Mark Egsmose

European scenarios for exposure of soil organisms to pesticides

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

Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen

Abstract The conclusions of EFSA following the peer review of the initial assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co‐rapporteur Member State, Austria, for the pesticide active substance quinoxyfen are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of information targeted at the assessment of the potential persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) and persistent organic pollutant (POP) properties of quinoxyfen according to Article 11(2) of Regulation (EC) No 1107/2009. The reliable end points, appropriate for use in these regulatory hazard cut off assessments are presented. Missing information identified as being required by the regulatory framework is listed. The concern is identified that quinoxyfen may be considered to exhibit the hazard properties of both a PBT and vPvB substance considering the triggers specified in Annex II of Regulation (EC) No 1107/2009.

Peer review of the pesticide risk assessment of the active substance pethoxamid

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Austria, and co‐rapporteur Member State, the Czech Republic, for the pesticide active substance pethoxamid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of pethoxamid as a herbicide on maize and soya bean. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance mepanipyrim

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Belgium, and co‐rapporteur Member State, Greece, for the pesticide active substance mepanipyrim are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of mepanipyrim as a fungicide on table and wine grapes, and in field and protected strawberries and tomatoes. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment for the active substance terbuthylazine in light of confirmatory data submitted

Abstract 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 metazachlor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data regarding the groundwater exposure of metabolites and their toxicological relevance triggering an assessment. The conclusions were reached on the basis of the evaluation of the representative uses of metazachlor as a herbicide on winter and spring rapeseed and on ornamental trees and shrubs. 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.

Linking pesticide marketing authorisations with environmental impact assessments through realistic landscape risk assessment paradigms

Each year, the European Food Safety Authority, supported by a network of experts in the EU Member States, assesses and publishes the environmental risks of 30–40 pesticides active substances. The assessments support hundreds of national risk evaluations for marketing (re-)authorisations of Plant Protection Products. These prospective regulatory evaluations are based on worst-case scenarios in order to provide the high level of protection required by the EU legislations, and establishes the conditions for a correct use of the products including risk mitigations options. However, recent publications suggest that the desired high level of protection may not be achieved with the current risk assessment paradigm. The consideration of larger spatial scales and multiple stressors, including different pesticide uses, could improve the risk assessment process. A next step is the use of these larger spatial scales for evidence-based assessments, evaluating the overall impact of pesticide use on the European environment and biodiversity. Reaching this level would provide science-based support to the National Plans on sustainable use of pesticides and to the broader EU policies defined in the EU Environmental Action Programmes. Recent technological developments, as well as policy efforts, have solved two of the key issues blocking this progress in the past. Data availability and technical capacity for handling Big Data are no longer an unaffordable obstacle. The current proposal presents an alternative environmental risk assessment paradigm, integrating use patterns and pesticides properties with landscape ecotypes and eco-regions, covering the variability of the European agro-environmental conditions. The paradigm is suggested to be implemented in a spatially explicit conceptual model, using the ecosystem services approach and vulnerable key driver species to represent the service providing units. This approach would allow mapping the likelihood and magnitude of the impact of pesticide use on ecosystems functions, environmental resources, and biodiversity at the EU scale.

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadirachtin as an acaricide on greenhouse ornamentals. Conclusions are also represented for the representative use evaluated for the approval of azadirachtin, which was as an insecticide on potatoes. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance Bacillus subtilis strain IAB/BS03

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance Bacillus subtilis strain IAB/BS03 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. subtilis strain IAB/BS03 as a fungicide on field lettuce, orchards and protected cucurbits. The reliable endpoints appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance tolclofos‐methyl

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Sweden, and co‐rapporteur Member State, Denmark, for the pesticide active substance tolclofos‐methyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of tolclofos‐methyl as a fungicide on potatoes, lettuce and ornamentals. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the pesticide risk assessment of the active substance copper compounds copper(I), copper(II) variants namely copper hydroxide, copper oxychloride, tribasic copper sulfate, copper(I) oxide, Bordeaux mixture

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co‐rapporteur Member State, Germany, for the pesticide active substance copper compounds are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of copper compounds as a fungicide on grapes, tomatoes and cucurbits. The reliable end points appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.