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Sanco/13144/2010, version 3, 10 October 2014

Assessing Potential for Movement of

Active Substances and their Metabolites

to Ground Water in the EU The Final Report of the Ground Water Work Group of FOCUS (FOrum for the Co-ordination of pesticide fate models and their USe) Contributors: J J T I Boesten, R Fischer, B Gottesbüren, K Hanze, A Huber, T Jarvis, R L Jones, M Klein, M Pokludová,

B Remy, P Sweeney, A Tiktak, M Trevisan,

M Vanclooster, J Vanderborght

Updated by EFSA at the request of the European Commission to incorporate pertinent aspects of the EFSA PPR panel opinions on version 1 of

13 June 2009.

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DISCLAIMER AND IMPLEMENTATION

This document has been conceived as a working document of the Commission Services, which was elaborated in co-operation with the Member States and examined by the European Food Safety Authority which provided its scientific opinion on the matter. It does not intend to produce legally binding effects and by its nature does not prejudice any measure taken by a Member State within the implementation prerogatives under Regulation (EC) No 1107/2009, nor any case law developed with regard to this provision. This document also does not preclude the possibility that the European Court of Justice may give one or another provision direct effect in Member States. This document shall apply to applications submitted as from 1 May 2015.

FINAL COMMENTS RAISED BY MEMBER STATES

Comments from Germany on 17 September 2014

Comment to the uptake factor

FOCUS Groundwater II report May 2014, chapter 7.1, table 7-1, section 7.1.7 and FOCUS Groundwater II Generic guidance V2.2, chapter 2.4, point 2.4.4: We do not agree with the recommendation that the uptake factor should be estimated by Briggs equation using the log Kow value. The Briggs equation to derive uptake factors was not considered as state-of-the-art to predict PUF values: As discussed also at the EU PUF workshop (2nd September 2013 in York) the study of Briggs on TSCF values in barley is not up-to-date and is applicable to non-ionic substances applied in barley, only. The Briggs equation may not be applicable for all substances, crop combinations or experimental conditions as documented in several studies due to the high variability of uptake factors found for substances having a similar log Kow in different crops. This indicates

that the uptake factor is not only characteristic for a substance (log Kow, pKa) but also

depends on the experimental conditions (duration of exposure, temperature, pH of the pore water and nutrient solution in the experiment, respectively) and the crop (content of lipid, fiber, and carbohydrate of roots and shoots; root system). 3 Due to the currently existing uncertainties regarding the Briggs equation, we recommend that the value for an uptake factor should be set at zero for all substances (active ingredient and metabolites, ionic and non-ionic), unless appropriate experimental data are available. As it is difficult to derive accurate values for plant uptake factors with experimental data, we suggest to limit the plant uptake factor to 0.5 in general.

Comments from Germany on 7 October 2014

Due to the erroneous calculation of the plant uptake factor by using the log Kow there is a danger to significantly underestimate the input of active substances into the groundwater. We therefore propose the following changes to the FOCUS Report:

Table 7-1, line 7.1.7 Plant uptake, last column:

Please change wording to:

should be set at 0-0.5 depending on substance properties or experimental data calculated from log Kow measurement. In future harmonised experimental data might be an further

Chapter 7.1.7 Plant uptake:

Please add the underlined sentence at the end of the chapter: The default plant uptake factors (i.e. the transpiration stream concentration factor) can be adjusted to measured values if substance specific uptake factors have been determined in appropriate experiments with the crops species being assessed. In the absence of agreed EU guidance on what the appropriate experiments to measure the transpiration stream concentration factor should be, applicants should contact competent authorities to see what study design (if any) they would consider appropriate. See also considerations in EFSA PPR,

2013b. However a calculation of the TSCF from logKow using the Briggs equation considers

not the state-of-the-art to predict the plant uptake and is not applicable for ground water risk assessment.

Comments from Sweden on 26 September 2014

We have reservations regarding the

account, especially considering later publications on this topic, and the lack of an EFSA opinion specifically addressing these recommendations. 4 Furthermore, we do not agree to consider monitoring data as the highest tier, taking precedence over other relevant data. Monitoring data can be useful at all tiers, and should preferably be considered together with all other available data in a weight of evidence approach. Finally, we would like to support DE regarding their suggestion to limit the use of plant uptake factor to 0.5. If there is experimental data that show plant uptake than a value of 0.5 can be used. However the actual experimental value should not be used. Regarding the use of the

Briggs equation we have no comments.

ACKNOWLEDGEMENTS

The authors would like to thank all those people outside of the work group who assisted in this work by providing data or performing evaluations.

CITATION

Those wishing to cite this report are advised to use the following form for the citation: Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU Group, EC Document Reference Sanco/13144/2010 version 3, 613 pp. 5 FOREWORD BY THE FOCUS STEERING COMMITTEE (updated by EFSA) Since its beginning in 1993, FOCUS (FOrum for the Co-ordination of pesticide fate models and their USe) has established a number of work groups to develop procedures for estimating concentrations of plant protection products and their metabolites in various environmental compartments (ground water, surface water, soil, sediment, and air) and for performing kinetic analyses. The procedures for assessing potential movement to ground water became effective in December 2000 and have been used since then as part of the EU registration process. A few years after the release of the scenarios, scientific progress in the field of leaching models as well as experience with the use of the scenarios resulted in questions being raised regarding changes to the scenarios, harmonisation of the different leaching models, the role of more advanced assessment approaches (for example, graphical information systems and non-equilibrium sorption), how to use the results of simulations and experimental studies (lysimeter and field studies) in the assessment, and the coverage of new EU member states by the FOCUS scenarios. Therefore FOCUS established a work group of experts from regulatory authorities, research institutes, and industry to develop revised scenarios and an overall framework for assessing leaching potential. This FOCUS group met as a whole 16 times between February 2004 and June 2008 and also many times in various subgroups. This report is the result of extensive deliberation on the numerous issues that arose after conducting a survey of the opinions of the member states. The output of the work group also includes a completely revised set of models, input and output shells, and scenarios which became available at the FOCUS web site in April 2011. The EFSA Plant Protection Products and their Residues (PPR) panel published opinions on version 1 of this report in 2013. This version 2 of the report has incorporated the observations and recommendations of the EFSA PPR panel opinions. References to the legislation have also been updated as necessary. The version control process does not allow access to the models for regulatory use prior to their official release date. Therefore, the FOCUS Steering Committee recommended the revised models could be used for leaching assessments immediately after release, but that registrants may use the models released in 2000 for submissions up to one year following the release of these models on the FOCUS web site, i.e. April 2012. One of the specific details in the remit of the work group was that the revision of the scenarios would include harmonisation of the models (dispersion length, water balance, etc.). 6 This effort was largely successful and the Steering Committee recommended that the ground water assessments could be performed with any of the models (PEARL, PELMO, and PRZM) and there was no need to perform the assessments with more than one model. However the EFSA PPR panel opinion identified that particularly for non irrigated crops PEARL and PELMO provide very different results at the Sevilla scenario. Therefore in line with EFSA PPR (2013a), applicants and rapporteurs are advised that they should again provide simulations with PEARL and PELMO or PRZM. Where a crop of interest is defined for Châteaudun, MACRO simulations need to be run (EFSA PPR, 2013a). 7

Table of Contents

Executive Summary 13

1 Introduction 29

1.1 References .............................................................................................................. 30

2 Glossary 32

3 Introduction to Assessment Schemes for PEC in Ground Water 39

3.1 Objectives of the risk assessment for ground water contamination at EU and

national levels .......................................................................................................... 39

3.1.1 European level ............................................................................................. 39

3.1.2 National level................................................................................................ 40

3.2 Review of existing guidance on EU and national level ............................................. 41

3.2.1 Guidance given in EU and FOCUS documents ............................................ 41

3.2.1.1 Binding requirements in directives ................................................. 41

3.2.1.2 EU guidance documents ............................................................... 42

3.2.1.3 FOCUS guidance documents ........................................................ 44

3.2.2 Review of existing national approaches for leaching assessments ............... 45

3.2.2.1 The structure of and type of questions in the questionnaire ........... 45

3.2.2.2 Summary of questions and answers divided into the main topics. . 46

3.2.2.2.1 General questions ......................................................... 46

3.2.2.2.2 Regulatory questions .................................................... 47

3.2.2.2.3 Specific questions on scenarios .................................... 48

3.2.2.2.4 Model used ................................................................... 50

3.2.2.2.5 Parameterisation ........................................................... 50

3.2.2.2.6 Additional experimental data ......................................... 52

3.2.2.2.7 Interrelationship between models and higher tier

experiments .................................................................. 53

3.2.2.2.8 Handling of metabolites ................................................. 53

3.3 References .............................................................................................................. 53

4 Generic Assessment Scheme for PEC in Ground Water (General Overview) 55

4.1 Assessment of the representativeness, scope and limitations and usability of different

study types .............................................................................................................. 55

4.1.1 Relevance of experimental and modeling studies ......................................... 55

4.1.2 Study types for leaching assessment ........................................................... 56

4.2 General principles of a generic assessment scheme for PEC in ground water on

EU and national level ............................................................................................... 57

4.3 Proposal for a generic tiered approach .................................................................... 59

4.3.1 Tier 1 at EU and National Level .................................................................... 60

4.3.2 Tier 2 approaches (Tiers 2a and 2b) at EU and National level ...................... 61

4.3.2.1 Modelling with refined parameters (Tier 2a) .................................. 61

4.3.2.2 Modelling using refined scenarios (Tier 2b) ................................... 62

4.3.3 Tier 3 leaching assessment .......................................................................... 63

4.3.3.1 Tier 3a: Combination of modelling with refined parameters and

refined scenarios ........................................................................... 63

4.3.3.2 Tier 3b: Advanced spatial modelling .............................................. 63

4.3.3.3 Tier 3c: Higher tier leaching experiments set into context by

modelling ....................................................................................... 64

4.3.3.4 Tier 3d: Other modelling approaches ............................................ 65

4.3.4 Tier 4 (Monitoring) ........................................................................................ 66

4.4 References .............................................................................................................. 66

5 Interactions between Assessment Schemes on EU and on National Level 69

5.1 General interactions between the assessment schemes .......................................... 69

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5.2 Preferential flow in EU and national assessment schemes ...................................... 70

6 Consideration of Risk Mitigation and Management on EU and on National Level 73

6.1 Important aspects affecting or used in risk mitigation ............................................... 73

6.1.1 The GAP in the EU evaluation of active substances relative to the GAP on

a national level ............................................................................................. 73

6.1.2 Dose related risk mitigation .......................................................................... 74

6.1.3 Using more effective application methods .................................................... 74

6.1.4 Pesticide properties correlated to soil properties .......................................... 75

6.1.5 Hydrogeological properties ........................................................................... 75

6.1.6 Mitigation related to timing............................................................................ 76

6.2 Examples of risk mitigation measures ...................................................................... 76

6.3 Conclusion ............................................................................................................... 77

7 Approaches for Tier 2 Assessment 78

7.1 Pesticide parameter refinement (Tier 2a) ................................................................. 78

7.1.1 Soil specific sorption and degradation .......................................................... 80

7.1.1.1 Degradation parameters and soil properties .................................. 81

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