Authorization Of Plant Protection Products Research Articles

The Glyphosate Saga in Luxembourg: The Annulment by the Judiciary of the Legislative Ban of Glyphosate-Based Products – A Breach of European Union Law?

Administrative Tribunal of Luxembourg, 15 July 2022, case no 44377 and Court of Appeal of Luxembourg, 31 March 2023, case no 47873COn 15 July 2022, the Administrative Tribunal of Luxembourg annulled the decisions by which the Luxembourg Minister for Agriculture, Viticulture, and Consumer Protection had banned all glyphosate-based products. On 31 March 2023, the Court of Appeal upheld the ruling of the Administrative Tribunal. The ground of annulment was the breach by the Luxembourg State of the adversarial principle enshrined in Article 9 of the Grand-Ducal Regulation of 8 June 1979. Yet, for the sake of completeness, the Administrative Tribunal and the Court of Appeal verified the compliance of the decisions banning glyphosate-based products with Articles 36, 41 and 44 of Regulation no 1107/2009. Against this backdrop, this case note provides a critical assessment of the rulings of the Administrative Tribunal and the Court of Appeal from the perspective of European Union law. This analysis might prove to be useful as it enables us to shed light on the conditions allowing Member States to withdraw the authorisation of plant protection products under Regulation no 1107/2009 as well as to identify the hurdles that Member States might need to overcome when banning glyphosate-based products from their territory.

Considering variation in bee responses to stressors can reveal potential for resilience

Abstract Environmental stressors frequently have sublethal consequences for animals, often affecting the mean of phenotypic traits in populations. However, effects on inter‐individual variability are poorly understood. Since phenotypic variability is the basis for adaptation, any change due to stressors may have important implications for population resilience. Here, we explored this possibility in bees by analysing raw datasets from 23 studies (5618 bees) in which individuals were first exposed to stressors and then tested for cognitive tasks. While all types of stressors decreased the mean cognitive performance of bees, they increased cognitive variability. Focusing on 14 pesticide studies, we found that the mode of exposure to stressors and the dose were critical. Mean cognitive performance was more affected by a chronic exposure than by an acute exposure. Yet, cognitive variability increased with increasing doses following both exposure durations. Policy implications. Current guidelines for the authorization of plant protection products on the European market prioritize acute over chronic toxicity assessments on non‐target organisms. By overlooking the consequences of a chronic exposure, regulatory authorities may register new products or doses that are harmful to bee populations. Our findings call for more research on stress‐induced phenotypic variation and its incorporation into policy guidelines to help identify levels and modes of exposure animals can cope with.

Dermal measurement of exposure to plant protection products: Actual hand exposure from hand washing vs. wearing cotton gloves.

For the authorization of plant protection products, a quantitative non-dietary exposure risk assessment relies on established dermal exposure models, measured mainly using passive dosimetry. Exposure to the hands is determined via hand washing or using cotton gloves as a surrogate for skin. This study compared both methods using operator exposure data available from the Agricultural Operator Exposure Model (AOEM) project report. These data indicate that hand exposure determined using cotton gloves resulted in markedly higher exposure values for all exposure scenarios compared to those determined by hand washes. One explanation for this is that dermal uptake of the residues reduces the amount of residue that can be recovered by hand washing. Uncertainty due to dermal uptake can be addressed by either default assumptions or by specific dermal absorption data. However, this cannot solely account for the large difference observed between the values and is mainly likely to be due to the higher capacity of the cotton gloves vs. human skin to retain residues. The results further indicate that the variability between hand wash samples and cotton glove samples differs between the exposure scenarios. Hence, the level of conservatism related to the use of cotton gloves as surrogate skin remains unknown. In conclusion, this evaluation of the AOEM data indicates that the cotton glove method results in much higher levels of measured hand exposure than the hand wash method. It cannot be excluded that dermal uptake has contributed to that result. However, the findings suggest the higher retention capacity of cotton gloves vs. human skin to be the main impact parameter. The cotton glove method does not provide the results with regards to the protection level that can be expected from the use of protective gloves. Therefore, we believe that the application of the hand wash method is a more accurate measure of exposure levels, if either specific dermal absorption data or, in its absence, default assumptions are applied as adjustment factor.

Residue, dissipation, and dietary intake evaluation of fenpyroximate acaricide in/on guava, orange, and eggplant under open field condition.

Fenpyroximate is a widely used acaricide applicable in many crops. In this study, the residue behavior of fenpyroximate on eggplant, orange, and guava was investigated. The chronic and acute dietary intake was calculated at several sampling points, and preharvest intervals (PHI) were proposed to ensure compliance with the existing maximum residue levels. A simple extraction protocol combined with ultrahigh-performance liquid chromatography–tandem mass spectrometry (UHPLC-MS/MS) was employed to quantify residue levels. The method was successfully validated according to the European Union (EU) guidelines, and a limit of quantification of 0.01 mg/kg was set. The dissipation patterns in all crops could be described by the first-order kinetics model with half-lives of 1.7, 2.2, and 1.9 days for eggplants, guavas, and oranges, respectively. The dietary risk assessment at the authorized or more critical application patterns was acceptable for the consumers. For oranges and eggplant, a PHI of 3 and 7 days, respectively, can be proposed; however, a proposal was not possible for guava due to the absence of maximum residue limits (MRLs) and quantitative residue findings at all sampling points tested. The current work not only contributes to the practical application of fenpyroximate related to residue management in dryland areas, such as Egypt, but can also be used to estimate the appropriate PHIs and support the authorization of plant protection products as supplementary information.

Mix-Tool: An Edge-of-Field Approach to Predict Pesticide Mixtures of Concern in Surface Water From Agricultural Crops.

Current regulation on the authorization of plant protection products (PPPs) in the European Union is limited to the evaluation of ecological risks for the single active substances they contain. However, plant protection treatments in agriculture often consist of PPPs already containing more than one active substance; moreover, each cropped field receives multiple applications per year, leading to complex pesticide mixtures in the environment. Different transport processes lead to a multitude of heterogeneous and potentially toxic substances that, for example, may reach water bodies and act simultaneously on natural freshwater ecosystems. In this context, the development of methodologies and tools to manage risks of pesticides mixtures is imperative to improve the current ecological risk assessment procedures and to avoid further deterioration of ecological quality of natural resources. The present study suggests new procedures for identifying pesticide mixtures of potential concern released from agricultural crops in surface water. The approach follows the European Union regulatory context for the authorization of PPPs in the market (edge‐of field risk assessment) and requires the use of Forum for the Co‐ordination of pesticide fate models and their Use (FOCUS) models (Step 3 and 4) for calculating the concentrations in surface water of mixture components on a daily basis. Moreover, it uses concentration addition models to calculate the toxic potency of the pesticide mixtures released by a treated crop. To implement this procedure, we developed a simple Microsoft‐Excel‐based tool. We also considered two case studies (maize and apple tree), representative of Italian agricultural scenarios for annual and perennial crops. Moreover, we compared results with 3 years of monitoring data of surface water bodies of the Lombardia region (northern Italy) where the two crops are largely present. Environ Toxicol Chem 2022;41:2028–2038. © 2022 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Assessing assessors: proposal for a guidance for evaluating the scientific performance of a pesticide regulatory authority

External evaluations by an international committee of the scientific risk assessment and decision-making processes of the Netherlands Competent Authority for the authorisation of plant protection products and biocides (Ctgb) were conducted in 2013 and 2018. Based on the experience drawn from them, a general guidance for such visitations is suggested. An international visitation committee examined the structure and management of the Authority, its human resources and staff policy, the scientific processes and output, the documentation and communication of its decisions and the mechanisms for keeping up to date with international scientific developments. Attention was paid to the degree of openness and transparency throughout the organisation and in particular when dealing with confidential information. From the experience gained it can be concluded that visitations not aiming at finding mistakes and omissions but instead focusing on recommendations and constructive suggestions will result in cooperation, mutual trust and acceptance of the recommendations made. A follow-up visitation after a few years can be effective in maintaining a traceable, high-level scientific output. In view of the strong drive towards the European Union-wide harmonisation of the regulatory practices of hazardous chemicals, a voluntary evaluation of regulatory authorities’ scientific performance is recommended as a means for organisational learning.

Study of the different evaluation areas in the pesticide risk assessment process.

Approval of active substances and authorisation of plant protection products in the EU is made based on a strict risk assessment of the agronomic use of the plant protection products. Regulation 1107/2009 regulates the procedure in the EU with complex procedures involving many actors. ‘The Farm to Fork strategy’ and ‘The Biodiversity for 2030 strategy’, that are the heart of the ‘European Green Deal’, aiming to make food systems fair, healthy, environmentally friendly and put Europe's biodiversity on the path to recovery by 2030, for the benefit of people, climate and the planet. Therefore, ‘The Farm to Fork strategy’ and ‘The Biodiversity for 2030 strategy’ represents a challenge for the evaluation and authorisation of plant protection products in which the risk management will constitute a key element on the approval of active substances and authorisation of plant protection products. The aim of the work was to get knowledge of the large body of EU legislation and guidelines in the plant production products, identifying the most critical points of the pesticide evaluation in each of its areas, analysing the complexity and the interaction between these different areas. This study allowed to have a global and clearer vision of these procedures, with the focus on highlighting inconsistency and to propose speed up alternatives. Finally, this work will also facilitate not only the risk assessment but also the decision‐making on the approval of active substances and the authorisation of plant protection products.

Impact of Brexit on Zonal Approval Procedures and Mutual Recognition Procedures in Plant Protection Legislation

On 29 March 2017, the UK made use of Article 50 of the Treaty on European Union (TEU) and thus initiated its withdrawal from the European Union. As a result, the UK left the European Union on 31 January 2020 (23:00 UTC). This paper provides a legal assessment of the impact of the UK’s withdrawal from the European Union (Brexit) on zonal authorisation and mutual recognition procedures regarding the authorisation of plant protection products. Many legal issues are unclear in this respect due to the lack of European and national case law. The German Administrative Court of Braunschweig had to decide in an urgent procedure on the effects of Brexit with regards to the authorisation of a plant protection product in the mutual recognition procedure.

Comparative Assessment of Vegetative and Reproductive Terrestrial Plant Species Endpoints from Exposure to Herbicides and Potential Environmental Implications: A Review.

To investigate whether vegetative endpoints are protective of reproductive endpoints in terrestrial plant risk assessments (RAs) for authorization of plant protection products (PPPs), we assessed differences in sensitivity to herbicides between these parameters. Published literature and unpublished proprietary data generated for the registration of PPPs were used to compile a database. If reproductive endpoints were systematically more sensitive than the vegetative endpoints on which regulatory decisions are presently based, a concern could be raised about the protectiveness of the current RA process. Vegetative and reproductive endpoints were assessed considering further potentially relevant parameters. Reproductive endpoints were compared with vegetative endpoints of juvenile plants or with those of mature plants. Direct comparison by substance-species combination proved to be most adequate and was used to calculate quotients by effect level. In addition, we assessed the spread between different effect levels, estimating by which factor the conservatism would increase if effect rate (ER)50 endpoints were replaced by ER25 or ER10 endpoints with otherwise unchanged test parameters. Reproductive endpoints were found to be similarly sensitive as vegetative endpoints derived in nontarget terrestrial plant (NTTP) studies conducted following Organisation for Economic Co-operation and Development (OECD) or US Office of Chemical Safety and Pollution Prevention (OCSPP) guidelines. A switch from vegetative to reproductive endpoints would therefore not significantly change the conservatism (less than a factor of 1.5), whereas the change from ER50 to ER10 would (by a factor of ~5 to 6). However, because ecotoxicological tests on terrestrial plants bear intrinsic high variability that prevents the reliable detection of effects at the 10% effect level, ER10 endpoints are not a reliable basis for RA. No particular family, genus, or species with clusters of distinctly insensitive vegetative and sensitive reproductive endpoints could be identified that would call for regular testing of reproductive endpoints. Also, from the data set available, no specific herbicidal modes of action could be singled out for acting particularly on reproductive endpoints. Integr Environ Assess Manag 2020;16:166-183. © 2019 SETAC.

Assessment of occupational and dietary exposure to pesticide residues.

Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on the authorisation of PPPs containing approved substances. In agriculture, exposure to PPPs and their residues during occupational tasks is estimated prior to product authorisation, using models fed with study‐specific (e.g. absorption, dissipation) and default values. Exposure of workers to pesticide residues reduces with the pesticide's dissipation time during crop‐related tasks. However, the current risk assessment gap is that no methodology is available to calculate the re‐entry interval (REI) for workers, which specifies how long they should wear personal protective clothing during their first entry into pesticide‐sprayed crops. Protective clothing (such as gloves) can reduce pesticide residue exposure to an acceptable level of worker safety. Within the European Food Risk Assessment Fellowship Programme (EU‐FORA) assignment, a methodology was developed to calculate agricultural‐use‐specific and pesticide‐specific REIs for which period workers should wear gloves. This was an assignment of the Dutch Ministry of Social Affairs and Employment. Another important aspect of risk assessment to ensure consumer safety is dietary risk assessment. A critical evaluation of residue studies and metabolism of the pesticide in question in crops results in a residue definition for dietary risk assessment and for enforcement and monitoring to define maximum residue limits allowed legally on or in raw agricultural commodities when applying pesticides according to good agricultural practices. This work was assigned by the Dutch Ministry of Health, Welfare and Sport and contributes to the work of the Joint FAO/WHO Meeting on Pesticide Residues.

Is the risk for soil arthropods covered by new data requirements under the EU PPP Regulation No. 1107/2009?

Testing of effects on earthworms and non-target foliar arthropods is an integral part of the ecotoxicological risk assessment for the authorization of plant protection products. According to the new data requirements, which came into force in 2014 for active substances and in 2016 for plant protection products, the chronic earthworm toxicity test with Eisenia fetida based on reproductive, growth, and behavioral effects instead of the acute earthworm toxicity test based on mortality, has to be conducted routinely. Additional testing of effects on soil arthropods (Folsomia candida, Hyposaspis aculeifer) is required if the risk assessment of foliar applications raises concerns regarding non-target foliar arthropods (Aphidius rhopalosiphi, Typhlodromus pyri) or if the product is applied directly on or into the soil. Thus, it was investigated whether the sublethal earthworm endpoint is more sensitive than the sublethal soil arthropod endpoint for different types of pesticides and whether the risk assessment for non-target arthropods would trigger the testing of effects on soil arthropods in the cases where soil arthropods are more sensitive than earthworms. Toxicity data were obtained from Swiss ecotoxicological database, EFSA Conclusions and scientific literature. For insecticides and herbicides, no general conclusion regarding differences in sensitivity of either earthworms or soil arthropods based on sublethal endpoints were possible. For fungicides, the data indicated that in general, earthworms seemed to be more sensitive than soil arthropods. In total, the sublethal F. candida or H. aculeifer endpoint was lower than the sublethal E. fetida endpoint for 23 (34%) out of 68 active substances. For 26% of these 23 active substances, testing of soil arthropods would not have been triggered due to the new data requirement. These results based on sublethal endpoints show that earthworms and soil arthropods differ in sensitivity toward certain active substances and that the risk assessment for non-target foliar arthropods did not always trigger soil arthropod testing in the cases where soil arthropods were more sensitive than earthworms.

Pesticide regulatory risk assessment, monitoring, and fate studies in the northern zone: recommendations from a Nordic-Baltic workshop.

The recent revision of the legal framework for authorization of use of plant protection products and pesticides within the European Union/European Economic Area (EU/EEA; Regulation EC 1107/2009, Directive 2009/128/EC) imposes a need for close collaboration across country borders within the three pesticide authorization zones (designated the north, central, and south zones) in Europe. The principles of zonal evaluation and mutual recognition embedded in Regulation EC 1107/2009 concerning marketing of plant protection products are intended to reduce the approval times for pesticides. However, the three authorization zones represent a very simplified view compared to the 16 climatic zones/scenarios that have been outlined for pesticide modeling in Europe (Blenkinsop et al. 2008; Fig. 1). Pedoclimatic or agricultural constraints could entitle the individual states to adopt restrictions on the use of pesticides approved within their zone or even to refuse approval. Fig. 1 Zones for pesticide authorization overlaid on climatic zones for pesticide modeling (reprinted from Blenkinsop et al. 2008 with permission from Elsevier) in Europe To achieve a sound scientific basis for zonal evaluation and collaboration on a regulatory level, it is also necessary to increase research collaboration and knowledge exchange within the scientific community. Here, we report the main conclusions and recommendations from a Nordic-Baltic workshop on the environmental fate of pesticides, which was conducted in As, Norway, in September 2014 with the aim of promoting knowledge exchange, network building, and a common agenda for future research within the northern zone. Pesticide regulatory risk assessment in the northern zone Zonal evaluation and mutual recognition The “Guidance document on work sharing in the Northern zone in the authorization of plant protection products” (Anonymous 2015) states that the northern zone cooperation includes the EU member states Denmark, Sweden, Finland, Estonia, Latvia, and Lithuania, as well as the European Economic Community/European Free Trade Association (EEC/EFTA) members Norway and Iceland. The guidance document was implemented in all countries within the zone from January 2015. Climatic zones for pesticide modeling (Blenkinsop et al. 2008) reflect the complexity of the different authorization zones within Europe (Fig. 1). According to this classification, the northern zone countries cover seven of the 16 climatic zones (Table ​(Table1).1). The variation within the northern zone is further illustrated by the 13 environmental zones representing an aggregation of the environmental stratification of Europe (Metzger et al. 2005; Jongman et al. 2006), five of which are covered by the northern zone countries (Table ​(Table2).2). The duration of the growing season and the sum of active temperatures are doubled when moving southward from the alpine north to the Atlantic north. This will inevitably affect the possibility of harmonizing risk assessment procedures and/or requirements between the countries within the northern zone, and it will also influence the commercial viability of the pesticide industry. Table 1 Climate zones for pesticide modeling (Blenkinsop et al. 2008) in the northern zone countries Table 2 Growing season characteristics in the northern zone based on the environmental stratification of Europe (Metzger et al. 2005; Jongman et al. 2006) Due to the strict limits of the timeline for the zonal evaluation (SANCO/13169/2010 rev. 9), there must be good agreement between the countries in the northern zone to ensure a satisfactory risk assessment. The time frame during which the member states are to appraise specific national concerns comprises a period of 6 weeks for commenting on the draft regulatory report and 120 days for assessment after the initial zonal evaluation.

Pesticide exposure assessment for surface waters in the EU. Part 1: Some comments on the current procedure.

In 2001, the European Commission introduced a risk assessment project known as FOCUS (FOrum for the Coordination of pesticide fate models and their USe) for the surface water risk assessment of active substances in the European Union. Even for the national authorisation of plant protection products (PPPs), the vast majority of EU member states still refer to the four runoff and six drainage scenarios selected by the FOCUS Surface Water Workgroup. However, our study, as well as the European Food Safety Authority (EFSA), has stated the need for various improvements. Current developments in pesticide exposure assessment mainly relate to two processes. Firstly, predicted environmental concentrations (PECs) of pesticides are calculated by introducing model input variables such as weather conditions, soil properties and substance fate parameters that have a probabilistic nature. Secondly, spatially distributed PECs for soil-climate scenarios are derived on the basis of an analysis of geodata. Such approaches facilitate the calculation of a spatiotemporal cumulative distribution function (CDF) of PECs for a given area of interest and are subsequently used to determine an exposure concentration endpoint as a given percentile of the CDF. For national PPP authorisation, we propose that, in the future, exposure endpoints should be determined from the overall known statistical PEC population for an area of interest, and derived for soil and climate conditions specific to the particular member state. © 2016 Society of Chemical Industry.

Hazard and risk based allocation of safety instructions to operators handling pesticides

Prior to authorisation of plant protection products (PPP) according to Regulation (EC) No 1107/2009 it must be ensured that products placed on the market will not impair the health of humans and animals if used appropriately and as intended. For safe use of pesticides, it is generally necessary to assign obligatory instructions for operators to comply with risk mitigation measures. These instructions are allocated due to the intrinsic toxicological properties of the products combined with qualitative exposure aspects, e.g. for different formulation types and application scenarios. The toxicological properties of PPP are evaluated on the basis of the uniform principles according to Regulation (EC) No 1107/2009, and are communicated by the classification and labelling of the products. Additionally, quantitative exposure estimations carried out within the risk assessment for the products might result in additional instructions for safe use. Those instructions aim to ensure, that the respective toxicological reference value will not be exceeded. The latter issue will be addressed in another article. The general principles for assigning mandatory instructions for professional and non-professional operators of PPP concerning human health are based on the classification and labelling of PPP according to Regulation (EC) No 1272/2008 (CLP-Regulation). Plant protection products are classified based on toxicological tests (mainly acute toxicity, irritation and sensitisation) and on conventional methods based on the above mentioned Regulation (mainly for subacute and chronic effects). Since the CLP-Regulation is obligatory for classification and labelling of mixtures such as PPP from 1 June 2015 onwards, it will be necessary to replace BBA uniform principles for safeguarding the health of applicators of plant protection products (1993) Part 1, 3–3 and adapt its principles for assigning PPE and instructions for safe use on the basis of the new classification and labelling principles for products. This article will provide the necessary support for risk management decisions concerning human health. It presents principles to implement, adapt and specify the rather imprecise provisions concerning the use of PPE laid down in CLP-Regulation to the particular requirements for handling and applying PPP. It might be a basis for European harmonisation concerning allocation of risk mitigation measures to professional and non-professional operators of pesticides, thus, adjusting the different levels of operator protection in the Member States, as stated in Regulation (EC) No 1107/2009.

Laudation for PD Dr. Wolfgang Ahlf to celebrate his 65th birthday

In 1982, the University of Technology Hamburg-Harburg (TUHH), Germany, installed a new section under the programme title BPreventive Environmental Protection Technologies in an Ecological Context^. In retrospective, it was less difficult to find a director and a chief engineer, doctoral students and laboratory staff; rather, the search was for a broadly qualified biologist, who could manage the embedding of the other scientists and engineers within an ecological concept. The practical issues that the section needed to address were common knowledge in the BHamburg industrial landscape^: historical contaminated sediments in the Elbe, dredged materials in the harbour, arsenic in air and soil around the BAffi^ (the Norddeutsche Affinerie, a copper ore refinery and well-known industrial polluter in the 1970s and 1980s that was close to Hamburg) and soon the situation culminating in the international case of dioxins at Georgswerder. Professor AdolfWeber, director at the Botanical Institute of the University of Hamburg and an expert on environmental issues in the Hamburg State planning group, convinced a promising young colleague (Ahlf 1983) to join our team. At the end, even the administration at TUHH changed its strict department structure rules to provide a permanent position to Wolfgang Ahlf. Wolfgang Ahlf and his Becotoxicology^ research group fulfilled its specific mandate in all respects. Our Monday morning meetings got instructions at different levels, from scientific publishing to global environmental ethics, and our projects and those of the neighbouring departments were checked for their ecological correctness. The two big Collaborative Research Programs of the German Research Foundation (DFG), SFB 327 Interactions between Abiotic and Biotic Processes in the Tidal Elbe (1986–1995) and, particularly, SFB 188 Treatment of Contaminated Soil (1988–2000) profited much from Wolfgang Ahlf’s competence, eloquence and ecological spirit. During all these years, one cannot remember the failure of any proposal when he was personally involved. In our transdisciplinary view, one of the secrets for success of the Harburg ecotoxicologists was their pragmatic approach. From the beginning, the group focussed on interfaces and on real world situations rather than on models. The typical test systems for the study of competing sorption and uptake of contaminants by different substrates and organisms were two-chamber and multichamber devices (Ahlf 1985). The biggest challenge for ecotoxicologists is the transfer of laboratory and field results into risk assessment schemes and finally into regulations. The activities of Wolfgang Ahlf during the last 25 years centred around microbial biotests for the toxicological assessment of contaminated sediments, both in the international network of the Society of Environmental Toxicology and Chemistry (SETAC) and with a national focus on the contact test (Feiler et al. 2013). In 2002,Wolfgang Ahlf was appointed to the national committee of experts for the authorisation of plant protection products. Since 2003, the group undertook a new orientation in the direction of an ecological assessment of chemicals in foodstuffs. Since the beginning of the Journal of Soils and Sediments in 2001 until 2015, Wolfgang Ahlf served as a valuable member of the Editorial Board and both his * Ulrich Forstner u.foerstner@tu-harburg.de

A new model for the prediction of agricultural operator exposure during professional application of plant protection products in outdoor crops

A new predictive model for the estimation of agricultural operator exposure has been developed on the basis of new exposure data to improve the current agricultural operator exposure and risk assessment in the EU. The new operator exposure model represents current application techniques and practices in EU Member States (MS) and is applicable for national or zonal authorisation of plant protection products as well as for approval of active substances in plant protection products (PPP) supporting a stepwise risk assessment. 34 unpublished exposure studies conducted between 1994 and 2009 were evaluated for the new model. To ensure a very high quality of data the studies had to meet a set of quality criteria, e.g. GLP conformity or compliance with OECD guidance. Exposure data and supplementary information on the trials were used for a statistical analysis of exposure factors. The statistical analyses resulted in six validated models for typical outdoor scenarios of pesticide mixing/loading and application. As a major factor contributing to the exposure of operators, the amount of active substance used per day was identified. Other parameters such as formulation type, droplet size, presence of a cabin or density of the canopy were selected as factors for sub-scenarios. For two scenarios the corresponding datasets were too small to identify reliable exposure factors; instead the relevant percentiles of the exposure distribution were used. The whole project report on the development of the new model (including the underlying study data) and the corresponding exposure calculators will be published at the BfR website (http://www.bfr.bund.de) after confirmation of the model by EU MS.

Occurrence and distribution of earthworms in agricultural landscapes across Europe with regard to testing for responses to plant protection products

Within the regulatory framework for authorisation of plant protection products (PPPs) (EU Directive 91/414/1991/EEC replaced by Regulation (EC) 1107/2009), higher tier risk assessments and earthworm field tests are conducted in different countries across Europe. This paper describes dominant earthworm species for regulatory and biogeographical regions in agricultural landscapes across Europe and examines regional differences in earthworm communities and densities and their respective response to a toxic reference. For the assessment of earthworm abundance and species distribution, data of untreated control plots from 30 earthworm field studies were analysed; each conducted according to the ISO 11268–3 (1999) guideline by European Crop Protection Association member companies in the context of registration of PPPs. For the evaluation of the response to PPPs under different regional and climatic conditions, the effect on earthworm abundance was assessed by comparing plots treated with toxic references with untreated control plots. Additionally, a comparative literature review was included providing an overview of earthworm species composition and densities in agricultural crops from 14 European countries. The assessment of earthworm field studies from six different European countries revealed that common earthworm species of anecic and endogeic ecological groups are present at most field sites. Dominant species groups of endogeic and anecic earthworms can be defined that are abundant in all assessed countries. These are the endogeic species Aporrectodea caliginosa, Aporrectodea rosea and Allolobophora chlorotica, and the anecic species Lumbricus terrestris (Northern and Central Europe) and Lumbricus friendi (Southern Europe). Taking into account the high variability in total earthworm abundances, it can be concluded that the variability within regions was larger than the variability between regions. Analysis of the earthworm community and data of toxic references lead to the conclusion that testing in different zones is not considered necessary.

A new OECD test guideline for the predatory soil mite Hypoaspis aculeifer: Results of an international ring test

Predatory mites are considered important biological indicators to assess potential effects of plant protection products. Toxicity testing of terrestrial mite species is required for authorisation of plant protection products in the European Union in cases where testing of leaf dwelling mites is not relevant, i.e. for defoliating herbicides, or when persistence of the chemical in soil is a concern. Since a standardised guideline for soil mites was not available in the past, an international working group developed a soil ecotoxicity test with the gamasid mite Hypoaspis aculeifer. This paper outlines the guideline development process and the principles of the protocol, and presents the results of an international ring test from which the validity criteria for the final guideline were derived. The protocol, which was published as OECD guideline 226 in 2008, is suitable for routine regulatory testing and can be used to generate data for risk assessment of soil inhabiting arthropods.

Comments on pesticide risk assessment by the revision of Directive EU 91/414

Human health and the environment are major concerns for European Commission policy on the authorisation of plant protection products. The new regulation that revises and replaces the directive 91/414/EC moves towards the adoption of a Persistent Bioaccumulation Toxicity cutoff criterion because current pesticide risk assessment (PRA) is deterministic, based on few standard cases and therefore characterised by uncertainty. This revision could create concerns about sustainability. This paper analyses some effects of this directive on the agrochemical market and assumes new effects resulting from the introduction of the revision. Suggestions are made as to how pesticide risk assessment will have to adapt to answer the request of legislators on safety standards and sustainability, introducing probabilistic PRA. Toxicity and exposure functions will be fully characterised, producing distributions of predicted impact and quantifying the variability and uncertainty. For adopting PRA studies at the local/catchment scale, new assessment schemes will be necessary.

The Influence of Environmental Quality Standards and the River Basin Approach taken in the Water Framework Directive on the Authorisation of Plant Protection Products

The various approaches taken in European environmental legislation are not always coordinated. For example, the effect–oriented approach for river basins taken in the Water Framework Directive differs from the risk–based approach taken in pesticide legislation. In European environmental law there is ordinarily no method for determining the hierarchy of the obligations imposed under different environmental directives. If the relevant legislation itself is silent about the hierarchy, all the obligations apply. Coordination of the various directives and their instruments is then required. This article analyses in particular the relationship between the Water Framework Directive and the Plant Protection Products Directive. Recommendations are made on how to improve the coordination of these two directives and on the integration of the Water Framework Directive’s requirements into the national authorisation process for plant protection products.