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The analysis of combined effects of substances or risk factors has been a subject to science for more than a century. With different goals, combined effect analysis was addressed in almost all experimental biosciences. The major theoretical foundation can be traced back to two distinct origins. First, to the work by the pharmacologist Loewe on the concept of concentration additivity and second to the biometrician Bliss and the concept of independent action. In the search for a general solution and a unified terminology the interrelations of the concepts have extensively been studied and experimental findings reviewed. Meanwhile there seems to be consensus in experimental sciences that each concept has its role in predicting combined effect of agents and both are used for hazard und risk management. In contrast, epidemiologists describe combined effects mainly in terms of interactions in regression models. Although this approach started from a probabilistic model equivalent to the concept of independent action this origin is rarely acknowledged and effect summation is usually the preferred concept nowadays. Obscure biological meaning, the scale dependency of interaction terms as well as unavoidable residual confounding are taken as reasons why no new insights in combined effect analysis are likely to occur from epidemiology. In this paper we sketch the history of ideas and the state of the arts in combined effect analysis. We point to differences and common grounds in experimental biosciences and epidemiology.

EFSA, the European Food Safety Authority, was established in 2002 as the EU's independent risk assessment body for food and feed safety. This paper takes stock of what has been achieved and what challenges lie ahead. To do so, it first reviews scientific assessments conducted by EFSA from the perspective of a scientific experiment. This includes a hypothesis that is examined by scientific experts using existing evidence and employing agreed-upon assessment methods, the results of which are made public. Next, it considers a number of characteristics legitimising this work: quality, consistency, independence and impartiality, as well as transparency and openness. Other key considerations are relevance, evolving expectations and innovations, fitness-for-purpose and efficiency, along with sustainability of the system. By and large, the scientific assessment process in place at EFSA can be understood to mimic the conduct of a scientific experiment. However, being a regulatory support mechanism, it has some distinct characteristics. Therefore, its legitimising characteristics are not necessarily identical to those used in academic research. In conclusion, since its creation 15 years ago, EFSA has very much delivered on its mission. Whatever the achievements, the EU cannot rest on its laurels though. [ABSTRACT FROM AUTHOR]

The use of fish embryo toxicity (FET) data for hazard assessments of chemicals, in place of acute fish toxicity (AFT) data, has long been the goal for many environmental scientists. The FET test was first proposed as a replacement to the standardized AFT test nearly 15 y ago, but as of now, it has still not been accepted as a standalone replacement by regulatory authorities such as the European Chemicals Agency (ECHA). However, the ECHA has indicated that FET data can be used in a weight of evidence (WoE) approach, if enough information is available to support the conclusions related to the hazard assessment. To determine how such a WoE approach could be applied in practice has been challenging. To provide a conclusive WoE for FET data, we have developed a Bayesian network (BN) to incorporate multiple lines of evidence to predict AFT. There are 4 different lines of evidence in this BN model: 1) physicochemical properties, 2) AFT data from chemicals in a similar class or category, 3) ecotoxicity data from other trophic levels of organisms (e.g., daphnids and algae), and 4) measured FET data. The BN model was constructed from data obtained from a curated database and conditional probabilities assigned for the outcomes of each line of evidence. To evaluate the model, 20 data-rich chemicals, containing a minimum of 3 AFT and FET test data points, were selected to ensure a suitable comparison could be performed. The results of the AFT predictions indicated that the BN model could accurately predict the toxicity interval for 80% of the chemicals evaluated. For the remaining chemicals (20%), either daphnids or algae were the most sensitive test species, and for those chemicals, the daphnid or algal hazard data would have driven the environmental classification. Integr Environ Assess Manag 2020;16:452-460. © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC)., (© 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).)

Smoking is the major cause of lung cancer. While the risk of lung cancer increases with the number of cigarettes smoked and the duration of smoking, it also decreases upon smoking cessation. The development of candidate modified risk tobacco products (cMRTP) is aimed at providing smokers who will not quit with alternatives to cigarettes that present less risk of harm and smoking-related disease. It is necessary to assess the risk reduction potential of cMRTPs, including their potential to reduce the risk of lung cancer. Assessing the lung cancer risk reduction potential of cMRTPs is hampered by (i) the absence of clinical risk markers that are predictive of future lung cancer development, (ii) the latency of lung cancer manifestation (decades of smoking), and (iii) the slow reduction in excess risk upon cessation and a fortiori upon switching to a cMRTP. It is, therefore, likely that only long-term epidemiology will provide definitive answers to this question and allow to first verify that a cMRTP reduces the risk of lung cancer and if it does, to quantify the reduction in excess lung cancer risk associated with a cMRTP. For this to be possible, the cMRTP would need to be available in the market and used exclusively by a large portion of current smokers. Here, we propose that a mechanism-based approach represents a solid alternative to show in a pre-market setting that switching to a cMRTP is likely to significantly reduce the risk of lung cancer. This approach is based on the causal chain of events that leads from smoking to disease and leverages both non-clinical and clinical studies as well as the principles of systems toxicology. We also discuss several important challenges inherent to the assessment of cMRTPs as well as key aspects regarding product use behavior.

The Canadian environmental effects monitoring (EEM) program is a regulated, cyclical, industry-funded program designed to determine whether receiving water impacts exist when a mill is in compliance with its discharge limits. The results from three cycles of the fish monitoring program (1992 to 2004) are available from over 200 surveys of fish compared between sites located upstream and downstream of pulp and paper mill effluent outfalls. Previous meta-analyses have shown a national average response pattern across cycles characterized by an increase in endpoints measuring energy storage and growth and a decrease in a reproductive endpoint, consistent with a response of nutrient enrichment in combination with some form of metabolic disruption. Although the national average pattern of effects was temporally consistent, there was some variability in the magnitude of effects among cycles. Questions were raised as to whether the intercycle variability was due to changes in effluent quality or due, at least in part, to other factors. The present study compares responses over the first three cycles, and shows that the choice of sentinel species is likely to be a major contributing factor to the variability in observed effects. Subset analyses using studies from mills that used the same sentinel species across cycles reveal fairly uniform responses and little evidence of significant improvements in overall fish health from cycles one to three. However, a meta-analysis using 1991 data collected from 10 mills before the implementation of the EEM program and data from the same mills collected during cycles one to three of the program reveal significantly reduced effects on relative liver weight and potential improvements in other endpoints., (Copyright 2009 SETAC.)

In Pesticide Action Network Europe v Commission (Case T-536/22), Pesticide Action Network Europe (PAN Europe) contested the renewal by the European Commission of the active substance cypermethrin. This substance is used or is marketed as an insecticide in large-scale commercial agricultural applications as well as in consumer products for domestic purposes (ant and cockroach killer). PAN Europe sought the annulment of the European Commission's decision of 23 June 2022 by which the latter rejected the request for internal review made by PAN Europe in accordance with Regulation (EC) No. 1367/2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters. The applicant argued, in essence, that where a risk is established with sufficient certainty by the European Food Safety Authority (EFSA), the Commission could not disregard the conclusions of the scientific assessment by relying on its powers as risk manager. In stressing the discretion enjoyed by the Commission, the General Court dismissed the action of PAN Europe. This casenote suggests that the General Court applied the precautionary principle too formally. [ABSTRACT FROM AUTHOR]

Abstract The EFSA 2nd Scientific Conference ‘Shaping the Future of Food Safety, Together’ gathered an international audience composed of scientists, risk assessors, risk managers, as well as non‐governmental organisations and industry representatives. This article summarises the final plenary session where a panel was asked to draw out overall impressions and conclusions for the EFSA to take away for its strategic planning into the future. The main conclusions of the conference are presented under five major themes. With new methodologies, technologies, big data and the increased societal demand for enhanced engagement in the risk assessment process, there is a clear need to maintain levels of expertise from traditional areas and to consider the inclusion of new areas and sources of expertise to perform scientific assessments. Academia, industry, research and regulatory science should work together to achieve this goal. As science progresses at pace, the continued development of assessment methodologies to deal with increasingly complex assessment questions is necessary, as is the need for applied research to underpin the support to policy development that EFSA provides. Greater collaboration is needed to reach agreement on best methods and practices for scientific assessment not just internationally, but also, equally importantly, across legislative areas and scientific disciplines, and in consultation with society at large. The communication of complex science, including important concepts such as uncertainty and risk perception, is not a trivial task, and must be integrated into the scientific process. As such, the relationship between risk assessment and risk management must continue to mature, remaining close, yet independent.

On May 10, 2012, the European Commission issued a conditional marketing authorization valid throughout the European Union for pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma (NHL). Pixantrone is a cytotoxic aza-anthracenedione that directly alkylates DNAforming stable DNA adducts and cross-strand breaks. The recommended dose of pixantrone is 50 mg/m2 administered on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. In the main study submitted for this application, a significant difference in response rate (proportion of complete responses and unconfirmed complete responses) was observed in favor of pixantrone (20.0% vs. 5.7% for pixantrone and physician's best choice, respectively), supported by the results of secondary endpoints of median progression- free and overall survival times (increase of 2.7 and 2.6 months, respectively). The most common side effects with pixantrone were bone marrow suppression (particularly of the neutrophil lineage) nausea, vomiting, and asthenia. This article summarizes the scientific review of the application leading to approval in the European Union. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (http://www.ema.europa.eu). [ABSTRACT FROM AUTHOR]

The product Teysuno™ (S-1) contains tegafur, a prodrug of 5-fluorouracil (5-FU), and two modulators of 5-FU metabolism, gimeracil and oteracil. The main clinical study in this application was a randomized controlled study comparing S-1 plus cisplatin with 5-FU plus cisplatin. In this study, median overall survival times of 8.6 months and 7.9 months for S-1 plus cisplatin and 5-FU plus cisplatin, respectively, were observed (hazard ratio, 0.92; 95% confidence interval, 0.80 -1.05). The Committee for Medicinal Products for Human Use of the European Medicines Agency concluded that S-1 in combination with cisplatin (75 mg/m2) was noninferior to 5-FU plus cisplatin (100 mg/m2) in patients with advanced gastric cancer and adopted a positive opinion recommending the marketing authorization for this product for the treatment of advanced gastric cancer when given in combination with cisplatin. The recommended dose of S-1 is 25 mg/m2 (expressed as tegafur content) twice a day, for 21 consecutive days followed by 7 days rest (one treatment cycle), in combination with 75 mg/m2 cisplatin i.v. administered on day 1. This treatment cycle is repeated every 4 weeks. The most common side effects reported in the pivotal study were anemia, neutropenia, vomiting, diarrhea, abdominal pain, weight decrease, anorexia, and fatigue. The objective of this paper is to summarize the scientific review of the application leading to approval in the EU. The full scientific assessment report and the summary of product characteristics are available on the European Medicines Agency website (http://www.ema.europa.eu). [ABSTRACT FROM AUTHOR]

Accurate and timely risk assessment of short-term rainstorm-type flood disasters is very important for ecological environment protection and sustainable socio-economic development. Given the complexity and variability of different geographical environments and climate conditions, a single machine learning model may lead to overfitting issues in flood disaster assessment, limiting the generalization ability of such models. In order to overcome this challenge, this study proposed a short-term rainstorm flood disaster risk assessment framework under the integrated learning model, which is divided into two stages: The first stage uses microwave remote sensing images to extract flood coverage and establish disaster samples, and integrates multi-source heterogeneous data to build a flood disaster risk assessment index system. The second stage, under the constraints of Whale Optimization Algorithm (WOA), optimizes the integration of random forest (RF), support vector machine (SVM), and logistic regression (LR) base models, and then the WRSL-Short-Term Flood Risk Assessment Model is established. The experimental results show that the Area Under Curve (AUC) accuracy of the WRSL-Short-Term Flood Risk Assessment Model is 89.27%, which is 0.95%, 1.77%, 2.07%, 1.86%, and 0.47% higher than RF, SVM, LR, XGBoost, and average weight RF-SVM-LR, respectively. The accuracy evaluation metrics for accuracy, Recall, and F1 Score have improved by 5.84%, 21.50%, and 11.06%, respectively. In this paper, WRSL-Short-Term Flood Risk Assessment Model is used to carry out the risk assessment of flood and waterlogging disasters in Henan Province, and ArcGIS is used to complete the short-term rainstorm city flood and waterlogging risk map. The research results will provide a scientific assessment basis for short-term rainstorm city flood disaster risk assessment and provide technical support for regional flood control and risk management. [ABSTRACT FROM AUTHOR]

Copyright of Tunnel Construction / Suidao Jianshe (Zhong-Yingwen Ban) is the property of Tunnel Construction Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This document provides guidance on the strategy and methodologies followed by the European Food Safety Authority (EFSA) to consult on its scientific outputs with the objective of increasing transparency, visibility and openness of the scientific risk assessment. This initiative is framed within a larger activity devoted to the continuous improvement of the EFSA Quality Management System, a key component of the on‐going consolidation of its excellence and independency. The document illustrates all the relevant aspects to be taken into account when running a consultation: the motivation and scope of a consultation; the definition of the issues at stake in a given consultation; the identification of the relevant stakeholders to be involved in a given consultation; the selection of the most appropriate means of a consultation; and a description of how the comments received are addressed and followed up. The concluding description of the different steps in EFSA's scientific assessment that may be open for consultation, provides interested stakeholders with an explanation on EFSA's procedure to ensure consistency and harmonisation of the consultation process. [ABSTRACT FROM AUTHOR]

Safety is the key to airline operations. The premise for ensuring safety is valid classification and scientific assessment of hazardous sources. The airlines, however, are deficient in an overall mastery and effective analysis of the hazardous sources currently. Here, we propose a model for a safety risk assessment in airline operations based on constant-sum games, with a comprehensive analysis of hazardous sources identified by airlines. The subjective and objective weights of the hazardous source indicators are balanced depending on the optimal coefficients, which are determined by deriving the countermeasure model through the constant-sum game theory. The comparative analysis of safety risks and weaknesses in management for airlines or secondary departments is then conducted. Meanwhile, a long-term reward mechanism is introduced into the model to eliminate the negative effect of a sudden increase in safety risk indices caused by the newly added hazardous sources. This method provides airlines with an accurate assessment of the safety status and an estimation of safety development which trends to make targeted decisions and realize prevention beforehand. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Cultivated Plants / Journal für Kulturpflanzen is the property of Verlag Eugen Ulmer and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This report evaluates the training courses delivered under the contract OC/EFSA/SCER/2017/01 ‐ Lot 1. Within the period of January 2018 to February 2022 a total of 21 training courses were provided, eight on‐site training courses in Parma at EFSA, six virtual training courses during the Covid‐19 pandemic and seven eLearning courses comprising various numbers of modules. The courses covered different aspects of chemical and biological risk assessment and related tools, namely i) harmonisation of risk assessment methodologies for human health and ecological risk assessment of combined exposure to multiple chemicals (mixture assessment), ii) risk assessment of the application of nanoscience and nanotechnologies in agro/food/feed (nanotoxicity); iii) science‐based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides (endocrine disruption); iv) principles on genotoxicity on scientific assessment (genotoxicity) and v) computational toxicology approaches and tools (in silico). All tutors were experts in their field and had previously performed training courses on these topics. The target participants of the training courses were members of EFSA's Scientific Committee/Panels and their working groups as well as employees from national and international regulatory agencies associated with risk assessment of feed and food compounds. Members of the EFSA Networks as well as EFSA scientific staff also participated in the training courses. Courses were evaluated based on the feedback of participants and continuously improved also by integrating updated or new EFSA guidance documents. [ABSTRACT FROM AUTHOR]

The impact of geological disasters on mountainous settlement have been focused on in recent years. Despite the booming development in the modeling of hazards and vulnerability, the risk assessment in mountainous area still have difficulty in absence of refined data. Moreover, development imbalances widely exist in mountainous areas, which were ignored in previous research. In this study, the refined distribution of socioeconomic data is obtained by using spatialization from the census, which eases the situation of the lack of data. Then, a frequency ratio-random forest model is conducted to evaluate the geological disasters hazards. Meanwhile, vulnerability was evaluated using triangular fuzzy number‑based analytic hierarchy process. In vulnerability assessment, the inhomogeneity index is integrated to evaluate the imbalance between indicators, the use of which can reward a more realistic vulnerability result. Finally, risk map was produced by multiplying hazard and vulnerability. The risk assessment framework is applied in Lushan and Baoxing counties of Southwestern China, which is a typical mountainous area with frequent earthquakes, uneven development, and a lack of high-precision data. The total area of high and extremely high hazards (868.82 km2), vulnerability (258.66 km2), and risk (113.49 km2) are estimated and mapped. The proposed risk assessment framework quantifies the impact of development inhomogeneity on risk and contributes to the scientific assessment of vulnerability for mountainous settlements. [ABSTRACT FROM AUTHOR]

The EFSA 2nd Scientific Conference 'Shaping the Future of Food Safety, Together' gathered an international audience composed of scientists, risk assessors, risk managers, as well as non-governmental organisations and industry representatives. This article summarises the final plenary session where a panel was asked to draw out overall impressions and conclusions for the EFSA to take away for its strategic planning into the future. The main conclusions of the conference are presented under five major themes. With new methodologies, technologies, big data and the increased societal demand for enhanced engagement in the risk assessment process, there is a clear need to maintain levels of expertise from traditional areas and to consider the inclusion of new areas and sources of expertise to perform scientific assessments. Academia, industry, research and regulatory science should work together to achieve this goal. As science progresses at pace, the continued development of assessment methodologies to deal with increasingly complex assessment questions is necessary, as is the need for applied research to underpin the support to policy development that EFSA provides. Greater collaboration is needed to reach agreement on best methods and practices for scientific assessment not just internationally, but also, equally importantly, across legislative areas and scientific disciplines, and in consultation with society at large. The communication of complex science, including important concepts such as uncertainty and risk perception, is not a trivial task, and must be integrated into the scientific process. As such, the relationship between risk assessment and risk management must continue to mature, remaining close, yet independent. [ABSTRACT FROM AUTHOR]

Qualitative and quantitative risk assessments are carried out for a 3 000 m³ ethylene spherical tank. The differences between the two assessment methods are compared and analyzed, and the application principles of qualitative and quantitative assessment methods are determined. The analysis results show that the qualitative analysis steps of risk assessment are simple and easy to operate. When quantitative analysis is difficult, qualitative analysis could replace quantitative analysis to a certain extent, providing a practical method for reasonable risk control. There are some differences between the results of qualitative and quantitative analysis, but the differences are acceptable. Qualitative or quantitative analysis can provide scientific assessment results for the risk assessment of spherical tank. Two risk assessment methods should be reasonably used to maximize the use of risk assessment resources. [ABSTRACT FROM AUTHOR]

The current power distribution Internet of Things (PDIoT) lacks security protection terminals and techniques. Network security has a large exposure surface that can be attacked from multiple paths. In addition, there are many network security vulnerabilities and weak security protection capabilities of power distribution Internet of Things terminals. Therefore, it is crucial to conduct a scientific assessment of the security of PDIoT. However, traditional security assessment methods are relatively subjective and ambiguous. To address the problems, we propose to use the entropy-weight method and cloud model theory to assess the security risk of the PDIoT. We first analyze the factors of security risks in PDIoT systems and establish a three-layer PDIoT security evaluation index system, including a perception layer, network layer, and application layer. The index system has three first-level indicators and sixteen second-level indicators. Then, the entropy-weight method is used to optimize the weight of each index. Additionally, the cloud model theory is employed to calculate the affiliation degree and eigenvalue of each evaluation index. Based on a comprehensive analysis of all evaluation indexes, we can achieve the security level of PDIoT. Taking the PDIoT of Meizhou Power Supply Bureau of Guangdong Power Grid as an example for empirical testing, the experimental results show that the evaluation results are consistent with the actual situation, which proves that the proposed method is effective and feasible. [ABSTRACT FROM AUTHOR]

One-fifth of the way through the 21st century, a commonality of factors with those of the last 50 years may offer the opportunity to address unfinished business and current challenges. The recommendations include: (1) Resisting the tendency to oversimplify scientific assessments by reliance on single disciplines in lieu of clear weight-of-evidence expressions, and on single quantitative point estimates of health protective values for policy decisions; (2) Improving the separation of science and judgment in risk assessment through the use of clear expressions of the range of judgments that bracket protective quantitative levels for public health protection; (3) Use of comparative risk to achieve the greatest gains in health and the environment; and (4) Where applicable, reversal of the risk assessment and risk management steps to facilitate timely and substantive improvements in public health and the environment. Lessons learned and improvements in the risk assessment process are applied to the unprecedented challenges of the 21st century such as, pandemics and climate change. The beneficial application of the risk assessment and risk management paradigm to ensure timely research with consistency and transparency of assessments is presented. Institutions with mandated stability and leadership roles at the national and international levels are essential to ensure timely interdisciplinary scientific assessment at the interface with public policy as a basis for organized policy decisions, to meet time sensitive goals, and to inform the public., (© 2020 Society for Risk Analysis.)

The Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed (the Nano Network) was established in 2010 by the EFSA Advisory Forum, in accordance with EFSA's strategy for cooperation and networking with Member States. This Nano Network exchanges information and expertise between EFSA and Member States. It enhances dialogue among members, builds mutual understanding of risk assessment principles, improves knowledge and confidence in the scientific assessment carried out in the European Union, and increases the transparency of the process among Member States and EFSA. The annual reports of the Nano Network inform the public, stakeholders and research communities about the specific activities and achievements of the Nano Network. In 2020, the yearly meeting was held concomitantly with the 17th meeting of the EFSA cross‐cutting Working Group on Nanotechnologies, and converted to virtual network meeting in line with the measures established by EFSA to reduce the risk of coronavirus infection. The purpose of this annual meeting was to ensure information and knowledge exchange with risk assessor delegates of European Member States on the ongoing activities and further research priorities. The Nano Network members were informed on the last updates of the Guidance documents produced by EFSA in the field of Nanotechnologies, which are currently under finalisation. The Network was asked to contribute to the finalisation of the Guidances as well as their further implementation and dissemination. [ABSTRACT FROM AUTHOR]

Background: The high production volume of engineered nanomaterials (ENMs) may lead to high pressure on the environment, and a scientific assessment of ENMs that bioaccumulate in organisms and biomagnify in the food web is necessary. Within the regulation of chemicals in several jurisdictions, such as the European regulation REACH, the bioconcentration factor is the standard endpoint. The bioconcentration factor is mostly determined by flow-through fish tests. However, nanomaterials tend to agglomerate, which may lead to sedimentation in aquatic environments. The bioavailability of the tested nanomaterials may be thus impaired for pelagic species, including fish, in comparison to benthic or filtrating species. Several risk assessment regulations allow the usage of data gained during tests using invertebrates and such data may allow a waiver of further tests using vertebrates. The aim of this study was to elucidate the potential of different freshwater invertebrate species to be used in laboratory bioaccumulation studies on ENMs and to give some guidance for the use of bioaccumulation endpoints derived from studies using aquatic invertebrate species in the risk assessment process for ENMs. Results: The existing literature related to the testing of nanomaterial bioaccumulation with freshwater invertebrates was screened and reviewed to find suitable test species with regard to their ecology and physiology, as well as laboratory test systems allowing to investigate the bioavailability/bioaccumulation of nanomaterials with the respective species. Bivalvia, gastropoda, isopoda, amphipoda, and branchiopoda were reviewed and their suitability for bioaccumulation testing was assessed. Amphipods and bivalves represent worst-case scenarios and show clear advantages to be used as test organisms. However, only amphipods allow the examination of two clearly independent exposure pathways (water and diet). Conclusion: Amphipods are suitable test organisms for bioaccumulation testing of ENMs. The results from amphipod bioconcentration and biomagnification tests can be included in a tiered assessment suggested at the end of this study allowing a clear grading of the tested nanomaterials as "bioaccumulative" or "non bioaccumulative." Due to the worst-case scenario of the amphipod test, this approach may allow a waiver of further vertebrate tests. [ABSTRACT FROM AUTHOR]

One‐fifth of the way through the 21st century, a commonality of factors with those of the last 50 years may offer the opportunity to address unfinished business and current challenges. The recommendations include: (1) Resisting the tendency to oversimplify scientific assessments by reliance on single disciplines in lieu of clear weight‐of‐evidence expressions, and on single quantitative point estimates of health protective values for policy decisions; (2) Improving the separation of science and judgment in risk assessment through the use of clear expressions of the range of judgments that bracket protective quantitative levels for public health protection; (3) Use of comparative risk to achieve the greatest gains in health and the environment; and (4) Where applicable, reversal of the risk assessment and risk management steps to facilitate timely and substantive improvements in public health and the environment. Lessons learned and improvements in the risk assessment process are applied to the unprecedented challenges of the 21st century such as, pandemics and climate change. The beneficial application of the risk assessment and risk management paradigm to ensure timely research with consistency and transparency of assessments is presented. Institutions with mandated stability and leadership roles at the national and international levels are essential to ensure timely interdisciplinary scientific assessment at the interface with public policy as a basis for organized policy decisions, to meet time sensitive goals, and to inform the public. [ABSTRACT FROM AUTHOR]

The dynamics in climatic variability is prominently affecting the agriculture system, particularly the small and marginal land holding farmers in arid and semi-arid regions which are highly vulnerable. The present study in Kolar district assessed the variability scale and dynamics of rainfall over the decades, it revealed the current day’s agrarian crisis, resulting in impacts on farmers and adaptations by farmers to changing situations. The study also reveals that over the decades there has been a considerable variation in rainfall pattern in the study area but there was no significant average rainfall variation till the last decade, after which there was a significant seasonal variation that directly affects the sowing pattern and associated agricultural practices. The exploitation of groundwater for water-intensive commercial crops has increased rapidly from the past decade that resulted in the critically depleted groundwater table. To meet the livelihood demands some farmers were observed to have shifted to non-agricultural occupations. It is a serious threat at this point of time as the agriculture output has to be fed to the larger portion of the society and decreased output from agriculture eventually leads to inflation. So, it is very crucial to adapt all possible measures to retain farmers in agriculture practice. Hence, understanding and scientific assessment of the risks associated with the changing climate and its variables is the need of the hour, particularly in arid and semi-arid regions which are going to be highly vulnerable. Studies like this will help in policy-making and management planning to cope up with the dynamic climatic factors. [ABSTRACT FROM AUTHOR]

Frequently, decisions related to health protection are taken directly on the basis of scientific assessment and they are not clearly understood, as is highlighted in the Xylella example. Therefore, this article suggests that coherent processing of information in risk assessment may allow also a "third party" (who has not already expressed a specific interest in the procedure) to participate. In order to truly grasp the EU administration, an accountable way of communicating is helpful. Therefore, communication around the democratic process might be based on EU administrative principles and rules supporting a composite administrative system: it must not neglect the implications of compliance with the multilingual principle and its consequences for EU law, which would also lead to greater trust in risk assessment. [ABSTRACT FROM AUTHOR]

African swine fever (ASF) is a highly contagious and deadly disease in domestic and feral pigs that is transmitted through direct and indirect contact, ingestion of contaminated feed and certain vector tick species. ASF is considered one of the most dangerous diseases in pigs, affecting trade and having a serious socio-economic impact on human livelihoods. There are no vaccines or drugs to prevent ASF infection. It is therefore essential to keep ASF-free areas clean by preventing the introduction of the disease. All applicable control and eradication measures shall be based on classical methods of disease control, including surveillance, epidemiological surveillance, monitoring of pigs and their destruction on infected holdings. These measures must be combined with strict quarantine and biosecurity measures on pig holdings as well as animal movement controls. Due to the fact that no vaccine has yet been developed to prevent the disease, the old maxima that prevention is better than cure applies in full force to ASF. To control the spread of the disease in 2018 the Bulgarian Food Safety Agency has developed a Strategy for Combating ASF in Bulgaria, which is based on early detection of the disease, implementation of strict control and biosecurity measures in pig farms and maximum reduction of the wild boar population in the affected and neighboring regions. In this paper we aim to analyze how the Strategy should be applied to control the spread of ASF, as well as the extent it identifies and characterizes the existing and potential risks and their sources (including institutional risks), whether they are analyzed, the causal links and interdependencies, possible consequences (direct, indirect, chain, network and cascade effects of their implementation), as well as countermeasures in different scenarios, their technical, social, organizational, institutional, financial and economic feasibility. In this way, one of the basic requirements in risk management will be fulfilled, it will be based on a preliminary risk assessment. To evaluate the proposed strategy for combating ASF, we used a comparative method, based on which we compared to what extent the main risk factors for the spread of the disease from the EFSA scientific assessment of the risk of ASF spread in Southeast Europe were taken into account the requirements of the Terrestrial Animal Health Code. As a result of the analysis we can summarize that the Strategy should be improved by taking into account the comments made and to prepare an operational plan in which to describe in detail the specific objectives of each stage and its expected results, indicators of progress in the process. of the implementation, the actions for the preparation for the implementation of the separate stages, the duration of the stages and the necessary resources for their implementation, as well as the order and the manner of reporting the implementation. [ABSTRACT FROM AUTHOR]

A wide range of raw materials are now used routinely in aquaculture feeds throughout the world, primarily to supply protein and energy in the form of lipid from edible oils. Protein meals and oils used can generally be divided into those of plant or animal origin and many have considerable potential to supply the required dietary nutrients required by aquaculture species. However, the use of any raw material introduces a suite of risks that need to be considered to enable the production of safe, sustainable and functional feeds to underpin this sector. A lack of understanding of some of those risks can result in failure of dietary specifications being met and/or negative nutritional elements being introduced (e.g. antinutritional factors). Importantly, it is this feed that when fed to food‐producing animals is such an important element of food safety, and as such any undesirable aspects relating to feed production can also have a negative impact on the rest of the food chain. However, there is some disparity internationally among raw materials that are used and the perceptions surrounding the risk of their use. It is the scientific assessment of these risks that is the basis of this review. [ABSTRACT FROM AUTHOR]

Quantitative microbiological risk assessment (QMRA) of pathogens in food safety is well established, but steps are being taken to expand this methodology to food spoilage. Parallels can be drawn between the steps involved in a QMRA for pathogens and its application to specific spoilage organisms (SSO). During hazard characterisation for pathogens, the appropriate dose–response model is used to link the hazard level to the health outcome by estimating the probability of illness, resulting from the ingestion of a certain dose of the hazard. The dose–response model, in the case of food spoilage, may be translated into a spoilage‐response relationship linking the spoilage‐level with the probability the consumer will discard the food and not consume it. Such models are developed with sensory testing, assessing consumers sensitivity to microbial spoilage quality defects and correlating them to the SSO concentration. Ignoring food spoilage before the stated expiration date can lead to the final health risk being overestimated, since cases in which the food item poses a real risk to the consumer but is not consumed due to perceived spoilage are not excluded. Plenty of risk assessments have been carried out for pathogens in different RTE foods. What is missing is the integration of the two approaches into a single model that can estimate the risk of illness, factoring in the variability of consumer responses to spoilage. The spoilage‐response relationship was combined with a stochastic modelling approach for lactic acid bacteria (LAB) and Listeria monocytogenes growth, also taking into account microbial interaction between LAB and L. monocytogenes (Jameson effect) to increase accuracy. The comparison of results between the 'Baseline' and the 'Spoilage‐informed' approach showed significant difference in listeriosis cases, both for consumers under and over 65 years old. These results may suggest, that the hypothesis about overestimation of listeriosis risk in case of not taking into account product spoilage is correct. The combined QMRA model developed in the present study can be a useful tool for risk management decisions in the meat industry. [ABSTRACT FROM AUTHOR]

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Copyright of Mountain Research (10082786) is the property of Mountain Research Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

4- tert -octylphenol (4- tert -OP) is an ecologically hazardous substance, and exposure to it in the environment has been consistently reported in the past. Despite the hazards and widespread exposure to 4- tert -OP, tools for scientific assessment of 4- tert -OP exposure risk level in humans are lacking. The main purpose of this study was to develop a physiologically-based-toxicokinetic (PBTK) model for 4- tert -OP and to perform quantitative risk assessment of 4- tert -OP in various population groups using the established model. Based on the results of toxicokinetic experiments on male rats, the PBTK model for 4- tert -OP was established and verified, and this was converted to a model for humans through interspecies extrapolation. Based on the previously reported no-observed-adverse-effect-levels for rats, it was possible to estimate the 4- tert -OP reference dose in humans through reverse dosimetry using the model. Biomonitoring data derived from various population groups were applied to the human PBTK model to calculate external exposures and margin of safety for 4- tert -OP for each population group. The PBTK model established in this study adequately explained the toxicokinetic experimental values at acceptable levels and was able to quantitatively predict the 4- tert -OP exposure level in the testes related to male reproductive toxicity. In addition, the degree of external exposure to 4- tert -OP could be scientifically estimated based on biomonitoring values derived from various biological matrices. The reference doses for systemic and reproductive toxicity caused by 4- tert -OP in male humans were calculated to be 0.16 and 1.12 mg/kg/day, respectively. The mean external exposure to 4- tert -OP in each population group estimated based on plasma and urine biomonitoring data was 0.04–66.24 mg/kg/day, showing very large exposure diversity between groups. Exposure risks to 4- tert -OP in populations ranged from safe to risky, suggesting the need for continued monitoring and risk management of 4- tert -OP worldwide. This study provides valuable scientific insight regarding the 4- tert -OP human risk assessment. [Display omitted] • A scientific human risk assessment of 4- tert -OP using PBTK modeling was performed. • PBTK model that can consider reproductive toxicity to men has been newly developed. • Large exposure variability of 4- tert -OP was confirmed between populations. • It was suggested that continuous management and monitoring of 4- tert -OP is necessary. [ABSTRACT FROM AUTHOR]

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 Finland for the pesticide active substance fenoxaprop‐P‐ethyl 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 fenoxaprop‐P‐ethyl as a post‐emergence herbicide in wheat, durum wheat, rye, triticale and barley to control annual monocotyledonous weeds. 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. [ABSTRACT FROM AUTHOR]

Vitamins and essential minerals are micronutrients that are required for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. A tolerable upper intake level (UL) is a science‐based reference value that supports policy‐makers and other relevant actors in managing the risks of excess nutrient intake. EFSA's principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework for UL assessments. A draft was published in 2022 and underwent a 2‐year piloting period. The present document incorporates revisions based on the experience gained through its practical implementation. It covers aspects related to the planning of the risk assessment (problem formulation and definition of methods) and its implementation (evidence retrieval, appraisal, synthesis, integration, uncertainty analysis). As in the previous framework, the general principles developed for the risk assessment of chemicals in food are applied, i.e. hazard identification, hazard characterisation, intake assessment, risk characterisation. Specific to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homeostasis and accumulation of the nutrient in the body. Such considerations must also be taken into account when conducting risk assessments of nutrients. [ABSTRACT FROM AUTHOR]

The analysis of temporal and spatial variability in risk has garnered significant research attention, particularly regarding flash flood disasters in the context of warming and wetting conditions on the Qinghai–Tibetan Plateau. Focusing on the Lhasa River basin, this study develops a framework that integrates geographic information systems and a combined subjective–objective weighting approach to comprehensively assess flash flood risk despite limited observations. This paper investigates the distribution patterns of hazard, vulnerability, and the integrated risk of pluvial flash floods; demonstrates the reliability of the assessment results; and provides mitigation recommendations for disaster risk management at the county level. The results showed a trend in increasing flash flood risk in recent decades compared to the 1990s. Moreover, very-high- and high-risk areas were concentrated in downstream regions with frequent precipitation extremes and anthropogenic activity. From 1991 to 2020, the high to very high-risk areas gradually expanded from central Lhasa to neighbouring counties. This study contributes valuable insights into flash flood risk assessment cand mapping, which are crucial in terms of the protection of life and property in the plateau basin. [ABSTRACT FROM AUTHOR]

Cyclopiazonic acid (CPA) is an indole-tetramic acid neurotoxin produced by Aspergillus and Penicillium genera present mainly in fruit, cereals and nuts. This study compares the cytotoxicity produced by CPA after 24, 48 and 72 h of exposure using both monolayers and 3D spheroids in human neuroblastoma SH-SY5Y cells. Furthermore, CPA toxicokinetics was evaluated using in silico models. Cytotoxicity increased dose- and time-dependently, as shown by the MTT assay. The lowest CPA IC50 values were found in the monolayer study compared to the 3D spheroids at all exposure times (24 h: 864.01 vs. 1132; 48 h: 437 vs. 1069; 72 h: 392 vs. 567 nM). The CPA exposure on SH-SY5Y spheroid organization and morphology was also studied. Morphological changes, including spheroid disaggregation, were observed after mycotoxin exposure. The in silico methods, SwissADME and admetSAR, were used for short and full ADMEt profiles of CPA. The ADMEt predictive profile shows high gastrointestinal absorption and ability to penetrate the blood–brain barrier. Including in silico studies emphasizes the comprehensive approach to understanding mycotoxin toxicity and risk assessment. By combining in vitro 3D spheroid models with computational simulations, this study aims to provide a holistic perspective on the effects of CPA, enhancing the accuracy and relevance of our findings. [ABSTRACT FROM AUTHOR]

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, Italy, and co‐rapporteur Member State, Poland, for the pesticide active substance penoxsulam 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 penoxsulam as a herbicide on rice and chicory. 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. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance elemental iron and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 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 elemental iron in field and greenhouses (permanent and non‐permanent structures) via granule application by spreading on all edible and non‐edible crops, ornamental plants and amenity grassland to control molluscs. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. [ABSTRACT FROM AUTHOR]