European Food Safety Authority

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1 TECHNICAL REPORT APPROVED: 22 August 2017 doi: /sp.efsa.2017.en-1288 Outcome of the Public Consultation on the draft EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil Abstract European Food Safety Authority EFSA has performed a second public consultation on the draft EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil from 15 July to 9 September EFSA was asked by the European Commission to prepare a guidance of EFSA for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil. This EFSA Guidance Document provides guidance for users on how to estimate exposure to soil organisms when performing risk assessments according to Regulation (EC) No 1107/2009 of the European Parliament and the Council. This report presents statistics on the comments received and answers to them. These comments were taken into account when finalising the EFSA guidance. Key words: pesticides, PECs, modelling, exposure Requestor: On request from the European Commission Question number: EFSA-Q Correspondence: pesticides.ppr@efsa.europa.eu EFSA Supporting publication 2017:EN-1288

2 Acknowledgements: EFSA wishes to thank the members of the Working Group on PECs in soil: Aaldrik Tiktak, Michael Stemmer, Jos Boesten, Michael Klein, Giovanna Azimonti and Sylvia Karlsson (until June 2015), and EFSA staff Mark Egsmose and Chris Lythgo for the support provided to this technical report. Suggested citation: EFSA (European Food Safety Authority) Outcome of the Public Consultation on the draft EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil. EFSA supporting publication 2017:EN pp. doi: /sp.efsa.2017.en-1288 ISSN: European Food Safety Authority, 2017 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2017:EN-1288

3 Summary EFSA has performed a second public consultation on the draft EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil. A second public consultation was launched to provide the stakeholders the opportunity to comment on the updated draft guidance where methodology for soil exposure in permanent crops and annual crops grown on ridges was included. The public consultation on the draft guidance was held from 15 July to 9 September EFSA was asked by the European Commission to prepare a guidance of EFSA for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil. This EFSA Guidance Document provides guidance for users on how to estimate exposure to soil organisms when performing risk assessments according to Regulation (EC) No 1107/2009 of the European Parliament and the Council. This report presents statistics on the comments received and answers to them. These comments were taken into account when finalising the EFSA guidance. 3 EFSA Supporting publication 2017:EN-1288

4 Table of contents Abstract... 1 Summary Introduction Terms of References as provided by the requestor Screening and Evaluation of the comments received... 6 References EFSA Supporting publication 2017:EN-1288

5 1. Introduction In the context of the development of the EFSA Guidance Document (GD) for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil, a second public consultation was arranged. A second public consultation was launched to provide the stakeholders the opportunity to comment on the updated draft guidance where methodology for soil exposure in permanent crops and annual crops grown on ridges was included. The public was invited to submit comments on the draft GD of July 2016 via an online form available at from 15 July 2016 to 9 September The EFSA Pesticide Steering Network, risk assessors, risk managers, stakeholders and the scientific community were additionally informed via s about the open public consultation. Comments of a more general nature as well as very specific comments on the various section of the draft GD were received. This report is structured to give a statistical overview on the comments received and to address the main general comments as well as specific responses to the draft EFSA GD. The raised issues were considered by the EFSA Working Group (WG) on PECs in soil for the finalisation and publication of the GD. 1.1 Terms of References as provided by the requestor EFSA, and in particular the Pesticides Unit, is asked by the European Commission (DG SANTE) to draft an EFSA GD entitled EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil. The EFSA guidance should respect the science proposed and methodology developed in the adopted Plant Protection Products and their Residues (PPR) opinion mentioned in this document (EFSA PPR Panel, 2012a). EFSA proposed to the European Commission (DG SANTE) to include also guidance for permanent crops, crops grown on ridges and annual crops where no tillage is applied into the updated GD. The European Commission also accepted an extension of the deadline for finalisation of the guidance until end of EFSA was requested to organise public consultations on the draft GD, to ensure the full involvement of Member States and other stakeholders. To support the use of the new guidance, EFSA is requested to organise training of Member State experts, applicants and other relevant stakeholders. 5 EFSA Supporting publication 2017:EN-1288

6 2. Screening and Evaluation of the comments received All the comments received were scrutinised and subsequently tabulated with reference to the author(s) and the section of the draft Guidance Document to which each comment referred. Duplicate comments received from the same contributor appear only once in the table and where there was more than one comment from the same contributor but for different sections of the Guidance Document, the comments were separated and added to the relevant section. The references to chapters and appendices in the comments and the answers to the comments refer to the draft Guidance Document of July 2016 and not to the final document. The final number of comments was 179. Comments submitted formally on behalf of an organisation appear with the name of the organisation. A statistical summary of the comments received is provided in Tables 1 and 2. In table 3 the comments to the guidance are provided together with the responses by the EFSA WG PECs in soil. Table 1: Comments received on the draft Guidance Document per section Section Number of comments General Comments 9 Abstract 2 Summary 7 Background as provided by EFSA 0 Terms of reference as provided by the European Commission 0 Context 0 Assessment 0 1. Introduction Aim of this guidance document The exposure assessment goal Cropping and applications systems covered by this guidance Annual crops Permanent crops Protected crops Software tools Structure of this guidance document 1 2. Overview of the tiered approach and new developments General overview Properties of the predefined soil exposure scenarios Predefined scenarios for annual crops Predefined scenarios for permanent crops Dealing with litter in permanent crops Scenario adjustment factors Crop selection at Tier-2, 3A and 3B Model adjustment factors Crop canopy processes Applicability of the tiered assessment scheme for soil metabolites Exposure assessment based on the total amount in soil Exposure assessment for no-tillage systems in annual crops 1 3. Exposure assessment in soil for spray application Required software tools Tier-1: Predefined scenarios using the PERSAM tool Additional guidance for applications in row crops, crops grown on ridges and in 2 permanent crops Guidance for substance-specific parameters Guidance for the formation fraction of soil metabolites Tier-2: Spatially distributed modelling using PERSAM ph-dependent sorption Tier-3A: Crop- and substance-specific scenarios using the numerical models Selection of the Tier-3A scenario Building and running the Tier-3A scenarios Model inputs Warming-up period EFSA Supporting publication 2017:EN-1288

7 3.5. Tier-3B: Spatially distributed modelling with the numerical models Setting up the spatial schematisation Parameterisation of the unique combinations Calculation of the 95th spatial percentile of the concentration distribution Tier-4: Post-registration monitoring 5 4. Additional guidance for non-spray applications and for crops grown on ridges and in rows Additional guidance for spray applications in annual row crops Crop interception Additional guidance for spray applications in crops grown on ridges Crop interception Additional guidance for applications in permanent crops grown in rows Additional guidance for granules and seed treatments Applications to crops on level surfaces Granule applications in crops grown on ridges 0 5. Documentation to be provided 0 Conclusions or recommendations 2 References 0 Glossary and abbreviations 1 Appendix A. Description of the PERsistance in Soil Analytical Model 17 Appendix B. Parameterisation of the exposure scenarios 15 Appendix C. Scenario and model adjustment factors 7 Appendix D. The table of the fraction of the dose reaching the soil 7 Appendix E. Calculating the average fraction of dose reaching the soil between the rows in 3 permanent crops based on FOCUS surface water drift values Appendix F. Row treatments in the numerical models 1 Appendix G. Use of the rapidly dissipating fraction derived from field dissipation studies 2 Appendix H. Examples on how the EFSA Guidance Document can be used 0 Appendix I. Results of simulations for example scenarios and applications of one example 2 substance Appendix J. Excel sheet for the fraction of the dose reaching the soil 0 Appendix K. Detailed description of the input files of PEARL and PELMO 1 Total number of comments EFSA Supporting publication 2017:EN-1288

8 Table 2: Comments received on the draft EFSA guidance by organisation Organization Country Total Agence Nationale de Sécurité Sanitaire de l Alimentation de l Environnement et du Travail (ANSES) FRA 20 College voor de Toelating van Gewasbeschermingsmiddelen en Biociden (Ctgb) NLD 1 European Crop Protection Association ECPA DEU 58 Federal Environment Agency (UBA) DEU 24 Finnish Safety and Chemicals Agency (TUKES) FIN 1 Norwegian Food Safety Authority (NFSA) NOR 4 Norwegian Institute of Bioeconomy Research (NIBIO) NOR 1 Rijksinstituut voor Volksgezondheid en Milieu (RIVM) NLD 4 Institute of Environmental Protection (NRI) POL 13 Pesticide Registration Division (PRD) IRL 13 Scientific Consulting Company GmbH (SSC) DEU 24 Swedish Chemicals Agency (KEMI) SWE 16 Total Number of comments EFSA Supporting publication 2017:EN-1288

9 Table 3: Comments received on the draft EFSA Guidance Document on PECs in and responses by EFSA WG Organization Country Chapter Comments and EFSA WG responses ANSES FRA General Comments FR thanks the experts involved in this draft document. The contribution for updating risk assessment at EU and Zonal level is appreciated. Please find our comment below. EFSA: Thank you. ANSES FRA General Comments Paragraph page 28 is missing. However, this paragraph should exist as soil properties other than soil ph could be taken into account (line 118). EFSA: This is correct. We have included a small paragraph on sorption on clay minerals. Paragraph is missing. EFSA: The section was intentionally left out as the relevant information is presented in Paragraph is missing. EFSA: The section was intentionally left out as the relevant information is presented in Federal Environment Agency (UBA) DEU General Comments PERSAM configure substance A submenu can be activated for custom calculations with regard to Kom and DegT50. However both menus have the same title and buttons in the configure substance menu. It would be user friendly to indicate here which submenu is meant (Kom or DegT50) EFSA: This feature will be introduced into the PERSAM tool when updated. Norwegian Institute of Bioeconomy Research (NIBIO) NOR General Comments We are a group in Norway planning a new project application to the Norwegian Research Council (NRC) in a program called Research on hazardous substances and other pollution- relationship and impact on the environment, society and health. Norway is now a part of the Northern zone and for the approval of new pesticides, tools for calculating the concentration of pesticides in soil will be important especially for the climatic reason. We have downloaded the model and plan to look at data from Field Experiment in Norway and compare with results generated With PERSAM. Is it possible to extend the PERSAM to include Norway as we are member of the Northern Zone and could we establish collaboration with EFSA and JRC apply for funding from NRC for a common project for Norwegian conditions?. EFSA: EFSA has asked JRC if soil, weather and crop maps could be extended to include Norway. Some maps are not available for Norway. We propose that you contact JRC directly on how maps for Norway could be provided to JRC. Norwegian Food Safety Authority NOR General Comments For applications for authorization of PPPs in the Northern Zone (NZ), it is currently a NZ requirement to submit calculations of PECsoil values using the Finnish PECsoil calculator*. This calculator has been used for many years in the zone and consists of an Excel sheet that uses a scenario from Jokioinen, Finland. The Finnish calculator is easy to use, ensures transparency of the calculations and ensures that Nordic soil parameters and climate conditions are considered in the assessments. A shift from using the Finnish calculator to following the new GD on PECsoil calculations would increase the work load on evaluations of NZ applications, as the approach in the new GD is much more complex than the current NZ approach. [ ] the goal of simplifying 9 EFSA Supporting publication 2017:EN-1288

10 the exposure assessment for regulatory purposes (line and ) would therefore not be reached when it comes to evaluations of applications for authorization of PPPs in the NZ. Additionally, we question whether the aim of assessing the 90th percentile PECsoil in the tiers involving the use of PERSAM software will be reached for the NZ, see our comment below EFSA: EFSA is aware of the Finnish PECsoil calculator. The EFSA WG is not aware whether the overall protectiveness of the Finnish calculator has been carried out and this is outside the scope of this guidance. The EFSA guidance and the supporting software tools are developed to provide scientifically based guidance taking into account the natural variability in the countries included in the zonal list according to Regulation (EC) No 1107/2009. Since Norway is not included in this list, Norway was also not included in the calculation of the 90 th -percentile concentration. 2) [ ] all tiers aim to assess the spatial 90th percentile of the PECsoil considering the spatial statistical population of agricultural fields (in one of the three regulatory zones) where the target crop is grown and in which this PPP is applied (line ). Unfortunately, Norway is not included in the (General/Meteorological/Soil/CAPRI2000 Crop) datasets from which the PERSAM scenarios have been selected. Since the selection of the predefined (Estonian and Danish) scenarios for the NZ is not based on the actual total agricultural area in the NZ, it is likely that the scenarios will not assess the 90th percentile of the PECsoil in the zone. Other updates. *See An updated version of the calculator is under preparation and will include consideration of non-sfo kinetics and simultaneous calculation of parent compound and its metabolites in the same run, as well as other updates. EFSA: Also for the Northern Zone (NZ) the specific exposure protection goal is to assess the concentration of the spatial 90- percentile of the population of agricultural fields. Soil/weather and crop maps for Norway have not been included as Norway is not included in the zonal list according to EU regulation 1107/2009. However as mentioned in the comment box above EFSA has asked to include the relevant maps for Norway when they become available.. Pesticide Registration Division, Department of Agriculture, Food and the Marine, IRELAND IRL General Comments PERSAM-General remarks Thank you preparing the draft Guidance document The new proposed tiered methodology for PECsoil calculations is complex and appears significantly more conservative compared to the current approach. It would be helpful to explain why the current methodology is insufficient to meet the protection goals. As noted previously by other Member States, the need to safeguard the competitiveness of EU agriculture should be considered prior to adopting this guidance. Ireland supports the recommendation that an impact assessment should be performed. The methodology should be tested with real data sets. It is important to ensure that the adjustment/safety factors etc. are not double counted between the new ecotoxicology and PEC guidance documents. EFSA: The EFSA guidance provides a more scientific up-to-date approach than the current simplistic procedure for calculation of PECs in soil. The new guidance provides a number of features e.g. exposure refinement, handling of very persistent substances and metabolites, which are not possible in the current exposure procedure. The tiered approach ensures that lower tiers provide higher and more conservative values than higher tiers and therefore scenario adjustment factors and model adjustment factors were needed. There is no double counting with ecotox guidance because the highest tier does not have these adjustment factors. Depending on substance properties the EFSA guidance may not always provide more conservative calculations than what is provided today. The EFSA WG intends to do some comparison with the current procedure. The models supporting the guidance will be as user-friendly as possible so that the perceived complexity of the guidance will be minimal. We look forward to the PERSAM training courses and the publication of worked examples with the new methodology. EFSA: EFSA intends to organise a training/info session when the guidance is finalised.. A number of worked examples have 10 EFSA Supporting publication 2017:EN-1288

11 been included as appendices to the guidance. SCC GmbH DEU General Comments The risk assessment approach in the draft GD using 4 Tiers is quite complex including three different models as well as GIS and monitoring elements. However, compared to the current quite simple approach using the EU wide accepted formula proposed in the FOCUS Soil persistence model guidance (1997), PECsoil ranges to be expected by the new risk assessment approach seem mainly driven by very conservative assumptions with regard to the bulk density of scenario soils calculated from the organic matter content and the respective ecotoxicological averaging depth applied. It is therefore not clear whether the proposed approach leads to more realistic results compared to a refined simple formula using realistic assumptions with regard to soil density and averaging depths related e.g. to mobility classes of the substance. EFSA: The relevance and protectiveness of the current FOCUS (1997) approach for PECs in soil is highly uncertain as only one scenario is selected to cover the entire EU. In contrast to the current procedure the EFSA guidance takes into account the natural variability in the EU. Please see the response in the comment box above. SCC GmbH DEU General Comments The output of the models considered at the different tiers should be validated against actual concentrations found in soil, e.g. from field dissipation studies available for a great number of substances or from monitoring data. EFSA: We are not aware that the currently regulatory PECs in soil procedure have been validated against actual concentrations found in soil. The use of FOCUS models for groundwater and surface water assessments have been used for regulatory purposes for many years. The same FOCUS models have been adapted for use for supporting the EFSA guidance. The results from the FOCUS numerical models (PELMO and PEARL) are calibrated and compared with each other as well as with the PERSAM analytical model to provide reliable and consistent results. Swedish Chemicals Agency (KemI) SWE General Comments We appreciate that overall the approaches in this version of the guidance are simpler and more clear than in previous version (2015) despite the fact that the guidance now covers additional situations. EFSA: Thank you. ECPA DEU Abstract General comment (PERSAM not applicable, updated PEARL and PELMO not available) As the tools on which the guidance document depends are not available it is not possible to comment if they have been adequately implemented. The draft guidance is therefore premature and should have been delayed until it could be reviewed in its entirety EFSA: For the first public consultation in 2014 the software tools were released together with the guidance to provide the stakeholders and opportunity to gain experience with the software tools. For the second public consultation in 2016 the intention was to give the stakeholders the opportunity to provide input to the guidance at an early stage. The draft guidance was updated with relevant comments from stakeholders and the supporting modelling tools will be aligned accordingly probably in General comment (Timing of the issue of draft guidance) The accompanying guidance, to be based on the Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in-soil organisms has not yet been drafted and will inform the outputs required from the exposure models. Therefore the current draft guidance may need further reform once the out puts are known. Therefore attempts to finalize the guidance at this time seem premature. EFSA: At what time an EFSA guidance document is to be applied in a regulatory context under Regulation (EC) No 1107/2009 is outside the remit of EFSA and is under the responsibility of the European Commission and the MSs in Standing Committee of Plants Animals Food and Feed( SCoPAFF (legislation)) EFSA Supporting publication 2017:EN-1288

12 ECPA DEU Abstract Page 1 Role of document EFSA (European Food Safety Authority), 2015b. EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil. EFSA Journal 2015;13(4):4093, 102 pp., 1473 doi: /j.efsa should be clarified. Will be substituted/amended by new guidance? A version control for guidance documents would be necessary. EFSA: The EFSA GD published in 2015b will continue to be available on request. An updated GD version including the exposure assessment for permanent crops will be published in Only the most recent GD will be presented to Risk Managers(EC and MSs in SCoPAFF) for agreement for use for regulatory assessments in the EU under Regulation (EC) No 1107/2009. page 2-3 It is not explicitly mentioned that lower tiers may be skipped in the reporting. This shall be explicitly added for information of notifiers and regulators. EFSA: In chapter 5 line 1077 it is stated that Tier 1 or Tier 2 results from PERSAM should be provided or alternative results from both the numerical models in Tier 3A. This approach should be acceptable as the EFSA WG has tested that lower Tiers provide more conservative PECs than higher Tiers. ANSES FRA Summary FR notes that aims to identify a 90th percentile exposure concentration. However, no protection goal for soil organisms is available. The overall conservativeness of the proposed approach for future regulatory purpose cannot then be assessed. This concern should be mentioned in the introduction/summary part. EFSA: It was not part of the mandate from the European Commission to include protection goals for the effect assessment into this guidance. The current protection goal uses the TER approach for characterising the risk. This new EFSA soil exposure guidance can be applied using the TER approach under the current procedure. Ctgb NLD Summary Line All tiers are mentioned in this paragraph except tier 3b and tier 4 are not mentioned. Also include these tiers in this paragraph. EFSA: All tiers will be mentioned in the section in the guidance. However, Tier-3B should not be used until agreed tools are available and the Tier-3B approach is accepted by competent authorities. Institute of Environmental Protection - NRI POL Summary Lines : In this part of the Summary it is stated that the adjustment factors were introduced to ensure that the simple models would return more conservative results than the more realistic numerical models. The statement looks strange and rises doubts with regard to the reliability of the models within the proposed assessment scheme. That in turn may provide the basis for challenging the assessment and its results. Maybe therefore it would be good to reword the indicated paragraph, in particular lines in order not to provide the fuel for those wanting to challenge the scheme on "scientific basis"? ECPA DEU Summary page 3 line EFSA: The adjustment factors are introduced in the lower Tiers to ensure that these tiers provide more conservative PEC values than in the higher Tiers. This is common approach in risk assessment for pesticides to ensure that lower tiers are more conservative than higher tiers EFSA Supporting publication 2017:EN-1288

13 The GD states: Interception and subsequent dissipation at the crop canopy may be based on simulations with the numerical models. Nothing is said about the option to experimentally determine these parameters and feed the models with the experimental data. This shall explicitly be added. EFSA: The guidance accepts that experimental studies can be generated to replace crop canopy default values (crop DT50 and wash-off). See chapter Model inputs under canopy processes. Pesticide Registration Division, Department of Agriculture, Food and the Marine, IRELAND IRL Summary Line 66- it would be useful to define what is meant by a numerical model and analytical model. EFSA: Definitions of numerical models and analytical models have been added to the glossary. Line 82 typographical error: Tier-1are EFSA: This has been changed. Line This paragraph gives an overview of Tier1 to Tier 3A. However, Tier 3B is not mentioned. It would be useful to explain the difference between Tier 3A and Tier 3B in this paragraph. EFSA: The meaning of Tier-3A and Tier-3B has been added. SCC GmbH DEU Summary Line 78 ssq, line 330 ssq.: It is not clear to which extent the shift from a 90th percentile spatial distribution of the concentration proposed in earlier scientific opinions and draft versions of the GD on soil persistence, to the 95th percentile is justified due to the use of the average or median substance properties inputs. The 90th percentile concentration is quite established in risk assessment approaches, e.g. for leaching assessments in the EU and The Netherlands. The use of the 90th percentile spatial distribution of the concentration seems to be appropriate also in the light of the conservative scenario assumptions, e.g. with regard to soil bulk density, substance fraction reaching the soil surface and the 10th percentile precipitation. In this context it should also be noted that guidance on the use of output in ecotoxicological assessments and therefore the protection goals are not established to date. EFSA: The choice of the 95 th percentile is justified due to the uncertainty in substance properties and is in agreement with the published PPR Opinion (EFSA Journal 2012;10(2):2562 [76 pp.].) The argumentation for using a spatial 95th percentile can be found in Section of the PPR soil exposure opinion of We do not understand your argument on the conservative scenario assumptions because these apply only to lower-tier approximations whereas the spatial 95th percentile is also needed in the higher modelling tiers Norwegian Food Safety Authority NOR 1.1. Aim of this guidance document Figure 1, p 8: Please use an updated map. Norway and Iceland should also be included in the Northern Zone. EFSA: Norway and Iceland are not part of the Northern Zone according to Regulation (EC) No 1107/2009. EFSA has asked JRC to add countries to the maps. If the maps are available with JRC before the finalisation of the guidance they will be included into the supporting software tools; however, countries that are not in the list of regulatory zones will not be considered in the calculation of the 95 th -percentile. Norway and Iceland are encouraged to provide the relevant maps to JRC. Federal Environment Agency (UBA) DEU 1.2. The exposure assessment goal 314 Please note that newest developments as published by EFSA in 2016 (Scientific Option on the science behind the risk assessment for in-soil organisms) point to the fact that averaging concentrations over different soil depths might not be the relevant concentration to correctly estimate ecotoxicological effects. The cited Scientific Opinion refers also to the situation where 13 EFSA Supporting publication 2017:EN-1288

14 spatially explicit soil concentrations might be needed in future to assess the exposure of soil organisms moving from the soil surface to different soil depths in the profile. Could the present Guidance Document refer to these new developments? EFSA: The intention of this guidance is to provide practical and operational guidance on exposure in soil and not to introduce considerations on possible exposure concentrations that might become relevant in the future. This guidance recommends that exposure concentrations (Total Content) and assessment depth (5 cm) aligned to the currently used soil exposure procedure is applied (FOCUS, 1997). When future ecotox effect guidance is available and agreed by competent authorities other exposure concentrations eg Pore Water and assessment depths in addition to the 5 cms may be included. Institute of Environmental Protection - NRI POL 1.2. The exposure assessment goal Lines : It is proposed that the TWA PECs would be calculated for up to 56 days following the occurrence of the peak concentration. Could it be explained where that number was taken from? At present all time-dependent PEC values, bot actual and TWA, are calculated for up to 100 days within the EU evaluation scheme, with time points for the long-term PECs being set to 14, 21, 28, 42, 50 and 100 days. Why not maintain this system? Additionally, this proposal when introduced will be inconsistent with the way the time-dependent PEC values, both actual and TWA, are and will be reported in SW exposure assessment. Maybe it would be a good idea to maintain the consistency of the reporting of obtained results in soil and SW compartments? EFSA: The 56-d TWA was based on the fact that the standard soil ecotoxicological studies do not last longer than 56 days. Thus 100-d TWA values are generally not considered relevant for use in soil risk assessment. ECPA DEU 1.2. The exposure assessment goal Line In section of EFSA PPR (2012a) there is no mention of temporal percentiles. Therefore the affirmation that Together with the 100th percentile in time and the median or average substance properties, the overall goal (90th percentile concentration) is considered to be reached. is not sustained. Evidence that a combination of 95th spatial percentile, average substance parameters and 100th temporal percentile leads to the overall 90th percentile PEC should be provided. A justification for the choice of the 100th percentile is not given anywhere EFSA: We agree that this justification is missing and have added this in the revised guidance document. Pesticide Registration Division, Department of Agriculture, Food and the Marine, IRELAND IRL 1.2. The exposure assessment goal Line 322 It is noted the TWA concentrations are calculated for a period over a maximum of 56 d following after the occurrence of the peak concentrations Pease delete the word following or after. EFSA: we have deleted following. In our opinion the TWA concentration should be calculated using a moving time frame approach. EFSA: You do not provide an argument for your opinion. Because of the simplicity of the model, the proposed TWA calculation procedure generates the maximum possible TWA, so a moving time frame is not needed. SCC GmbH DEU 1.2. The exposure assessment goal Line 78 ssq, line 330 ssq.: It is not clear to which extent the shift from a 90th percentile spatial distribution of the concentration proposed in earlier scientific opinions and draft versions of the GD on soil persistence, to the 95th percentile is justified due to the use of the average or median substance properties inputs. The 90th percentile concentration is quite established in risk assessment approaches, e.g. for leaching assessments in the EU and The Netherlands. The use of the 90th percentile spatial distribution of the concentration seems to be appropriate also in the light of the conservative scenario assumptions, e.g. with regard to soil bulk density, substance fraction reaching the soil surface and the 10th percentile precipitation. In this context it 14 EFSA Supporting publication 2017:EN-1288

15 should also be noted that guidance on the use of output in ecotoxicological assessments and therefore the protection goals are not established to date. EFSA: We do not agree: the argumentation for using a spatial 95 th percentile can be found in Section of the EFSA soil exposure guidance of We do not understand your argument on the conservative scenario assumptions because these apply only to lower-tier approximations whereas the spatial 95 th percentile is also needed in the higher modelling tiers. ANSES FRA 1.3. Cropping and applications systems covered by this guidance ANSES FRA 1.3. Cropping and applications systems covered by this guidance ECPA DEU 1.3. Cropping and applications systems covered by this guidance The term small seeds should be defined in this document. EFSA: This was explained in footnote 9 on p. 37. In response to your request, we have moved this definition to chapter 1. The systems covered by the guidance are clearly defined. It is suggested to specify also whether applications by drip irrigation or dipping/drench are covered or not. EFSA: We have added this in the revised guidance document. Line 345 figure 2 The notation used emphasizes very much the characteristics of the crop but should focus much more on the application mode because the latter drives the exposure assessment. For example, cereals are planted in rows, nevertheless the entire field is covered relatively soon. But this is not the point. It is rather whether the application is homogeneously distributed over the whole field (which is typically the case) or if only a band is treated (e.g. in early development in combination with mechanical weed control between rows). This would also simplify the scheme as for example the treatment of row crops and ridge-furrow systems is the same (with different parameters). EFSA: Usually for spray applications in annual crops uniform application and distribution of product is assumed. If row/band treatment is applied this should be provided in the GAP-table including the fraction of area treated. The GD covers non-uniform treatments like row, band, strip and spot applications. Examples will be provided in the guidance. Further comment: It does not make sense to consider small seeds for soil application of crops planted in rows, because there are no small seeds in between the rows; or do EFSA mean that the crops in the row are grown from treated seed EFSA: We do not understand your comment. The applicant should specify in the GAP-table if the crop is grown in rows and row treatment is to be applied. RIVM NLD 1.3. Cropping and applications systems covered by this guidance Figure 2 and figure 3are not entirely consistent. Granules in figure 2 include incorporation whereas in figure 3 granules and incorporation are two separate methods. In practice, incorporation of both spray applications and granules occurs. EFSA: We do not understand your point that granules in Figure 2 include incorporation; this is nowhere mentioned. A practical example will be provided. It would be helpful to explicitly mention what is not covered in this guidance. Soil injection of gaseous substances should be excluded. This can be handled in PEARL and PELMO, but not in PERSAM. It is also doubtful whether substances that become gaseous quickly after application can be handled correctly. EFSA: we included in the final guidance that soil injection of fumigants should be dealt with caution. A special case is in-furrow spray application EFSA Supporting publication 2017:EN-1288

16 EFSA: We agree but decided to include not all types of applications in ridge-furrow systems because we generalised these applications into applications between the rows and applications within the rows. For some cases, not all standard output is applicable. EFSA: We do not understand this comment. ANSES FRA Annual crops The following is reported (lines ): Until guidance for no-tillage systems is developed, it is recommended to use the guidance for tilled systems for annual crops. For no tillage system, the proposed recommendation to use the guidance for tillage system for annual crop (20 cm) should be clarify regarding current risk assessment practice usually starting with 5 cm depth. EFSA: This was explained in Section 2.9 (admittedly, the reference to Section 2.8 in line 366 has to be replaced by Section 2.9). We have added that the assessment depth of 5 cm should be used for no-tillage systems in in line with the currently applied procedure. (FOCUS, 1997). Soil persistence models and EU registration. FOCUS. 29 February 1997) The assessment depths may be revised when the EFSA GD for in soil effect assessment is finalised and agreed by the SCoPAFF (Legislation). Pesticide Registration Division, Department IRL Annual crops Line371 What is meant by small seeds? EFSA: A definition of large seeds and small seeds has been included in chapter 1. of Agriculture, Food and the Marine, IRELAND ECPA DEU Protected crops Line 400 We would welcome the release of draft and final versions of the software tools, PERSAM, PEARL and PELMO, as soon as possible to ensure consistency between models, the guidance documents and the interaction between PERSAM and the two ground water models EFSA: We understand and agree but releasing final versions of software tools is complicated matter. The intention with this public consultation was to receive input to the guidance. The supporting software will be aligned with the final guidance. ANSES FRA 1.4. Software tools FR regrets that the updated PERSAM tool and PELMO/PEARL models were not made available during the commenting phase of the draft guidance document. The final version of this guidance should mention that updated tools were not made available during the commenting period. EFSA: Providing updated tools was unfortunately impossible; the intention with this public consultation was to receive input to the guidance. The supporting software tools will be made available when this guidance is finalised. ECPA DEU 1.4. Software tools Line 415 (EFSA spatial dataset) Transparency and clearness of the spatial data, that were used, is missing. The whole assessment and scenario development is based on huge amounts of spatial geodata as the EFSA spatial dataset. These datasets have much of a black box character. Due to their size and complexity the consistency of such data can practically not be assessed from outside. Therefore a real characterisation of the datasets should be added (e.g. probability distributions of parameters (OM, bulk density, etc) per crop and country/zone, total surface of crop per country/zone) and consistency checks should be documented. It should be mentioned that the EFSA database is the JRC database. EFSA: We understand your difficulties with getting grips on the dataset. However the data is publicly available on the JRC website and available in a very transparent way (ASCIIGRIDS). Moreover, the procedures for deriving the datasets have been published in peer-reviewed scientific papers EFSA Supporting publication 2017:EN-1288

17 The EFSA spatial dataset version 1.1 originally does not include information about permanent crops. According to the European Soil Data Centre (ESDAC) website additional data in relation to Beulke et al. (2015) have become available in August It would be less confusing if a new version of the EFSA spatial dataset had been issued after these major changes. EFSA: The EFSA spatial dataset version 1.1 does not include information about the distribution of permanent crops because this information was generated by Beulke et al (2015). A new harmonised version of the EFSA spatial dataset including also the permanent crops will be made available together with the release of the final guidance document and software tools. ECPA DEU 1.4. Software tools The GD states: "For higher tier assessments, models other than PEARL or PELMO are currently not supported. EFSA: With not supported we mean that the applicability of other models within the proposed tiered assessment scheme has not been tested. However, as stated in point 1.4 of the guidance that other models may be used if applicants demonstrate that their model produces the same output. However a problem remains for complex exposure pattern that can only be solved with an explicit 2D/3D model like e.g. Hydrus for examples in-soil-in-furrow band treatment of potatoes or maize; The GD should not claim so strong exclusive rights for existing models that however are not capable for the specific purpose; how should an applicant under these circumstances claim that his model is better EFSA: In the proposed exposure assessment procedure, no guidance is provided for such complex exposure patterns. This was done to simplify the guidance document, which was on the wish-list of regulators. If applicants wish to apply more complex exposure assessment procedures, it is recommended to agree their approach with the competent authority before submission. SCC GmbH DEU 1.4. Software tools Line , line 521 ssq., line 1748 ssq, line 1960 ssq.: Information on which extent leaching processes are considered in the models at the different tiers is not very clear. E.g. assuming 10th percentile precipitation for the entire area of annual crops, limiting the mobility of the substances mainly to convectional flow is a very conservative assumption giving that leaching is an important dissipation process throughout all climatic and pedological situations relevant for agriculture throughout Europe. Leaching processes should therefore be considered to a realistic extend at least at the higher tiers. It is not clear from the draft GD, how leaching in Tier 2 and 3 was considered, e.g. in the same way as in the leaching assessment model versions of PEARL and PELMO. EFSA: See our response to the same comment given to Appendix A. Swedish Chemicals Agency (KemI) SWE 1.4. Software tools Parametrisation of other models than PEARL and PELMO should not be an option. It does seem unnecessary to allow other models under the condition that they produce the same results as the two recommended models. Other models than PEARL and PELMO should only be allowed after they have been evaluated by EFSA. EFSA: EFSA will not have the resources to evaluate other models. It is therefore up to the applicant and the competent authority to agree if other models can be accepted. The EFSA Good Modelling Guidance can be helpful for this evaluation. The guidance recommends that If applicants chose to use other models than PERSAM, PEARL or PELMO, they should minimally demonstrate that their model produces the same output (see Section 3.1 of the guidance for more details) as the models used in this guidance document. ANSES FRA 1.5. Structure of this guidance document FR notes that the results presented through the draft document were performed using previous version of the numerical/analytical tools. Since the updated tools were not yet available, FR was not able to perform calculation to explore the potential impact on guidance implementation. The advice to the reader is not really straightforward regarding the changes that 17 EFSA Supporting publication 2017:EN-1288

18 may be expected using updated tools. EFSA: The intention of this consultation was to allow the stakeholders to provide input at an early stage. The off spin is of course that the concentrations reported may change slightly because the guidance will change based on this public consultation. The only intention of the advice is to warn the reader that this may happen. FR appreciated the effort already made to draft this guidance. Still, considering the consequences that such guidance can have on the regulatory risk assessment, FR is very concern that no worked examples could have been made available for commenting period. Such work usually helps to identify the critical issues and provide information regarding the impact of guidance implementation. FR regrets that such information is not part of the draft guidance circulated for comment. EFSA: We regret that it was impossible to provide worked examples given the time frame provided.. However in the final guidance worked examples are provided. The final version of this guidance should mention which parts were not made available during the commenting period. EFSA: When guidance document is finalised it is not usual to refer back to a draft document that was released under a public consultation. Further this may create confusion for the user of the final guidance. A study impact on the introduction of this guidance on the outcome of the exposure assessment would have been appreciated. EFSA: This was not part of the remit of the workgroup. ANSES FRA 2.1. General overview The amended tiered scheme (Figure 4) is welcome since easier to follow compared to the initial scheme proposed. EFSA: Thank you. Noted. Federal Environment Agency (UBA) DEU 2.1. General overview 2030 The use of average soil profiles is acceptable. But is the use of the five mineral textural classes common. The use of five mineral classes seems to be a disputable simplification for the entire EU. EFSA: Currently the EU-soil map only considers five soil textural classes, i.e. Very Fine, Fine, Medium, Coarse and Very Coarse. So there is no real alternative for this approach at the moment. Furthermore, this assumption will not lead to large errors because organic matter content and temperature are by far the most important parameters for the exposure assessment and these parameters are available at a high spatial resolution, i.e. they are continuous variables. Institute of Environmental Protection - NRI POL 2.1. General overview Lines : From the description it looks that the results obtained at Tiers 3A and 3B would be similar if not identical. at Tier-3A. The only difference is that at Tier-3A initially PERSAM tool is used to generate the input files for PELMO/PEARL calculating PEC values (the step not present in Teir-3B assessment). Could it be therefore explained why, instead of creating a single, well-conceived and uniform Tier-3 tool, as it is a case of SW exposure assessment, it is proposed to split this Tier between two options, one of them being seemingly quite complicated and possibly not user-friendly (whet is against a very basic principle of user-friendliness of the modelling tools)? Maybe it would be a good idea to create a single Tier-3 instead of two very similarly looking "sub-levels"? ECPA DEU 2.1. General overview Line 453 ff EFSA: The Tier-3B should not be used until an agreed software tool and further guidance is available EFSA Supporting publication 2017:EN-1288

19 ECPA DEU 2.1. General overview Line 470, Fig. 4 New tiered scheme ECPA DEU 2.1. General overview LINE 509ff Availability of Tier 3B for annual crops With the lower tiers generating higher PECs than is currently the case, many applicants will skip the lower tiers and simple run the PELMO and PEARL models at Tier-3A to generate soil PECs, particularly since these models have to be run in any case to generate ground water PECs. Consequently, the PERSAM model is unlikely to be used and perhaps resource should be used embedding the Step 3A functionality into PEARL and PELMO, rather than keeping it as a separate model. EFSA: The PERSAM is a fast an easy to use tool, which integrates all lower tiers. We see the point that integrating functionality of Tier-3A into the PEARL/PELMO shell has also advantages. However, it is up to the developers of these models to decide whether they would like to integrate the PERSAM functionality into the model shells of PEARL and PELMO, respectively. The current GD does not claim a monopoly for the current PERSAM tool only (see Section 1.4). It is generally appreciated that the tiered scheme was simplified without any loss in the quality of the exposure assessment. Though it is noted that this change comes at a late stage which leads to the unsatisfying situation that the software tools are not aligned with this change and that a recent guidance (that of 2015) is modified in its core although the reason for the current draft version was (merely) the inclusion of row and permanent crops. It would have been straightforward to first consolidate the tiered scheme and then produce (one) guidance. It is not unlikely that with the alignment of the software tools and the only then available concrete results new issues occur which make furthers adaptions necessary. EFSA: The reason for having the public consultation at this stage is to give stakeholders the opportunity to reflect on the GD so that the WG can consider the comments. If the public consultation would have been done later, the WG could not have incorporated comments in the GD and the tools anymore. It is not clear why Tier 3B has been made operational for permanent crops and not annual crops which represent the larger proportion of agriculture. Please clarify if and when tier 3 b for annual crops will be made available to the public EFSA: EFSA does not intend to make Tier-3B available in a user-friendly format. It is up to the individual model developers to make this Tier operational. The Tier 3B should not be used before guidance and software for this tier is available. Pesticide Registration Division, Department of Agriculture, Food and the Marine, IRELAND Pesticide Registration Division, Department of Agriculture, Food and the Marine, IRELAND IRL 2.1. General overview Line 471 Please separate the figure caption from the main text. EFSA: Editorial has been done. IRL 2.1. General overview Line 505 states It can, however, not a priori be guaranteed that spatially distributed modelling delivers lower concentrations than Tier-3A. For this reason, spatially distributed modelling is not considered to be a higher tier than Tier-3A. The implication of this is that Regulator would need to check the Tier 3B concentration is not greater than the concentration at Tier 3A. This increases the regulatory burden. EFSA: We will state in the guidance that Tier-3A should be used and that Tier-3B should not be used until agreed software and guidance is made available EFSA Supporting publication 2017:EN-1288