Plant Protection Products And Their Residues Research Articles

Development of Integrated Approaches to Testing and Assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment

The EFSA Panel on Plant Protection Products and their Residues (PPR) has developed, as a self-task mandate (EFSA-Q-2019-00100), two adverse outcome pathway (AOP)-informed integrated approach to testing and assessment (IATA) case studies to answer a developmental neurotoxicity (DNT) hazard identification and characterisation problem formulation that could support the regulatory decisions for the pesticide active substances deltamethrin and flufenacet. The IATA were developed to assess the applicability of the DNT in vitro testing battery (IVB), designed to explore fundamental neurodevelopmental processes, in the regulatory risk assessment of pesticides. For this purpose, an evidence-based-approach methodology was applied: 1) systematic literature review and critical appraisal of all the evidence i.e. human observational studies, in vivo data from rodent models and new approach methodologies (NAMs, i.e. in vitro studies including high-throughput testing from IVB and zebrafish studies from the literature) for both case studies; 2) a quantitative uncertainty analysis of all the evidence using expert knowledge elicitation (EKE) and a probabilistic approach; 3) integration of all the evidence using the AOP conceptual framework. This stepwise approach resulted in the postulation of an evidence-based AOP network for one of the case studies. A probabilistic quantification of the weight of evidence (WoE) using Bayesian network analysis allowed the assessment and the quantification of the uncertainty in the postulated AOP. The approach taken allowed conclusions to be drawn with an acceptable level of certainty in DNT hazard identification and characterisation of deltamethrin and that flufenacet is not a developmental neurotoxicant, supporting the relevance of the mechanistic understanding. The case studies show the applicability of the DNT-IVB for hazard identification and characterisation and illustrate the usefulness of an AOP-informed IATA for regulatory decision making. The overall activity led to improved interpretation of human data by providing a plausible mechanistic link to adverse outcomes, which would support their contextualisation in the risk assessment process. This Scientific Opinion allows the PPR Panel to draft several recommendations for the implementation of the AOP-informed IATA methodology and of the DNT-IVB in the regulatory risk assessment of pesticides.

Updated peer review of the pesticide risk assessment for the active substance terbuthylazine in light of confirmatory data submitted.

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance terbuthylazine are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data on groundwater metabolites. The conclusions were reached on the basis of the evaluation of the representative uses of terbuthylazine as a herbicide on maize and sorghum and taking into account the scientific opinion of the EFSA Panel on Plant Protection Products and their Residues (PPR) on the setting of health‐based reference values for metabolites of the active substance terbuthylazine. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.

Integration of epidemiological findings with mechanistic evidence in regulatory pesticide risk assessment: EFSA experiences.

Toxicological risk assessment of plant protection products (PPP) is currently carried out with the principal input from regulatory toxicology studies following OECD test guidelines, with little input from epidemiological data. An EFSA-commissioned systematic review of pesticide epidemiological studies (Ntzani et al. in Literature review on epidemiological studies linking exposure to pesticides and health effects. EFSA supporting publication 2013:EN-497, 2013) revealed statistically significant associations, among others, between pesticide exposures, and Parkinson's disease and childhood leukemia. Thereafter, EFSA launched a project with a mandate for the plant protection products and their residues (PPR) Panel to set the ground for the use of epidemiological data in the risk assessment of pesticides, as requested by Regulation (EC) 1107/2009. The project culminated with the publication of two EFSA's scientific opinions on the potential contribution of experimental investigations and epidemiological studies in PPP risk assessment and with the scientific conference held on 20 November 2017, in Parma, Italy. The application of modern methodologies in exposure assessment, toxicology and epidemiology would improve the pesticide risk assessment process and support a mechanistic shift for the integration of these three disciplines under a novel paradigm in risk assessment. The application of the adverse outcome pathway (AOP) conceptual framework to this approach would contribute to gain insight into the biological plausibility of a hazard identified in epidemiological or experimental studies and would inform an Integrated Approach to Testing and Assessment (IATA) within a regulatory context.

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms.

Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three different types of TKTD models are described, viz., (i) the ‘General Unified Threshold models of Survival’ (GUTS), (ii) those based on the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All these TKTD models follow the principle that the processes influencing internal exposure of an organism, (TK), are separated from the processes that lead to damage and effects/mortality (TD). GUTS models can be used to predict survival rate under untested exposure conditions. DEBtox models explore the effects on growth and reproduction of toxicants over time, even over the entire life cycle. TKTD model for primary producers and pesticides have been developed for algae, Lemna and Myriophyllum. For all TKTD model calibration, both toxicity data on standard test species and/or additional species can be used. For validation, substance and species‐specific data sets from independent refined‐exposure experiments are required. Based on the current state of the art (e.g. lack of documented and evaluated examples), the DEBtox modelling approach is currently limited to research applications. However, its great potential for future use in prospective ERA for pesticides is recognised. The GUTS model and the Lemna model are considered ready to be used in risk assessment.

Conference Report on the “Use of Epidemiological findings in Regulatory Pesticide Risk Assessment”

In 2013, as a follow up of a systematic review of epidemiological studies published from 2006 to 2012 investigating the association between pesticide exposure and many health outcome, the European Food Safety Authority (EFSA) lauched a project with a mandate for Plant Protection Products and their Residues (PPR) Panel to examine novel tools to improve the use of epidemiological data in the risk assessment of pesticides. The project culminated in the publication of two scientific opinions and this report summarises the discussions and outcomes of the scientific conference, held on 21 November, 2017, in Parma, Italy. More than 65 people attended the Conference and speakers and participants from European and non‐European countries discussed the two opinions developed by the PPR Panel and future scenarios where the application of modern methodologies in toxicology, exposure and epidemiology are expected to support a mechanistic shift for the integration of the three disciplines in the pesticide risk assessment and identify risk factors involved in complex diseases.

Guidance on dermal absorption.

This guidance on the assessment of dermal absorption has been developed to assist notifiers, users of test facilities and Member State authorities on critical aspects related to the setting of dermal absorption values to be used in risk assessments of active substances in Plant Protection Products (PPPs). It is based on the ‘scientific opinion on the science behind the revision of the guidance document on dermal absorption’ issued in 2011 by the EFSA Panel on Plant Protection Products and their Residues (PPR). The guidance refers to the EFSA PPR opinion in many instances. In addition, the first version of this guidance, issued in 2012 by the EFSA PPR Panel, has been revised in 2017 on the basis of new available data on human in vitro dermal absorption for PPPs and wherever clarifications were needed. Basic details of experimental design, available in the respective test guidelines and accompanying guidance for the conduct of studies, have not been addressed but recommendations specific to performing and interpreting dermal absorption studies with PPPs are given. Issues discussed include a brief description of the skin and its properties affecting dermal absorption. To facilitate use of the guidance, flow charts are included. Guidance is also provided, for example, when there are no data on dermal absorption for the product under evaluation. Elements for a tiered approach are presented including use of default values, data on closely related products, in vitro studies with human skin (regarded to provide the best estimate), data from experimental animals (rats) in vitro and in vivo, and the so called ‘triple pack’ approach. Various elements of study design and reporting that reduce experimental variation and aid consistent interpretation are presented. A proposal for reporting data for assessment reports is also provided. The issue of nanoparticles in PPPs is not addressed. Data from volunteer studies have not been discussed since their use is not allowed in EU for risk assessment of PPPs.

Review of the published exposure data to pesticides for residents and bystanders, and for environmental risk assessment: Final report

Review of the published exposure data to pesticides for residents and bystanders, and for environmental risk assessment: Final report

Compilation of a database, specific for the pesticide active substance and their metabolites, comprising the main genotoxicity endpoints

EFSA Supporting PublicationsVolume 14, Issue 5 1229E External scientific reportOpen Access Compilation of a database, specific for the pesticide active substance and their metabolites, comprising the main genotoxicity endpoints Francesca Metruccio, Francesca Metruccio International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorIlaria Castelli, Ilaria Castelli Universita' degli Studi di Milano - Public University, 20122 Via Festa del Perdono 7, Milan, ItalySearch for more papers by this authorConsuelo Civitella, Consuelo Civitella International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorCarmen Galbusera, Carmen Galbusera International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorFrancesco Galimberti, Francesco Galimberti International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorLuca Tosti, Luca Tosti Universita' degli Studi di Milano - Public University, 20122 Via Festa del Perdono 7, Milan, ItalySearch for more papers by this authorAngelo Moretto, Angelo Moretto Universita' degli Studi di Milano - Public University, 20122 Via Festa del Perdono 7, Milan, ItalySearch for more papers by this author Francesca Metruccio, Francesca Metruccio International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorIlaria Castelli, Ilaria Castelli Universita' degli Studi di Milano - Public University, 20122 Via Festa del Perdono 7, Milan, ItalySearch for more papers by this authorConsuelo Civitella, Consuelo Civitella International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorCarmen Galbusera, Carmen Galbusera International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorFrancesco Galimberti, Francesco Galimberti International Centre for Pesticides and Health Risk Prevention (ICPS), ASST Fatebenefratelli Sacco - Azienda Ospedaliera e Polo Universitario, 20157 via G.B. GRASSI 74, Milan, ItalySearch for more papers by this authorLuca Tosti, Luca Tosti Universita' degli Studi di Milano - Public University, 20122 Via Festa del Perdono 7, Milan, ItalySearch for more papers by this authorAngelo Moretto, Angelo Moretto Universita' degli Studi di Milano - Public University, 20122 Via Festa del Perdono 7, Milan, ItalySearch for more papers by this author First published: 17 May 2017 https://doi.org/10.2903/sp.efsa.2017.EN-1229Citations: 7 Question number: EFSA-Q-2014-00643 Disclaimer: The present document has been produced and adopted by the bodies identified above as author(s). In accordance with Article 36 of Regulation (EC) No 178/2002, this task has been carried out exclusively by the author(s) in the context of a grant agreement between the European Food Safety Authority and the author(s). The present document is published complying with the transparency principle to which the Authority is subject. It cannot be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. AboutPDF 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 References 1 Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market 2 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EC and 91/414/EEC. Official Journal L 309, 1-50. 24 November 2009 3 OECD, Guidance document on the definition of residue (as revised in 2009), Series on testing and assessment Nr. 63, Series on Pesticides Nr. 31, 28-Jul-2009 4 http://www.efsa.europa.eu/en/supporting/pub/44e.htm 5 http://www.efsa.europa.eu/en/supporting/pub/50e.htm 6 http://www.efsa.europa.eu/en/efsajournal/doc/49e.pdf 7 http://www.efsa.europa.eu/en/supporting/pub/169e.htm 8EFSA Panel on Plant Protection Products and their Residues (PPR); Scientific Opinion on Evaluation of the Toxicological Relevance of Pesticide Metabolites for Dietary Risk Assessment. EFSA Journal 2012; 10(07): 2799. [187pp.] doi:10.2903/j.efsa.2012.2799. Available online: www.efsa.europa.eu/efsajournal Citing Literature Volume14, Issue5May 20171229E ReferencesRelatedInformation

EFSA's 21st Scientific Colloquium on Harmonisation of human and ecological risk assessment of combined exposure to multiple chemicals

EFSA's 21st Scientific Colloquium on Harmonisation of human and ecological risk assessment of combined exposure to multiple chemicals

Outcome of the Public Consultation on the draft EFSA Guidance Document on the Assessment of Exposure for Operators, Workers, Residents and Bystanders in Risk Assessment for Plant Protection Products

EFSA Supporting PublicationsVolume 11, Issue 10 681E Technical reportOpen Access Outcome of the Public Consultation on the draft EFSA Guidance Document on the Assessment of Exposure for Operators, Workers, Residents and Bystanders in Risk Assessment for Plant Protection Products European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 23 October 2014 https://doi.org/10.2903/sp.efsa.2014.EN-681 Published date: 23 October 2014 Question number: EFSA-Q-2014-00081 AboutPDF 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 References EC (European Commission), 2009. Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. EFSA Panel on Plant Protection Products and their Residues (PPR), 2008 Scientific Opinion of the Panel on Plant protection products and their Residues (PPR) on the Science behind the Guidance Document on Risk Assessment for birds and mammals. Revision of Guidance Document under Council Directive 91/414/EEC (SANCO/4145/2000 – final of 25 September 2002). EFSA Journal (2008) 734: 1– 181 EFSA Panel on Plant Protection Products and their Residues (PPR), 2013. Scientific Opinion on the developmental neurotoxicity potential of acetamiprid and imidacloprid. EFSA Journal 2013; 11(12): 3471. doi:10.2903/j.efsa.2008.734. EFSA Scientific Committee, 2013. Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA Journal 2013; 11(3):3132 84 pp. doi:10.2903/j.efsa.2013.3132. Fantke P, Juraske R, 2013. Variability of Pesticide Dissipation Half-Lives in Plants, Environmental Science & Technology, 47 (8), pp 3548– 3562 Koenker R, 2005. Quantile Regression. Economic Society Monographs No 38, ed. by A Chesher and M Jackson, Cambridge University Press, 368 pp. Krishnamoorthy K, 2006. Handbook of statistical distributions with applications, Chapman & Hall, section 10.4.3, p. 130 OECD (Organisation for Economic Co-operation and Development), 1997. Guidance document for the conduct of studies of occupational exposure to pesticides during agricultural application. Series on testing and assessment no 9. Geisser S, 1993. Predictive inference: an introduction, Chapman & Hall, section 2.1, example 2.2, p. 9– 10. PSD (Pesticide Safety Directorate). Bystander exposure guidance. Available online: http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/B/Bystander-exposure-guidance.pdf Siebers JN, Binner R and Wittich KP, 2003. Investigation on downwind short-range transport of pesticides after application in agricultural crops. Chemosphere, 51, 397– 407. TNsG (2002) Human exposure to Biocidal Products—Guidance on exposure estimation (June 2002), TNsG (2007) Human exposure to Biocidal Products (June 2007). US Environmental Protection Agency (EPA) Advisory Panel on reentry exposure (http://www.epa.gov/opp00001/science/USEPA-OPP-HED_ExpoSAC%20Policy%203_July2012.pdf). US Environmental Protection Agency (EPA) Health Effects Division Office of Pesticide Programs (2012). Standard Operating Procedures for Residential Pesticide Exposure Assessment (available at http://www.epa.gov/opp00001/science/USEPA-OPP-HED_Residential%20SOPs_Oct2012.pdf) Volume11, Issue10October 2014681E ReferencesRelatedInformation

Outcome of the First Round of Public Consultation on the draft Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and Solitary Bees)

Outcome of the First Round of Public Consultation on the draft Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and Solitary Bees)

Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of plant protection products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific opinion on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) (EFSA Panel on Plant Protection Products and their Residues (PPR), 2012a) provided the scientific basis for the development of the Guidance Document. Specific Protection Goals were agreed in consultation with the Standing Committee on the Food Chain and Animal Health. The Guidance Document suggests a tiered risk assessment scheme with a simple and cost-effective first tier to more complex higher tier studies under field conditions. Each of the tiers will have to ensure that the appropriate level of protection is achieved.

Scientific Opinion on the report of the FOCUS groundwater working group (FOCUS, 2009): assessment of higher tiers

Following a request from the European Commission, the Panel on Plant Protection Products and their Residues (PPR) was asked to deliver a scientific opinion on the report of the FOCUS groundwater working group (FOCUS, 2009) with respect to the higher tier leaching assessments. The PPR Panel is of the general opinion that, as suggested in the FOCUS report, substance parameter refinement can be applied in risk assessment. State of the art knowledge has developed to such an extent that scenario refinement is feasible as well, but will make assessment more complex unless embedded in basic tools and adequate guidance. The same is true for spatial modelling but establishment of adequate databases will require quite some effort. The Panel considers current knowledge on groundwater hydrology insufficient for implementation of monitoring as the highest tier of the assessment at the European level. The implementation of scenario refinement and spatial modelling requires clear criteria on the extent of arable surface areas with estimated leaching rates below the threshold level.

Scientific Opinion on the report of the FOCUS groundwater working group (FOCUS, 2009): assessment of lower tiers

Following a request from the European Commission, the Panel on Plant Protection Products and their Residues (PPR) was asked to deliver a scientific opinion on the report of the FOCUS groundwater working group (FOCUS, 2009) with respect to lower tier leaching assessments. The PPR Panel is of the general opinion that the FOCUS groundwater working group has successfully harmonised major concepts in the leaching models and that, overall, the leaching estimations have improved. Despite several limitations, the PPR Panel considers that the revised FOCUS scenarios cover significant arable areas in the EU, including the New Member States, and allow for decision making at the EU level. The PPR Panel however has observed that flaws in underlying data have become apparent after finalising the report. Also new approaches on scenario selection have become available. The PPR Panel recommends that these flaws and new approaches are taken into account when developing revised scenarios.

Scientific Opinion on Evaluation of the Toxicological Relevance of Pesticide Metabolites for Dietary Risk Assessment

The European Food Safety Authority (EFSA) asked the Panel on Plant Protection Products and their Residues (PPR) to develop an opinion on approaches to evaluate the toxicological relevance of metabolites and degradates of pesticide active substances in dietary risk assessment. This opinion identifies the threshold of toxicological concern (TTC) concept as an appropriate screening tool. The TTC values for genotoxic and toxic compounds were found to be sufficiently conservative for chronic exposure, as a result of a validation study with a group of pesticides belonging to different chemical classes. Three critical steps were identified in the application of a TTC scheme: 1) the estimate of the level of the metabolite, 2) the evaluation of genotoxicity alerts and 3) the detection of neurotoxic metabolites. Tentative TTC values for acute exposure were established by the PPR Panel by analysis of the lowest 5th percentiles of No Observed Adverse Effect Levels (NOAELs) used to establish the Acute Reference Doses (ARfD) for the EFSA pesticide data set. Assessment schemes for chronic and acute dietary risk assessment of pesticide metabolites, using the TTC approach and combined (Q)SAR and read across, are proposed. The opinion also proposes how the risk assessment of pesticide metabolites that are stereoisomers should be addressed due to isomer ratio changes reflected in the composition of metabolites. The approach is ready for use, but it is anticipated that on many occasions the outcome of the assessment scheme will be that further testing is needed to reach a firm conclusion on the toxicological relevance of the metabolite. However, the benefit of applying the approach is that it will allow prioritisation of metabolites for subsequent testing. EFSA will develop a Guidance Document based on the results in this opinion.

Tier-1 and Tier-2A Scenario Parameterisation and Example Calculations - In Support of the Revision of the Guidance Document on Persistence in Soil under Council Directive 91/414/EEC and Parliament and Council Regulation (EC) 1107/2009 (SANCO/9188/VI/97 re

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 totalsoil 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

Development of a framework based on an ecosystem services approach for deriving specific protection goals for environmental risk assessment of pesticides

General protection goals for the environmental risk assessment (ERA) of plant protection products are stated in European legislation but specific protection goals (SPGs) are often not precisely defined. These are however crucial for designing appropriate risk assessment schemes. The process followed by the Panel on Plant Protection Products and their Residues (PPR) of the European Food Safety Authority (EFSA) as well as examples of resulting SPGs obtained so far for environmental risk assessment (ERA) of pesticides is presented. The ecosystem services approach was used as an overarching concept for the development of SPGs, which will likely facilitate communication with stakeholders in general and risk managers in particular. It is proposed to develop SPG options for 7 key drivers for ecosystem services (microbes, algae, non target plants (aquatic and terrestrial), aquatic invertebrates, terrestrial non target arthropods including honeybees, terrestrial non-arthropod invertebrates, and vertebrates), covering the ecosystem services that could potentially be affected by the use of pesticides. These SPGs need to be defined in 6 dimensions: biological entity, attribute, magnitude, temporal and geographical scale of the effect, and the degree of certainty that the specified level of effect will not be exceeded. In general, to ensure ecosystem services, taxa representative for the key drivers identified need to be protected at the population level. However, for some vertebrates and species that have a protection status in legislation, protection may be at the individual level. To protect the provisioning and supporting services provided by microbes it may be sufficient to protect them at the functional group level. To protect biodiversity impacts need to be assessed at least at the scale of the watershed/landscape.

Outcome of the Public Consultation on the DRAFT Guidance for evaluating and using results of field persistence and soil accumulation experiments for exposure assessment of soil organisms to substances in soil

EFSA JournalVolume 8, Issue 12 1938 Scientific and Technical ReportOpen Access Outcome of the Public Consultation on the DRAFT Guidance for evaluating and using results of field persistence and soil accumulation experiments for exposure assessment of soil organisms to substances in soil EFSA Panel on Plant Protection Products and their Residues (PPR), EFSA Panel on Plant Protection Products and their Residues (PPR)Search for more papers by this author EFSA Panel on Plant Protection Products and their Residues (PPR), EFSA Panel on Plant Protection Products and their Residues (PPR)Search for more papers by this author First published: 16 December 2010 https://doi.org/10.2903/j.efsa.2010.1938 Correspondence: PPR@efsa.europa.eu Acknowledgement: EFSA wishes to thank the members of the Sub-Working Group on Persistence in soil/Fate: Jos Boesten, Michael Klein, Richard Bromilow, Jan Vanderborght, Ton van der Linden, Walter Steurbaut for the preparatory work on this scientific output and EFSA staff: Nicoleta Alina Suciu and Mark Egsmose for the support provided to this scientific output. Approval date: 15 December 2010 Published date: 16 December 2010 Question number: EFSA-Q-2010-00932 On request from: EFSA AboutPDF 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 Volume8, Issue12December 20101938 RelatedInformation

Scientific Opinion on emissions of plant protection products from greenhouses and crops grown under cover: outline for a new guidance

The European Food Safety Authority (EFSA) asked the Panel on Plant Protection Products and their Residues (PPR) to develop an inventory of protected crop systems (e.g. greenhouses and cultivations grown under cover) and emissions from these systems to relevant environmental compartments, and to provide guidance on the importance of emission routes including the circumstances under which they are relevant. Based on literature research, the Panel concludes that such systems generally do not prevent emissions and that development of an environmental risk assessment is warranted for some cases. A system for classifying the variety of protected crop systems is proposed. Water and air may carry plant protection products across the boundaries of the systems. As the systems need ventilation and in general water is supplied in excess, it is to be expected that emissions are not necessarily different from emissions in the open field. The Panel proposes as a starting point that emissions are not different. A decision scheme was then developed in order to identify for which systems emissions might be different from field crops. However, in order to complete the decision scheme, further investigation, including scenario analyses, is necessary. These analyses will be addressed in a future opinion. The Panel concludes that it is not necessary to develop new methods for soil exposure in protected crop systems as this will be sufficiently covered by current methods.

The usefulness of total concentrations and pore water concentrations of pesticides in soil as metrics for the assessment of ecotoxicological effects ‐ Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR)

The usefulness of total concentrations and pore water concentrations of pesticides in soil as metrics for the assessment of ecotoxicological effects ‐ Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR)