ICPS Publications

Flooded Rice Pesticide Risk Assessment: the "orphan" cereal in current Guidance Documents
Document type: Poster - 2019 Language:

European Pesticide Registration requires a Risk Assessment for non-target organisms which has to be performed according to EU Regulation (Reg. 1107/2009 EC). Through the years European Authorities developed Guidance Documents (GD) for risk assessment ... show more

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considering exposure scenarios for the required organisms typical for terrestrial crops. GDs do not include scenarios for pesticide applications on rice: paddy is characterized by flooded cultivation conditions, typical of semi-aquatic environments and wetlands, representative of a unique exposure scenario, not comparable to the terrestrial ones. The current and available GD could be considered not adequate and sufficiently representative to describe and evaluate the risk in rice paddy during flooded periods. Aim of this work is to identify the main critical issues raising from the GD application for the mandatory categories of organisms: terrestrial vertebrates, aquatic organisms, nontarget arthropods, soil organisms, non-target terrestrial plants. A selection of possible exposure scenarios will be suggested for each group of organisms to define an appropriate approach for the development of a reserved risk assessment for pesticide applications in rice cultivation.

EFSA new guidance on endocrine disruptors: comments, critical aspects and a case study
Document type: Poster - 2019 Language:

The EFSA Endocrine Disruptors guidance has been developed to help assessors of the regulatory authorities on the definition of the scientific criteria for the determination of endocrine-disrupting properties in the context of Regulations (EU) ... show more

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No 16 528/2012 and (EC) No 1107/2009. The overall objective resulting from the present project was the compilation of a specific database for a pesticide active substance (named x) and its metabolites, which is comprising all available parameters that are considered relevant when investigating the ED properties. The database represented a practical tool to help assessors in assessing and analyze the evidence for endocrine disrupting properties. A useful-friendly client-side Form of the database was created. The Microsoft Access database was selected as suitable for this specific data collection due to the number of predicted records to be stored in and the ability of the toxicologist to work with this specific platform. To facilitate the data entry phase of the operators and to limit the data entry typos, most of the field were constrained with menu combo boxes and several queries were prepared to check the quality of the inserted data. The list of toxicity study type for mammalian toxicology and wild life toxicology comprises more than 10 different type of studies. Out of 55 studies that were scrutinized, 27 were performed on the active substance and 28 were performed on metabolites (4 metabolites) thus representing more than 50% of the total. In this particular case, the number of toxicity studies performed on metabolites was larger than normal; this is due to particular toxicity potential of three (non mammalian) metabolites that show higher chronic (specifically reproductive toxicity) toxicity than the parent. Studies on mammals (intact organism/cells) were 49 (23 on active substance and 26 on metabolites), while studies on wildlife (fish, amphibians) were 6 (4 on active substance and 2 on metabolites) Wilde life studies to investigate ED properties of active substances were not routinely performed in the past year. Please note that for substance X dossier year of study range from 1979 to 2012. Collection of data from substance x dossier represented a new exercise related to new approach for evaluating ED properties of active substances.

Identification of terrestrial vertebrate species in rice paddy
Document type: Poster - 2019 Language:

Pesticide registration in EU (Reg. 1107/2009 EC) requires appropriate risk assessment for non-target organisms including birds and mammals. The European Food Safety Authority developed a Guidance Document (GD) which doesn’t include scenarios ... show more

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for pesticide applications on rice; nowadays risk assessment is generally performed considering rice as the other cereals. Rice paddy is characterized by flooded cultivation conditions, typical of semi-aquatic environments and wetlands, representative of a specific exposure scenario. The avian and mammal community in rice area is composed by species and feeding guilds which are different from the one of a general cereal exposure scenario. The present work has considered the rice area growing in the North of Italy (Lombardy Region). For birds, data from monitoring program were processed through a Generalized Additive Model (GAM) to draw probability presence maps, while for mammals information related to species autoecology were used to draw suitability maps. The obtained maps were then integrated with land use maps to delineate the rice cultivation area (GIS approach). The aim of this work is to identify focal species, in relation to the specific feeding guilds, that will be proposed for the lower tiers of the ecotoxicological rice paddy Risk Assessment and suggested as potential model for the Southern European Zone involved in rice cultivation.

Mit-Mesw
Document type: Poster - 2019 Language:

The authorization process for plant protection products (PPP) requires, among others, the assessment of surface water contamination deriving from the use of each product. In some cases, the application of PPP might present some critical features ... show more

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for the aquatic environment and the application of mitigation measures to reduce the exposure are mandatory to protect the aquatic life. In addition, on a larger scale, the adoption of mitigation measures could bring to an improvement of the quality conditions of natural resources, with valuable social and economic advantages for the agricultural sector. Surface water contamination by PPP occurs mainly from three different routes: runoff, spray drift or drainage. In Italy, due to the characteristics of the territory, runoff and spray drift are the two major routes of contamination. Different pesticide risk mitigation measures can be adopted to reduce the exposure coming from these two routes of contaminations: anti-drift nozzles, specific equipment, buffer strips (vegetated or not), hedgerows etc. The combination of different mitigation measurements can produce a high level of mitigation. These huge amount of combinations cannot be included into a label; therefore, a simplified solution was adopted in Italy. In the label, the mitigation coming from modelling, performed according EU criteria is indicated together with the percentage of reduction of dose necessary to obtain a safe use. On the other hand, a harmonized value of reduction has been assigned to each possible mitigation measure. These values are in line with those proposed by the MAgPIE project (Mitigating the Risk of Plant Protection Products in the Environment), with other research projects (i.e. STRIPE-Ireland) and with some national researches and expert judgement. The possible mitigation measures applicable in Italy have been listed in a guidance document and an easy-to-use tool has been developed. The tool is called Mit-Mesw (MITigation MEasures for Surface-Water). This tool, through a series of combo-menus and images, aims at helping farmers in choosing the best equipment and agronomic practices to mitigate the pesticide risk, and pesticide risk assessors in quantifying the percentage of risk reduction due to each singular/combined adopted mitigation measures.

Application of VandA to the North of Italy
Document type: Poster - 2019 Language:

VandA is an innovative, easy to use tool to visualize the pesticide surface water contamination, assess the potential pesticide risk and address where to introduce mitigation measures to reduce the contamination and control ... show more

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the risk in the surface water environmental compartment (SETAC Rome 2018; VandA – Visualize and Assess: a tool for the pesticide risk mitigation in surface water). Recently, ISPRA, the Italian National Reference Institute for Environmental Research and Protection published a National report on pesticides in water resources [1]. The scenario which came out from the report is drastically negative all over the Italian territory, but mainly in the surface and ground water of the Padana Plain in the North of Italy. This evidence is in contrast with the latest great efforts of the four main Regions of the Padana plain to continuously improve the agricoltural sector, enchancing the ecological state of water resources, in line with objectives of the Directive 2009/128/CE on establishing a framework for Community action to achieve the sustainable use of pesticides. Aim of the present work is to run the VandA tool on pesticide residue data in surface water of the four main Regions in the Padana Plain, in order to propose an additional point of view which might agree or disagree with the ISPRA report. [1] Rapporto nazionale pesticidi nelle acque dati 2015-2016. Edizione 2018. 282/2018. ISBN: 978-88-448-0848-8

B-Rice: bird focal species identification in rice paddy
Document type: Poster - 2018 Language:

Pesticide registration in EU (Reg. 1107/2009 EC) requires appropriate risk assessment for non-target organisms including birds. The European Food Safety Authority developed a Guidance Document (GD) to conduct the risk assessment considering a series of ... show more

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exposure scenarios from a combination of crops and growth stages, selecting relevant species at the lower steps of a tiered approach. The actual GD doesn’t include scenarios for pesticide applications on rice; nowadays bird risk assessment is generally performed considering rice as the other cereals. Rice paddy is characterized by two cultivation conditions: the dry one, comparable to bare soil scenario (as common cereal), for which groups of species are equivalent to those identified for the actual risk assessment and already reported in GD; the flooded one, typical of aquatic environments and wetlands, representative of a unique exposure scenario not yet considered in the employed GD. The aim of this work is to characterize areas of rice growing in Northern Italy, which are representative for humid scenarios (via GIS approach), identify and link the relevant focal species to them. A review of the grey literature will be performed in order to estimate presence, abundance, dominance and diet of species associated to North of Italy rice paddies. Indicator and generic focal species will be proposed for the lower tiers of a Specific Rice Pesticide Risk Assessment and suggested as potential model for the Southern European Zone.

VandA - Visualize and Assess: a tool for the pesticide risk mitigation in surface water
Document type: Poster - 2018 Language:

The Directive 2009/128/CE of European Parliament and Council on Sustainable Use of Pesticides introduced a community action framework to protect the Environment of the EU and requested Member States to implement policies and actions in order to ... show more

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reduce the risk of pesticide use. In the Region of Lombardy, in Italy, this Directive was adopted with DGR n. X/3233. The aim of the present work is to develop an innovative, easy to use tool to visualize the pesticide surface water contamination, assess the potential pesticide risk and identify areas where to introduce mitigation measures to reduce the contamination, and consequently to reduce the risk in the surface water compartment. The datasets to start with are the monitored concentrations of pesticides in surface water, produced by the Regional EPA. These values are used in this context as Measured Environmental Concentration - MEC. . The ratio MEC/PNEC is proposed in this work as a sort of risk assessment, even though the limitation and the complexity of usage of monitored data is well known. In addition, the ratio MEC/EQS - Environmental Qualitative Standard (annual average concentration), is considered, to address the water quality with respect to the regulattory limit for pesticides in surface water (Directive 2000/60/EC). A MS Excel tool has been developed to map the monitored residues of pesticides, assess the potential pesticide risk (MEC/PNEC) and identify “hot spots”, thet is areas where mitigation measures should be included. The tool is thought to be an anyone-can-use one, even with no particular knowledge of GIS or database management. Its peculiarity to be built inside MS Excel gives itself the possibility to share and to ease the dissemination of results. For more advanced mapping, the tool can interact with ESRI ArcGIS. The openness of VandA makes it a tool suitable to work with other environmental compartments or other environmental thematics.

Minimal variation in input parameters highly influences PEARL and PELMO results: how can these results be trustable?
Document type: Poster - 2018 Language:

The calculation of Predicted Environmental Concentration of pesticides in groundwater (PECGW) is a crucial point in the registration and authorization process of plant protection products (PPPs) in Europe. ... show more

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Calculations are usually performed by FOCUS models, in particular PEARL and PELMO models. These models allow a realistic but conservative assessment of the potential leaching of pesticides in the groundwater compartment. Model results are influenced by substance specific parameters such as DT50, Kom and Freundlich coefficient (1/n). Great variations in PECGW values are expected when high variability occurs in one or more of the parameters listed above. In this work, we demonstrate that PECgw outputs are significantly affected also by minimal variation of the same parameters. Considering that a minimal variation is intrinsic in all laboratory studies (es. 25% uncertainty in KOM determination was calculated applying the Horwitz equation), it is questionable whether a corresponding high variation in model is scientifically acceptable. In a previous project (York, 2017), dummy substances with different combinations of DT50, KOM and 1/n values were used in FOCUS PEARL, in order to quantify the influence of each single parameter on the final PECgw. It was verified that the sensitivity of PEARL model can been considered quite excessive. In this follow-up project, further calculations were performed using FOCUS PELMO to compare the sensitivity of these two models, commonly used in a regulatory contest. Leachate concentrations were plotted as a function of KOM and as a function of degradation rate coefficient. PECgw obtained by the simulations of these two models were used to create a classification system for the input parameters KOM and DT50 according to models sensitivity. Conservative values for each parameter class, to be used in PECGW calculations, are proposed for all substances. This approach can minimise the effects of the intrinsic input variability providing a better scientific approach to the assessment of groundwater modelling in the regulatory context.

DAPHNE: a supporting tool for pesticides risk assessors and stakeholders
Document type: Poster - 2018 Language:

DAPHNE (DAtes and PHeNological Estimation) is a tool created to contribute supporting the Environmental Risk Assessment (ERA) of pesticides. The rationale behind its development is based on correlating crop phenological stages (BBCH) ... show more

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to specific dates for representative geographic areas is often a crucial step both for the exposure and (higher tier) effects assessment. However, currently there is no source of information clearly addressing this issue at the national, Zonal or EU scale. Data from a number of field efficacy trials were collected in a database that could realistically represent reference scenarios and typical Italian crops. These data included information on BBCH and related date, agronomic and pedoclimatic conditions. The dataset was primarily used to extrapolate BBCH vs date curves for selected crops. These interpolation curves are meant to be used to reduce the degree of uncertainty in both exposure and ecotoxicological higher tier effects evaluation. Among the potential applications, correlating dates and BBCH would help to: - harmonize the application date selection to parametrize the application scheme implemented in the SWASH model, in order to predict pesticide’s loading in surface water due to drift, drainage and run-off; - provide data to substantiate the geographic and temporal representativeness of higher tier ecotoxicological studies. Hence, to support the risk assessment process where a weight of evidence approach is envisaged.

Application of chemometric methods and QSAR models to support pesticide risk assessment starting form ecotoxicological datasets
Document type: Poster - 2018 Language:

Recently the International Center for Pesticides and Health Risk Prevention (ICPS) of Milan-IT, together with the Wageningen University and Research Centre of Wageningen-NL, worked on a data collection project commissioned by ... show more

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the European Food Safety Authority (EFSA). The aim of the project was to investigate the comparability of the ECx approach (Effect Concentration affecting a percentage x of test organisms) to the current NOEC approach (No Observed Effect Concentration), both derived from chronic and long term studies of a data sets of 70 active substances of plant protection products (PPP). The new Regulation for the authorization of PPPs requires that ecotoxicological endpoint values, derived from chronic or long-term studies submitted by the Applicant, are reported as EC10 or EC20 as well as NOEC. NOEC endpoints have been recently criticized since their values strongly depends on the experimental study design, whereas ECx values are considered more appropriate since they take into account the whole concentration-response curve. Ecotoxicological data gathered from 70 active substances’ approval dossiers were collected and stored into a database, and then analyzed to derive NOEC. Adequate statistical models were selected and used to calculate EC10, EC20, and EC50 with confidence intervals. In the present work, quantitative methods and models based on Structure-Activity Relationships (i.e. QSARs) were used to validate the Effect Concentrations of the active substances of the selected pesticides, and to predict missing data. The whole approach is mainly oriented to the aquatic environment, and can provide useful information to screen the potential undesired toxic effects of new pesticides, and of alternatives to existing active substances, starting just from the chemical structure.

Compilation of a database, specific for the pesticide active substance and their metabolites, comprising the main genotoxicity endpoints
Document type: Scientific Report - 2017 Language:

The terminal residues of pesticide active substances in food and feed commodities need to be duly identified following the requirements of Commission Regulation (EU) No 283/2013 in accordance with Regulation (EC) No 1107/2009. ... show more

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This information is necessary to derive the residue definition for the dietary risk assessment. EFSA initiated in 2009 a work programme to support the preparation of scientific guidance on the establishment of the residue definition for risk assessment. In 2012, the Panel on Plant Protection Products and their Residues (PPR Panel) adopted a scientific opinion on the toxicological relevance of pesticide metabolites for dietary risk assessment. In its opinion, the PPR Panel also indicated that the application of integrated approaches including the combination of QSAR models and read across for the genotoxicity assessment of pesticide residues would imply the availability of a robust database specific for pesticide active substances and their metabolites. The overall objective of the project is the compilation of a database specific for pesticide active substances and their metabolites, which is comprising the different genotoxicity endpoints i.e. point mutations, structural and numerical chromosome aberrations. For each substances and metabolites (and or impurities when available), data collection, data extraction and data entry has been performed according to a methodology agreed by EFSA and the consortium. The database represents a practical tool to complement the in-silico tools i.e. QSAR, grouping and read across for prediction and indication of the genotoxicity hazard. Moreover, the database is expected to increase the specificity and sensitivity of the in-silico tools and to enlarge the chemical domains for their applicability.

Exposure to PFOA and PFOS and fetal growth: a critical merging of toxicological and epidemiological data
Document type: Scientific Document - 2017 Language:

Toxicological and epidemiological evidence on the association between perfluorooctanoic acid (PFOA) or perfluorooctane sulfonic acid (PFOS) and birth/fetal weight was assessed. An extensive search for toxicological information in rats and mice, and a ... show more

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systematic search for epidemiological evidence were conducted. The linear regression coefficient (LRC) of birth weight (BrthW) on PFOA/PFOS was considered, and separate random effects meta-analyses for untransformed (i.e. not mathematically transformed) and log-transformed values were performed. Toxicological evidence: PFOA: 12 studies (21 datasets) in mice showed statistically significant lower birth/fetal weights from 5mg/kg body weight per day. PFOS: most of the 13 studies (19 datasets) showed lower birth/fetal weights following in utero exposure. Epidemiological evidence: Sixteen articles were considered. The pooled LRC for a 1 ng/mL increase in untransformed PFOA (12 studies) in maternal plasma/serum was -12.8 g (95% CI -23.2; 2.4), and -27.1 g (95% CI -50.6; -3.6) for an increase of 1 loge ng/mL PFOA (nine studies). The pooled LRC for untransformed PFOS (eight studies) was -0.92 g (95%CI -3.4; 1.6), and for an increase of 1 loge ng/mL was -46.1(95% CI -80.3; -11.9). No consistent pattern emerged for study location or timing of blood sampling. Conclusions: Epidemiological and toxicological evidence suggests that PFOA and PFOS elicit a decrease in BrthW both in humans and rodents. However, the effective animal extrapolated serum concentrations are 102–103 times higher than those in humans. Thus, there is no quantitative toxicological evidence to support the epidemiological association, thus reducing the biological plausibility of a causal relationship.

PERSAM PECsoil calculation and pesticides risk assessment: support or burden for regulators?
Document type: Poster - 2016 Language:

A new approach for the exposure assessment of soil organisms to plant protection products (PPPs) has been developed in the new EFSA Guidance Document. The recommended procedure consists of five tiers with different levels of complexity. ... show more

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The first tiers are performed using a new PECsoil calculation model called PERSAM. This work addresses the use of PERSAM in the context of the standard evaluation procedure that regulators have to deal with in their registration activity of both active substance and PPPs. A subset of PPPs authorized at National level has been considered. PECsoil for the selected active substances have been calculated either with PERSAM or with the equations used in the last 20 years; PECsoil has then been compared with the Regulatory Acceptable Concentration (RAC). The percentage of active substances showing an unacceptable risk for each Tier has been calculated, and comparison between the current assessment and the new one is presented together with some considerations on the efficacy, reliability and usefulness of all the PERSAM tiers. The influence of degradation between the applications in PECsoil results has also been evaluated.

Toxicological data collection and analysis to support grouping of pesticide active substances for cumulative risk assessment of effects on the nervous system, liver, adrenal, eye, reproduction and development and thyroid system
Document type: Scientific Report - 2016 Language:

EFSA and the PPR Panel have started in 2007 the development of methodologies to carry out cumulative risk assessment for Maximum Residue Levels setting which implies the establishment of cumulative assessment groups (CAGs) of pesticidal active ... show more

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substances on the basis of their toxicological properties. The aims of the present project is to finalise the collection of data for the nervous system (Task 1), the thyroid (Task 2), the reproductive and developmental system (Task 3) and the liver (Task 4) by collecting and analysing toxicological data for pesticides approved within the EU as well as for pesticidal active substances not approved for use within the EU, but detected as residues in food or feed. In addition, the collection of data has been performed for two other organs namely the adrenal (Task 5) and the eye (Task 6). Information on toxicological effects has been primarily retrieved from regulatory toxicological studies provided in support of approval and their evaluations under the peer review process of Directive 91/414/EC and Regulation (EC) 1107/2009. For each organ/system separately, a data collection table has been drawn according to a methodology agreed by EFSA and the consortium including a predefined list of specific effects and their related indicators. Based on the collection table of each organ/system, preliminary CAGs have been proposed by the consortium. Furthermore, the collection tables would allow EFSA to access the relevant toxicological information necessary to define consolidated CAGs according to the criteria adopted in the PPR opinion on cumulative assessment groups (CAGs) EFSA Journal 2013;11(7):3293.

Methodology for spatial analysis of pesticide residue monitoring data in surface water
Document type: Poster - 2016 Language:

The Directive 2009/128/CE of European Parliament and Council on Sustainable Use of Pesticides introduced a community action framework to protect the Environment of the EU and requested Member States to implement policies and actions in order to ... show more

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reduce the risk of pesticide use. In Italy, this Directive was adopted by D.Lgs. n.150 14/08/2012, followed by DGR n. X/3233 adopted on 06/03/2015 in the Lombardy Region: “Approvazione delle linee guida per l’applicazione in Lombardia del piano di azione nazionale (PAN) per l’uso sostenibile dei prodotti fitosanitari”. Both pesticides (CE 1107/2009) and biocides (UE 528/2012), once introduced into the environment, might lead to the formation of metabolites, degradation and reaction products. They could also move from the compartment they have been applied, and migrate in other non-target compartments. Due to their intrinsic toxic characteristics, these substances might cause negative acute or chronic effects to humans and to the environment. A well designed monitoring campaign of residues of pesticides in water may provide a clear picture of their distribution in the aquatic environment. The monitoring of pesticides is quite a complex activity, due to the number of chemicals involved, to their large application areas and to the different chemical characteristics of the substances. In Italy, every year, the ISPRA institute addresses and coordinates the Regional Environmental Protection Agencies – REPAs in the monitoring campaign activities of surface and ground water: providing prioritizing pesticide lists, sampling methodologies, and coordinating laboratory analysis and control. It has to be considered that the REPAs, Regional Environmental Protection Agencies’ surface water monitoring network is not specifically designed for pesticide residues, but for other purposes, mainly related to water quality (classification of the biological and chemical conditions of surface water). In addition, the sampling frequency is usually scheduled to occur at least twice a year, which does not correspond to the best practice to detect pesticide in surface water. Even if the monitoring punctual data of the residue level of a pesticide in surface water is merely a snap-shot of a situation that could over/under estimate an environmental pesticide pollution, in this context it is used as a Predicted (Measured) Environmental Concentration. Obviously, the monitored pesticide concentration in surface water is not a real PEC, and does not depend just on application methods, application doses and application period. Therefore, this assumption is to be considered as a first step of the environmental Concentration assessment of a pesticide in the surface water. The pesticide maximum concentrations were considered as the Monitored Environmental Concentration (MEC). A first screening of the potential pesticide risk for surface water was performed by comparing the MEC with the Environmental Quality Standard (annual average concentration) – EQS, Italian regulation limit for pesticides (DM 260/2010). To assess the pesticide risk to the aquatic ecosystem, the measured MEC of an active substance was compared with the corresponding Predicted No Effect Concentration for the aquatic ecosystem, i.e. the concentration of the substance which is expected not to produce any adverse effects to the aquatic ecosystem. A collection of ecotoxicological data have been retrieved for all the monitored pesticides; for each pesticide, the PNEC was derived from the most sensitive ecotoxicological value divided by a safety factor which account for the variability inter and intra specie. According to this criterium, taking into account also aquatic plants when herbicides were considered, the PNECaquatic were calculated for the selected pesticides.

From NOEC to ECx: a large scale data analysis on ecotoxicological studies with pesticides
Document type: Poster - 2015 Language:

Historically chronic or long-term studies performed for the authorisation of plant protection products (PPP) result in the reporting of endpoint values in terms of No-Observed Effect Concentration (NOEC). The related Test Guidelines (OECD, ISO, EPA) ... show more

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were designed to fulfil the data requirement for NOEC determination. NOEC values are however criticised since their values strongly depends on the experimental study design, and actually the extrapolation of Effect Concentration affecting a percentage x of the test organisms or where a percentage x of an effects is observed (Ecx) is considered more appropriate since it takes into account the whole concentration-response curve. The new Regulation (EC) No. 1107/2009 for the authorisation of PPPs and the related data requirements (Commission Regulation (EU) No. 283/2013 and 284/2013) require that ecotoxicological endpoint data from chronic or long-term studies provided by the Applicant are reported as EC10 or EC20 values together with the NOEC. However, there is no systematic comparison available to compare NOEC values to EC10 and EC20 values derived from the same study. In the present work, 200 long term and chronic studies on aquatic organisms, equally distributed among fish, daphnids, algae and aquatic macrophytes, are re-analysed in order to calculate NOEC, EC10, EC20, EC50 and their limit of confidence (from the same study) using appropriate statistical analyses. A comparison of NOEC with Ecx values and their lower limit of confidence is performed by analysing the distribution of the NOEC/Ecx ratios. Considerations are made on studies based on the same organisms and on the study design (appropriately developed to calculate EC50 for algae and macrophytes and NOEC for fish and daphnids).

COMPARISON OF NOEC VALUES TO EC10/EC20 VALUES, INCLUDING CONFIDENCE INTERVALS, IN AQUATIC AND TERRESTRIAL ECOTOXICOLOGICAL RISK ASSESSMENT. CALL REFERENCE: GP/EFSA/PRAS/2013/01
Document type: Scientific Report - 2015 Language:

Ecotoxicological studies performed for the authorization of plant protection products (PPP) usually result in the reporting of endpoint values in terms of effect concentration (EC) affecting a percentage x of test organisms or where a x percentage ... show more

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of an effect is observed (ECx). The new Regulation (EC) No. 1107/2009 for the authorization of PPPs and the related data requirements provide that ecotoxicological endpoint data from chronic or long-term studies submitted by the Applicant are reported as EC10 or EC20 values together with the NOEC. NOEC values have been criticized since their values strongly depends on the experimental study design, whereas ECx values take into account the whole concentration-response curve and are therefore considered more appropriate. The aim of the project is to investigate the comparability of the ECx approach to the current NOEC approach on a larger data sets in view of the new Regulation requirements. Ecotoxicological data gathered from 70 active substances’ approval dossiers were collected and stored into a MS Access database. All the extracted ecotoxicological data were analyzed in order to derive NOEC and calculate EC10, EC20, EC50 with confidence intervals, using statistical models from the exponential and Hill families for continuous data, and logistic, log-logistic and complementary log-log models for quantal data. The optimal model was selected based on likelihood ratio tests and the Akaike Information Criterion. ECx/NOEC ratio distributions were calculated considering the whole set of data and model outputs; data were grouped in different categories to remark any differences in the ECx/NOEC ratio distributions.

Don't mix the grape and the grain: are ERA official procedures suitable for inorganic plant protection products?
Document type: Poster - 2014 Language:

Most of currently used active ingredients in Plant Protection Products (PPP) are organic xenobiotics. Despite in numerical terms, natural inorganic compounds represent a small minority, their usage is extremely widespread. According to FAO data, ... show more

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inorganics represent about half of the amount of fungicides applied in Europe in the last decade. Due to the high number of xenobiotics registered as new substances (or re-registered after the previous authorization has expired) each year, most of the EU official procedures to assess the ecological risk posed by PPP are calibrated on these chemicals. However, the regulation is common for all substances used as pesticides, disregarding their chemical nature. This work tries to assess to which extent ERA PPP EU official procedures are suitable to describe the environmental fate and related effects on non-target organisms of natural inorganic substances using copper compounds as case study. Copper is an heavy metal naturally present in most environmental compartments. It is involved in biological processes and plays an important role as micronutrient for several organisms. Beside agriculture, where its use dates back to several decades ago, copper enters many anthropogenic activities determining several kind of emissions into the environment. Predictive models usually recommended at EU level were used to estimate environmental concentrations of copper following its use as fungicide according to good agricultural practice. Estimations for soil, surface waters and groundwater were compared to monitoring data retrieved from the literature. The results will be discussed in the light of the mechanistic parameters guiding the exposure models. Also, the effects on several organisms measured in different tests was critically considered to assess the relevance of some environmental parameters in determining both the bioavailability and the overall toxicity of copper compounds, bearing in mind that copper body concentration, as for all the micronutrients involved in biological processes, is regulated by homeostatic mechanisms. The use of models such as toxicokineticstoxicodynamic models (TK/TD) or Biotic Ligand Models (BLM) can help in the evaluation of copper toxicity and bioavailability. Finally, some practical suggestions will be proposed to perform a proper ecological risk assessment of copper compounds within the framework of the EU PPP registration procedure.

Applicability of mitigation measures for surface water in Italy: the case study of the Lombardy Region.
Document type: Poster - 2012 Language:

In the authorization process of plant protection products (PPP), the evaluation of the impact of PPPs on surface water quality and on aquatic ecosystems is a crucial point. If the results of the risk assessment suggest an unacceptable risk for ... show more

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aquatic systems, after the pesticide application according the intended uses, mitigation measures have to be applied to reduce the concentration of PPPs which can reach water bodies. In this way the exposure of aquatic organisms is kept at acceptable level allowing a safe use for pesticides useful for crop protection but potentially dangerous for aquatic ecosystem. This study addresses the applicability of mitigation measures in a selected area of the Lombardy Region (LR) characterised by high density of water bodies. A multivariate analysis based on geo-pedological soil conditions, slope, distance between field and water bodies, considered representative of the Regional arable lands, was performed to evaluate mitigation measures applicability.

Birds species versus crops: GIS-based procedure to identify specific combinations
Document type: Poster - 2012 Language:

Pesticide registration in EU (Reg. 1107/2009 EC) requires, among others, appropriate risk assessment for birds. The bird species currently used in risk assessment are the ones considered the most sensitive to all pesticides. ... show more

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In this work a realistic approach has been developed to correlate the avian population at local level, derived from a monitoring survey, with the land-use (Corine land-cover) and the relative pesticide treatments. A GIS analysis was performed to identify peculiar combinations crop/bird species in order to determine which species is most likely to be exposed to a specific active substance. The area considered was the North of Italy characterised by an intensive agriculture and, consequently, high load of pesticides. These results can be considered an useful tool to display risk maps taking into the combination bird/ crop exposed to specific pesticides.

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