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Michail Gioutlakis et. al. (2025) Benchmark Dose Modelling in human tox and environmental risk assessment
Benchmark Dose Modelling in human tox and environmental risk assessment Benchmark Dose (BMD) Modelling is an approach used to derive toxicological endpoints for environmental (ERA) and human risk assessment. The aim of a BMD approach is to determine a dose-level that triggers a measurable change in a relevant toxicological parameter following exposure to a chemical, i.e. the Benchmark Response (BMR). The EFSA 2023 guidance on risk assessment for birds and mammals recommends the use of BMD for setting reproductive toxicity endpoints, rather than the current use of No-Observed-Adverse-Effect-Levels (NOAEL). The median BMD and a default response level for birds and mammals is set at 10% by EFSA 2023. However, further guidance on how to deal with different ecologically relevant parameters to be modelled and how to decide on the most appropriate BMR value is not available. Here, we report on analyses performed for real cases. First, the ecologically relevant parameters from mammalian toxicological studies were selected based on the EFSA 2023 guidelines. The data were then extracted from the toxicological study reports and their suitability for the BMD approach was assessed. The methodology outlined in the EFSA 2022 guidance on the use of BMD approach in risk assessment was followed, and results were obtained using the EFSA web tool for Bayesian BMD analysis. These results were checked against the EFSA 2023 validity criteria. For several active substances, the respective BMD values and their credible intervals were calculated for relevant parameters from mammalian toxicological studies. A key challenge with the BMD approach is that many toxicological studies are primarily designed to derive NOAELs, which are focused solely on identifying safe exposure levels. Consequently, not all extracted data sets were suitable for the BMD approach. In human risk assessment, the BMR level must be justified, and the lower limit of the credible interval should be used. In ERA the median BMD level is used and a default BMR level of 10% is recommended. However, these BMR levels of parameters of concern for ERA should be discussed in terms of ecological relevance. By presenting BMD approaches and their use in different areas of pesticide risk assessment we intend to initiate an open discussion on the selection process of ecologically relevant parameters and appropriate BMR levels, as well as the rationale behind these choices.
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Parvinder Kaur at al. (2025) Challenges in the interpretation of DNT endpoints and their regulatory implications
Challenges in the interpretation of DNT endpoints and their regulatory implications P. Kaur, A. Ochs, M. Gioutlakis, J. Schabacker, F. v. Blanckenhagen Developmental neurotoxicity (DNT) studies are designed to provide information on potential functional, behavioural and morphological effects on the developing nervous system after in utero and early-life exposure to chemical compounds. The current in vivo testing paradigm for DNT includes OECD TG 426, US EPA OPPTS 870.6300 and OECD TG 443 with the inclusion of DNT cohorts. However, several active substances have been impacted by methodological deficiencies, which adds to uncertainty in interpretation of results. We want to present and discuss several case studies from the pesticide regulatory framework where these challenges arise. The appraisal of these case studies using the Office of Health Assessment and Translation-National Toxicology Program Risk of Bias (RoB) assessment tool (NTP, 2015) in line with the EFSA Adverse Outcome Pathways-informed Integrated Approach to Testing and Assessment led to high RoB and non-acceptance of some endpoints. In view of these uncertainties, in certain instances the European commission has applied additional uncertainty factors. These case studies illustrate how differences in study design, number of doses, missing important key events and interpretation of behavioural and histopathological data can affect regulatory decisions. These case studies will emphasize the need for improved methodologies and robust uncertainty analysis to ensure reliable and consistent DNT assessments, which are crucial for regulatory toxicology decisions.
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The Festival of the snakes of Cocullo
Where is the connection between RIFCON, snakes, the Italian village Cocullo, between The New York Times, The Guardian and magazines such as Nature or Stern? …Does this pique your interest? Take a look here!
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EPAT 1.2 - Exposure Pattern Analysis Tool
EPAT is a tool for analysis of exposure patterns, e.g. FOCUS TOXSWA output files for concentrations in surface water, or measured concentrations or mass time patterns in an environmental compartment.
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Bauer et al. (2023) A Toxicokinetic–Toxicodynamic Modeling Workflow Assessing the Quality of Input Mortality Data
Toxicokinetic–toxicodynamic (TKTD) models simulate organismal uptake and elimination of a substance (TK) and its effects on the organism (TD). The Reduced General Unified Threshold model of Survival (GUTS‐RED) is a TKTD modeling framework that is well established for aquatic risk assessment to simulate effects on survival.
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Faupel et al. (2023) Precision farming and environmental pesticide regulation in the EU—How does it fit together?
Precision farming technology allows pesticides to be applied precisely to the target while leaving the rest of the field untreated. In the regulation of pesticides, however, a homogeneously sprayed field is considered as the standard scenario.
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Wittwer, Jakoby (2023) Evaluation of wind speed measurements published by th German Meteorological Service (DWD) for the years 2004 to 2020
Sowing of seeds treated with agrochemicals is common practice in agriculture. German regulatory authorities are requesting that seeds treated with plant protection products must not be sown at average hourly wind speeds exceeding 5 m/s (at 2 m above ground) unless the environmental risk assessment indicates a large margin of safety.
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Klein et al. (2022) Results of Ring‐Testing of a Semifield Study Design to Investigate Potential Impacts of Crop Protection Products on Bumblebees (Hymenoptera, Apidae) and a Proposal of a Potential Test Design
In Europe, the risk assessment for bees at the European Union or national level has always focussed on potential impacts on honeybees. During the revision of the European Food Safety Authority bee guidance it was explicitly stated that bumblebees and solitary bees should be considered as well and consequently concerns were raised regarding the representativeness of honeybees for these other bee species.
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Ludwigs et al. (2022) Assessing the Portion of Diet Taken by Birds and Mammals from a Pesticide‐Treated Area—Proposal for a Joint Way Forward
An environmental risk assessment for birds and mammals is an important part of any application package for potential registration of pesticides in Europe. A realistic estimation of the exposure of a certain species to the pesticide under field conditions is a refinement factor in long‐term higher‐tier risk assessments.
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Nickisch et al. (2022) Fish Species Sensitivity Ranking Depends on Pesticide Exposure Profiles
In the regulatory environmental risk assessment of plant protection products, the exposure tested in standard toxicity tests assumes simple exposure dynamics, such as constant exposure at the first stage of testing. However, environmental exposure can be highly dynamic.
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Singer, Nickisch, Gergs (2022) Joint survival modelling for multiple species exposed to toxicants
In environmental risk assessment (ERA), the multitude of compounds and taxa demands cross-species extrapolation to cover the variability in sensitivity to toxicants. However, only the impact of a single compound to a single species is addressed by the general unified threshold model of survival (GUTS).
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Sur, Herrmann (2022) Determination of transfer factors for solute concentrations from agricultural fields to drinking water abstraction points
The stepwise attenuation of solute concentrations has been determined, starting from the unsaturated zone underneath treated fields across the deeper aquifer, down to drinking water abstraction wells. The partial or overall transfer or attenuation factor may help to make informed decisions on the magnitude of the decrease in concentrations from shallow leachate to drinking water abstraction, which is largely caused by mixing.
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