller treated area enters the pond (0.45 ha), and (iv) the larger dilution in the pond (900 m

3) following drift deposit

compared to available dilution in the FOCUS ditch or stream (30 m3). This type of PEC surface water values

driven by spray drift entries is usually not sensitive to climatic parameters (EFSA, 2013b). Hence the pond scenarios passed the surface water assessment while the ditch and stream scenarios failed at tier 1.

It is interesting to note that the maximum PEC surface water after multiple applications in the Netherlands are similar to the values obtained after a single application at EU level, in Germany and the UK. Tier 1 assessment at EU level and in Germany are based on drift values calculated at the 90

th percentile for single

application (29.2% of applied amount for early application to fruit trees) and the 74th percentile for 4

applications (23.6%) from BBA (2000) and the Rautmann drift tables. The UK uses the 77th percentile for 3 or

more applications (23.9%). Thus for the EU, Germany and the UK, a lower percentage of initially applied

amount would enter surface water after multiple applications. Moreover, DT50 water of 2.5 days (DT90 = 8.3 days) indicate that a large proportion of the applied amount of compound 5 is degraded between each application (interval = 14 days). Therefore, for EU level, Germany and UK assessment, calculated maximum PEC surface water was observed to be higher after a single application than after multiple applications.

The Netherlands uses drift value of 17% of applied amount for fruit crops for single and multiple applications. Unlike at the EU level, in Germany and the UK, there is no reduction in the percentage of the applied amount that enters surface water following multiple applications, thus more residues from previous applications are added to subsequent applications with concentration after the last application used for PEC calculation. For example, the areic mean deposition of compound 5 for the D3 scenario was 17% with a corresponding PEC of 140 µg L

-1 after multiple applications and 139.7 µg L

-1 after single application. For edge-of-field water

body, the maximum PEC surface water occurred on day 0 after a single application and on day 45 (4th

application) after multiple applications.

It should be noted that Germany, Netherlands and the UK consider spray drift separately from other routes of exposure, whereas spray drift is added to losses via either runoff/erosion or drainage at EU level. Sorption to sediment is considered at EU level and in the TOXSWA simulations for the Netherlands, but not in Germany or the UK. Degradation in the water phase is accounted for at EU level and in Germany, Netherlands and the UK. The UK and Germany do not integrate drift over the width of the water body, this is a deviation from the FOCUS methodology. The Netherlands use drift values that are lower than those used in other MS and do not differentiate between single and multiple applications.

For Slovenia, tier 1 calculation of PEC surface water based on the Rautmann drift values as applied in the UK methodology indicated that compound 5 would not meet authorisation requirements in this MS, unless appropriate drift mitigation measures are applied to demonstrate safe uses.

Tier 1 assessment for Germany, Netherlands and UK indicated that compound 5 would fail the authorisation procedures based on exposure of surface water via spray drift or concentrations in drinking water abstraction points and/or via drainflow. As with other MS, higher tier assessments, including application of drift mitigation measures and drainflow modelling, would be required in order to demonstrate safe uses in these MS.

9 Standard Exposure Assessment for Compound 9

In order to evaluate effects of pH-dependent sorption and degradation on the exposure assessment of plant protection products, and hence on the regulatory outcome for individual MS, a search of draft assessment reports available on the European Food Safety Authority (EFSA) website was undertaken. From this search, one substance was identified as a suitable candidate. The environmental fate and ecotoxicological properties as well as application scenario were modified to ensure anonymity. The laboratory DT50 values at 20

oC and

pF = 2 and Koc data were modified with inclusion of additional data points for in order to obtain a clear pH-dependent relationship. The pKa value was set to 4.75. The substance was designated as compound 9 with the relevant pH-dependent properties. Relevant statistics are presented in Table 4 and Table 5 as well as Figure 11 and Figure 12, for acidic and alkaline conditions.

Table 4. Soil DT50 data for compound 9

Soil DT50 (days) DT50 @ pH < 7 DT50 @ pH >= 7

No of Samples 27 12 15

Arithmetic Mean 51.9 23.1 74.3

Geometric Mean 39.6 19.0 71.2

Median 60 17 75

Minimum 8 8 28

Maximum 100 60 100

Figure 11. Plot of pH vs modified soil DT50 values showing pH dependency

Table 5. Freundlich sorption data for compound 9

Kfoc (L kg

-1) Kfom (L kg

-1) 1/n (-)

Number of samples 8 8 8

Average all data 52.24 30.30 0.89

Average pH > 7 23.42 13.57 0.90

Average pH < 7 81.06 47.04 0.88

Minimum 17.5 10.15 0.88

Maximum 104.7 60.73 0.92

R² = 0.7156{20020406080100120

0 1 2 3 4 5 6 7 8 9 10DT50(d ays) pHDT50 (days) All Data

020406080100120

0 1 2 3 4 5 6 7 8 9 10DT50(d ays) pHDT50@ pH <7 DT50@ pH >=7

Figure 12. Plot of pH vs modified Freundlich sorption data showing pH dependency

Compound 9 was applied to winter cereals at a rate of 20 g a.s ha-1

14 days before emergence in autumn as ground application. Winter cereals emergence dates for each relevant FOCUS drainage and runoff scenario were obtained from FOCUS report (2001), and the precise application date for each scenario was calculated with the pesticide application timer (PAT) within the MACRO and PRZM models.

Based on pH-dependence of DT50 and sorption, properties of compound 9a (at pH <7) and compound 9b (at pH >7) were derived for exposure assessment. Selected properties, crop, application rate, method, timing as well as ecotoxicological endpoints applied for tier 1 groundwater and surface water assessment are listed in Table A2 of Appendix A.

FOCUS (2006) recommends the use of geometric mean DT50 and arithmetic mean Koc values for exposure assessment, and most MS in the Central Zone follow this approach. The arithmetic mean 1/n value for each pH range was used for PEC simulation as no specific EU guidance on selection of 1/n values for compounds with pH-dependent properties was identified. For those MS that apply FOCUS procedures, groundwater and surface water assessment under acidic (pH <7) and alkaline (pH >7) conditions for representative FOCUS scenarios are described in Section 9.1.2 and 9.2.2, respectively. A summary of the model input parameter values used for exposure assessment at MS level is presented in Table 6 and Table 7 below.

Information obtained from the survey undertaken by Fera as part of the evaluation of national approaches for pesticide exposure assessment in the EU (Central Zone) indicated that Belgium, Czech Republic, Germany, and the Netherlands adopt a different approach for the application of pH-dependent DT50 and sorption data for groundwater and surface water assessment or have developed specific scenarios and tools for exposure assessment. Therefore, the assessment of compound 9 was performed separately for these MS as outlined in their national approaches.

9.1 PEC Groundwater

9.1.1 FOCUS Groundwater Assessment of Compound 9 at EU Level

The 80th percentile annual average PEC groundwater for compound 9 under acidic and alkaline conditions

are shown in Figure 13 and also presented in Table A2 of Appendix A. Assessment of all the nine FOCUS groundwater scenarios indicated that PEC groundwater was below the drinking water standard of 0.1 µg L

-1

under acidic conditions. However under alkaline conditions, the calculated PEC groundwater exceeded the standard for all FOCUS scenarios except Sevilla.

Leaching models are very sensitive to changes in Koc and DT50 values and the weaker sorption and greater persistence of compound 9 under alkaline conditions resulted in much higher PEC groundwater than under acidic conditions. Based on the FOCUS tier 1 assessment, compound 9 would be eligible for inclusion in the EU pesticides database according to Regulation (EC) No 1107/2009, but the potential for leaching in alkaline soils would need to be highlighted in the review report.

Figure 13. Tier 1 calculated PEC groundwater for compound 9 under acidic and alkaline conditions

0.00000.00010.00020.0003Ch at eaud un H amb urg J ok i oi nen K remsmunst er Ok eh ampt on Pi acenza P ort o S evill a Th i v aPEC ground wat er( ug/l)

Compound 9 @ pH <70.00.51.01.52.0

Ch at eaud un H amb urg J ok i oi nen K remsmunst er Ok eh ampt on Pi acenza P ort o S evill a Th i vaPEC ground wat er( ug/l)Compound 9 @ pH >7

Table 6. Summary of input parameters for MS national groundwater and surface water assessment at pH <7

Member State Soil DT50 (d) Kom (l/kg) Kfoc (l/kg) 1/n Comments

Austria 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

Belgium 100 10.15 17.5 0.92 Worst-case DT50, Kfoc and 1/n values from Table 4 and Table 5

Czech Republic 19 47.04 81.1 0.89 Geomean DT50 and arithmetic mean Kfoc at pH <7 and 1/n values (all data) with Hamburg and D4

Germany NA NA NA NA Reference Table 8

Hungary 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/ values at pH <7 according to FOCUS guidance

Ireland 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

Netherlands NA NA NA NA Reference Table 9

Poland 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

Romania 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

Slovakia 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

Slovenia 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

United Kingdom 19 47.04 81.1 0.88 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

Table 7. Summary of input parameters for MS national groundwater and surface water assessment at pH >7

Member State Soil DT50 (d) Kom (l/kg) Kfoc (l/kg) 1/n Comments

Austria 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH >7 according to FOCUS guidance

Belgium 100 10.15 17.5 0.92 Worst-case DT50, Kfoc and 1/n values from Table 4 and Table 5

Czech Republic 71.2 13.57 23.4 0.89 Geomean DT50 and arithmetic mean Kfoc at pH <7 and 1/n values (all data) for Kremsmünster and R1

Germany NA NA NA NA Reference Table 8

Hungary 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH >7 according to FOCUS guidance

Ireland 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH >7 according to FOCUS guidance

Netherlands NA NA NA NA Reference Table 9

Poland 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH >7 according to FOCUS guidance

Romania 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH >7 according to FOCUS guidance

Slovakia 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH >7 according to FOCUS guidance

Slovenia 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH >7 according to FOCUS guidance

United Kingdom 71.2 13.57 23.4 0.90 Geometric mean DT50 and arithmetic mean Kfoc and 1/n values at pH <7 according to FOCUS guidance

9.1.2 Assessment of Compound 9 for MS that Apply FOCUS Procedures

Table A18 of Appendix A show 80th percentile annual average PEC groundwater for compound 9 under

acidic and alkaline conditions, respectively for FOCUS groundwater scenarios representative for MS in the Central Zone that use geometric mean DT50 and arithmetic mean Koc and 1/n values for PEC calculation according to FOCUS recommendations.

The UK position is that pH–dependent parameters relevant to the crop should be used. The UK would not require a combination of the worst-case DT50 and Koc if that combination does not exist (e.g. if degradation was slower in acidic soils and sorption was weaker in alkaline soils). The UK does accept the EU level approach of calculating PEC for alkaline and acidic soils separately based on the geometric mean DT50 and arithmetic mean Koc and 1/n values for each group of soils, as shown for compound 9 in Table 4 and Table 5 above. If the number of soils within each group is small and less than the number of results normally required by the data requirements, then the use of worst-case alkaline and worst-case acidic data would be more appropriate.

It should be noted that the assessment of relevance of FOCUS groundwater scenarios in the UK did not consider pH of the soils in the scenarios. Therefore the UK does not follow the approach advocated by FOCUS groundwater I report (selecting the DT50 and Koc value of the experimental soil with the pH closest to the scenario soil). Performing an assessment that matches the pH of the scenario with a particular pH-dependent value of a parameter implies that the locations represented by those scenarios will always have such a pH, and this is not necessarily correct. In reality a range of pH values can be associated with each of the FOCUS soil scenarios.

Simulations with PEARL and PELMO resulted in PEC groundwater that were below the limit of 0.1 µg L-1

for all representative MS scenarios under acidic conditions (pH <7). However, under alkaline conditions (pH >7), all PEC groundwater exceeded the limit for scenarios relevant to MS that apply FOCUS approach including Hungary where a limit value of 0.2 µg L

-1 is acceptable except for Châteaudun.

Based on tier 1 groundwater assessment, compound 9 would not meet requirements for authorisation in any of the following MS: Austria, Hungary, Ireland, Poland, Romania, Slovakia, Slovenia and UK. Assessment at tier 2 or higher tier would be required to demonstrate safe uses in accordance with requirements in each MS.

9.1.3 Groundwater Assessment of Compound 9 for Belgium

There is no specific guidance document at national level to address the potential leaching risk of an active substance with pH-dependent DT50 and Koc properties. However, information obtained from representatives of Belgium indicated that the worst-case values from the EU agreed endpoints for the entire data-set (acidic and alkaline) combined are used in order to obtain groundwater concentrations under vulnerable conditions. Further clarification obtained with respect to 1/n indicated that the worst-case 1/n should also be used in cases where the worst-case Koc is used. Therefore, groundwater assessment for Belgium was based on the worst-case DT50, Koc and 1/n values as shown in Table 6 and Table 7 above.

Simulations with PEARL resulted in PEC groundwater of 2.15—3.6 µg L-1

for all FOCUS scenarios relevant to Belgium, which considerably exceeded the 0.1 µg L

-1 limit. The results for Belgium, as well as all other MS

for which tier 1 assessment has been undertaken in accordance with their national authorisation procedures are presented in Table A18 of Appendix A.

The use of worst-case DT50, Koc and 1/n values from the EU agreed endpoints gave PEC groundwater that were 2—3 times higher than values obtained at the EU level under alkaline conditions and several orders of magnitude higher under acidic conditions. Therefore, a tier 1 assessment for Belgium would result in greater exceedances of the drinking water standard. Compound 9 would, therefore, not meet the requirements for product authorisation in Belgium. Further assessment at tier 2 or higher tier would be required to establish safe uses in accordance with this MS authorisation procedure.

9.1.4 Groundwater Assessment of Compound 9 for Czech Republic

There is no specific guidance document at national level to address the potential risk of an active substance with pH-dependent DT50 and Koc to groundwater. However information obtained from representatives of the

Czech Republic indicated that the worst-case values from EU agreed endpoints can be used, although this is not always necessary. A common approach is to separate the data-set for acidic and alkaline conditions and calculate the respective geometric mean DT50 and arithmetic mean Koc along with the arithmetic mean 1/n values for all data-set. Then calculate PEC groundwater with the acidic data for Hamburg scenario; and with the alkaline data for Kremsmünster scenario.

Geometric mean DT50 and arithmetic mean Koc and 1/n values (all data) used for groundwater assessment under acidic and alkaline conditions, respectively are listed in Table 6 and Table 7 for the Czech Republic. The only difference with EU level input data was use of arithmetic mean 1/n value for all available data-set.

PEC groundwater calculated using PEARL are also shown in Table A18 of Appendix A. The calculated value for Hamburg representing acidic conditions was 0.0004 µg L

-1; and the value for Kremsmünster representing

alkaline conditions was 1.163 µg L-1

. These results are similar to those calculated at EU level where the limit of 0.1 µg L

-1 was only exceeded under alkaline conditions.

The assessment for the Czech Republic indicated that compound 9 would not meet requirements for product authorisation. Assessment at tier 2 or higher tier would be required to establish safe uses in accordance with this MS authorisation procedure.

9.1.5 Groundwater Assessment of Compound 9 for Germany

The German authorisation procedures for groundwater at tier 1 are based on leaching assessments for the FOCUS Hamburg and Kremsmünster scenarios performed with PELMO and parameterised using the Input-Decision tool. The tool is based on a decision-tree for selecting laboratory or field degradation and sorption data for PEC groundwater simulations in the national authorisation of pesticides. An evaluation of the data in Table 4—5 indicated that: (1) degradation of compound 9 is slower in alkaline soils than in acidic soils (Table 4); and (2) a negative correlation exists between the Kfoc of compound 9 and soil pH (Figure 12).

Based on the above evaluation, two simulations are required and the worst-case PEC groundwater should be selected: (1) Hamburg scenario using geometric mean DT50 from all soils, two Koc values for highest and lowest pH reported in Table 5, and arithmetic mean 1/n values for all soils; and (2) Kremsmünster scenario using the geometric mean DT50 for alkaline soils, two Koc values for highest and lowest soil pH reported in Table 5, and arithmetic mean 1/n value for all soils. Flow charts of decision trees for selecting DT50 and Koc values for groundwater assessment are provided in

Figure 14 and Figure 15, respectively. A summary of the input values used for PEC groundwater simulations with PELMO is also presented in Table 8 below.

The Koc values for high and low pH were derived by fitting a curve to the relationship between the Koc data and the pH of the test soils using the Input-Decision tool. This returns fitted Koc values at various soil pH. A representative from the German authority UBA informed us that the Koc value at a low and high pH (e.g. pH 5 and 10) should be selected from the list of fitted values. These are then entered into the input screen for pH dependent sorption in PELMO, together with the pKa. The Koc for the Hamburg and Kremsmünster soil are calculated by the model. The model uses the same equation as the Input-Decision tool to interpolate between the two entered pairs of Koc and pH values.

The tier 1 assessment indicated that worst-case groundwater concentration of compound 9 following single pre-emergence application to winter cereals at 20 g a.s ha

-1 in autumn would occur in Kremsmünster

(1.220 µg L-1

) under alkaline conditions compared to the Hamburg (0.342 µg L-1

) scenario under acidic conditions. In Germany, the assessment failed at tier 1 for both acidic and alkaline conditions, whereas at EU level and in many MS, the predicted concentrations under acidic conditions were well below the 0.1 µg L

-1

trigger. This is due to longer DT50 (39.6 days for Germany Hamburg compared with 19 days at EU level) and a smaller Koc value (PELMO calculated a Koc value of 36.9 L kg

-1 in the topsoil with pH 6.4, compared

with the mean Koc of 81.1 L kg-1

for the acidic soils at EU level).

The PEC groundwater resulting from bank infiltration calculated with EXPOSIT depends on the risk category. The category is selected based on Koc, DT50 and solubility. It determines the drainage inputs into surface water, and the reduction of the pesticide concentration during infiltration to groundwater. Two Koc inputs are needed in EXPOSIT, one for the risk category and one for runoff/erosion calculations. A UBA representative explained that the Koc used to determine the risk category should be a worst-case. For compound 9, the 10

th

percentile Koc of 19.3 L kg-1

was recommended because there was no correlation between Kf and organic

carbon content and the variability (~70%) between the Koc values was quite large. It should be noted that the risk categories in EXPOSIT are quite broad, and the selection of worst-case or average properties has a limited influence on the outcome if they fall into the same category. The Koc for runoff/erosion should be set to the arithmetic mean of all soils (52 L kg

-1).

The DT50 value influences the risk category and the predicted concentrations in surface water, but only one single value is needed. The selection of the DT50 for EXPOSIT is a case-by case decision, making sure that the overall result is a worst-case. The recommended value for compound 9 was the 90

th percentile DT50 of

91.4 days. The selected Koc and DT50 resulted in an initial PEC groundwater of 0.001 µg L-1


-1 from drainage due to bank infiltration.

On the basis of the calculated PEC groundwater, compound 9 would not meet requirements for authorisation in Germany. Assessment at tier 2 or higher tier would be required to establish safe uses in accordance with German authorisation procedures.

Tier 2 of the German leaching assessment consists of more refined modelling approaches which include providing data on specific processes such as soil surface degradation or non-equilibrium sorption or the use of refined scenarios. Refined scenarios are appropriate when the tier 1 scenarios are not representative of a specific crop or the relationship between the compound properties and the scenario need to be considered

(Umweltbundesamt, 2011).

Table 8. Input Parameter Values for PECgroundwater Calculation with PELMO

Parameter Value Comments

PELMO 4.4.3 Vapour Pressure (Pa) 0 Vapour pressure set to 0 in PELMO for tier 1 leaching assessment

Plant Uptake Factor [-] 0 Plant uptake factor set to 0 in PELMO for tier 1 leaching assessment

DT50 (Hamburg) (days) 39.6 Geometric mean from all DT50 values in Table 4

DT50 (Kremsmünster) (days) 71.2 Geometric mean DT50 value from the neutral and alkaline soils

Kfoc (l kg-1

) 31.5 Koc value at the soil pH of 10 using Input-Decision tool

Kfoc (l kg-1

) 121.2 Koc value at the soil pH of 5 using Input-Decision tool

1/n 0.89 Arithmetic mean 1/n value from all soil data in Table 5

EXPOSIT 3.0 DT50 91.4 90

th percentile of all DT50 values in Table 4

Koc (Runoff/Erosion) 52 Arithmetic mean value from all Koc data in Table 5

Koc (Risk Category) 19.3 10th

percentile value from all Koc data in Table 5

Figure 14. Input-decision tree for selecting DT50 values for groundwater assesment in Germany

Figure 15. Input-decision tree for selecting Koc and 1/n values for groundwater assesment in Germany

Adsorption – Decision Scheme for PECgw

alternatively

If there is no correlation between the Kf- values and other soil parameters, it has to be checked whether a significant correlation can be demonstrated by

the exclusion of outlier values or any other considerations for relevant soil parameters. If a good individual correlation cannot be found, the presence of a

correlation between Kf and several soil properties (multiple correlations) should be considered. This task has to be realised by the notifier. Depending on the

correlation, appropriate values should be determined specific to the particular horizon by means of the specific correlation equation and the properties of the

Hamburg soil .

Does a significant positive correlation between Kf

and % oc-content exist or is CV of the Kfoc-values ≤ 60%?

Does a significant correlation between Kf and pH exist?

Does a significant correlation between Kf and clay or CEC

exist?

Is multicorrelation possible? (determination by notifier)

no

no

no

no

Are studies with less then 4 soils for the active substance and 3 soils for the metabolites with oc-content ≥ 0.3 % available?

yes

no

* If correlation of both parameters (clay and CEC) is significant, use the parameter with the

strongest correlation for calculating horizon specific Kf values.

Remarks:

AM = arithmetic meanCV = variation coefficient, accordingly AMCEC = cation exchange capacitySignificance = Kendall-τ

pH-value = pH-H2O

Hamburg Scenario with Kf-values:1.-3. horizon (with sorptive soil particles):

Kf = AM of all soils (CV ≤100%) or 10. percentile (CV > 100% )

1/n = AM of all soils4.-6. horizon (without sorptive soil particles):

Kf = 0

Hamburg Scenario with horizon specific Kf values:

Estimation of horizon specific Kf-values*1/n = AM of all soils (for each horizon)

2 simulations andselection of the

worst case PECgw by using

the pH-Tool

Selection of 2 Kfoc values at

different pH values.1/n = AM of all soils

Simulation runs with:

1.Hamburg

scenario2.Kremsmünster

scenario

Hamburg Scenario

(pH: 6,4-5,5)with Kf-values

1.-3. horizon,with sorptive soil

particles:Kf and 1/n = AM of

acidicsoils

4.-6. horizon,

withoutsorptive soil properties:

Kf = 0

2 simulations and selection of theworst case PECgw by using

Kf-values

1.Kremsmünster scenario:(pH: 7,7-7,0)

1.-5. horizon:Kf and 1/n = AM of neutral and

alkaline (if possible with pH-H2O that are approximately

> 1 to 2 units higher than the pKa-value

of the substance)

2.Hamburg scenario:1.-3.horizon: Kf and 1/n = AM of all

soils4.-6.horizon: Kf = 0

Hamburg scenario: Kfoc and 1/n-values that result in the most conservative PECgw

or demand for a study with a required number of soils with oc-content ≥ 0.3 %.

Experimental determination of horizon specific Kf-

values(soil properties should be in

the range of Hamburg reference soil )

Further proceeding according to non-

dissociating substancesyes

yes

yes

yes, neg. correlation(expected for acids)

yes, pos. correlation,(expected for bases)

yes

yesyes, pos. correlation yes, neg. correlation

Does a significant correlation between Kfoc and pH exist?

Is it a dissociating substance?

Does a significant correlation between Kf and pH exist?

nono 4 52

37

1Hamburg Scenario

AM of all soils of the Kfoc and

1/n values (accordingly EU

68

Hamburg Scenario with horizon specific Kf values:

Estimation of horizon specific Kf-values*1/n = AM of all soils (for each horizon)

yesno

9.1.6 Groundwater Assessment of Compound 9 for Netherlands

The Netherlands decision tree on leaching from soils consists of three tiers as illustrated in Figure 16. Tier 1 involves simple calculation for the FOCUS Kremsmünster scenario. Tier 2 determines whether the 90

th areal

percentile of the median annual leaching concentration is below the threshold of 0.1 µg L-1

. Compounds with pH-dependent degradation are assessed directly at tier 2 using the GeoPEARL 3.3.3 model.

GeoPEARL couples spatial data for Netherlands derived from Geographic Information Systems (GIS) with the point-scale leaching model PEARL to calculate leaching to the uppermost groundwater for the area of use (Tiktak et al., 2003). Parameterisation of GeoPEARL for calculating the PEC groundwater in accordance with requirements for pesticide authorisation in the Netherlands is given in Table 9 below.

The PEARL model contains a description of sorption to weak acids, which is pH-dependent as shown in the equation below (Tiktak et al., 2004):

where mom (kg kg-1

) is the mass content of organic matter in soil; Kom,eq (m3 kg

-1) is the coefficient of

equilibrium sorption on organic matter under alkaline (ba) or acidic (ac) conditions; M (kg mol-1

) is the molar mass with a ratio of 1 assumed between the neutral (alkaline) and acidic compound; pKa is the negative

logarithm of the dissociation constant; and pH is a pH correction factor.

In the version of PEARL that is used in GeoPEARL, transformation in the top horizon can be set dependent on the organic matter content, the clay content and the pH of this horizon. The reference half-life, DT50,r, is adjusted according to the following equations as applicable (Tiktak et al., 2004):

where DT50,plot (d) is the plot specific half-life of the pesticide in the well-moistened plough layer at reference temperature, fom (d), fl (d) and fpH (d) are factors for effect of organic matter, clay and pH, respectively, mom (kg kg

-1) is the mass fraction of organic matter, ml (kg kg

-1) is the mass fraction of clay and pH is the pH of

the soil. The suffix r refers to the conditions for the reference soil. DT50,min (d) and DT50,max (d) are user-specified minimum and maximum values for the calculated half-life time. The minimum and maximum values are also included to prevent the calculation of unrealistic (zero or negative) transformation rates in soils with extreme properties (Tiktak et al., 2003).

Assuming that the degradation of compound 9 is dependent only on pH, the following equation was obtained for describing the relationship between DT50 and pH:

DT50,plot = DT50,ref + fpH (pH—pHr)

By fitting the above equation to data of soil DT50 in Table 4 and Kom in Table 5, parameter optimisation was performed with excel solver to obtain the GeoPEARL model input values for calculating PEC groundwater as summarised in Table 9 below.

Table 9. Parameter Values Used for PEC Groundwater Calculation with GeoPEARL

Parameter Value Comments

Reference half-life (days) 54.2 Optimised value based on equation 62 of GeoPEARL manual Minimum half-life (days) 8 Minimum from all DT50 values from Table 2 Maximum half-life (days) 100 Maximum from all DT50 values from Table 2 PTF-Factor pH, fpH (days) 23.2 Optimised slope based on equation 62 of GeoPEARL user manual pKa 4.75 pKa value of compound 9 pH Correction Factor 0

Reference pH 7 pH lower limit (for plot selection) 2.7 GeoPEARL lower default limit for the Netherlands

pH upper limit (for plot selection) 7.8 GeoPEARL upper default limit for the Netherlands Kom acidic conditions (l kg

-1) 158.9 Optimised value based on equation 43 of GeoPEARL manual

Kom basic conditions (l kg-1

) 17.74 Optimised value based on equation 43 of GeoPEARL manual

Figure 16. Overview of Netherlands decision tree on groundwater assessment (adapted from Van der Linden et al. (2004).

Using the median value from 20 annual averaged concentrations over a simulation period of 20 years, the 90

th percentile concentration of compound 9 in space was calculated for the area of application to cereals in

the Netherlands. Compared to PEC groundwater calculated at the EU level for Kremsmünster under worst-case alkaline conditions (1.24 µg L

-1), the value of 0.492 µg L

-1 calculated with GeoPEARL is 2.5 times lower.

Nonetheless, compound 9 would not meet requirement for authorisation in the Netherlands unless additional assessment at tier 2, including lysimeter or field leaching studies or use of more realistic half-life i.e. field DT50 data can be used to demonstrate that predicted 90

th percentile concentrations in groundwater are

below the regulatory limit.

Further assessment as tier 3 considers the fate of pesticides in the saturated zone of the soil between 1 and 10m below the soil surface and is divided into two parts: (i) sorption and transformation studies showing that transformation is fast enough to reduce groundwater concentrations of the substance below the threshold of 0.1 µg L

-1, and (ii) monitoring data obtained from a depth of 10m or more below soil surface showing that the

90th percentile concentration will remain below 0.1 µg L

-1.

9.1.7 Conclusions of PEC Groundwater Assessment

Groundwater assessment of compound 9 for individual MS indicated greater vulnerability to leaching under alkaline conditions, and that the predicted concentrations in groundwater following application at the rate of 20 g a.s ha

-1 to winter cereals (no interception) would exceed the limit of 0.1 µg L

-1 in all the MS. In those MS

that use EU methodology, the assessment indicated a low risk for acidic soils. This could, in principle, lead to a label restriction for use of the product containing the active substance only on acidic soils, provided the national legislation gives this option.

Use of worst-case DT50, Koc and 1/n values from the EU agreed endpoints as required in Belgium mean the calculated PEC groundwater would be 2—3 times higher than the values predicted under alkaline conditions at EU level. Assessment for Czech Republic was similar to the EU level due to the small difference between the two 1/n values used. Parameterisation of PELMO using the German Input-Decision tool resulted in an increased vulnerability of compound 9 under acidic conditions and an exceedance of the limit of 0.1 µg L

-1.

Lastly, although spatially distributed modelling at tier 2 resulted in lower concentrations in groundwater, the drinking water standard was still exceeded in the Netherlands.

Therefore, further assessment at tier 2 or higher tier, including refinement of substance properties, lysimeter or field leaching studies and groundwater monitoring would be required to establish safe uses of compound 9 in accordance with MS authorisation procedures in the Central Zone.

It should be noted that the pH-dependency of both degradation and sorption assumed for compound 9 is rare. Often, only one of these two properties shows a relationship with pH. A combination of the worst-case DT50 with the worst-case Koc and 1/n is, therefore, unusual. More often, the worst-case DT50 would be combined with average sorption data or vice versa.


9.2.1 FOCUS Surface Water Assessment of Compound 9 at EU Level

Global maximum PEC surface water under acidic and alkaline conditions are shown in Figure 17 below and also presented in Table A2 of Appendix A. The Koc derived for soil were also assumed to be the same as for sediment. The half-life for degradation in water and sediment was assumed not to show any pH-dependency as indicated in Table A2 of Appendix A. An RAC of 0.25 µg L

-1 based on the aquatic plant (Lemna) EC50

was applied for the aquatic risk assessment.

Figure 17. Calculated maximum surface water concentrations of compound 9 under acidic and alkaline condition at FOCUS Step 3

0 .000 .250 .500 .751.001.251.50Dit chD3 P ondD4 St reamD4 P ondD5 St reamD5 Dit chD6 P ondR1 St reamR1 St reamR2 St reamR3 St reamR4Gl ob alM axi mumPEC(

ug/ l) RAC = 0 .25 ug/ lCompound 9 @ pH<7 Compound 9 @ pH>7

Calculated global maximum PEC surface water for compound 9 exceeded the RAC at FOCUS Steps 1 and 2 under both acidic and alkaline conditions. At Step 3, drainage scenarios D3, D4 and D5, as well as the runoff scenarios pond R1 and stream R4 passed the aquatic risk assessment under acidic conditions. However, under alkaline conditions, all scenarios except pond R1 and stream R4 failed the aquatic risk assessment. It should be noted that the R2 scenario is not relevant for winter cereals.

Mass loading of compound 9 to surface waters was dominated by drainage inputs for all drainage scenarios and runoff inputs for the runoff scenarios, with only nominal contribution from drift deposits.

Based on the Steps 1—3 surface water assessment, safe uses were identified for compound 9 with respect to potential impact on surface water at the EU level. Therefore, compound 9 would be eligible for inclusion in the EU pesticides database in accordance with Regulation (EC) No 1107/2009.

9.2.2 Assessment of Compound 9 for MS that Apply FOCUS Procedures

The global maximum PEC surface water and sediment for compound 9 under acidic and alkaline conditions for FOCUS scenarios relevant to MS in the Central Zone are shown in Figure 18 and also in Tables A19 and A20 of Appendix A, respectively.

Under acidic conditions (Table A19), compound 9 failed the surface water assessment for only stream R1 and R3 scenarios which are required for authorisation in Austria, Belgium, Czech Republic, Hungary, Ireland, Poland, Romania, Slovakia and Slovenia. However, under alkaline conditions, most FOCUS scenarios used by MS as representative national scenarios failed surface water assessment, except for pond R1 and stream R4.

The highest sediment concentrations (0.383 µg kg-1

dw) were predicted for stream R3 under acidic conditions

and pond D4 (0.815 µg kg-1

dw) under alkaline conditions. For most scenarios relevant to MS, the predicted concentrations in sediment were generally higher under alkaline than under acidic conditions. This is probably due to the larger entry into surface water as a result of the greater persistence and weaker sorption of compound 9 in alkaline soils (DT50 = 71.2 days, Koc = 23.4 L kg

-1) compared to the acidic soils (DT50 =

19 days, Koc = 81.1 L kg-1

).

Based on results of surface water assessment, compound 9 would not meet the requirements of the MS in the Central Zone that use a selection of FOCUS scenarios in their national authorisation process. Higher tier assessment would therefore be required in accordance with the evaluation procedures in these MS in order to demonstrate safe uses.

Figure 18. Calculated maximum surface water concentrations of compound 9 under acidic and alkaline conditions at FOCUS Step 3

9.2.3 Surface Water Assessment of Compound 9 for Belgium

Surface water assessment for Belgium was based on use of the worst-case DT50, Koc and 1/n values listed in Table 6 and Table 7 for the calculation of PEC in accordance with the national requirements. The global

0.000.250.500.751.001.251.50Di tchD3 P ondD4 S treamD4 P ondD5 S treamD5 Di tchD6 P ondR1 S treamR1 S treamR2 S treamR3 S treamR4Gl ob al maxi mumconc

entrati on Compound 9 @ pH <7SurfaceWater RAC = 0.25 ug/ l Sediment (ug/ kg dw)0.000.250.500.751.001.251.50

Di tchD3 P ondD4 S treamD4 P ondD5 S treamD5 Di tchD6 P ondR1 S treamR1 S treamR2 S treamR3 S treamR4Gl ob al maxi mumconcentrati on Compound 9 @ pH >7Surf aceW at er RA C = 0.25 ug/ l Sediment (ug/ kg dw )

maximum PEC surface water are presented in Table A19—A20 of Appendix A and indicate that the relevant FOCUS scenarios used in Belgium failed the aquatic risk assessment except for pond R1. For surface water scenarios that failed, the use of worst-case input parameter values resulted in predicted concentrations that were 1—2 times higher than values calculated at EU level under alkaline conditions. There is no requirement to derive separate PECs under acidic or alkaline conditions. Therefore, compound 9 would not be eligible for product authorisation in Belgium unless higher tier assessment can be used to demonstrate safe uses in this MS.

9.2.4 Surface Water Assessment of Compound 9 for Czech Republic

For Czech Republic, the aquatic risk assessment was based on use of geometric mean DT50 and arithmetic mean Koc corresponding to acidic conditions for drainage scenario D4 and alkaline conditions for runoff scenario R1, combined with the arithmetic mean 1/n values (all dataset) as listed in Table 6 and Table 7. The global maximum PEC surface water are also presented in Table A19—A20 of Appendix A, respectively and are similar to values obtained for the EU level assessment with potential risk indicated for stream R1 under alkaline conditions. Further refinement or higher tier risk assessment would therefore be required in order to demonstrate acceptable risk to surface water for compound 9 in the Czech Republic.

9.2.5 Surface Water Assessment of Compound 9 for Germany

German authorisation procedures for surface water at tier 1 are based on assessments of (i) spray drift and volatilisation using EVA; (ii) runoff/erosion, and (iii) drainage inputs using EXPOSIT. Unlike the groundwater assessment with PELMO, guidance on the selection of appropriate values for surface water assessment for substances with pH-dependent degradation and sorption was not identified, and so clarification was sought from representatives of the relevant Authorities in Germany.

Based on the information received through personal communication, calculation of PEC surface water with EXPOSIT was performed with the 90

th percentile geometric mean DT50 (91.4 days), the 10

th percentile Koc

value for the selection of the risk category for drainage and the arithmetic mean Koc value of 52 L kg-1

for runoff/erosion calculations which corresponds to 0.197% of the applied amount that is lost to runoff/erosion.

The calculated maximum PEC surface water based on drift deposit and volatilisation with EVA was 0.185 µg L

-1. Calculation of the maximum PEC in the ditch resulting from runoff/erosion and drainage gave

0.15 µg L-1

and 0.19 µg L-1

, respectively. The assessment indicated that spray drift deposit and drainage inputs were the main exposure routes for surface water, although predicted input from runoff was also significant. In all cases, however, the predicted concentrations in surface water were below the RAC value of 0.25 µg L

-1. The results are presented in Table A19—A20 of Appendix A.

Compound 9, therefore, passed the tier 1 surface water assessment for Germany and would be eligible for product authorisation in contrast to some MS in the Central Zone where the RAC was exceeded. However, it should be noted that compound 9 failed the groundwater assessment for Hamburg and Kremsmünster.

9.2.6 Surface Water Assessment of Compound 9 for Netherlands

Three types of surface water bodies are evaluated in the Netherlands authorisation procedures. Tier 1: (i) the edge-of-field water body which only considers exposure via spray drift following normal agricultural practice and (ii) drinking water abstraction points which involve pre-registration modelling and where relevant, post-registration monitoring. A standard of 0.1 µg L

-1 is applied to the drinking water abstraction points; and Tier 2:

(iii) Water Framework Directive (WFD) water body in which a substance is evaluated against a maximum permissible concentration (MPC).

9.2.6.1 Edge-of-Field Water Body

The calculation of PEC surface water for the edge-of-field ditch exposed via spray drift was performed using TOXSWA 1.2. Model parameterisation is specific to the Netherlands and a spray drift value of 1% is used for arable crops. Surface water concentrations were predicted under acidic and alkaline conditions based on the properties of compound 9 as listed in Table A2 of Appendix A. For acidic and alkaline conditions, a maximum PEC surface water of 0.095 µg L

-1 was calculated. Since tier 1 edge-of-field assessment was passed, there

was no need for a tier 2 evaluation of the WFD water body.

9.2.6.2 Drinking Water Abstraction Points

For tier 1 evaluation of potential impact of substances on drinking water abstracted from surface water in the Netherlands, the edge-of-field concentrations were first calculated for the FOCUS D3 scenario for acidic and alkaline conditions (as for the EU level) but with Dutch drift value of 1% for arable crops. This approach was taken in the absence of specific guidance on model parameterisation of D3 scenario for substances with pH-dependent properties. The concentrations at abstraction points were then calculated with DROPLET on the basis of the edge-of-field concentrations for all crops in the intake area on which the pesticide can be used. Results shown in Table A19—A20 of Appendix A indicated that the drinking water standard of 0.1 µg L

-1 was

not exceeded in any of the drinking water abstraction points.

As for Germany, compound 9 passed the tier 1 surface water assessment for the Netherlands and would be eligible for product authorisation, although it should be noted that it failed the tier 2 assessment of leaching to groundwater.

9.2.7 Surface Water Assessment of Compound 9 for the UK

Surface water assessment in the national authorisation procedure for the UK comprises drift deposition and drainflow. Assessment of spray drift was based on the DT50 water of 21 days; and assessment of drainflow was based on the geometric mean DT50, arithmetic mean Koc and 1/n values for acidic and alkaline soils as listed in Table 6 and Table 7. Slovenia only considers exposure via drift which is calculated following the UK method. Therefore, assessment of surface water exposure via spray drift for the UK would also be applicable to Slovenia.

The calculated PEC surface water from drift deposit was 0.185 µg L-1

. However, separate calculations of the input from drainflow resulted in PEC surface water of 1.08 µg L

-1 for acidic conditions and 2.92 µg L

-1 for the

alkaline conditions, both of which exceeded the RAC. The use of compound 9 would therefore be considered to pose potentially unacceptable risk to aquatic organisms and would not meet requirement for authorisation in the UK, unless higher tier assessments such as drainflow modelling and application of appropriate drift mitigation measures can be used to demonstrate safe uses.

9.2.8 Conclusions of PEC Surface Water Assessment

Compound 9 is characterised by high solubility in water, low Koc, relatively long DT50 in alkaline soils, and the method of application favoured drainage and run-off entries rather than spray drift. Thus, drainage was observed as the major route of entry into surface water in the drainage scenarios and runoff in the runoff scenarios. This type of PEC surface water is sensitive to rainfall pattern shortly after application as drainage and runoff processes are event driven.

Assessment of potential impact of compound 9 on aquatic organisms following application to winter cereals i.e. ground application at 20 g a.s ha

-1 (assuming 0% interception) has identified potentially unacceptable risk

for most FOCUS surface water scenarios used by MS in their national authorisation procedures. Based on Steps 1—3 assessments, compound 9 would not meet national authorisation requirements for the following MS: Austria, Belgium, Czech Republic, Hungary, Ireland, Poland, Romania, Slovakia and the UK. Higher tier assessments, including application of mitigation measures, would be required to demonstrate safe uses in these MS.

Use of worst-case input values for Belgium resulted in predicted concentrations that were 1—2 times higher than values derived at the EU level. Results obtained for the Czech Republic were similar to those at the EU level, the only difference in the model parameterisation being a preference for the arithmetic mean 1/n value from all available data-set.

Compound 9 passed tier 1 surface water assessment for Germany which considers exposure via spray drift deposition, volatilisation and dry deposition, runoff/erosion and drainage. Assessment of edge-of-field water body and drinking water abstraction points in the Netherlands also indicated acceptable risks, as was spray drift exposure in Slovenia and the UK. However, assessment of surface water exposure via drainflow in the UK indicated potentially unacceptable risk. It should be noted that, although eligible for product authorisation in Germany, the Netherlands and Slovenia, compound 9 failed groundwater assessment for these MS.

10 Application of Mitigation Measures

A review of the information provided by MS representatives to a survey by Fera and also literature sources including FOCUS (2007) report on “Landscape and mitigation factors in aquatic ecological risk assessment” indicated that the range of higher tier assessment approaches and risk mitigation measures currently applied by MS for the protection of groundwater, surface water and aquatic ecosystem quality vary considerably.

Mitigation measures considered for groundwater protection include timing of application outside periods of heavy rainfall; reductions in the rate and number of applications per season; restrictions on the use on heavy clay and sandy soils or in drained, calcareous areas.

The approaches for Step 4 recommended by FOCUS surface water group was to examine more specific and realistic combination of cropping, soil, weather, topography and aquatic bodies than those applied at Step 3, considering the potential range of use of the plant protection product. In addition to refinement of the generic chemical input and fate parameters, mitigation measures considered by MS in their authorisation procedures include label restrictions for: no-spray buffer zone of 5—100 m from the edge of surface water bodies and spray drift reduction of 50—99% through use of drift reducing nozzles. Vegetative filter strips (VFS) up to 20 m are also recommended for run-off/erosion mitigation by most MS.

The European Crop Protection Association (ECPA) has recommended Best Management Practices (BMP) to reduce the losses to water from diffuse sources—runoff, erosion and spray drift—under the TOPPS (Train Operators to Promote best Practices and Sustainability) Prowadis (Protecting Water from Diffuse Sources) project (ECPA 2013a, 2013b). Similar initiative by SETAC Europe on “Mitigating the Risk of Plant Protection Products in the Environment” (MAgPIE) took place at a workshop in April 2013 in Rome with the objective to achieve a better harmonisation of risk mitigation and management measures for Plant Protection Products in Europe. The second part of the MAgPIE workshop is planned for November 2013.

A summary of FOCUS Step 4 mitigation measures currently applied or considered by MS in the Central Zone based on responses received from representatives to the recent survey by Fera is provided in Table 10 and Table 11 below for arable and fruits crops, respectively.

10.1 Refinement of FOCUS Step 3 PEC Surface Water Using SWAN

The Surface Water Assessment eNabler (SWAN 3.0.0) is a software tool developed by ECPA to assist in the application of mitigation measures for spray drift and runoff/erosion at FOCUS Step 4 of PEC surface water calculation. With SWAN, drift mitigation was simulated by defining a no-spray buffer width and/or percentage nozzle reduction. The vegetative filter strip model (VFSmod) was used to simulate the fractional reductions in runoff volume, runoff flux, erosion mass and erosion flux. In addition, 90

th percentile worst-case values for

reduction efficiencies in runoff water, eroded sediment and substance mass for different widths of vegetated buffer strips based on the report of FOCUS (2007) were simulated.

Based on recommendations for no-spray buffer zones, drift reducing nozzles and vegetative strips by MS, a total of 26 combinations of drift and runoff mitigation options including: (i) no-spray buffer zones of 10—50m, (ii) drift reduction by 50—99%, (iii) 10—50m VSFmod, (iv) 60—85% reduction efficiencies in runoff/erosion and substance mass, and (v) 85—95% reduction efficiencies in runoff/erosion and substance mass were all simulated for compounds 5 and 9 which failed several FOCUS surface scenarios at Steps 3 that are used by many MS for their national authorisation.

It should be noted that PEC surface water calculated for compounds 5—8 at Step 3 are similar, therefore only compound 5 in addition to compound 9 have been assessed at Step 4. The calculated PEC surface water for various combinations of spray drift and runoff mitigation are presented in Tables A21 and A22 of Appendix A for compound 5 and 9, respectively.

10.2 Step 4 Assessment of Compound 5

Compound 5 was applied as an air blast fungicide to apples with four applications per season, and failed the Step 3 surface water assessment for several scenarios at EU level and for individual MS that use FOCUS scenarios for their national assessment. The mass loading of compound 5 to surface waters was dominated by drift deposits for all relevant FOCUS scenarios with nominal inputs from drainage and runoff.

Table 10. Summary of mitigation measures currently applied by MS in the Central Zone to arable crops

FOCUS Step 4 Mitigation Measures

Member State No Spray Buffer Zone Drift Reducing Nozzles No Spray + Drift Red. Vegetative Strip VSFmod simulation % Runoff Reduction

Austria 50 m 50%, 75%, 90% 95% drift red. 20 m Not accepted No information

Belgium 20 m 50%, 75%, 90% 20 m + 90% drift red. 20 m Not yet accepted No information

Czech Republic 50 m 50%, 75%, 90% 50 m, No drift red. 20 m Not accepted 40--80%a; 40--95%

b

Germany 20 m 50%, 75%, 90% 20 m + 90% drift red. 20 m Not yet accepted No information

Hungary 50 m 50%, 75% 50 m, No drift red. 20 m Not accepted No information

Netherlands 5 m; No Maximum Set 90% 95% drift reduction Not Applicable Not Applicable NA

Poland 100 m 95% 95% drift reduction 20 m Not yet accepted No information

Ireland Under Review Under Review Under Review Under Review Under Review No information

Romania No Information No Information No Information No Information No Information No Information

Slovakia 20 m 50%, 75%, 90% Not specified 20 m Accepted No Information

Slovenia No Information No Information No Information No Information No Information No Information

United Kingdom 20 m LERAPc LERAP

c NA NA NA

Table 11. Summary of mitigation measures currently applied by MS in the Central Zone to fruit crops

FOCUS Step 4 Mitigation Measures

Member State No Spray Buffer Zone Drift Reducing Nozzles No Spray + Drift Red. Vegetative Strip VSFmod simulation % Runoff Reduction

Austria 50 m 50%, 75%, 90%, 95% 95% drift red. 20 m Not accepted No information

Belgium 30 m 50%, 75%, 90%, 99% 30 m + 90% drift red. 20 m Not yet accepted No information

Czech Republic 50 m 50%, 75%, 90% 50 m, No drift red. 20 m Not accepted 40--80%a; 40--95%

b

Germany 20 m 50%, 75%, 90% 20 m + 90% drift red. 20 m Not yet accepted No information

Hungary 50 m 50%, 75% 50 m, No drift red. 20 m Not accepted No information

Netherlands 9 m; No Maximum Set 95% 95% drift reduction Not Applicable Not Applicable NA

Poland 100 m 95% 95% drift reduction 20 m Not yet accepted No information

Ireland Under Review Under Review Under Review Under Review Under Review No information

Romania No Information No Information No Information No Information No Information No Information

Slovakia 50 m 50%, 75%, 90% Not specified 20 m Accepted No Information

Slovenia No Information No Information No Information No Information No Information No Information

United Kingdom 20 m LERAPc LERAP

c NA NA NA

aReduction in volume of runoff water and pesticide mass.

bReduction in mass of eroded sediment and pesticide mass.

cReduction in buffer width specified on

the product label is possible at farm level under the Local Environmental Risk Assessment for Pesticides scheme when drift reducing equipment is used.

Results of the application of various Step 4 mitigation measures for the refined assessment of PEC surface water for compound 5 are presented in Table A21 of Appendix A. A comparison of the efficiencies of the various combinations of the mitigation options with the maximum PEC surface water calculated at FOCUS Step 3 are also shown in Figure 19 and Figure 20 below.

Figure 19. Effectiveness of applying no-spray buffer zone and drift reducing nozzles for compound 5

Figure 20. Effectiveness of runoff/erosion reduction with VFSmod and vegetated filter strips for compound 5

No-spray buffer width of 20 m or drift reduction by 75% is required to reduce concentrations of compound 5 entering surface water below the RAC, corresponding to reduction of Step 3 PEC by 71.5—88.9% in order to pass the surface water scenarios. Simulations of a 20 m vegetative filter strip with VFSmod or corresponding to an 80—95% reduction efficiency in runoff and eroded sediment produced similar results as the standalone application of a no-spray buffer width of 20 m. This was because entry into surface water was dominated by drift deposit. Therefore, mitigation of spray drift and management of exposure risk to surface water following application of compound 5 to apples can be achieved by implementing a no-spray buffer zone or vegetative filter strip of 20 m as part of the label restriction and recommendations attached to authorisation at MS level.

Implementation of no-spray buffer zone up to 20 m or 75% reduction in drift from nozzles is acceptable by all MS in the Central Zone from which a survey response was received, but only Slovakia at present considers use of VSFmod feature of SWAN to calculate reduction in runoff and erosion loading to surface water. Apart from the Czech Republic which considers a simulation of 40—95% reduction efficiency in runoff/erosion, no other national requirements for runoff/erosion reduction efficiencies were identified for other MS.

Based on application of drift mitigation measures at Step 4 including up to 20 m no-spray buffer zone or 75% drift reduction using low drift nozzles or application of vegetative filter strip of 20 m, compound 5 would pass all the FOCUS surface water scenarios at EU and MS level, and would be eligible for product authorisation, (subject to passing groundwater assessment at higher tier as indicated previously) except the UK where tier 1 drainflow assessment was failed.

050100150200Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4M axPEC surf acewat er( ug

/l) RAC = 50 ug/lSt ep 3 PEC 10m No Spray Z one 20m No Spray Z one050100150200

Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4M axPEC surf acewat er( ug/l) RAC = 50 ug/lSte p3 PEC 50% Lowe r Drift 75% Lowe r Drift 90% Lowe r Drift

050100150200Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4M axPEC surf acewat er( ug

/l) RAC = 50 ug/lSt ep 3 PEC 10mNSZ +VFSmod 20m NSZ +V FSmod050100150200

Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 P ond R1 St reamR1 St reamR2 St reamR3 St reamR4M axPEC surf acewat er( ug/l) RAC = 50 ug/lStep 3 PEC 10mNSZ+60]85% Reduction eff. 20m NSZ+80]95% Reduction eff.

For application of compound 5 to fruit crops in Germany, a no-spray buffer zone of 15 m would be required to demonstrate safe use. This distance corresponds to a PEC surface water of 35.4 µg L

-1 which is below the

RAC of 50 µg L-1

. In the UK, mitigation of spray drift can be considered by using a spreadsheet developed by the Chemicals Regulation Directorate (CRD) to calculate initial PEC surface water via drift for different buffer zones based on the Rautmann spray drift values. A no-spray buffer zone of 15 m would also be required to demonstrate safe use in the UK. This buffer zone corresponds to an initial PEC surface water of 44.5 µg L

-1

which is also below the RAC.

For product authorisation in the UK, compound 5 passed the assessment of spray drift which is the dominant entry route into surface water at a no-spray buffer zone of 15 m, but failed the tier 1 assessment of drainflow. Therefore, higher tier drainflow modelling would be required to demonstrate safe uses on cereal crops grown on heavy clay soils in the UK.

10.3 Step 4 Assessment of Compound 9

Compound 9 which has pH-dependent properties was applied as a ground spray pre-emergence herbicide to cereals, and also failed the Step 3 surface water assessment for several scenarios at EU level and for MS that use FOCUS scenarios in their national assessment. However, compound 9 passed tier 1 assessment for Germany, the Netherlands as well as exposure via spray drift for Slovenia and the UK. This was because mass loading to surface water was dominated by drainage or runoff entries with nominal contributions from drift deposits. Worst-case Step 3 outputs under alkaline conditions were used for the Step 4 simulations.

Results of the application of various Step 4 mitigation measures for the refined assessment of compound 9 are presented in Table A22 of Appendix A. A comparison of the efficiency of different combinations of the mitigation option with the maximum PEC surface water calculated at Step 3 are also shown in Figure 21 and Figure 22 below.

Figure 21. Effectiveness of applying no-spray buffer zone and drift reducing nozzle for compound 9 under alkaline conditions

Figure 22. Effectiveness of runoff/erosion reduction with VFSmod and vegetated buffer strips for compound 9 under alkaline conditions

0.01.02.03.04.0Dit ch D1 St reamD1 Dit ch D2 St reamD2 Dit ch D3 P ondD4 St reamD4 P ondD5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR3 St reamR4M axPEC surf acewat er( ug

/l) RAC = 0.25 ug/lSt ep 3 PEC 10mNo Spray Zone 20m No Spray Zone0.01.02.03.04.0

Dit ch D1 St reamD1 Dit ch D2 St reamD2 Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR3 St reamR4M axPEC surf acewat er( ug/l) RAC = 0.25 ug/lSt ep 3 PEC 50 % Low er Drift 75% Low er Drift 90 % Low er Drift

0.01.02.03.04.0Dit ch D1 St reamD1 Dit ch D2 St reamD2 Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR3 St reamR4M axPEC surf acewat er( ug

/l) RAC = 0.25 ug/lSt ep 3 PEC 10m NSZ +VFSmod 20mNSZ +VFSmod0.01.02.03.04.0

Dit ch D1 St reamD1 Dit ch D2 St reamD2 Dit ch D3 P ond D4 St reamD4 P ond D5 St reamD5 Dit ch D6 P ond R1 St reamR1 St reamR3 St reamR4M axPEC surf acewat er( ug/l) RAC = 0.25 ug/lStep 3 PEC 10m NSZ+60Â85%Reduction eff. 20m NSZ+80Â95%Reduction eff.

As can be seen in Figure 21 and Figure 22, application of no-spray buffer zones and drift reducing nozzles did not reduce surface water concentrations in the FOCUS drainage scenarios below the Step 3 levels. This was not surprising as entry of compound 9 into surface water in these scenarios was controlled by drainage inputs with this route contributing ~100% of the amount reaching surface water with only nominal contribution from drift deposit.

Of the runoff scenarios, R1 (pond) and R4 passed the surface water assessment at Step 3. In R1 (stream), a 10 m vegetative strip with VFSmod simulation or 20 m vegetative strip corresponding to 80—95% reduction efficiency of runoff/erosion was required to reduce the concentration entering surface water below the RAC. For R3 (stream), a 20 m vegetative strip with VFSmod simulation was not sufficient to reduce concentrations below the RAC. Application of 90

th percentile worst-case values for reduction efficiencies in runoff/erosion for

a 20 m vegetated strip according to FOCUS (2007) (i.e. 80—95% reduction efficiency of runoff/erosion) did not reduce the surface water concentrations sufficiently for the R3 scenario to pass at Step 4.

Most MS use a selection from drainage scenarios D3, D4 and D5, as well as runoff scenarios R1, R3 and R4 for their national assessment of surface water. But none of the MS currently accept VFSmod simulations of runoff/erosion reduction or a vegetative filter strip greater than 20 m. Mitigation of exposure via drainage is also not considered by MS. Therefore, compound 9 would fail most FOCUS scenarios relevant to those MS that apply FOCUS procedures, and would not be eligible for product authorisation. For these MS, additional options for higher tier exposure assessment include the refinement of ecotoxicological endpoints, catchment scale modelling and probabilistic risk assessment.

For authorisation in the UK, compound 9 passed the surface water assessment of spray drift, but failed tier 1 drainflow assessment. The drainage entry route to surface water and characteristics of the preferential flow scenario mean that use of SWAN which simulates drift and runoff/erosion mitigation is not feasible in the UK. Further higher tier drainflow modelling would be required in order to demonstrate safe uses on cereal crops grown in heavy clay soils in the UK.

However, for MS such as Germany, Netherlands and Slovenia that apply their own national scenarios or use specific approaches and/or models, compound 9 passed at tier 1 of the respective national assessments and would, therefore, be eligible for authorisation subject to passing the groundwater assessment at higher tier as indicated previously.

11 Discussion

The new European Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market entered into force on 14 June 2011, and replaced Directive 91/414/EEC. A major goal of the new regulation is the harmonisation of the criteria, procedures and conditions for authorisation of plant protection products among MS. To avoid duplication of work, reduce the burden on industry and on MS, and to provide for more harmonised availability of plant protection products, authorisations granted by one MS should be accepted by other MS where agricultural and environmental conditions are comparable under the principle of mutual recognition set out in Regulation (EC) No 1107/2009. To this end, the EU community was divided into three regulatory zones—Northern, Central and Southern Zone.

Following inclusion in the EU pesticides database, applicants for authorisation of plant protection products submit a dossier to all MS in the zone where they wish to obtain authorisation consisting of core assessment and national addenda to accommodate MS specific requirements. One lead country in the zone, the zonal rapporteur MS, then completes evaluation of the core dossier on behalf of the other MS. However, current experience of the zonal as well as individual MS authorisation procedures suggests that the requirements for groundwater and surface water assessment vary considerably with implications for the regulatory outcome at MS level.

To compare assessment approaches among MS in the Central Zone, a total of nine dummy substances with a wide range of sorption and degradation properties were assessed in order to identify the effects of key elements of groundwater and surface water exposure assessment on the regulatory outcome as well as the implications of any differences and/or similarities in MS authorisation procedures for harmonisation as set out in Regulation (EC) No 1107/2009.

Four of these test substances (compounds 1—4) were variations of the same substance (only soil DT50 and Koc were changed), and each had the same metabolite. These substances were applied to winter cereals as post-emergence ground spray. An additional set of four test substances (compounds 5—8) were variations of a different substance (only soil DT50 and Koc were changed) with no formation of metabolites. These substances were applied to apples as air blast. The final test substance was selected to evaluate the effects of pH-dependent degradation and sorption on the regulatory outcome at EU and MS level. This substance was also applied to winter cereals but as pre-emergence ground spray.


The EU level assessment involved calculation of concentrations in groundwater as recommended by FOCUS (2000) and (2009) for nine scenarios. At least one scenario must be passed for the active substance to be included in the EU pesticides database. FOCUS scenarios used by MS for their national assessment include two or more of the following: Châteaudun, Hamburg, Kremsmünster, Okehampton, Piacenza and Porto. All relevant scenarios must be passed to obtain authorisation at the MS level.

Most MS accept the current version of FOCUS PEARL for groundwater assessment. Poland requires current versions of PEARL and PELMO and results from both models are used in decision making. Key model input parameters such as DT50, Koc and 1/n are derived according to FOCUS guidelines and agreed endpoints in the Review Report. Germany uses the current version of PELMO but with volatilisation and plant uptake set to zero for tier 1 assessment. The Netherlands requires PEARL 3.3.3 at tier 1 and GeoPEARL 3.3.3 for tier 2 groundwater assessment. The current practice among MS, except Poland, is to accept PEC groundwater calculations based on one model as recommended by FOCUS (2009). However, EFSA (2004, 2013c) does not support this approach and recommends that PEC groundwater calculations for decision making should be based on more than one leaching model.

At the same DT50 of 28 days, a decrease in Koc from 66 to 34 L kg-1

(a factor of 2) resulted in an increase of ~3 fold in the calculated PEC groundwater for compound 4 compared to compound 1. Similarly, at DT50 value of 56 days, a decrease in Koc from 200 to 66 L kg

-1 (a factor of 3) resulted in an increase of ~10 fold in

the calculated PEC groundwater for compound 3 compared to compound 2.

For weak acids such as compound 9 with pH-dependent DT50 and Koc, the highest PEC groundwater were predicted for the Hamburg scenario using input data for alkaline conditions and Okehampton scenario under acidic conditions. However, regardless of DT50 and Koc values of the active substance, crop and application

timing, the highest PEC groundwater were always predicted for Hamburg or Okehampton scenario followed by Kremsmünster, with lower concentrations predicted for Châteaudun, Piacenza and Porto as illustrated in Figure 23 for the parent compounds. Hamburg and Okehampton were also the most vulnerable scenarios for the metabolites of substances 1—4. For all compounds tested, PEC groundwater simulated with PEARL for Hamburg or Okehampton were always greater than those simulated with MACRO for Châteaudun.

Figure 23. Comparison of tier 1 PEC groundwater calculated with PEARL 4.4.4 for FOCUS scenarios used by MS

11.1.1 Groundwater Assessment for MS that Apply Different Procedures

Up to two FOCUS groundwater scenarios with climatic and soil conditions relevant to Germany are required at tier 1. These are Hamburg and Kremsmünster. Soils of these two scenarios cover the pH-range of agricultural soils and allow the pH-dependent behaviour of substances to be addressed. The effect of setting plant uptake factor and volatilisation to zero in PELMO was to increase the PEC groundwater by a factor of 1.5—2 for compounds 1—4 which are non-volatile; and by a factor of ~3.5 for compound 5 in which losses due to volatilisation is significant.

Parameterisation of PELMO using the German Input-Decision tool for assessment of compound 9 resulted in PEC groundwater for Kremsmünster that were close to the values for the same scenario at EU level (alkaline conditions), but several orders of magnitude higher for Hamburg compared to EU level assessment (acidic conditions). The input decision scheme for Germany could also lead to more conservative Koc and DT50 values for dissociating substances, depending on the variability between the measurements. Based on these results, the tier 1 groundwater assessment for product authorisation in Germany was more conservative than at EU or other MS level for compounds 1—4 and associated metabolites as well as compound 9 under acidic conditions.

Germany is the only MS that considers bank infiltration due to runoff/erosion and drainage as an exposure route to groundwater in addition to the assessment of leaching at tier 1. The PEC in groundwater from bank infiltration was smaller than the PEC due to leaching calculated with PELMO for all test substances.

Poland requires simulations with PEARL and PELMO for decision making in their national authorisation of plant protection products; Ireland requires PEARL or PELMO; Czech Republic and the UK require PEARL, PELMO or PRZM for their national assessment. The UK requires an additional simulation with MACRO and the Châteaudun scenario for substances with Koc >100 L kg

-1.

For the test substances assessed, PEARL gave higher concentrations in Châteaudun compared to PELMO. However, for test compounds 1—4 which are non-volatile, PELMO consistently gave higher concentrations for Kremsmünster, Okehampton, Piacenza and Porto. For Hamburg, higher concentrations were predicted by PEARL in most cases. In general, PELMO predicted much lower concentrations than PEARL for test compounds 5—8 which are volatile, except for Piacenza. This indicated that PELMO is more sensitive to simulation of volatilisation losses than PEARL.

Additional simulation of preferential (macro-pore) flow of compounds 2 and 5 with MACRO and Châteaudun resulted in predicted groundwater concentrations of compound 2 (Koc = 200 L kg

-1) that were higher by a

factor of 2.5 compared to simulations with PEARL. The PEC calculated with MACRO exceeded the limit of 0.1 µg L

-1, but the concentration calculated with PEARL was below 0.1 µg L

-1. However, this did not influence

the regulatory outcome as results for other scenarios were above the regulatory threshold. For compound 5 with Koc of 500 L kg

-1, the results were comparable between MACRO and PEARL which may be attributed

to greater adsorption and less potential for movement to groundwater at similar DT50 values (56 days for compound 2 and 50 days for compound 5). Simulations were also undertaken with MACRO for metabolites of compounds 1—4. The PEC in groundwater simulated with MACRO were greater than those for PEARL for the metabolites of compounds 1 and 2, but smaller for metabolites of compounds 3 and 4.

Tier 1 groundwater assessment with PEARL 3.3.3 for the Netherlands resulted in slightly higher PEC values for the Kremsmünster scenario compared to the current version PEARL 4.4.4 used for EU level assessment, but this is unlikely to significantly affect the regulatory outcome at tier 1. These can be explained by the latest changes made by the FOCUS groundwater group (FOCUS, 2009), i.e. the 80

th percentile concentration is

calculated as the average of the 16th and 17

th largest annual average concentration in leachate at 1 m depth

in PEARL 4.4.4 whereas the 17th largest value is used in PEARL 3.3.3. Changes were also made to the crop

rooting depth (reduced from 1.6 to 1 m for apples, no change for winter cereals) and in the crop factors to minimise differences in transpiration between the various FOCUS models.

Spatially distributed modelling with GeoPEARL as required in the tier 2 Netherlands evaluation procedures indicated that compounds 5—7 with DT50 of 16—56 days and Koc of 120—500 L kg

-1 passed the drinking

water standard of 0.1 µg L-1

. Based on Koc values, these compounds may be classed as moderately mobile (CRD, 2009). However, compounds 1, 2, 3, 4 and 9 with DT50 of 19—71 days and Koc of 23—200 L kg

-1

failed the assessment. Compound 8 with DT50 of 120 days and upper end Koc of 840 L kg-1

also failed tier 2 groundwater assessment. Closer inspection of these results indicated that the difference in the regulatory outcome between compound 5 for example (Koc = 500 L kg

-1, DT50 = 50 days), and compound 8 (Koc =

840 L kg-1

, DT50 = 120 days) can be attributed to the longer DT50 and hence greater persistence and potential for leaching in soils.

Spatially distributed modelling for the Netherlands resulted in 90th percentile concentrations that were 42—

91% lower than values calculated for Kremsmünster at tier 1. EFSA (2013a) noted that spatially distributed modelling is more important at MS level, where the groundwater protection goal is likely to account for the entire crop area instead of a safe use area, as required at EU level. At present only the Netherlands use advanced spatial modelling in the assessment of plant protection products for authorisation. Austria is also understood to be considering spatially distributed modelling for groundwater assessment in their national authorisation procedure.

The drinking water standard of 0.1 µg L-1

is applied to active substances and relevant metabolites by MS. But Hungary accepts a limit of 0.2 µg L

-1 for representative FOCUS scenarios except Châteaudun. According to

SANCO (2003), metabolites found at concentrations exceeding 0.1 µg L-1

in leachates should be subject to further assessment of (non)relevance, and a 5-step process is proposed. Metabolites which passed steps 1—3 of the assessment of relevance and for which estimated concentrations in groundwater lie between 0.75 µg L

-1 (from step 4) and 10 µg L

-1 will require a refined assessment of their potential toxicological

significance. However, no guidance is provided where actual or predicted concentrations of a non-relevant metabolite exceed 10 µg L

-1. None of the metabolites of test compounds 1—4 exceeded the lower limit of

0.75 µg L-1

. If the metabolites passed assessment for relevance at step 3, then they would be expected to pass at individual MS level based on the threshold of no concern approach or refined risk assessment for non-relevant metabolites.

Although potentially eligible for inclusion in the EU pesticides database, all the active substances evaluated in this work failed the national assessment of groundwater at tier 1 for all MS in the Central Zone. However, assessment at tier 2 for the Netherlands which involves spatially distributed modelling resulted in compounds 5, 6 and 7 passing the national scenario. FOCUS (2009) provided a generic tiered approach for assessing the risk of active substances to groundwater which is presented in Figure 24. Most MS surveyed by Fera indicated that they accept the tiered approach, and particularly for higher tier groundwater risk assessment: modelling with refined parameters and scenarios relevant to each MS soil-climatic conditions (tier 3a); use of lysimeter and field data (tier 3b); and groundwater monitoring data where available (tier 4).

Figure 24. Proposed generic tiered assessment scheme for groundwater


At the EU level, prediction of surface water concentration was performed at Steps 1—3 as recommended by FOCUS (2012) and EFSA (2013b). For application to winter cereals, six drainage and three runoff scenarios were assessed at Step 3 with the exception of scenario R2 which is not relevant for winter cereals. For application to apples, three drainage and four runoff scenarios were assessed at Step 3 with the exception of scenarios D1, D2 and D6 which are not relevant for apples. At least one of the scenarios must be passed in order for the active substance to be included in the EU pesticides database. FOCUS scenarios used by most MS for their national assessment include two or more of the following: drainage scenarios D3, D4 and D5 and/or runoff scenarios R1, R3 and R4. However, Germany, Netherlands, Slovenia and the UK use different methodologies for assessment of surface water. All representative scenarios must be passed at MS level in order to obtain authorisation of the plant protection product.

Compounds 1—4 and metabolites passed surface water assessment in all MS that use FOCUS procedures. Mass loading of parent compounds to surface water was dominated by drainage or runoff entries, with inputs from drift deposits occurring on the day of application. For compound 5, mass loading was dominated by drift with predicted concentrations exceeding the RAC in the ditch and stream scenarios. Only the pond scenarios passed the tier 1 assessment because of the much greater dilution effect compared to the ditch and stream scenarios. Compound 9 failed most scenarios under alkaline conditions but only few under acidic conditions. Entry into surface water was dominated by drainage inputs in the drainage scenarios and runoff inputs in the runoff scenarios, with only nominal contributions from drift deposits. For all active substances assessed, the highest concentrations in surface water were predicted for stream R3 which is used by Austria, Hungary and Ireland for their national authorisation.

11.2.1 Spray Drift Deposition

Unlike at EU level (FOCUS Steps 1—3) where spray drift is added to losses from runoff/erosion or drainage, Germany, Netherlands, Slovenia and the UK assess spray drift separately from other routes of exposure.

Except in the Netherlands where a lower drift percentage of 1% is applied to field crops and 17% to fruit crops, calculation of PEC surface water from spray drift is based on the Rautmann drift values at the EU level and for other MS including Germany and the UK. Among the MS in the Central Zone, only Netherlands uses different drift values for surface water assessment.

At EU level, the nominal concentrations in surface water from drift calculated with the SWASH drift calculator were 0.044—1.285 µg L

-1 for compounds 1—4; 9.2—197 µg L

-1 for compound 5; and 0.004—0.128 µg L

-1 for

compound 9. For Germany and the UK that use a standard water body of 100 m x 1 m x 0.3 m next to a 1 ha field, the following concentrations were calculated: 1.85 µg L

-1 for compounds 1—4; 203—246 µg L

-1 for

compound 5; and 0.185 µg L-1

for compound 9. The standard water body in the Netherlands has a length of 320 m and the calculated concentrations were 0.952 µg L

-1 for compounds 1—4; 202—245 µg L

-1 for

compound 5; and 0.095 µg L-1

for compound 9. These results indicate that the assessment of surface water exposure via drift deposit is more conservative in Germany and the UK than in other MS. This is because the UK and Germany, unlike for EU level assessment, do not integrate drift over the width of the water body.

No guidance was identified for Germany on how to calculate the metabolite concentrations in surface water exposed via spray drift and volatilisation deposits. Thus, unlike Netherlands and UK procedures, assessment of surface water concentrations of metabolites formed in the water column was not performed at tier 1 of the German national assessment. At EU level, formation of metabolites in the water column is not considered either, but the release of a new FOCUS version of TOXSWA that includes this feature is imminent.

It is interesting to note that multiple applications of compound 5 to apples resulted in lower concentrations in surface water compared to the respective single application for MS that apply FOCUS procedures, as well as for Germany and the UK; whereas, concentrations after multiple applications in the Netherlands were higher than for the single application. The Netherlands uses a drift percentage of 17% for fruit crops for both single and multiple applications, with no progressive reduction in the percentage that enters surface water as is the case at EU level, in Germany and the UK (29% for one application and 24% for four applications). Residues from previous applications in the water body are added to subsequent applications with the last application used for PEC calculation.

The UK and Germany deviate from the FOCUS approach in that drift deposit is not integrated over the width of the water body to derive an areic mean percentage deposition. The Netherlands uses drift values that are lower than that used in other MS and does not differentiate between single and multiple applications.

11.2.2 Volatilisation and Dry Deposition

Germany is the only MS that considers volatilisation of plant protection products from plant and soil surfaces and subsequent dry deposition at tier 1 of the national assessment. In case of multiple applications, only one volatilisation following the last use is considered. Volatilisation and dry deposition was not a relevant route for exposure of compounds 1—4 and 9 to surface waters as both compounds passed the trigger values of 10

-5 and 10

-4 Pa for volatilisation from plant and soil surfaces, respectively. However, compound 5 failed the

tier 1 triggers, with dry deposition contributing 1% to the total PEC surface water from volatilisation and spray drift. As noted above, the result is that the German national assessment is more conservative than at EU level.

11.2.3 Runoff/Erosion and Drainage

Most MS that apply FOCUS procedures use at least one drainage and one runoff scenario for their national assessment. However, Hungary does not consider drainage entries as relevant for their national assessment and only runoff scenarios are assessed. Slovenia requires assessment of surface water exposure via spray drift only and does not yet consider runoff/erosion or drainage. Although runoff is considered relevant in Slovenia, the FOCUS scenarios are considered to be not relevant and this MS has not yet developed its own scenarios. Runoff/erosion is not considered an entry route to surface water in the Netherlands. Drainage scenario D3 is used as starting point for calculation with the drinking water assessment tool DROPLET. The latest version of PEARL (4.4.4) includes the option to simulate drainage and preferential flow and a Dutch drainage scenario exists which is expected to be considered in the regulatory process at some point.

For Germany, up to 0.45% of the applied substance is assumed to be transferred to surface water via runoff/ erosion and up to 0.25% via drainage following a rainfall event 3 days after application. Drift and drainflow

are the most important exposure routes for the UK. The UK only considers runoff for certain cases where runoff is indicated as an important entry route, and a runoff scenario is still under discussion. Up to 1.9% of applied amount per 10 mm drain water is assumed to be lost via drainflow. The UK is the only MS that considers preferential flow as part of tier 1 national assessment.

All the active substances assessed passed the runoff/erosion and drainage scenarios for Germany at tier 1. By contrast, all the active substances, except compound 2, failed the tier 1 drainflow assessment for the UK. PEC surface water via drainflow was 14.6 µg L

-1 for compounds 1, 3—4; 28.8—72.1 µg L

-1 for compound 5;

and 1.07—2.92 µg L-1

for compound 9. These results are similar to those obtained for stream D2 at EU level: 13—18 µg L

-1 for compounds 1, 3—4; and 0.8—2.22 µg L

-1 for compound 9 (compound 5 was not assessed

for D2). It should be noted that FOCUS D2 scenario is based on a clay soil data from Brimstone Farm, UK, and the UK drainflow assessment is derived from measurements at this site.

Predicted concentrations of the active substances were highest for the runoff scenario R3 used by Austria, Hungary and Ireland in their national authorisation. However, no clear concentration trends were observed for the drainage scenarios.

11.2.4 Spray Drift and Runoff/Erosion Mitigation

Spray drift and runoff/erosion mitigation measures considered by most MS include: (i) no-spray buffer zones up to 50 m, (ii) drift reducing nozzles up to 95%, and (iii) vegetative buffer strip up to 20 m. These mitigation measures can be implementation with a software tool (SWAN) which has been developed on behalf of ECPA and recommended by FOCUS (2009). However, only Slovakia currently accepts mitigation of runoff/erosion based on simulations with the VFSmod feature of SWAN in their authorisation procedures.

FOCUS (2007) provided the 90th percentile worst-case values for reduction efficiencies for different widths of

vegetated buffer strips and different phases of surface run-off. The Czech Republic indicated in a survey that 40—95% reduction efficiencies are acceptable for runoff/erosion mitigation in their national assessment. But no information on acceptable runoff/erosion reduction efficiencies was provided by other MS and so we have assumed that MS would accept mitigation of runoff/erosion based on default reduction efficiencies of 60—85% for a 10 m VFS and 80—95% for a 20 m VFS given by FOCUS (2007).

Implementation of up to 20 m no-spray buffer or 75% drift reduction would result in compound 5 passing all FOCUS surface water scenarios relevant to MS. Simulations with VFSmod and the maximum runoff/erosion reduction efficiencies recommended by FOCUS (2007) produced similar results because entry into surface water was dominated by drift deposition (the default assumption in SWAN is that the vegetative buffer is not sprayed and drift reduction is automatically included). Assessment at Step 4 would ensure that compound 5 passed national assessments for those MS that use FOCUS scenarios, in addition to Germany, Netherlands and Slovenia which failed at tier 1. However, the application of drift and runoff/erosion mitigation measures would not result in a pass for the UK because of the requirement to assess drainflow as an entry route which was failed by compound 5 at tier 1.

Because entry of compound 9 into surface waters was dominated by drainage in the drainage scenarios, the application of no-spray buffer zones, drift reducing nozzles and the various combinations of vegetative buffer strips as well runoff/erosion reduction efficiencies as mitigation measures did not reduce the surface water concentrations in any of the drainage scenarios below the Step 3 levels. Currently, none of the MS considers mitigation of drainage entry in the regulatory risk assessment, and SWAN does not provide simulations of mitigation for this entry route. Of the runoff scenarios that failed at Step 3, vegetative buffer strips were more effective as mitigation measures in stream R1 than in R3 where the highest concentrations were recorded among FOCUS scenarios used by MS.

11.3 Implications for Harmonisation

11.3.1 Groundwater Assessment

The following MS use two or more FOCUS groundwater scenarios and apply approaches outlined in FOCUS (2000, 2006, 2009 and 2011) for groundwater assessment in their national authorisation procedures for plant protection products:

Austria, Belgium, Czech Republic, Hungary, Ireland, Poland, Romania, Slovakia, Slovenia and the UK.

These MS use the current versions of FOCUS PEARL, PELMO and/or PRZM for calculating concentrations of active substances in groundwater. Current practice among MS, except Poland, is to accept PEC groundwater calculation based on one leaching model as recommended by FOCUS (2009). Most MS accept PEC groundwater calculations with PEARL, and only Poland requires simulations with PELMO in addition to PEARL. However EFSA (2004, 2013c) recommend that the PEC groundwater calculations for decision making should be based on more than one leaching model. Also, CRD (personal comms) indicated that if results of more than one leaching model were submitted, the worst-case results with e.g. PELMO would not be ignored in the decision process for authorisation. For non-volatile substances, compounds 1—4 and 9, the calculated PEC groundwater were generally within a factor of 1.5 for PEARL and PELMO.

The UK requires an additional simulation with MACRO 4.4.2 and the Châteaudun scenario for substances with Koc >100 L kg

-1. The calculated PEC for MACRO Châteaudun were within the range of the results for

the scenarios used by other MS. Where the PEC exceeded 0.1 µg L-1

for this scenario, the assessment also failed for one or more of the other model/scenario combinations.

For substances that are considered volatile, results indicated that groundwater concentrations predicted with PELMO at the EU level were much lower than those calculated with PEARL. For compounds 5—8, PELMO simulated much greater losses via volatilisation as compared to PEARL. Whilst the reasons for this large difference requires investigation by the FOCUS Version Control group, the regulatory outcome for volatile substances may be significantly influenced by the choice of leaching model in addition to MS requirements for model parameterisation, both of which may constitute obstacles to harmonisation.

Germany uses the Hamburg scenario with current version of FOCUS PELMO parameterised using the Input-Decision tool in addition to setting plant uptake and volatilisation to zero for tier 1 assessment. Substances showing pH-dependent degradation and/or sorption are assessed for both the Hamburg and Kremsmünster scenarios. Germany is the only MS that requires assessment of bank infiltration with the model EXPOSIT in addition to leaching. Because of the special requirements for scenario, models and model parameterisation, tier 1 groundwater assessment for Germany resulted in the worst-case PEC amongst MS for compounds 1—4 that are non-volatile. For volatile substances like compounds 5—8, groundwater concentrations predicted with PELMO for Germany and the Hamburg scenario were higher than those predicted with PELMO at EU level, but generally lower than those predicted with PEARL.

The Netherlands requires use of PEARL 3.3.3 for groundwater assessment in their national authorisation of plant protection products in contrast to PEARL 4.4.4 used at EU level. Results from the active substances assessed in this work indicated that only small differences in the PEC groundwater can be expected for both versions. Therefore, it is considered that harmonisation can be best achieved and the burden for applicants and regulators alike reduced if only one version of the PEARL model was used for groundwater assessment.

Only the Netherlands currently uses a spatially-distributed model, GeoPEARL, for groundwater assessment as part of the national assessment procedure. Spatially distributed modelling for the Netherlands resulted in 90

th percentile concentrations that were 42—91% lower than values calculated at tier 1 for Kremsmünster.

As spatially distributed models are currently not available in other MS as part of the evaluation procedures, applicants are faced with the difficult challenge of undertaking field leaching and monitoring studies for new active substances at higher tiers.

Currently, assessment of substances with pH-dependent degradation and/or sorption at EU level is based on common practice i.e. separate assessments under acidic and alkaline conditions based on agreed endpoints in the review report. A survey by Fera including information obtained from personal communication indicated that, whilst most MS adopt the common practice, others like Belgium use worst-case DT50 and Koc values from the EU agreed endpoints; and Germany uses the Input-Decision tool to determine input values that give the worst-case groundwater concentrations. For substances such as compound 9, worst-case groundwater concentrations will always be predicted for Belgium and probably followed by Germany (in particular for the acidic Hamburg scenario).

Currently, only Germany requires plant uptake factor to be set equal to zero for tier 1 assessment. Other MS national assessments and current versions of FOCUS leaching models use a default value of 0.5. However, EFSA (2013a) has recommended a default value of zero as a first step in groundwater assessments. In a

second step, the Briggs’ formula (Briggs et al. 1982) should be used. Further refinements of the uptake factor should be based on results of uptake experiments with appropriate and agreed set-up to be developed. Discussions are currently ongoing between European stakeholders with the aim to develop a test design that will allow to determine a plant uptake factor that is consistent with the concepts of the FOCUS models.

Results for the 9 test substances selected for this work indicated that the highest PEC groundwater were always predicted for the Hamburg or Okehampton scenarios when PEARL was used as the simulation tool. All MS except the Netherlands and Romania use the Hamburg scenario for their national assessment, and most MS use the Okehampton scenario. Predictions of groundwater concentrations were also undertaken for 50 test substances during the initial screening (Section 4). The largest concentrations were again always simulated for either the Hamburg or Okehampton scenario. Further information is available from previous R&D work under PS2211 ‘Development of a framework for extrapolation of FOCUS GW results between uses’. PEC GW were calculated with an older version of FOCUS PEARL (2.2.2) for Châteaudun, Hamburg, Kremsmuenster and Okehampton for a total of 432 combinations of compound, crop and application timing. Hamburg or Okehampton gave the largest PEC for 388 of the 432 combinations. For most of the 44 combinations where this was not the case, the differences between the scenario with the maximum PEC and Hamburg / Okehampton were small. Although further testing would be required, the use of the Hamburg and Okehampton scenarios as realistic worst-cases for standard groundwater assessment within the Central Zone could be a potential area to explore for scenario harmonisation at tier 1.

11.3.2 Surface Water Assessment

Most MS use two or more FOCUS surface water scenarios and apply approaches outlined in FOCUS (2012) and EFSA (2013b) for the assessment of surface water in their national authorisation procedures for plant protection products. The MS include:

Austria, Belgium, Czech Republic, Hungary, Ireland, Poland, Romania and Slovakia.

These MS use drainage scenarios D3, D4 or D5 and/or runoff scenarios R1, R3 or R4 with current versions of FOCUS surface water model (SWASH, PRZM, MACRO, TOXSWA). However, Germany, Netherlands, Slovenia and the UK do not use these scenarios or models and apply different approaches for assessment of surface water in their national authorisation procedures. The differences regarding drift deposit include: (1) consideration of spray drift as a separate entry route, (2) no integration of drift deposit over the width of the surface water body, (3) the inclusion of additional entry routes such as dry deposition following volatilisation, (4) deviating drift percentages. The result is that the assessment of surface water exposure via spray drift is more conservative for Germany and the UK than for other MS.

The percentage drift deposition following single and multiple applications of the active substance is based on the Rautmann drift values which is used at EU level and by other MS except the Netherlands. Results of this work indicated that for compound 5 whose entry into surface water is dominated by drift deposit and which has a short DT50 in water, the peak PEC surface water was calculated to be lower for multiple applications than for one application at EU and most MS levels. However, results based on approach in the Netherlands showed the opposite – the peak PEC surface water for multiple applications was higher than for the single application. There is, therefore, the need for harmonisation of percentage drift values that lead to consistent evaluation of surface water exposure via this route among MS.

Unlike groundwater assessment, the scenarios and entry routes of plant protection products into surface water considered by MS are more diverse and reflect the agricultural and environmental conditions specific to MS which potentially present obstacles to harmonisation. Even among those MS that follow the FOCUS procedures, scenarios used for national authorisation reflect the routes of entry into surface water that are considered relevant in those MS. For example, Hungary does not consider drainage entries as relevant for their national assessment. Slovenia requires assessment of spray drift only. Germany is the only MS that requires assessment of volatilisation in addition to spray drift at tier 1. The UK considers spray drift and drainflow as most relevant. A major difference between the UK and the other MS is that preferential flow on clay dominated soils is of concern in this country and this must be addressed in the assessment of losses via drainflow for authorisations in the UK. The Netherlands uses lower drift values and does not consider runoff/ erosion as relevant entry routes.

For all active substances assessed in this work, the highest concentrations were consistently calculated for the FOCUS stream R3 which is used by only Austria, Hungary and Ireland for their national authorisation. Tier 1 drainflow calculation for the UK produced results that were similar to those obtained for stream D2 at the EU level which is based on clay soil data from Brimstone Farm, UK. But the D2 scenario is not used by any MS, nor does any MS except the Netherlands consider drinking water abstraction points or WFD water bodies for their national assessment. Thus the current diversity of approaches to surface water assessment among MS presents more challenges and obstacles to harmonisation.

It is interesting to note that compounds 1—4 and 9 passed the surface water assessment at EU level, for those MS that use the FOCUS approach and for Germany, the Netherlands and Slovenia. Moreover, with the application of drift mitigation measures (e.g. 20 m no-spray zone), compound 5 would pass in these MS. However, the requirement to assess preferential flow as an entry route into surface water in the UK meant that all the active substances assessed, except compound 2, failed at tier 1 and would not be eligible for authorisation unless higher tier drainflow modelling is performed to demonstrate safe uses in the UK. The UK drainflow calculations are consistent with results obtained for drainage scenario D2 at EU level. Thus, if the UK were to adjust its authorisation procedures by using the same FOCUS methodology as a number of the other Central Zone MS, there would not necessarily be harmonised decision-making as the UK is likely to take into account the D2 scenario which is not used by any other MS that use the FOCUS methodology.

Information on assessment of metabolites formed in surface water was identified for the UK (CRD, 2009) and for the Netherlands (personal communication). However, information for Germany was only available for assessment of runoff/erosion and drainage with EXPOSIT, but not on how to calculate the metabolite concentrations in surface water exposed via spray drift and volatilisation deposits. At EU level, formation of metabolites in the water body is not considered either, but the release of a new FOCUS version of TOXSWA that includes this feature is understood to be imminent. Implementation of a consistent approach for predicting metabolite concentration in the water body at tier 1 can, therefore, be considered as a potential area for harmonisation.

The survey undertaken by Fera, including personal communication with MS representatives, indicated that there are common approaches to the implementation of mitigation measures for exposure of surface water to plant protection products in the authorisation procedures of MS. In general, MS accept no-spray buffer zones up to 50 m, low drift nozzles of up to 95% and vegetative filter strips up to 20 m. In addition, FOCUS (2007) has provided the 90

th percentile worst-case values for reduction efficiencies for different widths of vegetated

filter strips and different phases of surface run-off and this is accepted by most MS that consider runoff as a relevant exposure route for surface water.

There are also currently several initiatives to harmonise the post-registration management of plant protection products in the EU. These initiatives include: (i) ECPA BMP to reduce losses to water from diffuse sources under the TOPPS Prowadis project (ECPA 2013a, 2013b); and (ii) SETAC Europe MAgPIE Workshop which is also aimed at achieving better harmonisation of risk mitigation and management measures across Europe.

12 Conclusions

To compare groundwater and surface water assessment in the national authorisation procedures of MS in the Central Zone, nine test substances with a range of degradation, sorption and ecotoxicological properties and two application scenarios including: (i) ground spray to winter cereals in the spring and in autumn with and without interception and (ii) air blast application to apples were assessed. Key elements of the exposure assessment which influenced the regulatory outcome at EU and MS level can be summarised as follows:


Although the test substances passed at EU level and were eligible for inclusion in the EU pesticides database, all test substances failed tier 1 groundwater assessment at MS level.

For the non-volatile compounds 1—4 and metabolites, PELMO predicted higher concentrations than PEARL for Kremsmünster, Okehampton, Piacenza and Porto. For Hamburg, higher concentrations were predicted by PEARL in most cases. However, PELMO simulated much lower concentrations than PEARL for the volatile compounds 5—8. This indicated that PELMO may be more sensitive to simulation of volatilisation losses than PEARL.

For compound 9 with pH-dependent DT50 and Koc, the highest concentrations were simulated for Hamburg using input data under alkaline conditions and for Okehampton under acidic conditions.

Regardless of the DT50 and Koc values of the active substance and the crop and application timing, the highest PEC groundwater was always predicted for the Hamburg or Okehampton scenario.

Concentrations for substances with Koc > 100 simulated with MACRO for the Châteaudun scenario were lower than those for Hamburg and Okehampton simulated with PEARL.

Tier 1 groundwater assessment with PEARL 3.3.3 for the Netherlands resulted in slightly higher PEC values for the Kremsmünster scenario compared to the current version PEARL 4.4.4 used for EU level assessment, but this is unlikely to significantly affect the regulatory outcome at tier 1.

Spatially distributed modelling with GeoPEARL as required in the tier 2 of the Netherlands evaluation procedures indicated that compounds 5—7 with Koc of 120—500 L kg

-1 passed the drinking water

standard of 0.1 µg L-1

. However, compounds 1, 2, 3, 4 and 9 with Koc of 23—200 L kg-1

failed the assessment. Compound 8 with the highest Koc of 840 L kg

-1 also failed the tier 2 groundwater

assessment. Close inspection of these results indicated that the difference in the regulatory outcome between compound 5 (DT50 = 50 days) and compound 8 (DT50 = 120 days) can be attributed to the longer DT50 and hence greater persistence in soils.

There are more similarities than differences between the approaches used to assess groundwater in the various MS and some harmonisation could be possible across the Central Zone. An assessment using the Hamburg and Okehampton scenarios appears promising as a simplified first-tier that is protective for all MS. The FOCUS group has greatly reduced the discrepancies between the models and many MS now only require calculation with a single model. However, we identified considerable discrepancies between PEARL and PELMO for volatile substances and this may need further consideration. It should also be noted that Hamburg and Okehampton are not always worst-case when PELMO is used to simulate PEC GW.

Differences in the methodology to derive model inputs between MS are an obstacle to harmonisation. Compound properties are a characteristic of the substance and not a MS-specific factor, and a common approach should ideally be found. One option could be the acceptance of the agreed EU endpoints at MS level, or an agreed alternative approach applicable to all MS. Whether or not volatilisation should be switched off in the calculations of PEC groundwater would also need some discussion. The parameterisation of plant uptake has recently received a lot of attention and a change in the current procedures on how to describe and parameterise this process is expected. Ideally the recommendations by EFSA (2013a) should be adopted at EU level and by all MS.

Development of spatially-distributed database for higher tier groundwater assessment in other MS as in the Netherlands would also be an important consideration so that scenarios harmonisation efforts can focus on lower tiers.

The application of common approach for assessing substances with pH-dependent properties by all MS rather than the use of worst-case input values or a complex process of model parameterisation would promote efforts at harmonisation.


Compounds 1—4 and associated metabolites passed surface water assessment in all MS that use FOCUS procedures. Mass loading of the parent compounds to surface water was dominated by drainage or runoff entries, with inputs from drift deposits occurring on the day of application.

For compound 5, mass loading was dominated by drift with predicted concentrations exceeding the RAC in the ditch and stream scenarios. Only the pond scenarios passed the tier 1 assessment.

Compound 9 failed most scenarios under alkaline conditions but only few under acidic conditions. Entry into surface water was dominated by drainage or runoff, with only nominal contributions from drift deposits.

Predicted concentrations of compounds 1—9 were highest for runoff scenario R3 used by Austria, Hungary and Ireland for their national authorisation. However, no clear concentration trends were observed for the drainage scenarios.

Germany, Netherlands, Slovenia and the UK assess spray drift separately from runoff/erosion and/or drainage. Among MS in the Central Zone, only the Netherlands uses different drift values for surface water assessment.

The UK and Germany deviate from the FOCUS approach in that drift deposit is not integrated over the width of the water body to derive an areic mean percentage deposition although this is in line with the approach used for EU spray drift assessment prior to the introduction of FOCUS surface water methodology. The Netherlands uses drift values that are lower than that used in other MS and does not differentiate between single and multiple applications.

Germany is the only MS that considers volatilisation of plant protection products from plant and soil surfaces and subsequent dry deposition at tier 1 of the national assessment.

All the active substances assessed, except compound 2, failed tier 1 drainflow assessment for the UK. The UK is the only MS that considers preferential flow as part of tier 1 national assessment. Calculated PECs in surface water were similar to those obtained for stream D2 scenario at EU level.

Germany uses the EXPOSIT model to calculate exposure of surface water via drainage and runoff/ erosion. The calculated concentrations for test substances were always lower than for the FOCUS scenarios likely to be relevant for Germany (D3, D4 and R1).

The approach used in the Netherlands differs considerably from the FOCUS procedure. Runoff is not considered relevant. Drainage is currently not explicitly considered. The FOCUS drainage scenario D3 that is used as a basis for concentrations at drinking water abstraction points with Droplet has a relatively low vulnerability and several reduction factors are applied. Drift is currently the main route of entry considered in the Netherlands. It is the only country that includes an assessment at the point of drinking water abstraction into the registration procedure for pesticides.

Spray drift and runoff/erosion mitigation considered by most MS include: (i) no-spray buffer zones up to 50 m, (ii) drift reducing nozzles by up to 95%, and (iii) vegetative buffer strip up to 20 m.

Implementation of up to 20 m no-spray buffer zone or 75% drift reduction would result in compound 5 passing all FOCUS surface water scenarios relevant to MS.

Because the entry of compound 9 into surface waters was dominated by drainage in the drainage scenarios, application of no-spray buffer zones, drift reducing nozzles and the various combinations of vegetative buffer strips as well runoff/erosion reduction efficiencies as mitigation measures did not reduce the surface water concentrations in any of the scenarios below the Step 3 levels.

The differences in the agricultural and environmental conditions lead to a greater disparity in the approaches used in the surface water assessment than the groundwater assessment. This is because the relative importance of the various routes of entry into surface water–drift, drainage and runoff/erosion differs considerable between MS. Differences in soil types used for agriculture lead to the fact that loss of pesticides to drains via preferential flow is only relevant in parts of Europe. The UK drainflow calculations are consistent with results obtained for FOCUS drainage scenario D2 at the EU level where preferential flow is important. Thus, if the UK were to harmonise its authorisation procedures by using the same FOCUS methodology as a number of the other Central Zone MS, there would not necessarily be harmonised decision-making as the UK is likely to take into account the D2 scenario which is not used by any other MS. In addition, the UK currently has no methods for mitigating surface run-off and therefore could find it difficult to take account of situations where run-off is indicated to be a critical route of contamination leading to failure of risk assessment. In addition, previous UK R&D reports (PS2214 and PS2229) indicated that the FOCUS scenarios are not representative of UK agriculture in terms of weather or cropping associated with several scenarios. Adopting standard EU FOCUS surface water methodology could potentially lead to a reduction in protection of aquatic life, whilst adopting a modified version better tailored for the UK would lose benefits of harmonisation.

In conclusion, harmonisation of the assessment of drainage and runoff/erosion inputs into surface waters across Europe does not appear appropriate as the discrepancies are justified and based on MS specific conditions. There is some potential for the harmonisation of the drift calculations. A review of the current percentage drift deposition used by MS with a view to applying a harmonised and consistent approach could be useful. Continued efforts should also be made to developing harmonised approaches for application of pre and post-registration mitigation measures among MS across the EU.

13 References

Adriaanse, P.I., Linders, J.B.H.J., van der Berg, G.A., Boesten, J.J.T.I., van der Bruggen, M.W.P., Jilderda, K., Luttik, R., Merkens, W.S.W., Stienstra, Y.J., Teunissen R.J.M. (2008). Development of an assessment methodology to evaluate agricultural use of plant protection products for drinking water production from surface waters. A proposal for the registration procedure in the Netherlands. Alterra Report 1635.

BBA (2000). Bekanntmachung über die Abtrifteckwerte, die bei der Prüfung und Zulassung von Pflanzenschutzmitteln herangezogen werden. (8. Mai 2000) in : Bundesanzeiger No.100, amtlicher Teil, vom 25. Mai 2000, S. 9879.

Briggs, G.G., Bromilow, R.H. and Evans, A.A. (1982). Relationships between lipophilicity and root uptake and translocation of non-ionized chemicals by barley. Pestic. Sci. 1982, 13:495-504.

CRD (2009). Data requirement handbook. Chapter 6: Environmental Fate and Behaviour. General guidance on data requirements to assess the fate and behaviour of agricultural pesticides in the environment. Chemicals Regulation Directorate, UK.

ECPA (2013a). TOPPS Prowadis (2011-2014). Best Management Practices to reduce water pollution with plant protection products from runoff and erosion. European Crop Protection Agency.

ECPA (2013b). TOPPS Prowadis (2011-2014). Best Management Practices to reduce spray drift. European Crop Protection Agency.

EFSA (2004). Opinion of the Scientific Panel on Plant Protection Products and their Residues (PPR) on a request from EFSA on the FOCUS groundwater models comparability and the consistency of this risk assessment of groundwater contamination. The EFSA Journal (2004) 93, 120—20.

EFSA (2013a). Scientific Opinion on the report of the FOCUS groundwater working group (FOCUS, 2009): assessment of higher tiers. European Food Safety Authority, Parma, Italy. EFSA Journal 2013; 11(6):3291.

EFSA (2013b). Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters. European Food Safety Authority, Parma, Italy. EFSA Journal 2013; 11(7): 3290.

EFSA (2013c). Scientific Opinion on the report of the FOCUS groundwater working group (FOCUS, 2009): assessment of lower tiers. EFSA Journal 2013; 11(3):3114.

FOCUS (2000). FOCUS groundwater scenarios in the EU review of active substances. Report of the FOCUS Ground-water Scenarios Workgroup, EC Document Reference Sanco/321/2000, rev.2, 202pp.

FOCUS (2001). FOCUS surface water scenarios in the EU evaluation process under 91/414/EEC”. Report of the FOCUS Working Group on Surface Water Scenarios, EC Document Reference SANCO/4802/2001-rev.2. 245 pp.

FOCUS (2006). Guidance document on estimating persistence and degradation kinetics from environmental fate studies on pesticides in EU registration. Sanco/10058/2005 v2.0.

FOCUS (2007). Landscape and mitigation factors in aquatic risk assessment. Volume 1. Extended Summary and Recommendations‘. Report of the FOCUS Working Group on Landscape and Mitigation Factors in Ecological Risk Assessment, EC Document Reference SANCO/10422/2005 v2.0. 169 pp.

FOCUS (2009). Assessing potential for movement of active substances and their metabolites to groundwater in the EU. Report of the FOCUS Groundwater Work Group, EC Document Reference Sanco/13144/2010 v1, 604pp.

FOCUS (2011). Generic guidance for tier 1 FOCUS groundwater assessments.v2.0

FOCUS (2012). Generic guidance for FOCUS surface water scenarios. v1.1

Rautmann, D (2000). New basic drift values in the authorisation procedure for plant protection products. Paper for the FOCUS-Surface Water Group, 2000. 9p.

SANCO (2003). Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under council directive 91/414/EEC. SANCO/221/2000 rev.10. 25 February 2003.

Tiktak, A., van der Linden, A.M.A. and Boesten, J.J.T.I. (2003). The GeoEARL model: Model description, application and manual. RIVM report 716601007/2003.RIVM, Biithoven.

Tiktak, A., Van der Linden, A.M.A., Boesten, J.J.T.I., Kruijne. R. and van Kralingen, D. (2004). The GeoEARL model: Part II. User guide and model description update. RIVM report 716601008/2004.RIVM, Biithoven.

Umweltbundesamt. (2011). Recommendations for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECgw) in the national assessment for authorisation in Germany. Federal Environment Agency.

Van der Linden, A.M.A., Boesten, J.J.T.I., Cornelese, A.A., Kruijne, R., Leistra, M., Linders, J.B.H.J., PoI, J.W.W., Tiktak, A. and Verschoor, A.J. (2004). The new decision tree for the evaluation of pesticide leaching from soils. RIVM report 601450019. RIVM, Bilthoven.

Van Leerdam, R.C; Adriaanse, P.I; ter Horst, M.M.S. and te Roller, J.A. (2010). DROPLET to calculate concentrations at drinking water abstraction points. User manual for evaluation of agricultural use of plant protection products for drinking water production in the Netherlands. Alterra report 2020.

Appendix A Tables of Predicted Environmental Concentrations (PECs)

Table A1. Test Compounds 1 -- 4 Compd 1 Metab 1 Compd 2 Metab 2 Compd 3 Metab 3 Compd 4 Metab 4

Active Ingredient Herbicide Metabolite Herbicide Metabolite Herbicide Metabolite Herbicide Metabolite

Crop W Cereals NA W Cereals NA W Cereals NA W Cereals NA

Application Rate to Crop (kg ha-1) 0.2 NA 0.2 NA 0.2 NA 0.2 NA

Crop Interception 50% NA 50% NA 50% NA 50% NA

Effective Application Rate to Soil (kg/ha) 0.1 NA 0.1 NA 0.1 NA 0.1 NA

Number of Applications 1 NA 1 NA 1 NA 1 NA

Application Timing >01 March NA >01 March NA >01 March NA >01 March NA

Application Interval NA NA NA NA NA NA NA NA

Method of Application Ground NA Ground NA Ground NA Ground NA

Properties of Substance

Molar mass (g mol-1) 255.0 197.0 255.0 197.0 255.0 197.0 255.0 197.0

Saturated Vapour Pressure (Pa) 3.78E-09 0.00 3.78E-09 0.00 3.78E-09 0.00 3.78E-09 0.00

Water solubility (mg l-1) 91.0 91.0 91.0 91.0 91.0 91.0 91.0 91.0

Koc (L kg-1) 66 580 200 580 66 580 34 580

Half-life in Soil (days) 28 58 56 58 56 58 28 58

Half-life in Water (days) 24 33 24 33 24 33 24 33

Half-life in sediment (days) 24 33 24 33 24 33 24 33

Kom Soil (L kg-1) 38.28 336.43 116 336.43 38.28 336.43 19.72 336.43

Kom suspended Solids (L kg-1) 38.28 336.43 116 336.43 38.28 336.43 19.72 336.43

Kom Sediment (L kg-1) 38.28 336.43 116 336.43 38.28 336.43 19.72 336.43

Freundlich Exponent [-] 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00

Kmp Macrophytes (L kg-1) 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Fraction of metabolite (%) in Soil NA 35.50 NA 26.22 NA 26.22 NA 35.50

Fraction of metabolite (%) in Sediment NA 29.98 NA 29.98 NA 29.98 NA 29.98

Ecotoxicological Endpoints

Fish Acute LC50 (ug l-1) 14,300 39,000 14,300 39,000 14,300 39,000 14,300 39,000

Aquatic Invertebrate EC50 (ug l-1) >100,000 >49,000 >100,000 >49,000 >100,000 >49,000 >100,000 >49,000

Algae EC50 (ug l-1) 49,800 >45,000 49,800 >45,000 49,800 >45,000 49,800 >45,000

Lemna EC50 (ug l-1) 12,300 ND 12,300 ND 12,300 ND 12,300 ND

Fish Chronic NOEC (ug l-1) 200 ND 200 ND 200 ND 200 ND

Aquatic Invertebrate Chronic NOEC (ug l-1) 100 ND 100 ND 100 ND 100 ND

Step 1 - Global Max PECsurface water (ug l-1) 63.114 10.74 54.470 8.040 63.110 8.040 65.610 10.74

Step 2a - Global Max PECsurface water (ug l-1) 7.098 1.24 6.400 0.980 7.380 0.980 7.370 1.24

Step 2b - Global Max PECsurface water (ug l-1) 12.65 2.22 11.41 1.710 13.21 1.710 13.14 2.22

Step 3 - Global Max PECsurface water (ug l-1)

Ditch D1 19.1160 0.7580 9.0020 1.1300 20.1180 0.5950 24.0750 0.5690

Stream D1 11.9590 0.4730 5.6390 0.7230 12.5840 0.3720 15.0270 0.3550

Ditch D2 20.8250 0.6710 10.6100 0.9920 22.0600 0.4760 28.6950 0.4410

Stream D2 13.0680 0.4210 6.6590 0.6210 13.8420 0.2980 17.9400 0.2770

Ditch D3 1.2880 0.0092 1.2770 0.0049 1.5710 0.0477 1.3560 0.0246

Pond D4 0.2750 0.1270 0.4550 0.1780 1.3440 0.1440 0.4910 0.1140

Stream D4 1.0650 0.1520 1.0610 0.2200 1.3100 0.1490 1.1340 0.1240

Pond D5 0.1250 0.0687 0.2590 0.1100 0.4780 0.0871 0.1650 0.0590

Stream D5 1.0380 0.0619 1.1110 0.0989 1.2070 0.0705 1.0560 0.0513

Ditch D6 1.3990 0.0883 1.3260 0.1810 1.4930 0.1340 1.4220 0.0745

Pond R1 0.1370 0.0013 0.1200 0.0017 0.1390 0.0007 0.1300 0.0010

Stream R1 4.6400 0.0277 3.8740 0.0218 4.7000 0.0140 7.9950 0.0201

Stream R2 NA NA NA NA NA NA NA NA

Stream R3 7.2490 0.0255 5.0360 0.0223 7.3030 0.0129 7.9950 0.0201

Stream R4 0.8350 0.0142 0.8350 0.0229 0.8350 0.0072 0.8350 0.0105

Tier 1 - 80th Percent. PECgroundwater (ug l-1)

Chateaudun 0.09283 0.03156 0.04220 0.01579 1.06599 0.14833 0.43788 0.09453

Hamburg 0.50756 0.14078 0.28118 0.09745 2.66416 0.33314 1.47414 0.28185

Jokioinen 0.25798 0.05758 0.09313 0.02598 1.86168 0.17723 1.12948 0.13637

Kremsmunster 0.35576 0.13378 0.20492 0.07921 2.04437 0.29884 1.10614 0.28460

Okehampton 0.56774 0.17285 0.31847 0.11315 2.56200 0.31083 1.49476 0.31296

Piacenza 0.26424 0.10026 0.14534 0.05891 1.49406 0.23696 0.68372 0.22593

Porto 0.15818 0.03266 0.10738 0.03170 1.08148 0.09136 0.51312 0.07319

Sevilla 0.00424 0.00023 0.00012 0.00003 0.04960 0.00438 0.02548 0.00142

Thiva 0.01570 0.00908 0.01493 0.00602 0.38987 0.08408 0.08949 0.02705

PECsurface water highlighted in yellow represent exceedance of the regulatory acceptable concentration (RAC) of 10 ug l-1; aNorth Europe (March -- May)

PECgroundwater highlighted in yellow represent exceedance of the EU tier 1 regulatory trigger value of 0.1 ug l-1; bSouth Europe (March -- May)

Table A2. Test Compounds 5 -- 9 Compd 5 Compd 6 Compd 7 Compd 8 Compd 9a Compd 9b

Active Ingredient Fungicide Single Appl Fungicide Fungicide Fungicide Herbicide Herbicide

Crop Apples Apples Apples Apples W Cereals W Cereals

Application Rate to Crop (kg ha-1) 2.50 2.50 2.50 2.50 0.02 0.02

Crop Interception 70% 70% 70% 70% 0% 0%

Effective Application Rate to Soil (kg/ha) 0.75 0.75 0.75 0.75 0.02 0.02

Number of Applications 4 1 4 4 4 1 1

Application Timing >01 April >01 April >01 April >01 April >01 April Rel. Emerg Rel. Emerg

Application Interval 14 Days 14 Days 14 Days 14 Days NA NA

Method of Application Air Blast Air Blast Air Blast Air Blast Air Blast Ground Ground

Properties of Substance @ pH <7 @ pH >7

Molar mass (g mol-1) 286.1 286.1 286.1 286.1 358 358

Saturated Vapour Pressure (Pa) 1.30E-04 1.30E-04 1.30E-04 1.30E-04 3.00E-09 3.00E-09

Water solubility (mg l-1) 2.60 2.60 2.60 2.60 12500 12500

Koc (L kg-1) 500 120 280 840 81.1 23.4

Half-life in Soil (days) 50 16 30 120 19 71.2

Half-life in Water (days) 2.5 2.5 2.5 2.5 21 21

Half-life in sediment (days) 28 28 28 28 26 26

Kom Soil (L kg-1) 290.02 69.6 162.4 487.24 47.04 13.57

Kom suspended Solids (L kg-1) 290.02 69.6 162.4 487.24 47.04 13.57

Kom Sediment (L kg-1) 290.02 69.6 162.4 487.24 47.04 13.57

Freundlich Exponent [-] 1.00 1.00 1.00 1.00 0.88 0.90

Kmp Macrophytes (L kg-1) 0.00 0.00 0.00 0.00 0.00 0.00

Fraction of metabolite (%) in Soil NA NA NA NA NA NA

Fraction of metabolite (%) in Sediment NA NA NA NA NA NA

Ecotoxicological Endpoints

Fish Acute LC50 (ug l-1) >18,000 >18,000 >18,000 >18,000 >100000 >100000

Aquatic Invertebrate EC50 (ug l-1) 6000 6000 6000 6000 >100000 >100000

Algae EC50 (ug l-1) >1020 >1020 >1020 >1020 75 75

Lemna EC50 (ug l-1) ND ND ND ND 2.5 2.5

Fish Chronic NOEC (ug l-1) 500 500 500 500 20000 20000

Aquatic Invertebrate Chronic NOEC (ug l-1) 1950 1950 1950 1950 15000 15000

Step 1 - Global Max PECsurface water (ug l-1) 2970.0 3850.0 3400.0 2550.0 6.200 6.650

Step 2a-Global Max PECsurface water (ug l-1) 204.11 243.31 200.87 202.28 206.47 2.750 3.270

Step 2b-Global Max PECsurface water (ug l-1) 230.92 243.31 205.47 233.18 218.36 2.230 2.650

Step 3 - Global Max PECsurface water (ug l-1)

Ditch D1 NA NA NA NA NA 0.7180 1.2920

Stream D1 NA NA NA NA NA 0.4950 0.9800


Stream D2 NA NA NA NA NA 0.8150 2.2250

Ditch D3 153.6250 193.9650 153.6460 153.6390 153.6030 0.1270 0.3760

Pond D4 10.6460 11.8520 10.6480 10.6470 10.6540 0.0657 0.6740

Stream D4 159.2540 185.9370 159.2920 159.2830 159.2290 0.1110 0.5860

Pond D5 11.4660 11.8340 11.5510 11.5410 11.4870 0.0929 0.4780

Stream D5 169.8770 188.2010 170.0810 170.1180 169.9320 0.1180 0.3330


Pond R1 11.0950 11.7930 11.1150 11.1040 11.0820 0.0114 0.0127

Stream R1 122.8250 156.9540 122.8610 122.8460 122.7920 0.7480 0.8660

Stream R2 165.6010 208.2340 165.6500 165.6300 165.5570 NA NA

Stream R3 174.4670 222.0510 174.5170 174.4960 174.4220 1.0000 1.4210

Stream R4 123.7610 157.8800 123.7970 123.7820 123.7280 0.1530 0.0839

Tier 1 - 80th Percent. PECgroundwater (ug l-1)

Chateaudun 0.079391 ND 0.173611 0.084864 0.659369 <0.0001 1.1678

Hamburg 0.224778 ND 0.276515 0.220643 1.135112 0.00017 1.8996

Jokioinen 0.014237 ND 0.076575 0.024995 0.091596 <0.0001 1.4258

Kremsmunster 0.104927 ND 0.141728 0.114388 0.728781 <0.0001 1.2360

Okehampton 0.133302 ND 0.229181 0.161605 0.913169 0.00022 1.4577

Piacenza 0.113177 ND 0.099535 0.102285 0.786742 <0.0001 1.0710

Porto 0.053614 ND 0.040117 0.053185 0.397899 <0.0001 1.1751

Sevilla 0.040802 ND 0.128728 0.071430 0.336263 <0.0001 0.0326

Thiva 0.050225 ND 0.085335 0.050540 0.515049 <0.0001 0.8218

Compounds 5--8 RAC = 50 ug l-1; (a) North Europe (March -- May); (b) South Europe (March -- May)

Compound 9a and 9b RAC = 0.25 ug l-1; region/season of application: (a) North Europe (October - February); (b) South Europe (October - February)

Table A3. Calculated 80th Percentile PEC Groundwater for Parent Compound 1 and Metabolite at EU and Central Zone Member States Level

Parent (ug l-1) RAC (ug/l) EU Level Austria Belgium Czech R Germany Hungaryb

Netherlands Netherlands Poland R Ireland Romania Slovakia Slovenia UK UK

PEARL 4.4.4 (PEARL 3.3.3) (GeoPEARL) (MACRO 4.4.2)

Ch

teaudun 0.1 0.0928 0.093 0.093 0.093 0.093 0.093 0.093 0.093 0.125d

Hamburg 0.1 0.5076 0.508 0.508 0.508 0.508 0.508 0.508 0.508 0.508 0.508

Jokioinen 0.1 0.2580

Kremsmunster 0.1 0.3558 0.356 0.356 0.356 0.356 0.406 0.143c

0.356 0.356 0.356 0.356

Okehampton 0.1 0.5677 0.568 0.568 0.568 0.568 0.568 0.568

Piacenza 0.1 0.2642 0.264 0.264 0.264

Porto 0.1 0.1582 0.158

Sevilla 0.1 0.0042

Thiva 0.1 0.0157

PELMO 4.4.3

Ch

teaudun 0.1 0.075 0.075

Hamburg 0.1 0.535 0.715a

0.535

Jokioinen 0.1 0.357

Kremsmunster 0.1 0.416 0.416

Okehampton 0.1 0.645

Piacenza 0.1 0.301

Porto 0.1 0.227

Sevilla 0.1 0.005

Thiva 0.1 0.011

Metabolite (ug l-1)

PEARL 4.4.4

Ch

teaudun 0.1 - 10 0.0316 0.032 0.032 0.032 0.032 0.032 0.032 0.042d

Hamburg 0.1 - 10 0.1408 0.141 0.141 0.141 0.141 0.141 0.141 0.141 0.141 0.141

Jokioinen 0.1 - 10 0.0576

Kremsmunster 0.1 - 10 0.1338 0.134 0.134 0.134 0.134 0.148 0.045c

0.134 0.134 0.134 0.134

Okehampton 0.1 - 10 0.1729 0.173 0.173 0.173 0.173 0.173 0.173

Piacenza 0.1 - 10 0.1003 0.100 0.100 0.100

Porto 0.1 - 10 0.0327 0.033

Sevilla 0.1 - 10 0.0002

Thiva 0.1 - 10 0.0091

PELMO 4.4.3

Ch

teaudun 0.1 - 10 0.023 0.023

Hamburg 0.1 - 10 0.137 0.198a

0.137

Jokioinen 0.1 - 10 0.073

Kremsmunster 0.1 - 10 0.140 0.140

Okehampton 0.1 - 10 0.178

Piacenza 0.1 - 10 0.102

Porto 0.1 - 10 0.036

Sevilla 0.1 - 10 0.001

Thiva 0.1 - 10 0.003aCalculated with plant uptake factor and volatilisation = 0;

bHungary applies a limit value of 0.2 ug l

-1 for representative groundwater scenarios except Châteaudun

cTier 2 90th percentile PECgroundwater for the area of use calculated with GeoPEARL

dCalculated with MACRO 4.4.2 for compounds (parent or metabolite) with Koc > 100

Table A4. Calculated Maximum PEC Surface Water for Parent Compound 1 at EU and Central Zone Member States Level

FOCUS Surface Water Scenarios (ug l-1) RAC (ug/l) EU Level Austria Belgium Czech R Germany Hungary Netherlands Poland R Ireland Romania Slovakia Slovenia UK

Ditch D1 10 19.116

Stream D1 10 11.959

Ditch D2 10 20.825

Stream D2 10 13.068

Ditch D3 10 1.288 1.288 1.288

Pond D4 10 0.275 0.275 0.275 0.275 0.275 0.275 0.275

Stream D4 10 1.065 1.065 1.065 1.065 1.065 1.065 1.065

Pond D5 10 0.125 0.125 0.125 0.125

Stream D5 10 1.038 1.038 1.038 1.038

Ditch D6 10 1.399

Pond R1 10 0.137 0.137 0.137 0.137 0.137 0.137 0.137 0.137 0.137

Stream R1 10 4.640 4.640 4.640 4.640 4.640 4.640 4.640 4.640 4.640

Stream R2 10 NA

Stream R3 10 7.249 7.249 7.249 7.249

Stream R4 10 0.835 0.835 0.835

Germany Tier 1 National Assessment

PEC Drift Deposit 10 1.850

PEC Volatilisation Deposit 10 NA

PEC Total Deposit 10 1.850

PEC Runoff/Erosion 10 0.700

PEC Drainage 10 0.890

Netherlands Tier 1 National Assessment

De Punt 0.1 0.008

Andijk 0.1 0.001

Nieuwegein 0.1 0.005

Heel 0.1 0.010

Amst.-Rijnkanaal 0.1 0.004

Brakel 0.1 0.004

Petrusplaat 0.1 0.004

Twentekanaal 0.1 0.001

Scheelhoek 0.1 0.005

Bommelerwaard 0.1 0.002

Edge-of-Field Water Body

Maximum Surface Water Concentration 10 0.952

Maximum Sediment Concentration ND 12.06

UK Tier 1 National Assessment

Spray Drift 10 1.847 1.847

Drainflow 10 14.62

Table A5. Calculated Maximum PEC Surface Water for Metabolite of Compound 1 at EU and Central Zone Member State Level

Surface Water Scenarios (ug l-1) RAC (ug/l) EU Level Austria Belgium Czech R Germany Hungary Netherlands Poland R Ireland Romaniac

Slovakia Slovenia UK

Ditch D1 390 0.759

Stream D1 390 0.473

Ditch D2 390 0.671

Stream D2 390 0.421

Ditch D3 390 0.009 0.009 0.009

Pond D4 390 0.130 0.130 0.130 0.130 0.130 0.130 0.130

Stream D4 390 0.152 0.152 0.152 0.152 0.152 0.152 0.152

Pond D5 390 0.070 0.070 0.070 0.070

Stream D5 390 0.062 0.062 0.062 0.062

Ditch D6 390 0.088

Pond R1 390 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001

Stream R1 390 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028 0.028

Stream R2 NA NA

Stream R3 390 0.026 0.026 0.026 0.026

Stream R4 390 0.014 0.014 0.014


PEC Drift Deposit 390 NA

PEC Deposit Volatilisation 390 NA

PEC Total Deposit 390 NA




De Punt 0.1 0.001

Andijk 0.1 0.000


Heel 0.1 0.001


Brakel 0.1 0.000









Spray Drift 390 0.428a

0.428a

Drainflow 390 1.054aPEC of metabolite of compound 1 resulting from spray drift calculated as 200 g a.s ha

-1 x 0.2998 x (197/255) = 46.3 g a.s ha

-1 x 0.0277 / 3

= 0.428 ug l

-1





Ch

teaudun 0.1 0.0422 0.042 0.042 0.042 0.042 0.042 0.042 0.110d

Hamburg 0.1 0.2812 0.281 0.281 0.281 0.281 0.281 0.281 0.281 0.281 0.281


Kremsmunster 0.1 0.2049 0.205 0.205 0.205 0.205 0.216 0.101c

0.205 0.205 0.205 0.205

Okehampton 0.1 0.3185 0.318 0.318 0.318 0.318 0.318 0.318

Piacenza 0.1 0.1453 0.145 0.145 0.145

Porto 0.1 0.1074 0.107

Sevilla 0.1 0.0001

Thiva 0.1 0.0149

PELMO 4.4.3

Ch

teaudun 0.1 0.029 0.029

Hamburg 0.1 0.283 0.377a

0.283

Jokioinen 0.1 0.129



Piacenza 0.1 0.164

Porto 0.1 0.193

Sevilla 0.1 0.001

Thiva 0.1 0.006

Metabolite (ug l-1)

PEARL 4.4.4

Ch

teaudun 0.1 -- 10 0.0158 0.016 0.016 0.016 0.016 0.016 0.016 0.0391d

Hamburg 0.1 -- 10 0.0974 0.097 0.097 0.097 0.097 0.097 0.097 0.097 0.097 0.097

Jokioinen 0.1 -- 10 0.0260

Kremsmunster 0.1 -- 10 0.0792 0.079 0.079 0.079 0.079 0.085 0.036c

0.079 0.079 0.079 0.079

Okehampton 0.1 -- 10 0.1131 0.113 0.113 0.113 0.113 0.113 0.113

Piacenza 0.1 -- 10 0.0589 0.059 0.059 0.059

Porto 0.1 -- 10 0.0317 0.032

Sevilla 0.1 -- 10 0.0000

Thiva 0.1 -- 10 0.0060

PELMO 4.4.3

Ch

teaudun 0.1 -- 10 0.010 0.010

Hamburg 0.1 -- 10 0.093 0.129a

0.093

Jokioinen 0.1 -- 10 0.036

Kremsmunster 0.1 -- 10 0.081 0.081

Okehampton 0.1 -- 10 0.112

Piacenza 0.1 -- 10 0.058

Porto 0.1 -- 10 0.048

Sevilla 0.1 -- 10 0.000

Thiva 0.1 -- 10 0.002aCalculated with plant uptake factor and volatilisation = 0;



cTier 2 90th percentile PECgroundwater for the area of use calculated with GeoPEARL;

dCalculated with MACRO 4.4.2 for compounds with Koc > 100



Ditch D1 10 9.002

Stream D1 10 5.639

Ditch D2 10 10.61

Stream D2 10 6.659

Ditch D3 10 1.277 1.277 1.277

Pond D4 10 0.455 0.455 0.455 0.455 0.455 0.455 0.455

Stream D4 10 1.061 1.061 1.061 1.061 1.061 1.061 1.061

Pond D5 10 0.259 0.259 0.259 0.259

Stream D5 10 1.111 1.111 1.111 1.111

Ditch D6 10 1.326

Pond R1 10 0.120 0.120 0.120 0.120 0.120 0.120 0.120 0.120 0.120

Stream R1 10 3.874 3.874 3.874 3.874 3.874 3.874 3.874 3.874 3.874

Stream R2 10 NA

Stream R3 10 5.036 5.036 5.036 5.036

Stream R4 10 0.835 0.835 0.835








De Punt 0.1 0.008

Andijk 0.1 0.001


Heel 0.1 0.010


Brakel 0.1 0.004









Spray Drift 10 1.847 1.847

Drainflow 10 5.385


Surface Water Scenarios (ug l-1) RAC (ug/l) EU Level Austria Belgium Czech R Germany Hungary Netherlands Poland R Ireland Romania Slovakia Slovenia UK

Ditch D1 390 1.130

Stream D1 390 0.723

Ditch D2 390 0.992

Stream D2 390 0.621

Ditch D3 390 0.005 0.005 0.005

Pond D4 390 0.182 0.182 0.182 0.182 0.182 0.182 0.182

Stream D4 390 0.220 0.220 0.220 0.220 0.220 0.220 0.220

Pond D5 390 0.112 0.112 0.112 0.112

Stream D5 390 0.099 0.099 0.099 0.099

Ditch D6 390 0.181

Pond R1 390 0.002 0.002 0.002 0.002 0.002 0.002 0.002 0.002 0.002

Stream R1 390 0.022 0.022 0.022 0.022 0.022 0.022 0.022 0.022 0.022

Stream R2 NA NA

Stream R3 390 0.022 0.022 0.022 0.022

Stream R4 390 0.023 0.023 0.023








De Punt 0.1 0.001

Andijk 0.1 0.000


Heel 0.1 0.001


Brakel 0.1 0.000










0.428a


-1 x 0.2998 x (197/255) = 46.3 g a.s ha

-1 x 0.0277 / 3 = 0.428 ug l

-1





Châteaudun 0.1 1.0660 1.066 1.066 1.066 1.066 1.066 1.066 1.110

Hamburg 0.1 2.6642 2.664 2.664 2.664 2.664 2.664 2.664 2.664 2.664 2.664


Kremsmunster 0.1 2.0444 2.044 2.044 2.044 2.044 2.051 1.181c

2.044 2.044 2.044 2.044

Okehampton 0.1 2.5620 2.562 2.562 2.562 2.562 2.562 2.562

Piacenza 0.1 1.4941 1.494 1.494 1.494

Porto 0.1 1.0815 1.081

Sevilla 0.1 0.0496

Thiva 0.1 0.3899

PELMO 4.4.3

Châteaudun 0.1 0.869 0.869

Hamburg 0.1 2.355 3.526a

2.355

Jokioinen 0.1 2.059



Piacenza 0.1 1.549

Porto 0.1 1.256

Sevilla 0.1 0.118

Thiva 0.1 0.238

Metabolite (ug l-1)

PEARL 4.4.4

Châteaudun 0.1 -- 10 0.1483 0.148 0.148 0.148 0.148 0.148 0.148 0.133d

Hamburg 0.1 -- 10 0.3331 0.333 0.333 0.333 0.333 0.333 0.333 0.333 0.333 0.333

Jokioinen 0.1 -- 10 0.1772

Kremsmunster 0.1 -- 10 0.2988 0.299 0.299 0.299 0.299 0.299 0.146c

0.299 0.299 0.299 0.299

Okehampton 0.1 -- 10 0.3108 0.311 0.311 0.311 0.311 0.311 0.311

Piacenza 0.1 -- 10 0.2370 0.237 0.237 0.237

Porto 0.1 -- 10 0.0914 0.091

Sevilla 0.1 -- 10 0.0044

Thiva 0.1 -- 10 0.0841

PELMO 4.4.3

Châteaudun 0.1 -- 10 0.117 0.117

Hamburg 0.1 -- 10 0.297 0.477a

0.297

Jokioinen 0.1 -- 10 0.187

Kremsmunster 0.1 -- 10 0.292 0.292

Okehampton 0.1 -- 10 0.301

Piacenza 0.1 -- 10 0.214

Porto 0.1 -- 10 0.093

Sevilla 0.1 -- 10 0.011








Ditch D1 10 20.118

Stream D1 10 12.584

Ditch D2 10 22.060

Stream D2 10 13.842

Ditch D3 10 1.571 1.571 1.571

Pond D4 10 1.344 1.344 1.344 1.344 1.344 1.344 1.344

Stream D4 10 1.310 1.310 1.310 1.310 1.310 1.310 1.310

Pond D5 10 0.478 0.478 0.478 0.478

Stream D5 10 1.207 1.207 1.207 1.207

Ditch D6 10 1.493

Pond R1 10 0.139 0.139 0.139 0.139 0.139 0.139 0.139 0.139 0.139

Stream R1 10 4.700 4.700 4.700 4.700 4.700 4.700 4.700 4.700 4.700

Stream R2 10 NA

Stream R3 10 7.303 7.303 7.303 7.303

Stream R4 10 0.835 0.835 0.835








De Punt 0.1 0.060

Andijk 0.1 0.005


Heel 0.1 0.075


Brakel 0.1 0.029









Spray Drift 10 1.847 1.847

Drainflow 10 14.62



Ditch D1 390 0.595

Stream D1 390 0.372

Ditch D2 390 0.476

Stream D2 390 0.298

Ditch D3 390 0.048 0.048 0.048

Pond D4 390 0.149 0.149 0.149 0.149 0.149 0.149 0.149

Stream D4 390 0.149 0.149 0.149 0.149 0.149 0.149 0.149

Pond D5 390 0.089 0.089 0.089 0.089

Stream D5 390 0.071 0.071 0.071 0.071

Ditch D6 390 0.134

Pond R1 390 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001

Stream R1 390 0.014 0.014 0.014 0.014 0.014 0.014 0.014 0.014 0.014

Stream R2 NA NA

Stream R3 390 0.013 0.013 0.013 0.013

Stream R4 390 0.007 0.007 0.007








De Punt 0.1 0.001

Andijk 0.1 0.000


Heel 0.1 0.001


Brakel 0.1 0.000










0.428a


-1 x 0.2998 x (197/255) = 46.3 g a.s ha

-1 x 0.0277 / 3 = 0.428 ug l

-1





Châteaudun 0.1 0.4379 0.438 0.438 0.438 0.438 0.438 0.438 0.386

Hamburg 0.1 1.4741 1.474 1.474 1.474 1.474 1.474 1.474 1.474 1.474 1.474


Kremsmunster 0.1 1.1061 1.106 1.106 1.106 1.106 1.139 0.505c

1.106 1.106 1.106 1.106

Okehampton 0.1 1.4948 1.495 1.495 1.495 1.495 1.495 1.495

Piacenza 0.1 0.6837 0.684 0.684 0.684

Porto 0.1 0.5131 0.513

Sevilla 0.1 0.0255

Thiva 0.1 0.0895

PELMO 4.4.3

Châteaudun 0.1 0.343 0.343

Hamburg 0.1 1.434 2.141a

1.434

Jokioinen 0.1 1.352



Piacenza 0.1 0.742

Porto 0.1 0.614

Sevilla 0.1 0.022

Thiva 0.1 0.059

Metabolite (ug l-1)

PEARL 4.4.4

Châteaudun 0.1 -- 10 0.0945 0.095 0.095 0.095 0.095 0.095 0.095 0.079d

Hamburg 0.1 -- 10 0.2818 0.282 0.282 0.282 0.282 0.282 0.282 0.282 0.282 0.282

Jokioinen 0.1 -- 10 0.1364

Kremsmunster 0.1 -- 10 0.2846 0.285 0.285 0.285 0.285 0.316 0.091c

0.285 0.285 0.285 0.285

Okehampton 0.1 -- 10 0.3130 0.313 0.313 0.313 0.313 0.313 0.313

Piacenza 0.1 -- 10 0.2259 0.226 0.226 0.226

Porto 0.1 -- 10 0.0732 0.073

Sevilla 0.1 -- 10 0.0014

Thiva 0.1 -- 10 0.0271

PELMO 4.4.3

Châteaudun 0.1 -- 10 0.074 0.074

Hamburg 0.1 -- 10 0.252 0.405a

0.252

Jokioinen 0.1 -- 10 0.153

Kremsmunster 0.1 -- 10 0.291 0.291

Okehampton 0.1 -- 10 0.308

Piacenza 0.1 -- 10 0.228

Porto 0.1 -- 10 0.064

Sevilla 0.1 -- 10 0.004








Ditch D1 10 24.075

Stream D1 10 15.027

Ditch D2 10 28.695

Stream D2 10 17.940

Ditch D3 10 1.356 1.356 1.356

Pond D4 10 0.491 0.491 0.491 0.491 0.491 0.491 0.491

Stream D4 10 1.134 1.134 1.134 1.134 1.134 1.134 1.134

Pond D5 10 0.165 0.165 0.165 0.165

Stream D5 10 1.056 1.056 1.056 1.056

Ditch D6 10 1.422

Pond R1 10 0.130 0.130 0.130 0.130 0.130 0.130 0.130 0.130 0.130

Stream R1 10 7.995 7.995 7.995 7.995 7.995 7.995 7.995 7.995 7.995

Stream R2 10 NA

Stream R3 10 7.995 7.995 7.995 7.995

Stream R4 10 0.835 0.835 0.835








De Punt 0.1 0.051

Andijk 0.1 0.005


Heel 0.1 0.065


Brakel 0.1 0.025









Spray Drift 10 1.847 1.847

Drainflow 10 14.62



Ditch D1 390 0.569

Stream D1 390 0.355

Ditch D2 390 0.441

Stream D2 390 0.277

Ditch D3 390 0.025 0.025 0.025

Pond D4 390 0.117 0.117 0.117 0.117 0.117 0.117 0.117

Stream D4 390 0.124 0.124 0.124 0.124 0.124 0.124 0.124

Pond D5 390 0.060 0.060 0.060 0.060

Stream D5 390 0.051 0.051 0.051 0.051

Ditch D6 390 0.075

Pond R1 390 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001 0.001

Stream R1 390 0.020 0.020 0.020 0.020 0.020 0.020 0.020 0.020 0.020

Stream R2 NA NA

Stream R3 390 0.020 0.020 0.020 0.020

Stream R4 390 0.011 0.011 0.011








De Punt 0.1 0.001

Andijk 0.1 0.000


Heel 0.1 0.001


Brakel 0.1 0.000










0.428a


-1 x 0.2998 x (197/255) = 46.3 g a.s ha

-1 x 0.0277 / 3 = 0.428 ug l

-1

Table A15. Calculated 80th Percentile PEC Groundwater for Compound 5 at EU and Central Zone Member States Level

Groundwater Scenarios (ug l-1) RAC (ug/l) EU Level Austria Belgium Czech R Germany Hungaryb



Châteaudun 0.1 0.0794 0.079 0.079 0.079 0.079 0.079 0.079 0.086d

Hamburg 0.1 0.2248 0.225 0.225 0.225 0.225 0.225 0.225 0.225 0.225 0.225


Kremsmunster 0.1 0.1049 0.105 0.105 0.105 0.105 0.1388 0.013c

0.105 0.105 0.105 0.105

Okehampton 0.1 0.1333 0.133 0.133 0.133 0.133 0.133 0.133

Piacenza 0.1 0.1132 0.113 0.113 0.113 0.113

Porto 0.1 0.0536 0.054

Sevilla 0.1 0.0408

Thiva 0.1 0.0502

PELMO 4.4.3

Châteaudun 0.1 0.045 0.045

Hamburg 0.1 0.045 0.152a

0.045

Jokioinen 0.1 0.010



Piacenza 0.1 0.144

Porto 0.1 0.053

Sevilla 0.1 0.002

Thiva 0.1 0.009aCalculated with plant uptake factor and volatilisation = 0;





Table A16. Calculated Maximum PEC Surface Water for Multiple Application of Compound 5 at EU and Central Zone Member States Level


Ditch D1 NA

Stream D1 NA

Ditch D2 NA

Stream D2 NA

Ditch D3 50 153.625 153.625 153.625

Pond D4 50 10.646 10.646 10.646 10.646 10.646 10.646 10.646

Stream D4 50 159.254 159.254 159.254 159.254 159.254 159.254 159.254

Pond D5 50 11.466 11.466 11.466 11.466

Stream D5 50 169.877 169.877 169.877 169.877

Ditch D6 NA

Pond R1 50 11.095 11.095 11.095 11.095 11.095 11.095 11.095 11.095 11.095

Stream R1 50 122.825 122.825 122.825 122.825 122.825 122.825 122.825 122.825 122.825

Stream R2 50 165.601

Stream R3 50 174.467 174.467 174.467 174.467

Stream R4 50 123.761 123.761 123.761



PEC Volatilisation Deposit 50 2.400





De Punt 0.1 0.000

Andijk 0.1 0.001


Heel 0.1 0.063


Brakel 0.1 0.022






Maximum Surface Water Concentration 50 245

Tier 2 WFD Water Body 50 20.14


Spray Drift 50 203.87

Drainflow 50 72.14a

aCalculated from mass of compound 5 remaining in the soil on 30th April after three (3) applications within the drainflow period in the UK

Table A17. Calculated Maximum PEC Surface Water for Single Application of Compound 5 at EU and Central Zone Member States Level

Surface Water Scenarios (ug l-1) RAC (ug/l) EU Annex 1 Austria Belgium Czech R Germany Hungary Netherlands Poland R Ireland Romania Slovakia Slovenia UK

Ditch D1 NA

Stream D1 NA

Ditch D2 NA

Stream D2 NA

Ditch D3 50 193.965 193.965 193.965

Pond D4 50 11.852 11.852 11.852 11.852 11.852 11.852 11.852

Stream D4 50 185.937 185.937 185.937 185.937 185.937 185.937 185.937

Pond D5 50 11.834 11.834 11.834 11.834

Stream D5 50 188.201 188.201 188.201 188.201

Ditch D6 NA

Pond R1 50 11.793 11.793 11.793 11.793 11.793 11.793 11.793 11.793 11.793

Stream R1 50 156.954 156.954 156.954 156.954 156.954 156.954 156.954 156.954 156.954

Stream R2 50 208.234

Stream R3 50 222.051 222.051 222.051 222.051

Stream R4 50 157.88 157.88 157.88



PEC Volatilisation Deposit 50 2.400





De Punt 0.1 0.000

Andijk 0.1 0.001


Heel 0.1 0.063


Brakel 0.1 0.022






Maximum Surface Water Concentration 50 202

Tier 2 WFD Water Body 50 9.96


Spray Drift 50 243.33

Drainflow 50 28.84a

aCalculated from mass of compound 5 remaining in the soil on 1st April after one (1) application within the drainflow period in the UK

Table A18. Calculated 80th Percentile PEC Groundwater for Compound 9 at EU and Central Zone Member States Level

Acidic Conditions pH <7 RAC (ug/l) EU Level Austria Belgiumb

Czech Republicb

Germanyb

Hungarya

Netherlandsb

Poland R Ireland Romania Slovakia Slovenia UK

PEARL 4.4.4

Châteaudun 0.1 <0.0001 3.558 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

Hamburg 0.1 0.00017 0.000 3.254 0.0004 0.00017 0.00017 0.00017 0.00017 0.00017 0.00017

Jokioinen 0.1 <0.0001

Kremsmunster 0.1 <0.0001 <0.0001 2.394 NA <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

Okehampton 0.1 0.00022 2.149 0.00022 0.00022 0.00022 0.00022 0.00022

Piacenza 0.1 <0.0001 <0.0001 <0.0001 <0.0001

Porto 0.1 <0.0001 <0.0001

Sevilla 0.1 <0.0001

Thiva 0.1 <0.0001

PELMO 4.4.3

Châteaudun 0.1 <0.0001 <0.0001

Hamburg 0.1 0.001 0.342 0.001

Jokioinen 0.1 <0.0001

Kremsmunster 0.1 <0.0001 NA <0.0001

Okehampton 0.1 <0.0001

Piacenza 0.1 <0.0001

Porto 0.1 0.001

Sevilla 0.1 <0.0001

Thiva 0.1 <0.0001

Alkaline Conditions pH >7

PEARL 4.4.4

Châteaudun 0.1 1.1678 3.558 1.168 1.168 1.168 1.168 1.168

Hamburg 0.1 1.8996 1.900 3.254 NA 1.900 1.900 1.900 1.900 1.900 1.900


Kremsmunster 0.1 1.2360 1.236 2.394 1.163 1.236 1.236 1.236 1.236 1.236

Okehampton 0.1 1.4577 2.149 1.458 1.458 1.458 1.458 1.458

Piacenza 0.1 1.0710 1.071 1.071 1.071

Porto 0.1 1.1751 1.175

Sevilla 0.1 0.0326

Thiva 0.1 0.8218

PELMO 4.4.3

Châteaudun 0.1 0.918 0.918

Hamburg 0.1 1.899 NA 1.899

Jokioinen 0.1 1.439

Kremsmunster 0.1 1.208 1.220 1.208


Piacenza 0.1 1.413

Porto 0.1 1.389

Sevilla 0.1 0.403

Thiva 0.1 0.839

GeoPEARL 3.3.3 0.492aHungary applies a limit value of 0.2 ug l

-1 for representative groundwater scenarios except Châteaudun;

bGroundwater assessment was based on specific national requirements for model and / or selection of pH-dependent DT50 and Koc values by the MS which are different for the EU level assessment

Table A19. Calculated Maximum PEC Surface Water for Compound 9 at EU and Central Zone Member States Level at pH <7

FOCUS Surface Water Scenarios (ug l-1) RAC (ug/l) EU Level Austria Belgiuma

Czech Ra

Germanya

Hungary Netherlands Poland R Ireland Romania Slovakia Slovenia UKa

Ditch D1 0.25 0.718

Stream D1 0.25 0.495

Ditch D2 0.25 1.307

Stream D2 0.25 0.815

Ditch D3 0.25 0.127 0.740 0.127

Pond D4 0.25 0.066 0.066 1.075 0.067 0.066 0.066 0.066

Stream D4 0.25 0.111 0.111 0.810 0.111 0.111 0.111 0.111

Pond D5 0.25 0.093 0.093 0.093 0.093

Stream D5 0.25 0.118 0.118 0.118 0.118

Ditch D6 0.25 0.607

Pond R1 0.25 0.011 0.011 0.012 0.011 0.011 0.011 0.011 0.011

Stream R1 0.25 0.748 0.748 0.830 0.748 0.748 0.748 0.748 0.748

Stream R2 NA

Stream R3 0.25 1.000 1.000 1.000 1.000

Stream R4 0.25 0.153 0.153 0.153


PEC Drift Deposit 0.25 0.185

PEC Volatilisation Deposit 0.25 NA

PEC Total Deposit 0.25 0.185

PEC Runoff/Erosion 0.25 0.150

PEC Drainage 0.25 0.190


De Punt 0.1 0.000

Andijk 0.1 0.000


Heel 0.1 0.001


Brakel 0.1 0.000






Maximum Surface Water Concentration 0.25 0.095



Spray Drift 0.25 0.185 0.185

Drainflow 0.25 1.077aSurface water assessment was based on specific national requirements for selection of pH-dependent DT50 and Koc values by the MS which are different for the EU level assessment

Table A20. Calculated Maximum PEC Surface Water for Compound 9 at EU and Central Zone Member States Level at pH >7

Surface Water Scenarios (ug l-1) RAC (ug/l) EU Level Austria Belgiuma

Czech Ra

Germanya

Hungary Netherlands Poland R Ireland Romania Slovakia Slovenia UKa

Ditch D1 0.25 1.292

Stream D1 0.25 0.980

Ditch D2 0.25 3.545

Stream D2 0.25 2.225

Ditch D3 0.25 0.376 0.740 0.376

Pond D4 0.25 0.674 0.674 1.075 0.674 0.674 0.674

Stream D4 0.25 0.586 0.586 0.810 0.586 0.586 0.586

Pond D5 0.25 0.478 0.478 0.478 0.478

Stream D5 0.25 0.333 0.333 0.333 0.333

Ditch D6 0.25 1.045

Pond R1 0.25 0.013 0.013 0.012 0.013 0.013 0.013 0.013 0.013 0.013

Stream R1 0.25 0.866 0.866 0.830 0.869 0.866 0.866 0.866 0.866 0.866

Stream R2 NA

Stream R3 0.25 1.421 1.421 1.421 1.421

Stream R4 0.25 0.084 0.084 0.084


PEC Drift Deposit 0.25 0.185

PEC Deposit Volatilisation 0.25 NA

PEC Total Deposit 0.25 0.185

PEC Runoff/Erosion 0.25 0.150

PEC Drainage 0.25 0.190


De Punt 0.1 0.012

Andijk 0.1 0.001


Heel 0.1 0.015


Brakel 0.1 0.006






Maximum Surface Water Concentration 0.25 0.095



Spray Drift 0.25 0.185 0.185

Drainflow 0.25 2.923aSurface water assessment was based on specific national requirements for selection of pH-dependent DT50 and Koc values by the MS which are different for the EU level assessment

Table A21. Step 4 Global Maximum Surface Water Concentrations (ug/l) of Compound 5 Following Multiple Application to Apples (RAC = 50 ug/l)

FOCUS Surface Water Scenarios

FOCUS Step 4 Spray Drift and/or Runoff Mitigation Options Ditch D3 Pond D4 Stream D4 Pond D5 Stream D5 Pond R1 Stream R1 Stream R2 Stream R3 Stream R4

Step 3 PECsurface water @ 3m 153.62 10.646 159.25 11.466 169.88 11.095 122.82 165.60 174.47 123.76

1. No Spray Buffer Zonea

10m 68.516 6.707 78.586 7.259 84.079 6.984 60.481 81.546 85.912 60.943

2. No Spray Buffer Zoneb

20m 17.058 6.452 19.639 3.592 21.268 2.026 27.982 40.543 32.997 35.32

3. No Spray Buffer Zonec

35m 3.748 6.451 13.769 3.592 5.199 0.756 27.982 40.543 32.997 35.32

4. No Spray Buffer Zonec

50m 1.418 6.451 13.769 3.592 5.199 0.449 27.982 40.543 32.997 35.32

5. Nozzle Reduction of Spray Driftd

50% 76.813 6.452 79.861 5.788 85.482 5.547 61.412 82.801 87.234 61.881


75% 38.408 6.452 40.058 3.592 43.099 2.774 30.707 41.402 43.619 35.32

7. Nozzle Reduction of Spray driftd

90% 15.364 6.451 16.327 3.592 17.693 1.29 27.982 40.543 32.997 35.32


99% 2.574 6.451 13.769 3.592 5.199 0.533 27.982 40.543 32.997 35.32

9. No Spray Buffer Zone + VFSmoda

10m x 10m 68.516 6.707 78.586 7.259 84.079 6.984 60.481 81.546 85.911 60.942

10. No Spray Buffer Zone + VFSmodb

20m x 20m 17.058 6.452 19.639 3.592 21.268 2.026 15.056 20.299 21.386 15.17

11. No Spray Buffer Zone + VFSmodc

35m x 35m 3.748 6.451 13.769 3.592 5.199 0.628 3.307 4.459 4.697 3.332

12. No Spray Buffer Zone + VFSmodc

50m x 50m 1.418 6.451 13.769 3.592 5.199 0.284 1.25 1.686 1.776 1.26

13. Nozzle Reduction + No Spray Buffer Zone + VFSmoda

50% x 10m 34.259 6.452 39.383 3.684 42.335 3.492 30.24 40.771 42.954 30.47


75% x 10m 17.131 6.452 19.787 3.592 21.465 1.746 15.12 20.386 21.478 15.235


90% x 10m 6.854 6.451 13.769 3.592 9.014 0.717 6.048 8.155 8.591 6.094


99% x 10m 1.539 6.451 13.769 3.592 5.199 0.262 0.605 0.815 0.961 0.609

17. Nozzle Reduction + No Spray Buffer Zone + VFSmodb

50% x 20m 8.53 6.451 13.769 3.592 10.877 1.013 7.528 10.15 10.693 7.585


75% x 20m 4.266 6.451 13.769 3.592 5.716 0.507 3.764 5.075 5.347 3.793


90% x 20m 1.903 6.451 13.769 3.592 5.199 0.266 1.506 2.03 2.139 1.517


99% x 20m 0.736 6.451 13.769 3.592 5.199 0.137 0.223 0.25 0.534 0.306

21. Nozzle Reduction + No Spray Buffer Zone + VFSmodc

50% x 35m 1.875 6.451 13.769 3.592 5.199 0.314 1.653 2.229 2.349 1.666


75% x 35m 0.939 6.451 13.769 3.592 5.199 0.157 0.827 1.114 1.174 0.833


90% x 35m 0.377 6.451 13.769 3.592 5.199 0.0628 0.331 0.446 0.47 0.333


99% x 35m 0.0399 6.451 13.769 3.592 5.199 0.00628 0.033 0.0444 0.0468 0.0332

25. % Runoff/Erosion Reduction + 10m Vegatative Stripe

60% x 85% 68.516 6.707 78.586 7.259 84.079 6.984 60.481 81.546 85.911 60.942

26. % Runoff/Erosion Reduction + 20m Vegetative Stripf

80% x 95% 17.058 6.452 19.639 3.592 21.268 2.026 15.056 4.386 21.386 15.171

aIncluding 24 hr dry deposition rate (mg/m2) at 10m downwind from treated crop calculated with EVA 2.1

bIncluding 24 hr dry deposition rate (mg/m2) at 20m downwind from treated crop calculated with EVA 2.1

cIncluding 24 hr dry deposition rate (mg/m2) at 35--50m downwind from treated crop = 0

dIncluding 24 hr dry deposition rate (mg/m2) at default distance of 3m (Step 3 mass loading) downwind from treated crop calculated with EVA 2.1

eReduction in volume of runoff = 60%; Reduction in pesticide mass transported in runoff = 60%; Reduction in mass of eroded sediment = 85%; Reduction in pesticide mass transported in sediment = 85%

fReduction in volume of runoff = 80%; Reduction in pesticide mass transported in runoff = 80%; Reduction in mass of eroded sediment = 95%; Reduction in pesticide mass transported in sediment = 95%

Table A22. Step 4 Global Maximum Surface Water Concentrations (ug/l) of Compound 9 (Alkaline Conditions) Following Single Application to Winter Cereals (RAC = 0.25 ug/l)

FOCUS Surface Water Scenarios

FOCUS Step 4 Spray Drift and/or Runoff Mitigation OptionsNB

Ditch D1 Stream D1 Ditch D2 Stream D2 Ditch D3 Pond D4 Stream D4 Pond D5 Stream D5 Ditch D6 Pond R1 Stream R1 Stream R3 Stream R4

Step 3 PECsurface water @ 1m 1.292 0.98 3.545 2.225 0.376 0.674 0.586 0.478 0.333 1.045 0.0127 0.866 1.421 0.0894

1. No Spray Buffer Zone 10m 1.292 0.980 3.545 2.225 0.267 0.674 0.586 0.478 0.333 1.045 0.0113 0.866 1.421 0.0299




5. Nozzle Reduction of Spray Drift 50% 1.292 0.980 3.545 2.225 0.313 0.674 0.586 0.478 0.333 1.045 0.0109 0.866 1.421 0.0420


7. Nozzle Reduction of Spray drift 90% 1.292 0.980 3.545 2.225 0.262 0.674 0.586 0.477 0.333 1.045 0.0094 0.866 1.421 0.0299


9. No Spray Buffer Zone + VFSmod 10m x 10m 1.292 0.980 3.545 2.225 0.267 0.674 0.586 0.478 0.333 1.045 0.0027 0.016 0.571 0.0161




13. Nozzle Reduction + No Spray Buffer Zone + VFSmod 50% x 10m 1.292 0.980 3.545 2.225 0.258 0.674 0.586 0.478 0.333 1.045 0.0014 0.008 0.571 0.0081












25. % Runoff/Erosion Reduction + 10m Vegatative Stripa

60% x 85% 1.292 0.980 3.545 2.225 0.267 0.674 0.586 0.478 0.333 1.045 0.0059 0.388 0.649 0.0161

26. % Runoff/Erosion Reduction + 20m Vegetative Stripb

80% x 95% 1.292 0.980 3.545 2.225 0.259 0.674 0.586 0.478 0.333 1.045 0.0033 0.202 0.340 0.0086

NB: Dry deposition after volatilisation was not applied because compound 9 was not considered to be volatile. The vapour pressure of 3E-09 Pa was well below the trigger of 1E-4 Pa.aReduction in volume of runoff = 60%; Reduction in pesticide mass transported in runoff = 60%; Reduction in mass of eroded sediment = 85%; Reduction in pesticide mass transported in sediment = 85%

bReduction in volume of runoff = 80%; Reduction in pesticide mass transported in runoff = 80%; Reduction in mass of eroded sediment = 95%; Reduction in pesticide mass transported in sediment = 95%

Appendix B Summary of National Approaches for Pesticide Exposure Assessment in the Central

Zone

1

Table 1a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Austria

Regulatory Issue Assessment Approach Additional Comments Source of Information

FOCUS Approach Tier 1—4 Fera Survey

FOCUS Scenarios Hamburg; and Kremsmunster Fera Survey

National Scenarios Not Applicable Fera Survey

FOCUS Models PEARL Fera Survey

National Models Not Applicable Fera Survey

DT50 Geometric Mean Fera Survey

Koc Arithmetic Mean Fera Survey

1/n Arithmetic Mean Fera Survey

Metabolites According to SANCO/221/2000 Rev.10 (2003) Fera Survey

pH-Dependent DT50 Geometric mean for acidic and alkaline soils Separate simulation for acidic and alkaline data-sets Fera Survey

pH-Dependent Koc Arithmetic mean for acidic and alkaline soils Separate simulation for acidic and alkaline data-sets Fera Survey

pH-Dependent 1/n No Information Fera Survey

Regulatory Endpoint 0.1 ug/l Fera Survey

Table 1b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Austria


FOCUS Approach Steps 1—4 Fera Survey

FOCUS Scenarios D4; D5; R1; and R3 Fera Survey


FOCUS Models SWASH, PRZM, MACRO, TOXSWA; SWAN Fera Survey






pH-Dependent DT50 Geometric mean for acidic and alkaline conditions Separate simulation for acidic and alkaline data-sets Fera Survey

pH-Dependent Koc Arithmetic mean for acidic and alkaline conditions Separate simulation for acidic and alkaline data-sets Fera Survey


Regulatory Endpoint Toxicity—Exposure Ratio (TER) Fera Survey

No Spray Buffer Zone Up to 50m Fera Survey; Personal Communication

Drift Reducing Nozzles Up to 90% Fera Survey; Personal Communication

Vegetative Buffer Strip Up to 20m Fera Survey; Personal Communication

2

Table 2a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Belgium



FOCUS Scenarios Châteaudun; Hamburg; Kremsmunster; and Okehampton Fera Survey








pH-Dependent DT50 Worst-case for all data-set (acidic and alkaline) combined Personal Communication

pH-Dependent Koc Worst-case for all data-set (acidic and alkaline) combined Personal Communication

pH-Dependent 1/n Worst-case for all data-set (acidic and alkaline) combined Personal Communication


Table 2b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Belgium



FOCUS Scenarios D3; D4; and R1 Fera Survey








pH-Dependent DT50 Worst-case for all data-set (acidic and alkaline) combined Personal Communication

pH-Dependent Koc Worst-case for all data-set (acidic and alkaline) combined Personal Communication

pH-Dependent 1/n Worst-case for all data-set (acidic and alkaline) combined Personal Communication





3

Table 3a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Czech Republic



FOCUS Scenarios Hamburg; and Kremsmunster Fera Survey


FOCUS Models PEARL, PELMO or PRZM Fera Survey






pH-Dependent DT50 Geometric mean for acidic and alkaline soils separately Hamburg, D4 (acidic); Kremsmunster, R1 (alkaline) Personal Communication

pH-Dependent Koc Arithmetic mean for acidic and alkaline soils separately Hamburg, D4 (acidic); Kremsmunster, R1 (alkaline) Personal Communication

pH-Dependent 1/n No Information Personal Communication


Table 3b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Czech Republic



FOCUS Scenarios D4; and R1 Fera Survey








pH-Dependent DT50 Geometric mean for acidic and alkaline conditions Hamburg, D4 (acidic); Kremsmunster, R1 (alkaline) Personal Communication

pH-Dependent Koc Arithmetic mean for acidic and alkaline conditions Hamburg, D4 (acidic); Kremsmunster, R1 (alkaline) Personal Communication






4

Table 4a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Germany



FOCUS Scenarios Hamburg Fera Survey


FOCUS Models PELMO parameterised using the Input-Decision tool Volatilisation and plant uptake set to zero at tier 1 Fera Survey

National Models EXPOSIT Calculation of groundwater PEC due to bank infiltration Fera Survey





pH-Dependent DT50 Geometric mean DT50 for Hamburg and Kremsmunster All data-sets (Hamburg); Alkaline data-set (Kremsmunster) Personal Communication

pH-Dependent Koc Worst-case Koc at highest and lowest soil pH value Worst-case Koc determined using the Input-Decision tool Personal Communication

pH-Dependent 1/n Arithmetic mean for all data-set (acidic and alkaline) Acidic and alkaline data-sets combined Personal Communication


Table 4b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Germany


FOCUS Approach Not Applicable Fera Survey

FOCUS Scenarios Not Applicable Fera Survey

National Scenarios Drift/Volatilisation; Runoff/Erosion; and Drainage Separate TERs derived for each exposure scenario Fera Survey

FOCUS Models Not Applicable Fera Survey

National Models EVA; EXPOSIT; Input-Decision tool Fera Survey

DT50 Use Input-Decision tool Fera Survey

Koc Use Input-Decision tool Fera Survey



pH-Dependent DT50 90th

percentile geometric mean No guidance on pH-dependent DT50 identified Personal Communication

pH-Dependent Koc Arithmetic mean Koc for runoff/erosion scenario 10th

percentile Koc for risk category for drainage Personal Communication

pH-Dependent 1/n Arithmetic mean for all data-set Acidic and alkaline data-sets combined Personal Communication





5

Table 5a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Hungary



FOCUS Scenarios Châteaudun; Hamburg; Kremsmunster; Okehampton; and Piacenza

Fera Survey











Regulatory Endpoint 0.1 ug/l for Châteaudun; 0.2 ug/l for other scenarios Fera Survey

Table 5b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Hungary



FOCUS Scenarios R1; R3; and R4 Drainage not considered important in Hungary Fera Survey















6

Table 6a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Netherlands



FOCUS Scenarios Kremsmunster Tier 1 groundwater assessment with PEARL 3.3.3 Fera Survey

National Scenarios Tier 2 National Assessment Based on spatially-distributed data for the Netherlands Fera Survey

FOCUS Models PEARL 3.3.3 Fera Survey

National Models GeoPEARL Calculation of 90th spatial percentile PEC groundwater Fera Survey

DT50 Geometric Mean at tier 1; Optimised value at tier 2 Optimisation based on equation 62 in GeoPEARL manual PEARL, GeoPEARL Manual

Koc Arithmetic Mean at tier 1; Optimised value at tier 2 Optimisation based on equation 43 in GeoPEARL manual PEARL, GeoPEARL Manual



pH-Dependent DT50 Geometric mean DT50 for Hamburg and Kremsmunster All data-sets (Hamburg); Alkaline data-set (Kremsmunster) Personal Communication

pH-Dependent Koc Worst-case Koc at highest and lowest soil pH value Worst-case Koc determined using the Input-Decision tool Personal Communication


Regulatory Endpoint 0.1 ug/l; 0.01 ug/l for groundwater protection areas Fera Survey

Table 6b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Netherlands




National Scenarios Edge-of-field water body; drinking water abstraction point; and Water Framework Directive water body

Separate TERs derived for each exposure scenario; Fera Survey

FOCUS Models SWASH, MACRO, TOXSWA for D3 scenario Initial simulation with D3 using Dutch drift values Fera Survey

National Models TOXSWA; DROPLET; and Simple Calculations Fera Survey








Regulatory Endpoint Toxicity—Exposure Ratio (TER); 0.1 ug/l Standard of 0.1 ug/l is applied to WFD water body Fera Survey

No Spray Buffer Zone Default 3—5m; No maximum set Fera Survey; Personal Communication


Vegetative Buffer Strip Not Applicable Runoff not considered important in the Netherlands Fera Survey; Personal Communication

7

Table 7a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Poland



FOCUS Scenarios Châteaudun; Hamburg; and Kremsmunster Fera Survey












Table 7b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Poland


















8

Table 8a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Ireland



FOCUS Scenarios Châteaudun; Hamburg; and Okehampton Fera Survey


FOCUS Models PEARL or PELMO Fera Survey










Table 8b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Ireland



FOCUS Scenarios D4; R1; R3; and R4 Fera Survey












No Spray Buffer Zone Under Review Fera Survey; Personal Communication

Drift Reducing Nozzles Under Review Fera Survey; Personal Communication

Vegetative Buffer Strip Under Review Fera Survey; Personal Communication

9

Table 9a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Romania



FOCUS Scenarios Okehampton; and Porto Fera Survey












Table 9b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Romania



FOCUS Scenarios D5; and R1 Fera Survey












No Spray Buffer Zone Fera Survey; Personal Communication

Drift Reducing Nozzles Fera Survey; Personal Communication

Vegetative Buffer Strip Fera Survey; Personal Communication

10

Table 10a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Slovakia



FOCUS Scenarios Châteaudun; Hamburg; Kremsmunster; and Piacenza Fera Survey












Table 10b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Slovakia


















11

Table 11a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for Slovenia



FOCUS Scenarios Châteaudun; Hamburg; Kremsmunster; Okehampton; and Piacenza

Fera Survey












Table 11b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for Slovenia


















12

Table 12a. Summary of Approach for Groundwater Assessment in the National Authorisation Procedures for the UK



FOCUS Scenarios Châteaudun; Hamburg; Kremsmunster; and Okehampton Fera Survey


FOCUS Models PEARL, PELMO or PRZM Additional simulation with MACRO for substance with Koc >100 l kg-1

Fera Survey






pH-Dependent DT50 Geometric mean for acidic and alkaline soils Separate simulation for acidic and alkaline data-sets Personal Communication

pH-Dependent Koc Arithmetic mean for acidic and alkaline soils Separate simulation for acidic and alkaline data-sets Personal Communication



Table 12b. Summary of Approach for Surface Water Assessment in the National Authorisation Procedures for the UK




National Scenarios Spray drift deposit; drainflow Simple calculations at tier 1 Fera Survey

FOCUS Models Not Applicable Fera Survey

National Models Simple calculations for spray drift and drainflow Fera Survey





pH-Dependent DT50 Geometric mean for acidic and alkaline conditions Separate simulation for acidic and alkaline data-sets Personal Communication

pH-Dependent Koc Arithmetic mean for acidic and alkaline conditions Separate simulation for acidic and alkaline data-sets Personal Communication


Regulatory Endpoint Toxicity—Exposure Ratio (TER) or RAC Fera Survey

No Spray Buffer Zone 20m Fera Survey; Personal Communication

Drift Reducing Nozzles LERAP Fera Survey; Personal Communication

Vegetative Buffer Strip Not Applicable Runoff not usually considered important in the UK Fera Survey; Personal Communication

comparison of national approaches for pesticide exposure...

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