Validation of the exposure assessment for veterinary medicinal products.

Under the EU Directive 2004/28/EC, an environmental risk assessment of new veterinary medicinal products is required. Given the nature of risk assessment for new applications, there is a need to model exposure concentrations. Critical evaluations are essential to ensure that the use of models by regulators does not result in the propagation of misleading information. The empirical validations of soil exposure models, previously discussed in this journal, indicate that it is impossible to analyse the contribution of every model parameter to the variability in the predictions. In particular, the prediction of the slurry concentration is challenged by uncertainties concerning dilution, mixing and dissipation of residues. Surface water and groundwater models generated highly deviating results compared to the field results, questioning the usefulness of the available screening models. Animal husbandry, slurry handling and environmental conditions throughout Europe are considered in order to define realistic worst case scenarios, to be used in conjunction with distribution models for the environmental risk assessment of veterinary medicinal products at registration. Given the variability in manure management practice throughout Europe, a deterministic approach for the manure-to-soil model was selected. Both worst case and best case scenario were developed. Several modelling assumptions applied in the surface water exposure model for fish nursery effluent were validated against newly available data. Since the available data give no proof that a settling tank contributes to the removal of pesticides from waste water, it is recommended for risk assessment purposes to consider the contribution of the settling tank to removal of pesticides and medicines to be negligible. Surface water dilution factors may be considered to be rather small, a factor of 2, for low flow situations

Organic contaminants in fertilising products and components materials

The new European Fertilising Products Regulation (EU) 2019/1009 (FPR) enters into force in 2022. With a few exceptions, organic contaminants are not restricted in CE fertilisers. For food/feed intended as component materials, labelling requirements are set with a view to inform the end user to decide whether it can be safely used. Labelling is only required when threshold values are exceeded and not for other component materials. The Dutch Fertiliser Act (DFA) sets more concentration limits to various, but not all, fertilisers. The implementation of the FPR in 2022 provides options to uphold the DFA for national products, and to set provisions to the use of CE products. All combinations of options offer different benefits for producers, end users, administration and environment, and are variably flexible to respond to future developments. Recommendations are made to streamline the control oforganic contaminants for the purpose of reducing waste and valorising nutrients while protecting human health and the environment

Assessment of persistency and bioaccumulation in pesticide registration frameworks within the Organization for Economic Cooperation and Development.

This article describes the results of a survey conducted in 2003 on methods used by different member countries within the Organization for Economic Cooperation and Development (OECD) to evaluate persistent and bioaccumulative pesticides. The objectives were to establish the differences in taking persistence (P) and bioaccumulation (B) into account in the decision-making process and to establish the influence of the assessors' subjectivity to data interpretation and data selection. Fifteen countries participated in the survey, which generated a vast amount of information on decision making, risk assessment, risk classification, and data treatment. Survey results indicated clear differences in approaches to the use of P, B, and toxicity (T) information in scientific risk assessment. Using the same data for 2 different pesticides, several OECD member countries responded differently in classifying both substances as P, B, and T. Differences in regulatory decision-making were also apparent because, based on identical classifications, several OECD member countries adopted different decisions on pesticide registration; recommendations were based, with respect to technical guidance, on data handling, training of assessors, and handling of uncertainty in risk assessment

Gewasbeschermingsmiddelen: vergelijking van erfafspoeling en spuitdrift als emissieroutes naar het oppervlaktewater

Dit rapport gaat over de emissie van gewasbeschermingsmiddelen naar het oppervlaktewater. Het doel van dit rapport, opgesteld in het kader van het project Gewasbescherming van de Kennisimpuls Waterkwaliteit, is om de relatieve bijdrage van emissies vanaf het erf te bepalen en af te zetten tegen emissies door verwaaiing (spuitdrift) vanaf het perceel. De resultaten bieden aangrijpingspunten voor reductie van emissie naar het oppervlaktewater

Diergeneesmiddelen in het milieu : een synthese van de huidige kennis

In dit rapport zijn gegevens over diergeneesmiddelen in water, bodem en mest van grazers samengevat. Vervolgens is aangegeven wat dit betekent voor onze leefomgeving. De studie is grotendeels gebaseerd op reeds bestaande gegevens en rapportages. In enkele gevallen zijn aanvullende analyses uitgevoerd, zoals de afzetgegevens van diergeneesmiddelen en een risicobeoordeling op basis van een vergelijking van meetconcentraties met risicogrenzen