Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Abstract The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quality of the data provided, the proposed fitting procedure of aged sorption experiments and the proposed method for combining results obtained from aged sorption studies and lower‐tier studies on degradation and adsorption. Aged sorption was a relevant process in all cases studied. The test revealed that the guidance could generally be well applied and resulted in robust and plausible results. The Panel considers the guidance suitable for use in the groundwater leaching assessment after the recommendations in this Scientific Opinion have been implemented, with the exception of the use of field data to derive aged sorption parameters. The Panel noted that the draft guidance could only be used by experienced users because there is no software tool that fully supports the work flow in the guidance document. It is therefore recommended that a user‐friendly software tool be developed. Aged sorption lowered the predicted concentration in groundwater. However, because aged sorption experiments may be conducted in different soils than lower‐tier degradation and adsorption experiments, it cannot be guaranteed that the higher tier predicts lower concentrations than the lower tier, while lower tiers should be more conservative than higher tiers. To mitigate this problem, the Panel recommends using all available higher‐ and lower‐tier data in the leaching assessment. The Panel further recommends that aged sorption parameters for metabolites be derived only from metabolite‐dosed studies. The formation fraction can be derived from parent‐dosed degradation studies, provided that the parent and metabolite are fitted with the best‐fit model, which is the double first‐order in parallel model in the case of aged sorption

Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters

EFSA’s Panel on Plant Protection Products and their Residues (PPR) was tasked to revise the Guidance Document (GD) on Aquatic Ecotoxicology under Council Directive 91/414/EEC (SANCO/3268/2001 rev.4 (final), 17 October 2002). This Guidance of the PPR Panel is the first of three requested deliverables within this mandate. It has its focus on tiered acute and chronic effect assessment schemes with detailed guidance on tier 1 and higher tier effect assessments for aquatic organisms in edge-of-field surface waters and on proposals regarding how to link effects to exposure estimates. The exposure assessment methodology was not reviewed and it is assumed that the current FOCUS surface water exposure assessment methodology will continue to be used for exposure assessment at EU level. The current GD is intended to be used for authorisation of active substances at EU level as well as for plant protection products at Member State level. The effect assessment schemes in this GD allow for the derivation of regulatory acceptable concentrations (RACs) on the basis of two options: (1) the ecological threshold option (ETO), accepting negligible population effects only, and (2) the ecological recovery option (ERO), accepting some population-level effects if ecological recovery takes place within an acceptable time period. In the tiered effect assessment schemes, in principle, all tiers (1, 2 and 3) are able to address the ETO, while the model ecosystem approach (tier 3), under certain conditions, is able to also address the ERO. The GD provides the scientific background for the risk assessment to aquatic organisms in edge-of-field surface waters and is structured to give detailed guidance on all assessment steps. An executive summary joining all parts of the guidance and decision schemes in a concise way is provided and is intended to help applicants and regulatory authorities in day-to-day use

Investigation into experimental toxicological properties of plant protection products having a potential link to Parkinson's disease and childhood leukaemia

In 2013, EFSA published a literature review on epidemiological studies linking exposure to pesticides and human health outcome. As a follow up, the EFSA Panel on Plant Protection Products and their residues (PPR Panel) was requested to investigate the plausible involvement of pesticide exposure as a risk factor for Parkinson's disease (PD) and childhood leukaemia (CHL). A systematic literature review on PD and CHL and mode of actions for pesticides was published by EFSA in 2016 and used as background documentation. The Panel used the Adverse Outcome Pathway (AOP) conceptual framework to define the biological plausibility in relation to epidemiological studies by means of identification of specific symptoms of the diseases as AO. The AOP combines multiple information and provides knowledge of biological pathways, highlights species differences and similarities, identifies research needs and supports regulatory decisions. In this context, the AOP approach could help in organising the available experimental knowledge to assess biological plausibility by describing the link between a molecular initiating event (MIE) and the AO through a series of biologically plausible and essential key events (KEs). As the AOP is chemically agnostic, tool chemical compounds were selected to empirically support the response and temporal concordance of the key event relationships (KERs). Three qualitative and one putative AOP were developed by the Panel using the results obtained. The Panel supports the use of the AOP framework to scientifically and transparently explore the biological plausibility of the association between pesticide exposure and human health outcomes, identify data gaps, define a tailored testing strategy and suggests an AOP’s informed Integrated Approach for Testing and Assessment (IATA)

Tier-1 and Tier-2A scenario parameterisation and example calculations: 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, 12.07.2000)

European scenarios for exposure of soil organisms to Plant Protection Products are currently not available (EFSA Panel on Plant Protection Products and their Residues (PPR), 2010). In this document, the parameterisation of realistic worst-case scenarios for Tier-1 and Tier-2A simulations is described which are part of a tiered approach. The aim of this scheme is to assess such Predicted Environmental Concentrations (PEC), chosen to be the 90th spatial percentile, resulting from the use of the plant protection product. In order to account for the uncertainty in substance and soil properties, the Tier-2A scenarios are combinations of soil and climatic properties within a zone, for which the predicted concentration is equal to the 95th percentile of all concentrations within the area of annual crops. The selected soil profiles are based on digitised information from topsoil (organic matter and texture) combined with calculated average soil profiles available in the SPADE-1 database. The daily weather information for the scenarios is taken from the MARS database using the period 1990-2009. In order to have a sufficient overview on the differences between simulations performed with the analytical Tier-1 model and the numerical Tier-2A models, PEARL and PELMO test runs are performed covering all relevant substance properties and all evaluation depths. For each of the total soil scenarios, both models simulate nearly the same concentration. Small differences between PEARL and PELMO can be found for the pore-water scenarios due to differences in the calculation of soil moisture contents. The comparison with the analytical model shows that Tier-1 concentrations are usually above the respective Tier-2A concentrations in accordance with the philosophy of the tiered assessment scheme. However, due to the different handling of soil moisture, Tier-1 simulations may occasionally give concentrations below those of Tier 2A, which occurrence necessitates additional calibration using special model-adjustment factors

'Kansrijk landbouw- en voedselbeleid'

In deze studie Kansrijk landbouw- en voedselbeleid beoordelen we een breed scala aan maatregelen op effectiviteit, uitvoerbaarheid en juridische legitimiteit. Daarbij zijn de effecten van deze maatregelen op de leefomgeving, het sociale systeem en de economie beschouwd. De gekozen maatregelen in Kansrijk landbouw- en voedselbeleid zijn afkomstig uit het politieke en maatschappelijke debat en zijn gegroepeerd in vier thema’s die veel aandacht krijgen in dit debat: (i) gezond en duurzaam voedsel, (ii) het sluiten van kringlopen, (iii) landbouw en natuur in balans en (iv) een duurzaam verdienvermogen van de landbouw. Kansrijk beleid: effectief, uitvoerbaar, legitiem en aanvaardbaar Welk van de bovengenoemde effecten het zwaarst wegen, is afhankelijk van de waarden en doelen van maatschappelijke en politieke partijen. In deze Kansrijkstudie beschouwen we maatregelen die passen bij uiteenlopende maatschappelijke en politieke opvattingen. Dat doen we omdat in het politieke en maatschappelijke debat over landbouw en voedsel verschillende visies bestaan over wat exact het probleem is en wat daarvoor de meest geëigende oplossingen zijn. Het uiteindelijke antwoord op de vraag of de maatregelen kansrijk zijn, hangt daarom niet alleen af van de vraag of ze gewenste effecten hebben, goed zijn uit te voeren en passen binnen het recht, maar ook van de vraag of ze aanvaardbaar (te maken) zijn vanuit verschillende maatschappelijke perspectieven: zijn bijvoorbeeld prijsprikkels aanvaardbaar die consumenten richting een duurzamer en gezonder eetpatroon sturen of ligt de voorkeur bij voorlichting en Geen ‘laaghangend fruit’; keuzes noodzakelijk Uit de beschouwing van de 27 beleidsmaatregelen blijkt dat geen van de maatregelen op álle doelen voor de leefomgeving, economie en sociale aspecten positief scoort en tegelijkertijd gemakkelijk te nemen is. In die zin is er geen ‘laaghangend fruit’. De effectiviteit van beleidsmaatregelen hangt ook af van de samenhang met andere maatregelen. Zo zijn bijvoorbeeld natuurmaatregelen weinig effectief als de emissies van stikstof en gewasbeschermingsmiddelen te hoog zijn. Het bevorderen van de consumptie en productie van regionale- en streekproducten heeft een aannemelijk positief effect op de regionale economie, maar er is geen consensus dat dit positief is voor de leefomgeving. Daarnaast hebben we bij meerdere beleidsmaatregelen geconstateerd dat een gecombineerde aanpak met verschillende beleidsinstrumenten meer effect voor de leefomgeving en/of gezondheid oplevert. Maatregelen gericht op een gezonder en duurzamer eetpatroon kunnen elkaar versterken. Ook gebiedsgerichte projecten waarin bewustwording, begeleiding, subsidiemogelijkheden voor investeringen en ook regelgeving gecombineerd worden, kunnen leiden tot een groter effect op de leefomgeving en volksgezondheid. De kosten van maatregelen verschillen daarbij. De toekomst van het landbouw- en voedselbeleid vergt dus politieke keuzes. Deze studie reikt kennis aan om die keuzes te onderbouwen.

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, 12.07.2000)

European scenarios for exposure of soil organisms to plant protection products are currently not available. As part of the revision of the Guidance Document on Persistence in Soil (9188/VI/97 rev 8 published in 2000), the PPR-panel was therefore asked to start the development of tiered exposure-assessment approaches for soil organisms in which European exposure scenarios play an important role. This report contributes to this revision by developing a systematic approach to the selection of realistic worst-case scenarios for exposure of soil organisms. Realistic worst-case conditions are defined as the 90th spatial percentile of the exposure concentration (the maximum over time) in the intended area of use in each of three regulatory zones defined in Council regulation (EC) 1107/2009. Separate scenarios were developed for the concentration in total soil (mg kg-1) and for the concentration in the liquid phase (mg l-1), giving six scenarios to be developed. The scenario selection began with the compilation of a coherent database. Then, a simplified model was selected to generate maps of the concentration in total soil and the concentration in the liquid phase over the entire area of annual crops in the three zones. In the subsequent two steps, procedures were applied to account for parameter uncertainty and scenario uncertainty (i.e. the likelihood that a scenario that is derived for one substance is not conservative enough for another). In the final step, the six scenarios were selected by defining their air temperature, soil organic matter content and their soil textural class. The concentration in total soil was shown to decrease in the order North>Central>South, whereas the concentration in the liquid phase showed an opposing trend with the highest concentration in the Southern European scenario. The scenario development was based on the total area of annual crops in the EU-27, but the endpoint of the exposure assessment is the 90th percentile of the intended use area. The scenarios may therefore not be conservative enough. To ensure that the selected scenarios are sufficiently conservative, safety factors were derived

European Scenarios for Exposure of Soil Organisms to Pesticides

Standardised exposure scenarios play an important role in European pesticide authorisation procedures (a scenario is a combination of climate, weather and crop data to be used in exposure models). The European Food Safety Authority developed such scenarios for the assessment of exposure of soil organisms to pesticides. Scenarios were needed for both the concentration in total soil and for the concentration in the liquid phase. The goal of the exposure assessment is the 90th percentile of the exposure concentration in the area of agricultural use of a pesticide in each of three regulatory European zones (North, Centre and South). A statistical approach was adopted to find scenarios that are consistent with this exposure goal. Scenario development began with the simulation of the concentration distribution in the entire area of use by means of a simple analytical model. In the subsequent two steps, procedures were applied to account for parameter uncertainty and scenario uncertainty (i.e. the likelihood that a scenario that is derived for one pesticide is not conservative enough for another pesticide). In the final step, the six scenarios were selected by defining their average air temperature, soil organic-matter content and their soil textural class. Organic matter of the selected scenarios decreased in the order North-Centre-South. Because organic matter has a different effect on the concentration in total soil than it has on the concentration in the liquid phase, the concentration in total soil decreased in the order North-Centre-South whereas the concentration in the liquid phase decreased in the opposite order. The concentration differences between the three regulatory zones appeared to be no more than a factor of two. These differences were comparatively small in view of the considerable differences in climate and soil properties between the three zones.JRC.H.5-Land Resources Managemen

EFSA Guidance Document 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 the exposure assessment of soil organisms to plant protection products (PPPs) and their transformation products in accordance with Regulation (EC) No. 1107/20091 of the European Parliament and the Council. This guidance was produced by EFSA in response to a question posed by the European Commission according to Article 31 of Regulation (EC) No. 178/20022 of the European Parliament and of the Council. Guidance is provided for all types of concentrations that are potentially needed for assessing ecotoxicological effects, i.e. the concentration in total soil and the concentration in pore water, both averaged over various depths and time windows. The current guidance considers both permanent crops and annual crops. The recommended exposure assessment procedure consists of four tiers. To facilitate efficient use of the tiered approach in regulatory practice, user-friendly software tools have been developed. In higher tiers of the exposure assessment, crop interception and subsequent dissipation at the crop canopy may be included. The models that simulate these processes were harmonised. In addition, easy-to-use tables for the fraction of the dose intercepted by the canopy that is washed off have been developed, which should be used in combination with the simple analytical model. With respect to substance-specific model inputs, this guidance generally follows earlier documents; however, new guidance is included for some specific substance parameters