Scientific report of EFSA on the ‘repair action’ of the FOCUS surface water scenarios
2020; Wiley; Volume: 18; Issue: 6 Linguagem: Inglês
10.2903/j.efsa.2020.6119
ISSN1831-4732
AutoresPaulien Adriaanse, Arnaud Boivin, Michael Klein, Nicholas Jarvis, Michael Stemmer, Gabriella Fait, Mark Egsmose,
Tópico(s)Pesticide Residue Analysis and Safety
ResumoEFSA JournalVolume 18, Issue 6 e06119 Scientific ReportOpen Access Scientific report of EFSA on the ‘repair action’ of the FOCUS surface water scenarios European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) PRAS.Secretariat@efsa.europa.eu Correspondence: PRAS.Secretariat@efsa.europa.euSearch for more papers by this authorPaulien Adriaanse, Paulien AdriaanseSearch for more papers by this authorArnaud Boivin, Arnaud BoivinSearch for more papers by this authorMichael Klein, Michael KleinWG member up to April 2019. Subsequently hearing expert.Search for more papers by this authorNick Jarvis, Nick JarvisWG member up to April 2019. Subsequently hearing expert.Search for more papers by this authorMichael Stemmer, Michael StemmerSearch for more papers by this authorGabriella Fait, Gabriella FaitSearch for more papers by this authorMark Egsmose, Mark EgsmoseSearch for more papers by this author European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) PRAS.Secretariat@efsa.europa.eu Correspondence: PRAS.Secretariat@efsa.europa.euSearch for more papers by this authorPaulien Adriaanse, Paulien AdriaanseSearch for more papers by this authorArnaud Boivin, Arnaud BoivinSearch for more papers by this authorMichael Klein, Michael KleinWG member up to April 2019. Subsequently hearing expert.Search for more papers by this authorNick Jarvis, Nick JarvisWG member up to April 2019. Subsequently hearing expert.Search for more papers by this authorMichael Stemmer, Michael StemmerSearch for more papers by this authorGabriella Fait, Gabriella FaitSearch for more papers by this authorMark Egsmose, Mark EgsmoseSearch for more papers by this author First published: 08 June 2020 https://doi.org/10.2903/j.efsa.2020.6119Citations: 3 Requestor: European Commission (DG SANTE) Question number: EFSA-Q-2017–00070 Acknowledgements: EFSA wishes to thank the following hearing experts for the support provided to this scientific output: Fredrik Stenemo, Stefan Reichenberger and Gerald Reinken. Approved: 21 April 2020 This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1850/full AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract The European Commission asked EFSA to undertake a ‘repair action’ of the FOCUS surface water report after the EFSA Pesticide Steering Network had been consulted. The main request was to introduce into all FOCUS surface water scenarios (both run-off and drainage) a 20-year assessment period instead of the current 12- or 16-month assessment period. Because of the 20-year assessment period, the way application dates are defined needed to be reviewed, reconsidering the functionality of the pesticide application timing currently used. Guidance on how substance parameters should be handled when correlated with soil properties has been provided. Foliar wash-off calculated in MACRO and Pesticide Root Zone Model was aligned and the appropriateness of including rotational crop aspects was discussed. Processing time and how to use the results of the exposure assessment were considered. Summary The European Commission asked European Union Safety Authority (EFSA) in 2016 to undertake this task after a consultation of Member States. The European Commission requested EFSA to address the following Terms of Reference: Introduce into all FOCUS surface water (sw) scenarios (both run-off and drainage) a 20-year assessment period instead of the current 12 or 16 months assessment period. Because of the 20-year assessment period, the way application dates are defined needs to be reviewed, i.e. pesticide application timing (PAT) calculator functionality used/modified or not and, if used, which year to run PAT within the context of dates for 20 years, is a critical task to be investigated and approach agreed. Add substance parameter input selection guidance when these parameters are correlated with the soil properties, e.g. pH. Foliar wash-off coefficient used in MACRO and Pesticide Root Zone Model (PRZM) and the equation used to describe foliar wash-off to be reviewed. The description of wash-off in FOCUS SW was questioned in the EFSA Opinion on scenarios for PECsoil (EFSA Journal 2012;10(2):2562). Repair should ensure that processing times of revised weather scenario definitions are not excessive and results are still easily produced and reproduced as part of regulatory assessments. Repair should consider how the results are to be presented and used in risk assessment. Repair to consider how rotational crops are to be dealt with in risk assessment. In the FOCUS run-off scenarios, complete 20-year MARS50 weather data have already been implemented by the FOCUS working group (WG) in 2001. The FOCUS Surface Water Repair WG considers these data still appropriate for the multiyear assessment approach without changes. However, a warming-up period of 6 years has been added also for the run-off scenarios to account for the potential accumulation in soil and sediment of more persistent substances. For the FOCUS drainage scenarios, the FOCUS Surface Water Repair WG used the original MARS50 weather data originally considered by the FOCUS WG as far as possible. It is noted that for the two scenarios D1-Lanna and D6-Thiva only 14-year and 18-year periods, respectively, have been available. To extend the data sets for these two scenarios to cover the entire 20-year assessment period, the FOCUS Surface Water Repair WG added weather data from the new MARS25 database on the basis of their locations (co-ordinates) specified by the FOCUS WG. For pragmatic reasons, the FOCUS Surface Water Repair WG simply added the 6 subsequent years (1995–2000) for D1-Lanna and 2 years (1995–1996) for D6-Thiva. The FOCUS WG used a 6-year warming-up period from 1988 to 1993 for all drainage scenarios without further justification of the selection of years in this period. For the new 20-year assessment period, a more consistent but simple method to select the 6 warming-up years for the drainage scenarios was employed. The FOCUS Surface Water Repair WG concluded that, to avoid inconsistencies with the water balance, irrigation events should not be scheduled with an external model such as ISAREG, but should be calculated within PRZM and MACRO based on internal water balances. Consequently, the FOCUS Surface Water Repair WG made use of the internal irrigation routines in PRZM and adapted them when necessary. Finally, MACRO has been adapted to calculate irrigation in an analogous way to PRZM. To align crop interception with approaches used in other exposure models (e.g. FOCUS groundwater and soil exposure), the FOCUS Surface Water Repair WG concluded that MACRO and PRZM should no longer internally calculate crop interception. Instead, in the repaired FOCUS sw scenarios predefined default FOCUS crop interception values are used based on the crop BBCH stage. BBCH stands for Biologische Bundesanstalt, Bundessortenamt und CHemische Industrie. This procedure ensures that the same crop interception is used in MACRO and PRZM as well as in all other exposure models. The FOCUS Surface Water Repair WG considers the default crop interception values used in the FOCUS groundwater scenarios and FOCUS surface water Step 2 (for olives only) to be the most appropriate. The FOCUS Surface Water Repair WG considers the assumption of a cumulative drift probability of the 90th percentile to determine the PECmax no longer justified, as spray drift deposition events should be considered as separate events if they do not lead to accumulation in the simulated watercourse. Very often the mass input to the watercourse due to spray drift has already flowed out before the next spray drift deposition event. In contrast, in ponds, the hydraulic residence time is in the order of at least 50 days and often more, so that spray drift depositions may indeed accumulate and using the cumulative drift deposition is justified. Overall, there is no straightforward solution for a drift percentile approach, which is valid for all types of water bodies (ditch, stream and pond) as well as all environmental compartments (water and sediment). As a pragmatic approach, the FOCUS Surface Water Repair WG changed the current procedure for multiple applications, setting the drift deposition for the last application in an application season to the 90th percentile, keeping the reduced percentile for all other applications. In this way, care is taken that there is at least one 90th percentile drift event in an application season without overestimating the entire load to the waterbody. This approach also makes the usual ‘single application’ run for multiple applications obsolete. The exposure to metabolites has not been changed compared with the current situation, except for the factor accounting for metabolites formed in the water of the upstream catchment of FOCUS streams. In the repaired FOCUS scenarios, the correction factor for metabolite formation in the upstream catchment is now based on the average water temperature and most conservative residence time of the 20-year evaluation period for each FOCUS sw scenario. To avoid being overly conservative, it has been checked that the most conservative hydraulic residence time used to calculate the correction factor was not an extreme case (i.e. the last-but-one most conservative residence time was used). Because of the new 20-year assessment period, the selection procedure for individual application dates was reconsidered by the FOCUS Surface Water Repair WG investigating different PAT options. The FOCUS Surface Water Repair WG kept the initial 2-mm rainfall criterion (i.e. maximum 2 mm of rainfall on 5 days consecutively around application) introduced with the current FOCUS PAT, as this is considered to mirror good agricultural practice. However, the second initial rainfall criterion (i.e. at least 10 mm of rainfall occurring within the next 10 days) is no longer considered defensible, as different rainfall pattern in the 20 years compensate for each other. Next, the FOCUS Surface Water Repair WG tested shorter application windows as currently used in FOCUS sw. As a result, the FOCUS Surface Water Repair WG considers an application window of 7 days (for a single application) to be a reasonable compromise: (i) allowing a limited number of applications on less favourable days, (ii) excluding extreme run-off/drainage events, (iii) reducing the day-to-day variability in PECs with respect to application timing and (iv) respecting the intended Good Agricultural Practices (GAP) (BBCH stage) as far as possible. So, for a single application, the application window in the revised FOCUS sw scenarios is set to ± 3 days around the intended application date (the so-called extension period in the revised PAT). For multiple applications, the application window now covers the period from 3 days before the first intended application to 3 days after the last intended application. In cases in which substance properties depend on soil pH, the FOCUS Surface Water Repair WG recommends performing calculations for two contrasting soil pH values in line with recommendations given for the FOCUS groundwater scenarios. If there is a significant change in substance properties within a soil pH range from 5.1 to 8.0 (i.e. the 10th and 90th percentile, respectively, for arable and permanent crops in the EU), it is recommended to perform two individual calculations assuming substance properties representative for soil pH values of 5.1 and 8.0 and to report the results from both runs. In contrast with soil pH, the clay content (soil texture) is considered part of the scenario definition and clearly linked to scenario vulnerability with respect to losses of pesticides by drainage and run-off/erosion. So, the FOCUS Surface Water Repair WG does not see the need to use any other clay content to calculate representative substance properties other than the clay contents of the soil horizons of the scenario. The FOCUS Surface Water Repair WG thoroughly investigated the foliar wash-off routines in MACRO and PRZM for varying half-lives on the crop canopy and wash-off coefficients. It was concluded that wash-off simulated in the two models is generally similar, except for applications on days with rainfall. For these specific days, the FOCUS Surface Water Repair WG adapted the wash-off calculation routines in PRZM to bring wash-off more in line with MACRO, where a rainfall of less than 18 mm on the day of application does not contribute to wash-off. The FOCUS Surface Water Repair WG notes that the processing time of PRZM will hardly change as it already runs for 20 years with the current FOCUS scenarios (note that in the revised scenarios, 6 warming-up years have been added). MACRO is expected to have similar run-times compared with the FOCUS groundwater scenario Châteaudun, which also runs for a 20-year assessment period (+6 warming-up years). TOXic substances in Surface WAters (TOXSWA) was improved by enabling the TOXSWA shell to distribute the runs of one project between available processors of the computer, so considerably shortening the project run-time. The FOCUS Surface Water Repair WG changed the procedure for PAT, which reduces the variability of input parameter selections related to application timing and therefore increases user confidence in the simulated surface water concentrations. The new approach is based on a close link between the BBCH stage (which is well defined for each application according to the GAP) and the calendar date at which this BBCH stage is reached at each scenario location. In the new Surface WAter Scenarios Help (SWASH) software, this approach is used to determine the so-called intended application dates. For a single application, the intended application date is always set at the first calendar date that is specified for a given BBCH stage. For multiple applications, intended application dates are determined according to the BBCH period, the number of applications and a standard interval between applications. The actual application dates, which may vary in each of the 20 assessment years according to rainfall, are finally determined by the revised PAT on the basis of the intended application dates (applying an extension period of ± 3 days) relaxing the rules if necessary. The FOCUS Surface Water Repair WG excluded drift values for ‘vines early’ in the exposure assessment as these drift values are based on application techniques, which are not standard farming practice for application in early vines. Furthermore, the FOCUS Surface Water Repair WG adapted the SWASH software using the more conservative drift data for ‘pome/stone fruits, early’ from BBCH 09 to 69 and the less conservative drift data ‘pome/stone fruits, late’ from BBCH 71 to 95, switching back to ‘pome/stone fruits, early’ at BBCH 97 and onwards. In the new 20-year assessment approach, the selection of a temporal percentile may have a strong impact on the exposure end-point (i.e. the annual maximum PEC in water or sediment), particularly if the exposure assessment is driven by drainage or run-off. In this respect, the FOCUS Surface Water Repair WG considers the 50th temporal percentile the lower limit to be selected and the 90th temporal percentile the upper limit. The lower temporal percentile, which is in line with the targeted 50th temporal percentile hydrological year selected by the FOCUS WG in 2001, reveals PECs that are more related to average and lower PECs in the current FOCUS approach, whereas the higher percentile covers the current FOCUS approach in most cases. It is self-evident that any percentile in between these two values could be selected. The FOCUS Surface Water Repair WG wants to make risk managers (RM) aware that a temporal percentile close to the 90th (rather than the 50th percentile) for the run-off/drainage entries would correspond better to the original intentions of the FOCUS working group of 1996–2001 of aiming at an overall 90th temporal percentile. At the same time, the FOCUS Surface Water Repair WG wants to mention that the spatial percentile of the FOCUS surface water scenarios was difficult to quantify, but it has not changed between the current and the repaired scenarios. Risk managers should also be aware that a fixed definition of a simple temporal percentile may not be suitable to cover the wide range of possible effect situations. So, a temporal percentile may also be selected by integrating effects modelling and overall exposure pattern. The current FOCUS sw Step 2 does not necessarily cover the new FOCUS sw Step 3 approach. The FOCUS Surface Water Repair WG therefore recommends reconsidering the parameterisation at FOCUS sw Steps 1 and 2, particularly with respect to default entries into the waterbody by drainage/run-off. This may also include reconsideration of the period from (last) application to drainage/run-off (currently 4 days in FOCUS sw Step 2). The revision of FOCUS sw Steps 1 and 2 should also cover the new proposed drift percentile setting for multiple applications. In the repaired FOCUS scenarios, sediment exposure is now expressed in total content on organic matter (OM) basis (μg/kg OM), total content on dry sediment mass basis (μg/kg dry sediment mass) and pore water basis (μg/L). Moreover, concentrations are averaged over the top 1 and 5 cm for the risk assessment for benthic invertebrates or plants, respectively, as was suggested by the EFSA Opinion on effect assessment on sediment organisms (EFSA PPR Panel, 2015). The FOCUS Surface Water Repair WG demonstrated that the current, as well as repaired, FOCUS surface water scenarios do not result in conservative estimates of the PEC in sediment, due to the relatively low organic carbon content of 5% in the sediment. It also notes that the PECsed values do not represent ‘best-case’ exposure values, as the concentrations in the overlying water layer are intended to represent ‘realistic worst-case’ concentrations and these water concentrations form one of the main driving factors for the PECsed. The FOCUS Surface Water Repair WG therefore recommends the development of a second set of scenarios to predict ‘realistic worst-case’ exposures in sediment to promote a scientifically sound risk assessment for benthic organisms and rooted water plants. The FOCUS Surface Water Repair WG notes that the upstream catchment concept implemented in the FOCUS surface water scenarios for streams and ditches already account for the fact that not the whole catchment area is treated with the simulated pesticide in any given year. This approach is equivalent to assuming that only a certain fraction of the catchment is covered with the simulated crop during the assessment year (i.e. 33% for ditches and 20% for streams), and so not the whole area of this crop is treated. In other words, effects of crop rotations are already indirectly included in the current FOCUS surface water modelling by ‘space for time’ substitution. The parameterisation of the run-off curve numbers (RCN) for perennial tall crops (vines, pome/stone fruit, citrus, olives and hops) in the FOCUS run-off scenarios (FOCUS, 2001) assumes a fairly good vegetation cover within and between the crop rows. Based on newly available data, it appears no longer defensible to simulate surface run-off for these crops assuming a complete and well-established vegetation cover as currently performed in FOCUS sw. The RCNs for these crops have therefore been adapted, leading to a more realistic representation of surface run-off in tall permanent crops. The FOCUS Surface Water Repair WG decided to replace the current procedure to calculate subsurface drainage water entering the waterbodies of the run-off scenarios by a new and more realistic reservoir approach with direct inflow of the daily fluxes. In the current FOCUS surface water scenarios, a monthly average water temperature is used in the scenario calculations, equal to the monthly average air temperature of the location of the meteorological station belonging to each of the 10 scenarios. In the repaired FOCUS surface water scenarios, this approach was improved by using a moving 3-day average air temperature (of the day itself and the 2 previous days) to represent the daily water and sediment temperature in the scenario calculations. Overall, it can be concluded that the new 20-year assessment delivers annual maximum PECs that are in the range of the current FOCUS approach. However, in contrast with the current single-year approach, the new assessment is much more robust with significantly less variability in PECs (for a certain temporal percentile) in relation to the application timing. 1 Introduction 1.1 Background and Terms of Reference as provided by the requestor The European Commission (EC) (DG SANCO1) sent by letter from Ladislav Miko to Berndhard Url, EFSA, dated 20 October 2016, a request for undertaking this task. Requests from Member States (MS) that are already being considered through FOCUS2 version control and by the European Crop Protection Association (ECPA) are considered outside the scope of FOCUS surface water (sw) ‘repair action’. These requests are listed under Annex 3 of the EC letter to EFSA for transparency. The need for a ‘repair action’ of the FOCUS surface water scenarios has been identified by EFSA. Following a commenting round with MS and discussion at the Pesticide Steering Network (PSN) meeting in November 2014, EFSA prepared the draft Terms of Reference (ToRs) and launched a second consultation. The draft was reviewed according to the provided comments and further discussed at the PSN meeting of February 2015. The repair action is limited to specific items suitable for a short-term repair action. Additional proposals received from MS have been included in Annex 2 of the letter from the EC and will be retained by EFSA for a possible future revision of the FOCUS surface water scenarios. Due to the nature and complexity of these proposals they have not been considered in the proposed FOCUS sw ‘repair action’. The purpose of the ‘FOCUS Surface Water Repair Action’ is to prepare a scientific/technical report for updating the FOCUS surface water report and to update the supporting software tools, Surface WAter Scenarios Help (SWASH)3 including the TOXSWA,4 MACRO5 and PRZM6 components. As a follow-up, a comprehensive revision of the FOCUS surface water scenarios might be developed in the future, including revised drift deposition numbers, exposure mapping and landscape-based approaches. Future developments would depend on the scientific needs identified by the PPR Panel, and would consider, in a consultation with the EU Commission and MS, the actual needs, priorities and the protection goals established by risk managers (RMs). The scientific developments in this area are intended to support the evaluation of substances under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.7 1.2 Terms of Reference from the European Commission (DG SANCO) Following the request from the EC (DG SANCO) the following Terms of Reference have been addressed: Introduce into all FOCUS surface water scenarios (both run-off and drainage) a 20-year assessment period instead of the current 12- or 16-month assessment period. Because of the 20-year assessment period, the way application dates are defined needs to be reviewed, i.e. pesticide application timing (PAT) calculator functionality used/modified or not and if used which year to run PAT within the context of dates for 20 years, is a critical task to be investigated and approach agreed. Add substance parameter input selection guidance when these parameters are correlated with the soil properties, e.g. pH. Foliar wash-off coefficient used in MACRO and PRZM and the equation used to describe foliar wash-off to be reviewed. The description of wash-off in FOCUS SW was questioned in EFSA Opinion on scenarios for PECsoil (EFSA Journal 2012;10(2):2562). Repair should ensure that processing times of revised weather scenario definitions are not excessive and results are still easily produced and reproduced as part of regulatory assessments. Repair should consider how the results are to be presented and used in risk assessment. Repair to consider how rotational crops are to be dealt with in risk assessment. After increasing the assessment period to 20 years and thorough checking of the new procedure with example calculations, EFSA will, together with the FOCUS Surface Water Repair WG, produce a set of alternatives to be presented to RMs and the decision from the RMs will be implemented. From 24 September to 5 November 2018, a stakeholder web consultation was organised on the draft scientific report. The FOCUS Surface Water Repair WG received 193 comments from MS and other stakeholders. All comments received were carefully reconsidered by the FOCUS Surface Water Repair WG for the final scientific report. The comments and the reply of the WG are published on the EFSA web in a stakeholder report. 2 Model framework The registration procedure for pesticides according to EU Council Directive 91/414/EEC8 and its successor, EU Regulation (EC) No 1107/20099 includes the possibility of using models for the calculation of Predicted Environmental Concentrations in surface water (PECsw). Ten FOCUS (FOrum for the Co-ordination of pesticide fate models and their USe) surface water scenarios form the third step in a stepwise approach to calculate the PECsw in ‘realistic worst-case’ scenarios. The scenarios were developed from 1996 to 2001 and were intended to cover a realistic range of surface water bodies, topography, climate, crops, soil types and related agronomic practices in the major agricultural areas of the European Union, consisting of 15 MSs by that time. The 15 MSs were Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Denmark, Ireland, United Kingdom, Greece, Spain, Portugal, Austria, Finland and Sweden and covered almost the whole of western Europe. In combination with appropriate aquatic ecotoxicological endpoints, model calculated exposure concentrations are used to assess the risk of pesticides in the European Union (FOCUS, 2001; EFSA PPR Panel, 2013b). Active substances in plant protection products can only be approved in the EU according to Regulation (EC) No 1107/2009 if they have a safe use in large areas that can be considered to be one FOCUS scenario. To pass a scenario, all the water bodies defined as being associated with the scenario need to have low risk demonstrated. Four of these 10 scenarios evaluate the importance of pesticide entries into surface water by run-off and erosion together with spray drift. The other six evaluate the importance of leaching through drainage and spray drift. The four run-off scenarios make use of the PRZM model (Carsel et al., 2003; Suárez, 2005), which simulates pesticide run-off from agricultural fields, while the six drainage scenarios make use of the MACRO model (Larsbo et al., 2005), which simulates pesticide leaching through the soil matrix and macropores towards edge-of-field surface water bodies. All scenarios make use of the TOXSWA model, which simulates pesticide behaviour in edge-of-field ponds, ditches and streams (Adriaanse, 1997; Adriaanse et al., 2013, 2017; Beltman et al., 2018). To limit the run-time needed to simulate pesticide behaviour in the FOCUS surface water scenarios, PEC values were calculated for a single ‘representative’ year. As at least some of the soil scenarios were considered to represent a 90th+ percentile worst case, the single climate year was selected to represent a hydrological year with a 50th to 70th percentile worst-case probability of occurrence. In this way, and as stated in the conclusions of FOCUS (2001) ‘the highest PECsw estimates of the 10 scenarios are likely to represent at least a 90th percentile worst case for surface water exposures resulting from agricultural pesticide use within the European Union’. This 90th percentile worst case (i.e. 90th percentile of occurrence in time and space of the PECsw) can be considered as the operational definition of the term ‘realistic worst case’ mentioned in the ‘uniform principles’.10 Later, it has been repeatedly demonstrated (e.g. Adriaanse et al., 2007; Klein, 2007; Bach et al., 2017a,b) that the PECs of the single simulated year do not necessarily represent a 90th percentile worst-case PECsw value. On the one hand, in a single-year simulation, the PEC depends too much on the time period between the day of application and the first rainfall event causing run-off or macropore flow to drains. On the other hand, the selected weather years pose problems: for example, for the run-off scenarios, no run-off events occur in the first 2–4 weeks after application for seven of the 12 combinations of application season (spring, summer, autumn) and location (R1–R4). Moreover, the concept of combining a 50th to 70th percentile hydrological year with a 90th percentile spray drift deposition to come to an overall 90th percentile of occurrence exposure concentration is not valid for waterbodies where the mass originating from the entry routes run-off/drainage and spray drift do not accumula
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