Regulatory Risk Assessment Research Articles

Drought risk assessment considering ecosystem resilience: A case study in the Huang-Huai-Hai Plain, China

Drought caused by global warming has a profound impact on the stability of terrestrial ecosystems and agricultural production. As one of the key indicators to measure the response of ecosystems to climate change, the spatial difference of ecosystem resilience will also affect the accuracy of regional drought risk assessment. In this study, the 12-month standardized precipitation evapotranspiration index (SPEI-12) was used to identify drought characteristics and combined with meteorological elements to characterize drought hazard. Drought vulnerability was characterized using crop and environmental sensitivity, disaster prevention, and mitigation capacity. Specifically, ecosystem resilience was also considered in assessing vulnerability. And drought exposure was investigated by considering crop sown area and population density. Based on this, a drought risk assessment framework was constructed using the random forest algorithm and applied to the Huang-Huai-Hai (HHH) Plain, China. The results showed that: (1) approximately 66.34 % of the HHH Plain had a drought hazard level above moderate; among them, southern Hebei, northern Anhui, northern Henan, and scattered small areas in Shandong were extreme high hazard areas. (2) The northeast Anhui, central and southern Shandong, and northeast Jiangsu were extreme high drought vulnerability areas, accounting for 10.34% of the total area. (3) The drought risk in the HHH Plain was low in the south and north, and high in the center. Among these, the drought risk in the border regions of Shandong and Anhui, the northeast part of Jiangsu, as well as central Henan were extreme high, accounting for 11.23%. (4) The drought risk assessment framework constructed by considering ecosystem resilience was more suitable for HHH Plain. This study result could provide scientific reference for managing water resources and preventing drought.

Intergenerational effects on fertility in male and female mice after chronic exposure to environmental doses of NSAIDs and 17α-ethinylestradiol mixtures

Non-steroidal anti-inflammatory drugs (NSAIDs) and 17α-ethinylestradiol (EE2) are extensively used in human and veterinary medicine. Due to their partial removal by wastewater treatment plants, they are frequent environmental contaminants, particularly in drinking water. Here, we investigated the adverse outcomes of chronic exposure to mixtures of NSAIDs (ibuprofen, 2hydroxy-ibuprofen, diclofenac) and EE2 at two environmentally relevant doses in drinking water, on the reproductive organ development and fertility in F1-exposed male and female mice and in their F2 offspring. In male and female F1 mice, which were exposed to these mixtures, reproductive organ maturation, estrous cyclicity, and spermiogenesis were altered. These defects were observed also in F2 animals, in addition to some specific sperm parameter alterations in F2 males. Transcriptomic analysis revealed significant changes in gene expression patterns and associated pathways implicated in testis and ovarian physiology. Chronic exposure of mice to NSAID and EE2 mixtures at environmental doses intergenerationally affected male and female fertility (i.e. total number of pups and time between litters). Our study provides new insights into the adverse effects of these pharmaceuticals on the reproductive health and will facilitate the implementation of a future regulatory environmental risk assessment of NSAIDs and EE2 for human health.

A comparison between field measurements of vapour concentrations of plant protection products and predictions by the BROWSE model

A database of field measurements of air concentrations of pesticide active ingredients has previously been compiled by CropLife Europe with an aim to revise the default air concentration values and assumptions applied in assessing vapour exposure in the risk assessment of bystanders and residents. The BROWSE model, released in 2014, which is a regulatory risk assessment model that includes the exposure of residents and bystanders has a component relating to post-application vapour inhalation. Predictions of concentration deduced from exposures obtained using the BROWSE model were compared with field measurements of 24-h and 7-day average concentrations. The methodology for obtaining concentration estimates from the BROWSE model is described, and the criteria for including field studies in the comparison are given. The field data were adjusted to account for differences between the field experiment and the BROWSE scenario using factors derived from a separate plume dispersion model. This showed that BROWSE provides a satisfactory level of conservatism in determining potential exposures of residents and bystanders to vapour and could be a reliable alternative to replace the current EFSA approach for predicting vapour inhalation exposures for pesticides where no compound-specific data are available.

Updated conclusion on the peer review of the pesticide risk assessment of the active substance mecoprop-P.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the initial competent authorities of the rapporteur Member State, the United Kingdom, and co-rapporteur Member State, Ireland, for the pesticide active substance mecoprop-P are reported. Due to the UK leaving the EU, the renewal of approval dossier on mecoprop-P was reallocated to Ireland, as RMS. 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 mecoprop-P as a herbicide on winter and spring wheat (including durum and spelt), barley, rye, oats and triticale. The conclusions were updated following the request from the European Commission to review the risk assessment as regards non-dietary exposure and the endocrine-disrupting properties of mecoprop-P. 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 reported where identified.

Peer review of the pesticide risk assessment of the active substance metalaxyl-M (amendment of approval conditions).

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, Belgium, and co-rapporteur Member State, Greece, for the pesticide active substance metalaxyl-M 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 for the amendment to the conditions of approval of metalaxyl-M as a fungicide seed treatment for sunflower and spinach seeds intended to be sown in field and on the basis of data submitted to update the specified level of an impurity in the technical active substance. 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 reported where identified.

Regression-based scenario earthquake selection for regional hazard-consistent risk assessments

Conventional probabilistic seismic hazard analysis (PSHA) is often repeated at many locations independently to develop uniform hazard maps. However, such maps are unsuitable for assessing risk to spatially distributed infrastructure because no single event will produce uniform hazard shaking intensities across a broad region. A robust but computationally expensive approach is to analyze spatially distributed infrastructure systems separately for every event considered in the seismic source characterization model used in the PSHA. This approach may not be practical when many scenario events are considered. An alternative is to select a manageable event subset that, in aggregate, approximately matches the hazard for single or multiple ground motion intensity measures across the spatially distributed system preserving contributions of different magnitudes and distances to the PSHA. We present a flexible and efficient regression-based method that meets these requirements using point-based PSHA results as inputs. The approach is illustrated with a case study of distributed infrastructure in southern California. We demonstrate the efficiency of the method by comparing it to a mixed-integer linear optimization method from the literature.

Integrating flood risk assessment and management based on HV-SS model: A case study of the Pearl River Delta, China

Global climate change has resulted in frequent extreme weather events in recent decades. The Pearl River Delta, one of the most developed regions in China, frequently faces the threat of flood disasters, causing significant human and economic losses. However, previous flood risk studies ignored the energy flow, material transfer and information transfer in the region, resulting in a disconnect between risk assessment results and management strategies, making it difficult to achieve the desired disaster prevention and mitigation effects. Thus, the HV-SS model was proposed with the aim of integrating flood assessment and management, thereby achieving more accurate and efficient risk management. The results showed that the majority of the study areas were under medium to high flood hazard levels, and their spatial distribution was closely related to natural conditions. The proportion of risk area was inversely proportional to the risk level, and the spatial distribution of flood risk exhibited a central-high and perimeter-low characteristic, with medium-risk surrounding the high-risk areas. Comparative verification, combined with the TOPSIS method achieved a matching rate of 89.89%, indicating that the assessment result was reasonable. The flood risk pattern constructed using the source-sink theory found that the primary risk sources were located in the central region and continuously transferred risk to surrounding areas through risk corridors. It is crucial to note that easily ignored risks were hidden around the risk nodes, and some reasonable flood management strategies were proposed. This study can provide a reference for regional flood risk assessment and management for sustainable development.

S02-03: Implementation of new approach methods into regulatory risk assessment using case studies

S02-03: Implementation of new approach methods into regulatory risk assessment using case studies

S14-01: Regulatory risk assessment of chemical mixtures: EFSA's approach

S14-01: Regulatory risk assessment of chemical mixtures: EFSA's approach

P22-26: New Approach Methods for Regulatory Risk Assessment of Azo Dyes in Textiles

P22-26: New Approach Methods for Regulatory Risk Assessment of Azo Dyes in Textiles

AUCKLAND COUNCIL’S PROGRESS ON SUSTAINABLE SHORELINE ADAPTATION PLANS

Auckland Council is currently developing shoreline adaptation plans across the Auckland region to support the sustainable management of public assets into the future with increasing coastal hazard risks. These build upon the Coastal Management Framework (Carpenter et al. 2017) and are being developed as 20 phased plans. At the time of writing the ‘Whangaparāoa’ and ‘Beachlands and East’ Shoreline Adaptation Plans (SAP) have been completed. The ‘Āwhitu Peninsula’ and ‘Manukau South’ SAPs are well underway, and the remaining SAPs are programmed to be completed over the next 4 years. To inform the development of the adaptation strategies numerous datasets were required. Coastal erosion and coastal flooding predictions have been mapped for the Auckland region to assess the evolving coastal hazards. Up-to-date coastal asset information was gathered through hundreds of coastal asset inspections for each SAP area. This asset data fed into adaptation strategy decisions as well as being incorporated into a regional risk assessment to assess the relative risk across Auckland’s SAP units.

Plastics as Non‐Toxic Disruptors of Aquatic Ecosystems

AbstractPlastics are receiving widespread attention as an environmental contaminant, but their role in disrupting the behavior and physiology of organisms remains neglected. Here, I highlight growing evidence that plastics have pervasive, non‐toxic effects in aquatic ecosystems, especially on feeding interactions. These effects ultimately have consequences for the flow of energy through food webs and the productivity of entire ecosystems. New research efforts are now needed to link synthetic polymers and their additive chemistries to food web interactions under field conditions. This knowledge could be used to strengthen regulatory risk assessments, similar to the process for other ecological‐disrupting compounds, such as those that interfere with hormone systems.

Machine learning-enabled regional multi-hazards risk assessment considering social vulnerability

The regional multi-hazards risk assessment poses difficulties due to data access challenges, and the potential interactions between multi-hazards and social vulnerability. For better natural hazards risk perception and preparedness, it is important to study the nature-hazards risk distribution in different areas, specifically a major priority in the areas of high hazards level and social vulnerability. We propose a multi-hazards risk assessment method which considers social vulnerability into the analyzing and utilize machine learning-enabled models to solve this issue. The proposed methodology integrates three aspects as follows: (1) characterization and mapping of multi-hazards (Flooding, Wildfires, and Seismic) using five machine learning methods including Naïve Bayes (NB), K-Nearest Neighbors (KNN), Logistic Regression (LR), Random Forest (RF), and K-Means (KM); (2) evaluation of social vulnerability with a composite index tailored for the case-study area and using machine learning models for classification; (3) risk-based quantification of spatial interaction mechanisms between multi-hazards and social vulnerability. The results indicate that RF model performs best in both hazard-related and social vulnerability datasets. The most cities at multi-hazards risk account for 34.12% of total studied cities (covering 20.80% land). Additionally, high multi-hazards level and socially vulnerable cities account for 15.88% (covering 4.92% land). This study generates a multi-hazards risk map which show a wide variety of spatial patterns and a corresponding understanding of where regional high hazards potential and vulnerable areas are. It emphasizes an urgent need to implement information-based prioritization when natural hazards coming, and effective policy measures for reducing natural-hazards risks in future.

Difficulties in translating in vitro hazards of local acute irritants to relevant human risk: Learnings from Captan and Folpet

In order to assess the regulatory value of New Approach Methodologies (NAMs), authors should provide their opinion on the physiological and exposure relevance of observed in vitro effects for correlation with predicted in vivo effects. Further, peer-reviewers should be encouraged to request such information during review. This is critical to scientifically transition to animal-free, reliable, robust and -- most importantly -- relevant regulatory toxicology and risk assessment approaches. Recently published studies using NAMs for the fungicides Captan and Folpet illustrate the difficulties and limitations of applying NAMs to adequately assess the toxicological relevance of these substances.

Peer review of the pesticide risk assessment of the active substance metconazole.

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, Belgium, and co-rapporteur Member State, the United Kingdom, for the pesticide active substance are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of metconazole as a fungicide on cereals and oilseed rape and as a plant growth regulator on oilseed rape. 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 reported where identified.

Updated peer review of the pesticide risk assessment of the active substance mepanipyrim.

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, 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 conclusions were updated with regard to the endocrine-disrupting properties following a mandate received from the European Commission in January 2019. 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 reported where identified.

Peer review of the pesticide risk assessment of the active substance metribuzin.

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, Estonia, and co-rapporteur Member State, Germany, for the pesticide active substance metribuzin and the assessment of application to amend existing residue definition are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use of metribuzin as a herbicide on potato and soybean (field use). 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 reported where identified.

Peer review of the pesticide risk assessment of the active substance folpet.

The conclusions of the European Food Safety Authority (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 Italy for the pesticide active substance folpet and of confirmatory data following the MRL review under Article 12 of Regulation (EC) No 396/2005. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of folpet as a fungicide on barley, wheat and wine grape (field uses) and tomato (field and greenhouse uses). The reliable end points, appropriate for use in regulatory risk assessment and the confirmatory data, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Benchmark dose modeling for epidemiological dose-response assessment using prospective cohort studies.

Benchmark dose (BMD) methodology has been employed as a default dose-response modeling approach to determine the toxicity value of chemicals to support regulatory chemical risk assessment. Especially, a relatively standardized BMD analysis framework has been established for modeling toxicological data regarding the formats of input data, dose-response models, definitions of benchmark response, and model uncertainty consideration. However, the BMD approach has not been well developed for epidemiological data mainly because of the diverse designs of epidemiological studies and various formats of data reported in the literature. Although most of the epidemiological BMD analyses were developed to solve a particular question, the methods proposed in two recent studies are able to handle cohort and case-control studies using summary data with consideration of adjustments for confounders. Therefore, the purpose of the present study is to investigate and compare the "effective count"-based BMD modeling approach and adjusted relative risk (RR)-based BMD analysis approach to identify an appropriate BMD modeling framework that can be generalized for analyzing published data of prospective cohort studies for BMD analysis. The two methods were applied to the same set of studies that investigated the association between bladder and lung cancer and inorganic arsenic exposure for BMD estimation. The results suggest that estimated BMDs and BMDLs are relatively consistent; however, with the consideration of established common practice in BMD analysis, modeling adjusted RR values as continuous data for BMD estimation is a more generalizable approach harmonized with the BMD approach using toxicological data.

Characterization of patterns and variability in the dynamics of outdoor aquatic mesocosms: exploring the capabilities and challenges in data supporting aquatic system models

Aquatic mesocosms are complex test systems used within regulatory risk assessment of plant protection products. These model ecosystems allow researchers to capture interactions of multiple species under realistic environmental conditions. They enable assessment of direct and indirect effects of stressors at all trophic levels (i.e., from primary producers to secondary consumers) and impacts on ecosystem functions. Due to the limited ability to test the multitude of potential exposure scenarios, cross-linking aquatic mesocosm studies with virtual mesocosms, i.e., aquatic system models (ASMs), can serve to meet the demand for more environmental realism and ecological relevance in risk assessment. In this study, full control data sets from seven aquatic mesocosm studies conducted at a single test facility under GLP were analysed graphically and using descriptive statistics. Thereby, not only a comprehensive data base but also an insight into the species present, their dynamics over time, and variability in unchallenged mesocosms was observed. While consistency in dynamics could be discerned for physical and chemical parameters, variability was evident for several biological endpoints. This variability points to amplification of small differences over time as well as to stochastic processes. The outline of existing gaps and uncertainties in data leads to the estimation of what can be expected to be captured and predicted by ASMs.