TECHNICAL REPORT. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy

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1 TECHNICAL REPORT Outcome of the Public Consultation on the Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil 1 European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy SUMMARY The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) carried out a public consultation on its Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil. The Opinion provides a revised methodology for assessing the exposure of soil organisms both for concentrations in total soil and in pore water. The goal of the exposure assessment is provisionally the 90 th percentile of the exposure concentration in the intended area of use in each of the three regulatory geographical zones. The exposure-assessment methodology is restricted to spray applications to annual crops under conventional or reduced tillage. The methodology is based on a tiered approach. Given the complexity of the calculations in the different tiers, the development of user-friendly software tools is recommended. The public consultation was open from 19 July to 13 September 2011, being held to obtain input from stakeholders about the new proposals included in the Scientific Opinion. In total, 135 comments were received. This report summarises the scope of the comments, and sets out the response of the PPR Panel to the specific points raised by stakeholders. EFSA wishes to thank all stakeholders for their contributions. KEY WORDS Field persistence, scenario, parameterisation, pore water, exposure, soil organism, pesticides 1 On request from EFSA, Question No EFSA-Q , issued on 13/02/ Correspondence: pesticides_ppr@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the members of the PPR Working Group on the Revision of the Persistence in Soil Guidance Document: Jos Boesten, Michael Klein, Richard Bromilow, Jan Vanderborght, Ettore Capri, Aaldrik Tiktak, Ton van der Linden and Walter Steurbaut for the preparatory work on this technical report and EFSA staff: Maria Arena and Mark Egsmose for their support Suggested citation: European Food Safety Authority; Outcome of the Public Consultation on the Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil.. [76 pp.]. Available online: European Food Safety Authority,

2 TABLE OF CONTENTS Summary... 1 Table of contents... 2 Background as provided by EFSA... 3 Terms of reference as provided by EFSA... 3 Assessment Introduction Screening and evaluation of the comments received Comments received General issues and considerations

3 BACKGROUND AS PROVIDED BY EFSA The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) has launched a public consultation on its Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations in soil. The Opinion aims to provide a revised methodology for assessing the exposure of soil organisms both for total concentration in soil and concentration in pore water. The goal of the exposure assessment is provisionally the 90th percentile of the exposure concentration. A tiered approach and the development of user-friendly software tools are proposed. TERMS OF REFERENCE AS PROVIDED BY EFSA The public consultation on the Draft Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations in soil was carried out to obtain input from stakeholders for consideration in the preparation of the Scientific Opinion under mandate No.: EFSA-Q References Anonymous, Generic Guidance for Tier 1 FOCUS Ground Water Assessments. Version 2.0. Available at Bateman H (1910). Solution of a system of differential equations occurring in the theory of radioactive transformation. Proc. Cambridge Phil. Soc. 15: EFSA Panel on Plant protection products and their Residues (PPR), 2009a. Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA on the usefulness of total concentrations and pore water concentrations of pesticides in soil as metrics for the assessment of ecotoxicological effects. EFSA Journal (2009) 922: 90 pp. EFSA Panel on Plant protection products and their Residues (PPR), 2010a. Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA on proposals for assessment of exposure of organisms to substances in soil. EFSA Journal (2010)1442, EFSA Panel on Plant protection products and their Residues (PPR), 2010b. Scientific Report of the Panel on Plant Protection Products and their residues (PPR) on a request from EFSA on Selection of Scenarios for Exposure of Soil Organisms to Plant Protection Products in support of Revision of the Guidance Document on Persistence in Soil under Council Directive 91/414/EEC and Council Regulation 11/07/2009 (SANCO/9188/VI/97 rev.8, ). EFSA Journal (2010) 1642, 82 pp. EFSA Panel on Plant protection products and their Residues (PPR), 2010c. Scientific Opinion on the development of specific protection goal options for environmental risk assessment of pesticides, in particular in relation to the revision of the Guidance Documents on Aquatic and Terrestrial Ecotoxicology (SANCO/3268/2001 and SANCO/10329/2002). EFSA Journal (10): 1821, 55 pp. EFSA Panel on Plant protection products and their Residues (PPR), 2010d. Guidance for evaluating laboratory and field dissipation studies to obtain DegT50 values of plant protection products in soil. EFSA Journal 2010; 8(12): 1936, 67 pp. FOCUS, Soil persistence models and EU registration. Report of the FOCUS Soil Modelling Workgroup. Available at FOCUS website 3

4 FOCUS, FOCUS groundwater scenarios in the EU review of active substances. Report of the FOCUS Groundwater Scenarios Workgroup, EC Document Reference Sanco/321/2000 rev.2, 202 pp. FOCUS, Assessing potential for movement of active substances and their metabolites to ground water in the EU. Report of the FOCUS Ground Water Work Group, EC Document Reference SANCO/13144/2010 version 1, 604 pp. Jensen PK, Spliid NH, Deposition of spray liquid on soil below cereal crops after applications during the growing season. Weed Res. 43: Leip A, Marchi G, Koeble R, Kempen M, Britz W, Li C, Linking an economic model for European agriculture with a mechanistic model to estimate nitrogen and carbon losses from arable soils in Europe. Biogeosciences 5: Taylor W, Andersen PG, Effect of application changes and cereal growth stage on spray deposition. Aspects of Applied Biology 14: Van Beinum W, Beulke S Collection and evaluation of relevant information on crop interception for the revision of the Guidance Document on Persistence in Soil. Report FERA, Sand Hutton, UK, 41 pp. Wauchope RD, Yeh S, Linders JBHJ, Kloskowski R, Tanaka K, Rubin B, Katayama A, Kordel W, Gerstl Z, Lane M,Unsworth JB, Pesticide soil sorption parameters: theory, measurement, uses, limitations and reliability. Pest Management Science 58:

5 ASSESSMENT 1. INTRODUCTION A public consultation was held on the Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil. The public was invited to submit comments on this Scientific Opinion via an online form at from 19 July to 13 September Risk assessors, risk managers, stakeholders and the scientific community were additionally informed via s and via presentations at scientific events about the open public consultation. 2. SCREENING AND EVALUATION OF THE COMMENTS RECEIVED 2.1. Comments received All the comments received were scrutinised and subsequently tabulated with reference to the author(s) and the section of the Scientific Opinion 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 Opinion, the comments were separated and added to the relevant section. The final number of comments becomes 135. Comments submitted by individuals in a personal capacity are listed anonymously. 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. Table 1: Comments received on the Scientific Opinion per section Sections Number of Comments Abstract 5 Summary 9 Background as provided by EFSA 1 Chapter 1. Introduction Background to the development of the guidance Relationship between effect and exposure assessment in the guidance development Specification of the exposure-assessment goal Introduction Specification of the spatial unit 2 5

6 Specification of the spatial statistical population of the spatial units Specification of the multi-year temporal statistical population of concentrations Limitations of the exposure assessment methodology 5 Chapter 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage Chapter 3. Description of the simple analytical model 16 Chapter 4. Development and parameterization of the Tier-2A scenarios 4.1. Introduction Data compilation Selection of the model for vulnerability mapping Illustrative calculations with the simple analytical model for the 2 area of annual crops in the EU Handling of uncertainty in soil and substance properties in the 5 scenario-selection procedure Selection of the scenarios Assessment of the crop extrapolation factors Parameterisation of the Tier-2A scenarios Example calculations with numerical models for Tier-2A scenarios 2 17 Chapter 5. Parameterization and assessment of the model adjustment factor for Tier 1 2 Chapter 6. Description of the other Tiers 6.1. Tier 2B Tier 2C Tier Tier Tier 5 3 Chapter 7. Guidance for substance properties and crop-interception percentages needed for the exposure assessment 7.1. Introduction Assessment of conservative Kom and/or DegT50 for substances 4 whose Kom and/or DegT50 depends on soil properties 7.3. Kom in dry soil 3 6

7 7.4. Formation fraction of soil metabolites Crop interception of applied substance Decline on plant surfaces Wash-off from plant surfaces 2 Chapter 8. Assessment of uncertainty in exposure resulting from uncertainty in substance properties as derived from regulatory dossiers (DEGT50 and KOM) 2 Chapter 9. Exposure assessment for soil metabolites 1 Conclusions and recommendations 5 Abbreviations Total number of comments 135 Table 2: Comments received on the Draft Scientific Opinion per organisation Organisation Country Comments Federal Environment Agency DEU 4 Ctgb (Board for the Authorisation of Pesticides) NLD 11 Rifcon GmbH (Regulatory Affairs Infobrokerage Faunistics) DEU 8 Swedish Chemicals Agency SWE 5 ANSES DPR (Agence Nationale de Sécurité Nationale) FRA 13 Danish EPA (Environmental Protection Agency) DNK 6 Chemicals Regulation Directorate GBR 37 ECPA (European Crop Protection Association) BE 31 Dr. Knoell Consult DEU 3 SCC GmbH (Scientific Consulting Company) DEU 4 Fera (The Food and Environment Research Agency) GBR 2 Institute of Environmental Protection, Warsaw, Poland POL 11 Total 135 7

8 2.2. General issues and considerations The main issues raised in the comments received were the following: a) Risk-management issues EFSA will forward, after discussion if needed, the risk-management issues that have emerged from the public consultation and revision of the draft Opinion. The timing of the introduction of the new guidance is up to the Standing Committee on the Food Chain and Animal Health. Several Stakeholders had remarks on how to handle crops not on the list from the Common Agricultural Policy Regional Impact assessment model (CAPRI list). The proposed exposure-assessment methodology is based on the population of all agricultural fields within a regulatory zone grown with the crop or group of crops that are considered for the plant protection product within the EU registration procedure. So to apply the exposure-assessment methodology for EU registration, a list of possible annual crops for this registration has to be defined. This definition is a riskmanagement decision and so the PPR Panel recommends that the SCFCAH makes a decision regarding this list of crops, after which it would be advisable to develop maps for as many of those crops as possible using the CAPRI methodology. b) EFSA guidance document The Opinion will be followed by an EFSA Guidance Document providing operational guidance (cook-book) on how to carry out exposure assessment in soil. The intention is further to provide training on the new procedures when the EFSA Guidance Document is finalised. The perceived increase in complexity of the proposed procedure was mentioned by several stakeholders. The proposed procedure is a tiered approach to calculate exposure concentrations both in total soil and in pore water for different thicknesses of soil layers over different times. The lower tiers are more conservative whereas the higher tiers introduce a more refined, realistic and targeted exposure estimate. The intention is to develop appropriate software for the lower tiers. The higher tiers will allow more refined and realistic exposure estimates. c) Guidance for annual crops A number of Stakeholders asked for guidance on exposure assessment for situations not covered by the Opinion. The Opinion provides procedures only for downward-sprayed annual crops on flat surfaces, a major route of potential exposure. Other crops (e.g. perennial crops and annual crops grown on ridges) and other potential exposure routes (e.g. seed treatments and granular applications) may be investigated at a later stage (see also the earlier Opinion of EFSA, 2010a). The PPR Panel recommends establishing methodology for other situations. The priority given to initiating these activities is however the responsibility of the EFSA Pesticide Steering Committee. Member States may submit proposals to the Committee for discussion and priority setting. d) Consultation with ecotoxicologists The Panel consulted ecotoxicologists on appropriate PEC concentrations. The soil ecotoxicologists indicated that concentrations in total soil and in pore water are both important as well as peak concentrations and time-weighted averages. The guidance in total soil can be used with currently available ecotoxicological endpoints, whereas the effect side for the use of 8

9 the pore-water concentrations will need to await experimental results and endpoints. The effect aspect will be further considered by the revision of the Guidance Document on Terrestrial Ecotoxicology which is currently ongoing by the PPR Panel. e) Development of models to calculate PECs Several Stakeholders questioned the feasibility of performing lower-tier assessments. It is however the intention of EFSA to support the establishment of the software tools for Tiers 1-2B-2C-3. No specific expertise in GIS will be needed as user-friendly software tools will be provided similar to the existing FOCUS models. f) Update of crop interception values The crop-interception values for cereals are available in the report by van Beinum & Beulke (2010) and published on the EFSA website. An open call was launched in July 2011by EFSA for generating interception values for other crops. A successful candidate has been appointed and updated interception values resulting from this call could be available by mid The report is foreseen to be published on the EFSA website. Proposals for use of the new interception values for crops other than cereals will not be made available until after the report on interception values has been published. g) Change from arithmetic mean to geomean The guidance for evaluating laboratory and field dissipation studies (EFSA Journal 2010;8(12):1936) states that the geomean should be used to derive the DegT50 values for use in the exposure assessment. This is justified because the geomean is a good estimator for the median for lognormal distributions and vice versa (such a distribution is commonly assumed to be the best guess for quantities that cannot be negative such as DegT50). For this Opinion, it is also proposed to use the geomean instead of the arithmetic means for adsorption constants. h) Introduction of 1.0 cm and other mixing depths for exposure to soil organisms. Currently mixing depths of 5 cm and 20 cm are used for exposure assessments in soil. In FOCUS (1997) the mixing depth of 5 cm is mentioned but with no scientific justification for applying this depth in risk assessment. The Panel therefore consulted soil ecotoxicologists on appropriate mixing depths and it was recommended to determine exposure for different depths depending on the species of soil organisms to be assessed (EFSA, 2009). As part of the revision of the Guidance Document on Terrestrial Ecotoxicology, the Panel will further consider effect assessment for soil organisms. This may result in a further change to the current procedure. 9

10 Table 3: Comments received on the Draft Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations in soil and responses given by the WG DATE OF SUMMISSION ORGANISATION COUNTRY CHAPTER TE DATE OF SUMMISSION ORGANISATION COUNTRY CHAPTER TEXT COMMENTS AND RESPONSES 13/09/2011 Federal Environment Agency/ Germany DEU 14/09/2011 Ctgb NLD 8/09/2011 Rifcon GmbH DEU 1. Introduction 1.1 Background to development of the guidance 1.1 Background to development of the guidance The proposed procedure is much more sophisticated compared to the actual approach. To justify the additional work this would generate, we wonder if it is possible to describe the differences for the outcome of the risk assessment (i.e. changed number of PPPs below TER, different PPPs below TER) EFSA: The proposed procedure is a tiered approach to arrive at exposure concentrations in total soil and in pore water, for different layer thicknesses. It is the intention to include lower tiers in appropriate software, such that the amount of work is limited for these tiers. For higher tiers, additional work has to be performed. At the moment it is impossible to quantify the number of substances below TER = 1. The ecotoxicological part of the system has to be established first. If that is available, it is relatively easy to determine the number for the first tier of the assessment. 317-it is written ''all tiers aim to assess the same exposure goal'' Shouldn t this read protection goal? EFSA: The line is correct. This Opinion is about determining exposure concentrations in total soil and pore water. The different tiers aim to assess the same exposure goal. For the risk assessment, the ecotoxicological part has also been developed. Page 9, line 548: It is mentioned that the exposure-assessment methodology is restricted to spray applications to annual crops. We would appreciate a hint on how to cope with seed treatment and/or granular applications. A remark on how is to proceed with perennial crops is missing too and therefore might be good as well. EFSA: The Working Group addressed one major route of potential exposure. Currently, it is unclear whether the scenarios derived for these applications are representative of perennial crops as the spatial distribution of these crops might be different and this must be investigated (at a later stage). For seed treatments and granular applications, the problem is not the spatial distribution but the way the substance is released and spread through the soil. This may lead to other exposure concentrations and also has to be investigated (see further the earlier Opinion of EFSA, 2010a). 10

11 lines : 8/09/2011 Swedish Chemicals Agency SWE 13/09/2011 ANSES DPR FRA 1.1 Background to development of the guidance 1.3 Relationship between effect and exposure assessment in the guidance development It would be helpful if the final guidance document would give some brief indication on how to estimate PEC soil also for other situations than those addressed in the current draft, especially i) other application methods than spraying, ii) applications to perennial crops. Although this particular comment does not address proposals in the current Draft Scientific Opinion we hope that it can be considered by the Working Group at a later stage when a final guidance document is developed. Except for the mixing depth (20 cm) and use of crop extrapolation factors and model adjustment factors it seems that the main elements of the simple analytical method, as described in section 3, at Tier 1 could be applied also for these situations to provide rough estimates until more detailed guidance is available. With respect to scenarios, at least the recommendations with regard to temperature seem applicable also for these other situations. EFSA: The Working Group addressed one major route of potential exposure. Currently, it is unclear whether the scenarios derived for these applications are representative of perennial crops as the spatial distribution of these crops might be different. This must be investigated (at a later stage). For seed treatment and granular applications, the problem is not the spatial distribution but the way the substance is released and spread through the soil. This may lead to other exposure concentrations and also has to be investigated at a later stage (see further the earlier Opinion of EFSA, 2010a). The same principles will apply for deriving scenarios, but the resulting scenario characteristics may be (slightly) different because, for example, of perennial crops having a different spatial distribution. Line : Each flow chart is based on a reference tier to which lower tiers are calibrated. Please, be precise as to what exactly is the reference tier in this case? EFSA: The reference tier is usually the highest tier or the highest feasible tier with currently available techniques. In this case, the highest tier is modelling specific scenarios with PEARL/PELMO as use of geomodelling for this purpose was not yet thought possible because of a lack of appropriate geodatabases. This is described in more detail in the EFSA 2010b. Line 345: This document provides calculations for determining PEC values in pore water and in total soil at several times and several depths. PEC water should be compared to a relevant endpoint in order to conduct the risk assessment. However, no toxicity endpoint based only on pore water exposure is available. All toxicity tests are conducted in treated soil and organisms are exposed to the total soil, by contact and ingestion. To conduct the risk assessment, the endpoint should be compared to total PEC soil values. EFSA: The PPR Panel/Working Group consulted ecotoxicologists on appropriate concentrations. The soil ecotoxicologists indicated that concentrations in total soil and in pore water are both important as well as peak concentrations and a number of timeweighted averages. In the assessment, the endpoint should match the PEC, and so an endpoint based on pore water must be compared to a PEC porewater. Moreover, toxicity tests on soil organisms are static tests. No PEC twa may therefore be 11

12 used to conduct the risk assessment as the degradation of the substance is already taken into account in the test, and should not be considered twice in the risk assessment. Only PEC twa 21d values are used to conduct the risk assessment for secondary poisoning of birds and mammals. There is a priori no use for other PEC twa calculations. EFSA: Ecotoxicologists within the EFSA PPR Panel and related working groups are of the opinion that the most appropriate endpoint should be used in risk assessment. This may be a peak concentration or a TWA. The PPR Panel agrees that degradation should not be considered twice. Therefore, if a TWA endpoint is considered to be the most appropriate then the result of the test has to be expressed as a TWA. This TWA can then be compared to the PEC TWA. The concentration may indeed be different in the different soil layers. Organisms are also different and it is a reality that collembolan live in the first centimeter, when earthworms live in deeper soil layers. However, collembolan tests are required when 100 = DT90 = 365 d and HQ for arthropods (Typhlodromus and Aphidius) >2. This means that collembolan tests are required when refinement is needed. These PEC soil in 1 cm will therefore be used as tier 2. However, they might be higher than the PEC soil values calculated in 20 cm. What will be the impact on the refined risk assessment? EFSA: The current Opinion deals with the concentration in the soil which is to be used in future methodology for risk assessment. The PPR Panel is of the opinion that current methodology might be reconsidered and changed. Therefore, the current procedure is not necessarily leading towards the development of new procedures. 8/09/2011 Rifcon GmbH DEU 13/09/2011 ANSES DPR FRA 1.3 Relationship between effect and exposure assessment in the guidance development 1.4 Specification of the exposure assessment goal Page 12: Figure 3 and the figure caption are not very clear and not giving much information. What does delivery of field-exposure estimates mean? If the figure means that any combination is possible, then we would propose to delete this figure and to state that any combination is possible in the text. EFSA: The figure indicates that estimates of exposure have to be made and delivered to soil ecotoxicologists for effect assessment. Because of the principles of tiered assessment, any exposure tier may deliver to any effect tier. Usually an assessment stops at the lowest tier that indicates risk to be acceptable. A lower tier for exposure may be combined with a higher tier for effects and vice versa. Methods to select and parameterize scenarios are only based on modelling approach. A comparison with datasets from field experimentations is missing, and a calibration would be needed. EFSA: In risk assessment a realistic worst-case scenario is usually used to evaluate a substance. Realistic worst case is frequently taken to be the 90 th -percentile. Derivation/selection of the scenario is indeed then based on a modelling approach. The PPR Panel sees no alternative to this approach as appropriate datasets are not available. The PPR Panel recommends that existing datasets are evaluated by establishing the rank of the experimental scenario in the cumulative distribution. 12

13 PEC values in total soil and pore water have to be modelled for different soil depths and time windows. For the risk assessment, it is important to have a guidance how ecotoxdata will be compared to these values. This should be addressed in a separate guidance. EFSA: This will be addressed in a future EFSA Opinion and Guidance on ecotoxicology. 13/09/2011 Federal Environment Agency/Germany DEU 1.4 Specification of the exposure assessment goal The opinion proposes to calculate the concentration in pore water as ERC. However, are there ecotox-data that could be compared to these concentrations? As long as an adequate ecotox test does not exist, it makes no sense calculating pore water concentrations in general. 12/09/2011 Danish EPA DNK Introduction EFSA: Ecotoxicologists indicated that, in specific cases, pore-water concentrations may be of more relevance than concentrations in total soil. Therefore, the scenario selection was also aiming at pore-water concentrations. Current tests may sometimes also be interpreted in terms of pore-water concentrations. In addition, it is the PPR Panel s opinion that in the future ecotoxicological endpoints may be given in terms of pore-water concentrations. LN 404: In order to make best use of pore-water concentrations, OECD should be asked to update/supplement relevant terrestrial test guidelines with effect endpoints as porewater concentration EFSA will inform the OECD. 13/09/2011 Chemicals Regulation Directorate GBR Specification of the spatial unit P 14, Section 1.4.2, Line this suggests that EFSA consider that there should be introduction of an interim system with upgrading to the more desirable methodology at an unknown period of time. As a point of practicality, introduction of interim methodology is only desirable if it is considered that the current exposure methodology is so flawed that it needs to be replaced quickly. Another point is related to the view that the more desirable methodology should be introduced when the soil ecoregion approach has been extended to the whole EU. This could potentially be an expensive and timeconsuming task, even more so when the potential expansion of the EU is taken into consideration. The question must be posed, How much more value does the soil ecoregion approach add to the risk assessment over the interim methodology? EFSA: As stated in the earlier section Background as provided by EFSA, several EU member states as well as the former EFSA PRAPER unit considered the current methodology to be in need of updating. Furthermore, currently, there are no representative EU scenarios for use in risk assessment. This was considered sufficient reason to start developing/updating the risk-assessment methodology. The ecoregion approach is considered to be insufficiently developed to be included at this stage. 13

14 13/09/2011 Chemicals Regulation Directorate GBR 14/09/2011 Ctgb NLD 13/09/2011 Chemicals Regulation Directorate GBR Specification of the spatial unit Specification of the spatial statistical population of the spatial units Specification of the spatial statistical population of the spatial units p13, Section Specification of spatial unit - in specifying the spatial unit as the agricultural fields where the target crop is grown, we wonder whether, with the extensive pan European data that is now available, there would be an opportunity to consider the scale of use in these assessments? As an example, it is possible that consideration of the 90th percentile for a major crop like winter cereals results in an area that is unquantified by the risk assessment (i.e. all land >90th percentile) that is actually greater than 100% of the growing area of many minor crops. Considerations such as these could be significant in aiding assessment of minor crops, and possibly simplifying future product authorisation procedures. EFSA: The PPR Panel considers current data not sufficiently detailed to allow development of specific scenarios for minor crops. For example, when deriving the scenarios, the Working Group had to revert to dominant land-use classes. 479-an example is given from the Netherlands for a situation where more than 1 type of annual crop is grown in the same calendar year (365 days period) on the same field (carrots and maize). However it must be said that this is a very exceptional case and will not happen on regular basis. More than 1 crop cycle for the same crop is more common if there are more crops in a calendar year. EFSA: The PPR Panel agrees that more than one crop cycle for the same crop occurs regularly. However, the PPR Panel disagrees with the statement that the occurrence of more than one crop in the yearly cycle is very exceptional. This situation is quite common when growing vegetables. The mentioned combination of carrots and maize occurs in sandy areas, where the carrots are sown early in the year and the soil is covered with mulch or plastic sheet in order to raise the temperature. P14, Section 1.4.3, Line 460 the CAPRI crops appear to cover 18 different crops/crop groupings, all apparently annual crops. Is it possible to extrapolate to biennial or perennial crops? How much effect does the crop alone have on the calculated PECsoil (other than via interception)? EFSA: The Opinion focuses on arable crops. The total list of CAPRI crops is longer than the list of Table 5. Perennial crops will have a spatial distribution that differs from that of arable crops. Also application techniques may be different. So the selection procedure will be different and this will lead to another scenario (90 th percentile) and therefore estimated concentrations. Interception will potentially add to the differences. 8/09/2011 Rifcon GmbH DEU Specification of the spatial statistical population of the spatial units Page 14, line 460: The term CAPRI crops should be explained at first occurrence. EFSA: agreed, the term CAPRI crops will be explained and added to the abbreviations. 14

15 14/09/2011 Ctgb NLD 13/09/2011 ANSES DPR FRA 13/09/2011 ECPA BE Specification of the multi-year temporal statistical population of concentrations Specification of the multi-year temporal statistical population of concentrations Specification of the multi-year temporal statistical population of concentrations This is in fact a general remark however the first time there is a clear indication is in paragraph On several issues in the document there is a request for risk management decisions. We wonder if risk managers, based on the presented information, can make qualified decisions. Risk managers are not risk assessors and vice versa. The panel should bear this in mind when writing their opinions. EFSA: The PPR Panel is aware of this. Furthermore, EFSA participates in meetings with risk managers in order to further inform them so that qualified decisions can be made. Crop rotations are usually not considered in the risk assessment, especially in lower tiers. The risk assessment is performed for one use at a time on a specific crop. We are therefore concerned by the relevance of the question in line 490. EFSA: The question is considered relevant for the determination of the (in this case temporal) population of PECs to be taken into account. The suggestion to choose only the year with the maximum PEC within one rotation is close to current practice. P15: Non-zero and very low concentrations in years without application are relevant for the assessment of long-term recovery of the ecosystem. EFSA: The PPR Panel is only considering peaks and TWA of 56 d (reference page 13, line 400). Longer time windows are not considered relevant for the risk assessment. The PPR Panel considers changing the sentence not to be necessary. Proposed Action: include a remark in the opinion that these low concentrations can be important for the risk assessment. EFSA: As stated in line 400, peak concentrations and TWA concentrations over periods up to 56 days are Ecotoxicological Relevant Concentrations (EFSA, 2009). It does not seem meaningful to calculate such concentrations for years without applications. 14/09/2011 Ctgb NLD 1.5 Limitations of the exposure assessment methodology Because the guidance will be applicable for a limited number of situations, it is impracticable for regulatory boards. What should be done for the rest? There is a need for completeness to give workable situations. It is not justified to have sophisticated methods with a lot of extra work for one situation and no guidance for others. EFSA: The PPR Panel/Working Group came to realise that establishing exposure scenarios for all possible crops and growing systems would not be feasible given the time and resource constraints for this mandate. The PPR Panel therefore chose arable annual crops grown on flat areas, as these constitute a major part of all possible combinations. The PPR Panel recommends that methodology for other combinations is established afterwards. With the experience gained, the development of scenarios for other situations might take less time. 15

16 It s pointed out that Ecoregion maps revealed marked differences between the countries. How the concept of ecoregion will be handled in the risk assessment for substance Annex I amendment, and in the core dossier of the Zonal registration reports since specific country risk assessment seems to be required? 13/09/2011 ANSES DPR FRA 1.5 Limitations of the exposure assessment methodology EFSA: As stated in the Opinion, the concept of ecoregions is not yet established for the entire EU-27. The PPR Panel cannot extrapolate from this limited knowledge and therefore does not know whether this would lead to country specific assessments. This document concerns the spray applications for the annual crop only. There will inevitably be a discrepancy between annual and perennial crops, as for the last ones the current risk assessment approach will still apply. EFSA: The PPR Panel indeed restricted itself to annual crops grown on flat areas. The PPR Panel recommends establishing methodology for other situations as well. 13/09/2011 Chemicals Regulation Directorate GBR 13/09/2011 ECPA BE 1.5 Limitations of the exposure assessment methodology 1.5 Limitations of the exposure assessment methodology P 16, Section 1.5, Lines it is possible to extrapolate the methodology to biennial/perennial crops or those grown on ridge and furrow systems, such as potatoes? Has any analysis of the impact of a ridge and furrow system on PECsoil been made? EFSA: Biennial/perennial crops will need different scenarios for reasons of different spatial distribution, possible different soil characteristics and possibly different soil management. The methods used to derive the scenarios for annual crops can be used to derive scenarios for the biennial/perennial crops. The PPR Panel has not done an impact analysis for a ridge and furrow system and is not aware of assessments on this. P16, L542: """ploughing may have a diluting effect on the concentration in the top centimetres"" According to EFSA Scientific Report (2009) 338, 1-32 and EFSA Journal 2010; 8(1):1442, the effect of ploughing reaches deeper than the top centimetres." Proposed action: Replace "centimetres" with "decimetres" or "top layers". EFSA: The sentence actually says that there is a large effect, whose size will depend on the ploughing depth. The exact ploughing depth is not important in this paragraph as it is only intended to indicate differences between tillage systems, i.e. systems with low or no dilution and systems with large dilution. The PPR Panel considers changing the sentence not to be necessary. 16

17 Lines /08/2011 Dr. Knoell Consult DEU 13/09/2011 ANSES DPR FRA 1.5 Limitations of the exposure assessment methodology 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage The document should give a recommendation how to assess the exposure scenarios not covered in this guideline. Is a simple approach accepted? Is it necessary to develop a specific approach according to this guideline? Which PEC values should be provided for the exposure scenarios not covered? Such a recommendation would lead a more straight-forward assessment of the not covered exposure scenarios. EFSA: The PPR Panel recommends developing methodology for these. The scheme organization of tier 2 a, b and c is not clear (consistency). Some details would be helpful. EFSA: This organisation was explained in detail in lines and lines The PPR Panel discussed the consistency of this scheme repeatedly and is convinced that it is consistent. The only way to clarify this further is by providing worked examples based on case studies. These will be provided at a later stage after the software package for Tiers 1-2B-2C-3 has been developed. Lines It appears that tier 1 calculations with the simple analytical model may be less conservative than the tier 2A calculation with realistic numerical models. This seems contradictory with the definition of the tiered approach (as stated in line 874). EFSA: These lines refer to the simple analytical model which is not identical to Tier-1 calculations. As described by Eqn 15 and in Section 5, Tier-1 calculations include a model adjustment factor to ensure the consistency of the tiered approach. 13/09/2011 SCC GmbH DEU 13/09/2011 Chemicals Regulation Directorate GBR 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage Lines : Being a highly complex approach with respect to Tiers 1 to 3 already, development and regulatory acceptance/use of Tier 4 seems to be rather ambitious. EFSA: We agree; as described in line 584, this is only a desirable future development. P. 20, Section 2, lines Please can the Panel clarify how far, if at all, they have progressed in parameterising any scenarios into any software tools. Later chapters suggest that some work has been done, but this paragraph suggests little if any progress has been made. EFSA: We have not yet worked on the software tools; calculations with PEARL and PELMO have been made with ASCII versions of these models. 17

18 13/09/2011 Chemicals Regulation Directorate GBR 13/09/2011 Chemicals Regulation Directorate GBR 13/09/2011 Chemicals Regulation Directorate GBR 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage P. 20, Section 2, lines we are unclear how an undeveloped Tier 4 can act as a yardstick for all other tiers. Logically, real measured values from actual monitoring of appropriately selected sites would be the true yardstick, unless the Tier 4 modelling has been appropriately validated as being representative of real soil concentrations. EFSA: As follows from these lines, we agree that this undeveloped Tier 4 does not act as the yardstick. We also agree that measured values would be the true yardstick but only if from these measurements 90 th -percentile concentrations can be estimated with sufficient accuracy for a range of relevant substances; we consider this a far more challenging task than developing Tier 4. P.18 & 19 Section 2, Figure 5 and lines Since the only difference between 2b and 2c appears to be the consideration of crop interception at 2c, perhaps tier 2b could be excluded for simplicity. Tier 1 already covers the worst case situation without crop interception. Is it really necessary to maintain this conservative approach in Tier 2b? EFSA: As described in lines , our only drive for including Tier 2B is that it may be more efficient than performing Tier-2A scenario calculations (which are needed for Tier 2C); we could simplify the flow chart by excluding Tier 2B but at the expense of losing efficiency. Once the software tool for Tier-1-2B-2C-3 is available, generation of Tier-2B results will take almost no time because the input for Tier 2B is identical to that of Tier 1. P.18 & 19, Section 2, Figure 5 and lines The structure and flow of assessment of Tier 2 is difficult to follow. However, it appears that Tier 2B may be a more logical next step following from Tier; this seems to be confirmed from lines which suggest that the simple analytical model at Tiers 1, 2B and 2C may be used to select Tier 2A scenarios. It also seems strange that the more complex Tier 2A mathematical model takes a less complex approach that the simple analytical model at Tiers 2B and 2C in the sense that Tiers 2B and 2C consider crop and crop interception respectively, but the numerical model considers only all arable land. Thus, simply from a presentational view, it may be worth considering re-considering the naming of the subtiers within Tier 2 or re-thinking how these different tiers actually work in relation to each other. Certainly we do not think this is a very clear structure at the present time and the concept behind the current Tier 2 structure is difficult to understand. We would certainly recommend a re-working of the scheme into a simpler linear flow chart to aid understanding. EFSA: We discussed this part of the flow chart extensively over a period of more than a year and we also modified this part repeatedly based on these ongoing discussions. Simplifying the flow chart is only possible by removing options; e.g. if we put Tier 2B above 2A in a linear flow chart, this would require that 2B is always more conservative than 2A which cannot be guaranteed. We could omit either Tier 2A or Tiers 2B+2C from the flow chart (and have a simple linear flow chart) but this would lead to loss of efficiency. It is a pity that, due to time constraints, we could only provide Tier-2A scenarios for arable land. We feel that the only way to clarify this further is by providing worked examples based on case studies. These will be provided at a later stage after the software package for Tiers 1-2B-2C-3 has been developed. 18

19 P 17, Section 2, Lines Tiers 1 and 2A use the spatial statistical population of all crops. This paragraph also suggests that for assessment of non-capri crops, extrapolation factors are required. If spatial statistical populations are based on EU cropping data, this implies that whilst acceptable for EU-wide assessment, decisions made with the proposed methodology may not be appropriate at a MS level if MS cropping distributions are not closely similar to the EU distributions. It would be useful to see an analysis of how sensitive PECsoil values at the different assessment tiers are to use of EU or Zonal cropping statistics versus MS cropping statistics. This is an important point because there will inevitably be pressure brought to bear on individual MS to accept EU-wide or other MS decisions, i.e. following Annex I/active substance approval decisions, at a MS level (particularly since the scenario selection recognises the zonal authorisation scheme of Regulation 1107). If PECsoil is highly sensitive to this information, the utility of the methodology could be relatively limited. 13/09/2011 Chemicals Regulation Directorate GBR 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage EFSA: We provided conservative estimates of crop extrapolation factors for any crop at the zonal level in Table 7. Because they are based on 100 th percentiles, these factors are also safe enough for each Member State (MS) in the indicated zone. Thus the sensitivity to MS cropping statistics can be so derived: the sensitivity to the crop area for the pore water is limited (at most a factor 1.39 in this table); for the concentration in total soil, the effect is at most a factor 2 to 3. These are the most extreme cases because they are based on the 100 th percentile. With respect to your last sentence, we would be interested in your suggestions for an alternative methodology that does not ignore this aspect. 13/09/2011 Chemicals Regulation Directorate GBR 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage P17 Section 2, Lines It may be considered undesirable to introduce an effectively two-tiered risk assessment system i.e. this relatively complex procedure for annual crops under conventional tillage and the existing scheme for all other crops. EFSA: The timing of the introduction of the proposed guidance is a risk-management aspect. 13/09/ /09/2011 Federal Environment Agency/Germany Institute of Environmental Protection, Warsaw, Poland DEU POL 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage 2. Tiered approach for spray In a tiered approach as presented here, the lower tiers are less realistic but also less time consuming. Tier 2B and 2C are similar only differing in the interception considered in 2C. As it is assumed that including interception data is not very complicated, we wonder if it is necessary to differ between tier 2B and 2C. Therefore, we would suggest to model the influence of interception already in Tier 2B, thus avoiding two separate tiers. EFSA: As described in lines , our only drive for including Tier 2B is that it may be more efficient than performing Tier-2A scenario calculations (which are needed for Tier 2C); so we could make the flow chart simpler by including interception in Tier 2B but at the expense of losing efficiency. Once the software tool for Tier-1-2B-2C-3 is available, generation of Tier-2B results will take almost no time because the input for Tier 2B is identical to that of Tier 1. Page 17, Line 605: It is said that for calculations at Tiers 1 and 2A following assumption is made: "Kom and DegT50 of the substance do not depend on soil properties". However 19

20 applications in annual crops with reduced or conventional tillage as Kom is defined as Freundlich adsorption constant in function of the soil organic matter content, this assumption is not defensible not only for some plant protection products and their metabolites, but generally for all plant protection products - adsorption processes depend on the properties of both adsorbent (here soil) and adsorbate (here active substance or its metabolite). Moreover the sentence is internally contradictory, because Kom depends on one of the basic soil properties - its organic matter content. Therefore maybe it would be better to precise which soil properties are considered, as otherwise the assumption is misleading and a bit confusing. The same concerns the DegT50 (were it not, there would be not a variability of the kinetic endpoints for the lab soil degradation studies and field dissipation studies even after normalisation). The comment is also applicable to the fragment on page 18, lines EFSA: We do not see this internal contradiction: why would the K om by definition depend on the organic-matter content? The Freundlich coefficient, K F, depends on organicmatter content but the K om does not. We accept that K om and DegT50 may be a function of for example the ph for substances that are ionisable and/or acid/base hydrolysed. However, in the scenario-selection procedure for Tiers 1 and 2A, we assume for such substances that K om and DegT50 do not depend on ph and we address conservativeness of the approach by using conservative estimates of these parameters in these tiers. In Tiers 2B and higher, we include for such substances the ph dependency in the scenario-selection procedure and we use realistic estimates of K om and DegT50. 12/09/2011 Danish EPA DNK 12/09/2011 Danish EPA DNK 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage 2. Tiered approach for spray applications in annual crops with reduced or conventional tillage LN 697: It would be preferred to have evidence that conservative values of Kom and DegT50 will ensure that Tier 1 and 2A are conservative enough EFSA: We agree but this can most efficiently be done after the Tier-1-2B-2C-3 software tool has been developed. See our recommendation in lines LN 622: In a tiered scheme it would be preferred to have only a sequential flow without parallel tiers, in order to keep the approach as simple as possible EFSA: We discussed the parallel tiers extensively over a period of more than a year and we also repeatedly modified this part of the flow chart based on these ongoing discussions. Simplifying the flow chart is only possible by removing options; e.g. if we put 2B above 2A in a linear flow chart, this would require that 2B is always more conservative than 2A which cannot be guaranteed. We could omit either Tier 2A or Tiers 2B+2C from the flow chart (and have a simple linear flow chart) but this would lead to loss of efficiency. 20