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.

Based on this literature review on effect assessment, the PPR Panel concludes that for softbodied soil organisms (earthworms, enchytraeids, nematodes) and plants in close contact with the soil solution, pore water mediated uptake of pesticides seems mainly responsible for the effects caused, and would therefore be the relevant metric for effects assessment, and consequently also for exposure assessment. For hard-bodied soil organisms in close contact with the soil solution, less scientific evidence is available, but the evidence found for Collembola generally supports the conclusion arrived at for soft-bodied soil organisms. However, for a number of relevant soil taxa with different life and feeding strategies (e.g. mites and isopods), no information is available. For these organisms, additional routes of uptake (e.g.

SUMMARY Following a request from the Commission, the Panel on Plant Protection Products and their Residues (PPR) was asked to deliver a scientific opinion on the possible developmental neurotoxicity of deltamethrin. The potential developmental neurotoxicity of deltamethrin was addressed by the notifier in guideline-compliant reproductive and developmental toxicity studies in different animal species including a multi-generation study in rats and a separate developmental neurotoxicity (DNT) study in the rat, in accordance with the new OECD guideline TG426. The data available from the open literature include experimental studies carried out in rodents involving exposure during prenatal life and/or during neonatal life. These studies had several limitations and did not provide any clear evidence for a developmental neurotoxic effect of deltamethrin. The PPR Panel concluded that deltamethrin has been adequately tested for developmental neurotoxicity and that the available data do not indicate that deltamethrin is a developmental neurotoxic agent. The existing health-based guidance values for deltamethrin are based on neurological signs, as the most relevant critical effects observed in adult animals from different species. The lowest NOAEL of 1 mg/kg bw/day, used for risk assessment, was obtained in the 90-day and 1-year dog studies for which a 100-fold default safety factor (SF) was considered appropriate. No developmental neurotoxicity was observed at the highest dose tested of about 7 mg/kg bw/day in the DNT study complying with the new OECD guideline. This study provides a state-of-the-science evaluation of

In this Opinion the PPR Panel self- tasked to evaluate and possibly refine existing methodologies for assessing risks of exposure to two or more pesticides in combination, particularly in the context of setting MRLs according to Regulation (EC) 396/2005.The PPR Panel is of the opinion that ideally, risk assessments for chemicals, whether individually or in combination, should consider all sources (e.g., plant protection products, veterinary drugs, human medicines), pathways (e.g., food, drinking water, residential, occupational) and routes (ingestion, dermal, inhalation) of exposure that could contribute materially to a person's total exposure. The PPR Panel noted however, that appropriate data on levels of exposure to pesticides from pathways and sources other than as plant protection product residues in food are not generally available and further work is required in this respect. Therefore, at this stage the PPR Panel restricted its consideration of combined risk assessment to exposures from residues in food that could arise from plant protection products.The combined toxicity of two or more compounds can take three possible forms: dose-addition, response-addition, or interaction. However, having considered the evidence on the different forms of combined toxicity and their potential relevance to risk assessment for pesticide residues at the levels occurring in food, the PPR Panel limited this opinion to the possible impact of doseaddition. In particular, the PPR Panel noted that although toxic interactions from pesticide residues in food cannot be ruled out, there is no empirical evidence for their occurrence at the expected levels of exposure from pesticide residues in food.The PPR Panel proposes criteria by which to include compounds in a cumulative assessment group (CAG), highlighting the possibility of different levels of refinement in a step-wise approach. The grouping can be based on general criteria like chemical structure, or mechanism of pesticidal action, or more refined criteria like common toxic effect, or ultimately toxic mode of action.Several methods for cumulative risk assessment are described that use the same underlying data, although expressing the information differently. The PPR Panel concluded that the most useful methods were in increasing levels of complexity and refinement, the hazard index, the reference point index, the relative potency factor method and physiologically-based toxicokinetic (PBTK) modeling.Acute and chronic exposure scenarios for risk assessments have been considered by the PPR Panel, both in the context of MRL-setting, and also in relation to actual exposures that result from the patterns of usage that occur in practice (i.e. based on monitoring data). Each scenario can be addressed using either a deterministic or a probabilistic approach. The Panel discussed what concentration levels were represented by supervised residue trial data and (targeted) monitoring data, and which data source should be used in each exposure scenario. Proposals were made on how to deal with residues below the Limit of Detection (LOD), Limit of Quantification (LOQ), or Limit of Reporting (LOR). An overview is provided of the food consumption data available at the European level, and how to use them in cumulative exposure assessment. It should be noted that a number of the issues highlighted as of concern in cumulative risk assessment apply to risk assessment in general. However, when the data are used cumulatively their importance is magnified and therefore the PPR Panel considered it important to include them in this opinion.The available probabilistic models are briefly discussed, as well as factors to consider when assessing the reasonableness of the upper-end percentile estimates.A critical overview of cumulative risk assessments already performed is also provided in this opinion. These include assessments of organophosphorous (OP) insecticides alone (in USA) or together with carbamates (in UK, DK, NL), triazines, chloroacetanilides, carbamates alone (in USA), and all compounds (in DE). The PPR Panel noted that not all assessments were of the same depth, and that some compounds initially included in a CAG on the basis of toxicological considerations were excluded from the cumulative risk assessment on the basis of exposure considerations. It was also noted that the cumulative assessments for anticholinesterases that have been performed by several bodies did not give materially different results.General issues on uncertainty as well as those specific to cumulative risk assessment are described in this opinion along the lines of a previous PPR opinion (EFSA, 2006). Uncertainties related to residue data, consumption and toxicity evaluation are presented and a qualitative estimate of their relevance is reported.The PPR Panel identified criteria for selecting groups of compounds for consideration in a combined risk assessment. These included (a) frequency of detection in monitoring programmes, (b) high use based on surveys or sales statistics, (c) evidence of "high" intake from biomonitoring data for the general population or for sub-populations/geographical areas, (d) compounds with high exposures relative to their reference values, (e) cumulative risk assessment carried out elsewhere showing possible unacceptable exposure, (f) high number of compounds (e.g., 5 or more) in a group, (g) assumptions on future trends in use of pesticides.In addition the PPR Panel noted that assessment of specific pesticide combinations might be carried out if there were a strong biological hypothesis that certain compounds may interact below their respective No Observed Adverse Effect Levels (NOAELs).It should also be noted that presence of relevant non-food sources of exposure might require an assessment of the margin of exposure for the food part.

After application of plant protection products the chemicals in the product may volatilise from the surface of the treated plants, soil or water. These airborne residues are transported downwind, transformed, and may be deposited at short range or in remote regions. This emission is caused by processes other than spray drift, drainage, or run-off from soil. Deposition of these airborne residues may then coincide with the exposure at the edge of field already assessed in the existing risk assessment schemes, but may also result in an unassessed exposure of the terrestrial or aquatic environment, either nearby or in remote areas.The FOCUS Air group was formed to develop guidance for applicants and Member States on appropriate methods for calculating exposure concentrations resulting from emission to air of plant protection products. The FOCUS Air group has produced a Report containing a proposal for exposure assessment for plant protection products in air. The Report considered that the contribution from the deposition of volatilised residues was quantitatively less important than spray drift at the edge of field. The relative importance of deposition after volatilisation increases if spray drift mitigation is required (e.g. buffers zones, drift reducing nozzles). The short-range transport (SRT) assessment scheme uses a vapour pressure trigger to identify substances of potential concern. The trigger in the Report is 10-5 Pa (at 20 degrees C) if a substance is applied to plants and 10-4 Pa (at 20 degrees C) if the substance is applied directly to soil. Substances that exceed these triggers, and require drift mitigation in order to pass the terrestrial or aquatic risk assessment, need to have deposition following volatilisation quantified and added to deposition from spray drift. The Report recommends quantification by modelling with the EVA2.0 model, if safety cannot be demonstrated by this means then further experimental data are required. The Report also recommends a trigger of a DT50 in air of 2 days to identify substances of potential concern for long-range transport (LRT). Substances having a longer DT50 require further evaluation to assess their potential impact upon the environment; recommendations on how such an evaluation may be done are presented in the FOCUS Air Group Report.The Scientific Panel on Plant Protection Products and their Residues was asked for a critical opinion on the scientific review and practical recommendations made by the FOCUS Air group on the exposure assessment for plant protection products in air. As a specific point the Panel was asked to consider whether the vapour pressure cut off values for not assessing short range transport are appropriate, in the context of the tiered risk assessment scheme outlined.The PPR Panel acknowledges the tremendous efforts which have gone into the preparation of the Report. The PPR Panel appreciates the broad view of the Report and the magnitude of the work completed.However, the PPR Panel concludes that the FOCUS Air Report does not reflect the state of the art of science in the field of atmospheric transport and deposition of pesticides.The PPR Panel is of the opinion that the exposure assessment scheme needs more clarification regarding its applicability for the various possible methods of pesticide application, as well as for introducing refinements.The PPR Panel recommends that the trigger values for volatilisation as proposed by the Report (10-5 Pa for plants and 10-4 Pa for soil) are not used to eliminate the need for a risk assessment at the short range.The PPR Panel is of the opinion that the Report's recommendations regarding the use of the EVA2.0 model for short range exposure assessment are scientifically not robust enough. The PPR Panel has investigated whether the proposed methodology for short range transport generates realistic worst case estimates of exposure, which are required for risk assessment. The PPR Panel has come to the conclusion that the recommended model does not give realistic worst case exposure estimates.The PPR Panel considers the Report's conclusion that the DT50 trigger of 2 days is suitable to assess the need for exposure assessment of long range transport, to be appropriate for practical reasons.The main recommendations of the PPR Panel are:1. The PPR Panel recommends the chapters on atmospheric transport and modelling be reconsidered. The PPR Panel recommends that the sections on atmospheric deposition and monitoring include a process description of dry and wet deposition. The PPR Panel recommends that transformation products in the atmosphere be considered, as is currently required by the Directive 91/414/EEC. The PPR Panel recommends that the Report should summarise the key properties of the useful models and provide further guidance for the practical use of these transport models. It should be stated whether these models have been validated for regularly measured air-pollution compounds.2. The PPR Panel recommends that in the SRT modelling the contribution of volatilisation to the exposure should be accounted for over a longer period of time than 24 hours. The PPR Panel recommends that for short range exposure in the field the Report should define realistic worst-case scenarios for field size and atmospheric conditions.3. The PPR Panel recommends a more thorough analysis of the uncertainty in the calculated exposure concentrations be carried out.4. The PPR Panel recommends the Report should provide guidance on how and when hazardous properties to the atmosphere should be assessed, and should consider the issue of solvent emissions as a potential problem.

SUMMARY Buprofezin is an insecticide with a thiadiazine structure. This active substance was proposed for inclusion in Annex I of the Directive 91/414/EEC in 2005, but in the Draft Assessment Report (DAR), the Rapporteur Member State (Finland) identified a data gap: "new studies for in vitro and in vivo chromosomal aberration assays were required because the potency to cause chromosomal aberrations was insufficiently studied through the submitted information". In the light of the results of the new genotoxicity studies the carcinogenic potential of buprofezin was reassessed by the Pesticide Risk Assessment Peer Review (PRAPeR) expert meeting (EFSA) but a conclusion could not be reached. Therefore the Scientific Panel on Plant Protection Products and their Residues (PPR Panel) of EFSA was asked for an opinion by the PRAPeR Unit on the genotoxic and carcinogenic potential of buprofezin in the context of the human risk assessment. The PPR Panel re-evaluated the long-term toxicity/carcinogenicity studies on buprofezin. Two studies on the carcinogenicity of buprofezin were conducted in mice and rats. The PPR Panel concluded that the differences from the EU guidelines in the protocol for the carcinogenicity study in rats were not such as to prevent its use for the evaluation of the carcinogenic potential of the test compound. In mice and rats, neither the nature nor the incidence of tumours was affected by the administration of buprofezin. The PPR Panel re-evaluated the genotoxicity studies on buprofezin.

hrsg. von der Biologischen Bundesanstalt fur Land- und Forstwirtschaft, Berlin-Dahlem. Ed. by Martin Streloke ...