Risk Assessment Methodology Research Articles

Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study.

Over the past 4 decades, obesity has escalated into a global epidemic, with its worldwide prevalence nearly tripling. Pharmacological treatments have evolved with the recent development of glucagon-like peptide 1 agonists, such as semaglutide. However, off-label use of drugs such as Ozempic for cosmetic weight loss has surged in popularity, raising concerns about potential misuse and the emergence of substandard and falsified products in the unregulated supply chain. This study aims to conduct a multifactor investigation of product quality and patient safety risks associated with the unregulated online sale of semaglutide by examining product availability and vendor characteristics and assessing product quality through test purchases. We used a complex risk and quality assessment methodology combining online market surveillance, search engine results page analysis, website content assessment, domain traffic analytics, conducting targeted product test purchases, visual quality inspection of product packaging, microbiological sterility and endotoxin contamination evaluation, and quantitative sample analysis using liquid chromatography coupled with mass spectrometry. We collected and evaluated 1080 links from search engine results pages and identified 317 (29.35%) links belonging to online pharmacies, of which 183 (57.7%) led to legal pharmacies and 134 (42.3%) directed users to 59 unique illegal online pharmacy websites.Web traffic data for the period between July and September 2023 revealed that the top 30 domains directly or indirectly affiliated with illegal online pharmacies accumulated over 4.7 million visits.Test purchases were completed from6 illegal online pharmacies with the highest number of links offering semaglutide products for sale without prescription at the lowest price range. Three injection vial purchases were delivered; none of the 3 Ozempic prefilled injection pens were received due to nondelivery e-commerce scams.All purchased vials were considered probable substandard and falsified products, as visual inspection indicated noncompliance in more than half (59%-63%) of the evaluated criteria. The semaglutide content of samples substantially exceeded labeled amounts by 28.56%-38.69%, although no peptide-like impurities were identified. The lyophilized peptide samples were devoid of viable microorganisms at the time of testing; however, endotoxin was detected in all samples with levels ranging between 2.1645 EU/mg and 8.9511 EU/mg. Furthermore, the measured semaglutide purity was significantly low, ranging between 7.7% and 14.37% and deviating from the 99% claimed on product labels by manufacturers. Glucagon-like peptide 1 agonist drugs promoted for weight loss, similar to erectile dysfunction medications more than 2 decades ago, are becoming the new blockbuster lifestyle medications for the illegal online pharmacy market. Protecting the pharmaceutical supply chain from substandard and falsified weight loss products and raising awareness regarding online medication safety must be a public health priority for regulators and technology platforms alike.

State-of-the-art nonstationary hypersurface damage assessment approach for energy harvesters

Since EH (Energy Harvesters) constitute nowadays a vital part of renewable energy engineering, experimental research is required in addition to numerical modeling, serving reliable structural design and ensuring prolonged device service time. The performance of GPEH (GalloPing EH) has been examined in this case study, utilizing comprehensive laboratory wind tunnel tests, carried out under realistic windspeed conditions. Novel structural multivariate risks assessment methodology, presented here, being feasible for nonstationary nonlinear GPEH dynamic systems, that had been either physically measured over a representative period, providing jointly quasi-ergodic time-series, or directly numerically MCS (Monte Carlo Simulated). Based on laboratory-measured GPEH dynamics, the presented analysis demonstrates that the proposed multivariate hypersurface methodology offers robust predictions of the structural failure/damage risks. Furthermore, when dealing with raw measured timeseries, representing the high-dimensional dynamic system, existing risk assessment techniques struggle to handle nonlinear inter-correlations between GPEH critical components. This case study's main objective has been to validate and benchmark the novel multimodal risk assessment methodology, which utilizes multivariate nonstationary lab-recorded time histories to extract relevant design information from the underlying GPEH dynamics.The proposed state-of-the-art nonstationary hypersurface reliability approach being of a generic nature, offering additional capacity for damage/failure risks prognostics for a wide range of nonlinear multidimensional nonstationary systems. Forecasted damage and failure risks have been supplied with confidence bands, demonstrating the experimental setup's robustness, as well as the useful design features of the presented nonstationary hypersurface risks assessment methodology. It should be noted that the presented reliability methodology being mathematically exact, and it does not rely on simplifying assumptions.

Multivariate risk assessment for offshore structures by Gaidai risk evaluation method under an accumulation of fatigue damage, utilizing novel deconvolution scheme

Current study presents a state-of-the-art structural spatiotemporal multimodal risk assessment methodology, that is particularly well-suited for multimodal structural dynamics, either recorded physically or numerically simulated over a representative timelapse. Offshore Jacket-type offshore platform, operating in Bohai Bay waters had been selected for the method’s verification. This investigation had shown that, in the presence of in-situ environmental stressors, it is possible to appropriately estimate dynamic structural system’s failure and damage risks. High dimensionality of engineering dynamic structural systems, alomg with nonlinear nonstationary inter-correlations between critical structural components, often present challenges for contemporary reliability methods, mostly limited to univariate and bivariate systems. Operating Jacket platform, subjected to in situ wave loads, had been chosen for this case study to benchmark advocated risk evaluation methodology. Number of hotspot stresses had been selected to represent multivariate structural system. Advocated multimodal method had been proven to be suitable for robust assessment of operational failure/damage risks, as well as for accurate structural life projection. Novel non-parametric deconvolution extrapolation scheme had been employed, providing enhanced numerical stability. Given increased safety concerns within offshore, naval, marine engineering, advocated multimodal reliability methodology may be utilized for safer and economically more viable structural design.

Role of cybersecurity for a secure global communication eco-system: A comprehensive cyber risk assessment for satellite communications

In an age where global connectivity has become pivotal to socio-economic development, satellite communication (SATCOM) systems have become the backbone of modern telecommunication infrastructure. However, the increasing reliance on SATCOM also elevates the potential impact of cyber threats. Cyber risk assessment is a critical component of any satellite communications risk management strategy. It plays a pivotal role in identifying and managing risks to satellite communications, which helps stakeholders isolate the most critical threats and select the appropriate cybersecurity measures. To the best of our knowledge, the field of satellite communications lacks an established framework for cyber risk assessment. Moreover, previous research work has focused only on a limited number of security threats and categories. Therefore, in this paper, we propose a comprehensive risk assessment methodology to qualitatively assess the risk associated with satellite communications cyber threats, following the NIST special publication 800-30: Guide for Conducting Risk Assessments. We analyze existing literature and real-world scenarios to identify potential satellite communications cyber threats and employ the STRIDE threat model for threat modeling. We validate the proposed methodology by performing a risk assessment for the cyber threats identified. Finally, we discuss existing challenges and open research problems for satellite communications cyber risk assessment.

Zinc oxide nanomaterials: Safeguarding food quality and sustainability

AbstractIn this era, where food safety and sustainability are paramount concerns, the utilization of zinc oxide (ZnO) nanoparticles (NPs) is a promising solution to enhance the safety, quality, and sustainability of food products. ZnO NPs in the food industry have evolved significantly over time, reflecting advancements in synthesizing methods, antimicrobial activities, and risk assessment considerations for human health and the environment. This comprehensive review delves into the historical trajectory, current applications, and prospects of ZnO NPs in food‐related contexts. Synthesizing methods, ranging from solvothermal and solgel techniques to laser ablation and microfluidic reactors, have facilitated the production of ZnO NPs with tailored properties suited for diverse food applications. The remarkable antimicrobial activity of ZnO NPs against a wide spectrum of pathogens has garnered attention for their potential to enhance food safety and extend shelf‐life. Furthermore, comprehensive risk assessment methodologies have been employed to evaluate the potential impacts of ZnO NPs on human health and the environment, regarding toxicity, migration, and ecological implications. By navigating the intricate interplay between synthesis methods, antimicrobial efficacy, inhibitory mechanisms, and risk assessment protocols, by elucidating the multifaceted role of ZnO NPs in shaping the past, present, and future of the food industry, this review offers valuable insights and promising avenues for researchers, policymakers, and industry stakeholders to enhance food safety, quality, and sustainability.

Assessment of Trace Organic Chemicals in anaerobically digested sludge and their partitioning behaviour: Simultaneous Soxhlet chemical extraction and quantification via LC-MS/MS analysis

The increasing number of trace organic contaminants (TrOCs) detected in anaerobically digested sludge (ADS) is triggering increasing concern on its circular-economy reuse practices. A large scientific effort has been performed to define their concentration limits, partition behaviour, and innovative technologies for their removal, which require the definition of versatile and economically sustainable analytical methodologies. In this study, a Soxhlet extraction method coupled with LC-MS/MS analysis was developed to simultaneously determine 32 TrOCs in ADS, 11 of them being quantified in this matrix for the first time. The targeted TrOCs were selected based on the European Urban Wastewater Treatment Directive, and on their frequency of detection in municipal wastewater and/or sludge and chemical diversity. The use of methanol as solvent allowed good recovery efficiencies from ADS solid phase, with an extraction time of 3.5 hours and without the need for subsequent clean-up procedures. The targeted LC-MS/MS method enabled high-sensitivity quantification of TrOCs in the liquid phase. At least 25 out of the 32 target compounds were detected in ADS samples from two wastewater treatment plants in Germany, providing their concentration data and highlighting the influence of TrOCs characteristics and sludge properties on contaminant partition coefficients (KD). The experimental outcomes highlight the versatility of the Soxhlet method, which is effective in extracting compounds characterized by diverse properties and structures, and opens new perspectives for the analysis of various substrates. This could support the European Sewage Sludge Directive, expanding its application to soils and cultivated foods and offering insights into TrOCs transfer among different substrates and their influence when used as fertilizer, aiding in the efficient definition of risk assessment methodologies and regulatory concentration limits.

Characterizing groundwater contamination flow-paths and heavy metal mobilization near a waste site in Southwestern Nigeria

This study investigates potential groundwater contamination near a waste disposal site in southwestern Nigeria. The area's complex geological setting, characterized by fractured rock formations, posed significant challenges for traditional monitoring methods. To address these challenges and comprehensively assess groundwater conditions, we employed a combined approach utilizing Electrical Resistivity Tomography (ERT), Ground Penetrating Radar (GPR), and geochemical analysis of heavy metals and water conductivity. This approach enabled the investigation of groundwater levels, identification of potential contamination zones, and delineation of contaminant flow paths. GPR identified a shallow zone, termed the “shadow zone,” with conductive residues indicating contaminants with anomalous conductivity ranging from 1 to 1.5 m. An intermittent reflection zone at a depth of 1.5–3.5 m suggested the potential presence of leachate-impacted groundwater. ERT confirmed a shallow resistive layer at depths of 0–2 m, attributed to compacted waste and topsoil, around the abandoned main dumpsite. Below this layer, a zone of low resistivity, decreasing downward through a porous weathered zone, was observed. This corresponded to high water conductivity in well data, ranging from 21 to 147 mS/m (equivalent to 6.80 to 47.62 Ω-m), indicating a high conductive anomaly suspected to be a leachate plume at depths of 2–10 m in a sandy-gravelly weathered zone. Validation against ground truth data confirmed the correlation between radar signatures, geoelectrical imaging, and subsurface lithology. Analysis of well and soil samples revealed concerningly elevated concentrations of cadmium, mercury, lead, arsenic, and cobalt, ranging from 641 to 1175 ppb, exceeding established safety limits for drinking water. Additionally, soil samples showed elevated levels of nickel and chromium, generally ranging from <0 to <1 ppb. These findings highlight the significant risk of groundwater contamination due to the proximity of the leachate zone to the groundwater table in the weathered basement complex. This study demonstrates the effective integration of geophysical and geochemical methods for comprehensive mapping of contaminated zones and identification of preferential pathways for contaminant migration. The findings underscore the critical need for implementing comprehensive risk assessment methodologies in similar complex geological settings.

Building a theoretical framework for financial risk management in emerging markets: Applying global best practices to the oil and gas industry in developing economies

Financial risk management is crucial for the sustainability and growth of the oil and gas industry in developing economies, where volatility and regulatory uncertainties present significant challenges. This abstract explores the construction of a theoretical framework for financial risk management, adapting global best practices to the specific contexts of emerging markets within the oil and gas sector. In developing economies, the oil and gas industry faces unique risks such as geopolitical instability, currency fluctuations, and regulatory changes. Effective financial risk management mitigates these risks through proactive strategies that balance risk exposure with strategic objectives. Adopting global best practices involves the integration of comprehensive risk assessment methodologies, scenario planning, and hedging techniques tailored to local market conditions. Key components of the theoretical framework include risk identification through comprehensive analysis of market, operational, and financial factors. This approach enables oil and gas companies to anticipate and mitigate risks before they escalate, ensuring financial stability and resilience in volatile environments. Furthermore, the application of global best practices in financial risk management fosters transparency and accountability, enhancing investor confidence and facilitating access to capital. By aligning risk management strategies with international standards and benchmarks, developing economy oil and gas firms can navigate uncertainty more effectively, thereby optimizing operational performance and sustaining long-term growth. However, challenges such as limited access to sophisticated financial instruments and expertise may hinder effective implementation. Overcoming these barriers requires capacity building, collaboration with experienced partners, and continuous adaptation of strategies to evolving market dynamics. In conclusion, building a theoretical framework for financial risk management in the oil and gas industry in developing economies is essential for mitigating volatility and maximizing opportunities. By applying global best practices tailored to local contexts, companies can strengthen their resilience, attract investment, and drive sustainable development in emerging markets.

Risk of rainfall caused leaching from bio-composite material based building façades into the aquatic environment

The increasing focus on sustainability and circularity is driving the global production of environmentally friendly products. The Netherlands started producing new bio-composite materials which are created by reclaiming resources from various sectors of the water industry. These materials can be used for a variety of applications including façade elements in buildings. However, their potential environmental impact, particularly with regard to leaching of potentially harmful substances into surface water, necessitates further evaluation. To address this issue, a systematic environmental risk assessment methodology combined with novel experimental data is presented here. To collect this data, façade panels made of two different bio-composite materials were first subjected to a series of laboratory tests, including analysis in both new and weathered forms, the latter subject to a cyclic UV radiation and high humidity, in order to simulate the effects of aging. Leaching tests were then conducted to determine the potential release of specific chemical substances such as heavy metals and resin compounds, under two different rainfall conditions (every day and more extreme). The data generated this way was used to perform the risk assessment using the existing European ERA framework. The results obtained reveal different leaching behaviour of the new and weathered samples, as well as between the two analysed bio-composite materials, depending on the rain intensity. To overcome the uncertainties caused by the limited input data, a sensitivity analysis was carried out whereby leaching concentrations and rainfall intensities were varied and their influence on the environmental risk was assessed. The results obtained demonstrated that, despite some variability, both materials appear safe to use, i.e., with estimated risks below the established safety threshold. While these findings provide a preliminary indication, they are based on laboratory conditions and assumptions hence further field studies are recommended to obtain more definitive conclusions.

Urban burden of disease estimation for policy making

Abstract Introduction The Urban Burden of Disease Estimation for Policy Making (UBDPolicy) project aims to estimate the health impacts resulting from urban and transport planning related exposures in nearly 1000 European cities. So far, quantitative burden of disease assessments have estimated premature mortality attributable to the environmental stressors of air pollution, noise, urban heat islands and lack of green space for the year 2015. Regular reporting and trend monitoring of the health impacts associated with urban environments is crucial for assessing the wider impacts of urban and transport planning. Methods For almost 1000 European cities, quantitative Health Impact Assessments (HIAs) will be conducted that employ the comparative risk assessment methodology. Baseline exposure levels of air pollution, noise, urban heat islands and green space will be estimated and preventable health impacts modelled using counterfactual exposure scenarios. Analysis will comprise two components: firstly, the 2018 HIA will incorporate multiple environmental exposures for that year, while the second component will monitor trends at three-yearly reporting intervals covering the years of 2015, 2018, 2021 and 2024. Results Results are intended to shape evidence-informed urban planning and policies throughout Europe. By ranking cities according to environmental exposures and health impacts, cities are encouraged to address challenges and learn from successful urban design and planning policies in other cities. Discussion HIAs serve as an effective tool for identifying the health impacts of current and future urban policies. The provision of burden of disease estimates will provide policy-makers and practitioners robust data for informed decision-making, while estimates over time will allow tracking of changes from implemented policies. To fully harness the potential of cities as key drivers of sustainable and healthy living, robust evidence must be at the forefront of this change. Key messages • A multitude of urban and transport planning pathways contribute toward the health of urban populations. • Compact city designs often promote health, however there are exceptions.

Improving Workplace Safety and Health Through a Rapid Ergonomic Risk Assessment Methodology Enhanced by an Artificial Intelligence System

The comfort of a worker while performing any activity is extremely important. If that activity extends beyond a person’s capacity to withstand physical and psychological stress, the worker may suffer from both physical and mental ailments. Over time, if the stress persists, these conditions can become chronic diseases and can even be the cause of workplace accidents. In this research, a methodology was developed for the rapid assessment of ergonomic risks and for calculating the level of ergonomic comfort in the workplace. This methodology uses artificial intelligence through a specific algorithm and takes into account a number of factors that, when combined, can have a significant impact on workers. To achieve a more accurate simulation of a work situation or to evaluate an ongoing work situation, and to significantly correlate these parameters, we used logarithmic calculation formulas. To streamline the process, we developed software that performs these calculations, conducts a rapid assessment of ergonomic risks, estimates a comfort level, and proposes possible measures to mitigate the risks and effects on workers. To assist in diagnosing the work situation, we used a neural network with five neurons in the input layer, one hidden layer, and two neurons in the output layer. As a result, most work situations, in any industrial field, can be quickly analyzed and evaluated using this methodology. The use of this new analysis and diagnosis tool, implemented through this new research technology, is beneficial for employers and workers. Moreover, through further developments of this methodology, achieved by increasing the number of relevant input parameters for ergonomics and integrating advanced artificial intelligence systems, we aim to provide high precision in assessing ergonomic risk and calculating the level of ergonomic comfort.

The ENDOMIX perspective: how everyday chemical mixtures impact human health and reproduction by targeting the immune system†.

Endocrine disruptor chemicals (EDCs) are natural and synthetic compounds found ubiquitously in the environment that interfere with the hormonal-immune axis, potentially impacting human health and reproduction. Exposure to EDCs has been associated with numerous health risks, such as neurodevelopmental disorders, metabolic syndrome, thyroid dysfunction, infertility, and cancers. Nevertheless, the current approach to establishing causality between EDCs and disease outcomes has limitations. Epidemiological and experimental research on EDCs faces challenges in accurately assessing chemical exposure and interpreting non-monotonic dose response curves. In addition, most studies have focused on single chemicals or simple mixtures, overlooking complex real-life exposures and EDC mechanistic insights, in particular regarding their impact on the immune system. The ENDOMIX project, funded by the EU's Horizon Health Program, addresses these challenges by integrating epidemiological, risk assessment, and immunotoxicology methodologies. This systemic approach comprises the triangulation of human cohort, in vitro, and in vivo data to determine the combined effects of EDC mixtures. The present review presents and discusses current literature regarding human reproduction in the context of immunotolerance and EDC mode of action. It further underscores the ENDOMIX perspective to elucidate the impact of EDCs on immune-reproductive health.

Regulation and Safety of Cosmetics: Pre- and Post-Market Considerations for Adverse Events and Environmental Impacts

Cosmetic products have been increasingly regulated, particularly in Europe. With the introduction of the cosmetic regulation in 2013, stricter quality standards were implemented, surpassing those set by the 1976 legislation. The primary objective of these regulations is to safeguard consumer safety during the use of cosmetic products. Despite these advancements, certain regulatory gaps remain, indicating the need for more effective measures to enhance human and environmental health protection. Considering the aforementioned, this work aims to provide an overview of the current Cosmetics Regulation, highlighting the weakest cornerstones that represent the missing link keeping the core objective from being achieved. While there is ongoing reliance on historical data from animal studies, efforts are actively underway to replace these methods with new new approach methodologies for risk assessment. Additionally, regulatory authorities continue to improve environmental considerations in the assessment process. These measures, along with enhanced surveillance systems, are gradually addressing existing gaps and contributing to a more robust regulatory framework that balances market access with consumer safety. Legally non-compliant—or perhaps compliant but unknowingly dangerous—products may be used by people who relativize them as inherently safe, leading to adverse events. Whether caused by an underlying disease or purely by the chemical’s toxicity, these may never come to the attention of the authorities as they are generally under-reported, making it unfeasible to implement corrective or preventive measures to address their root cause. To illustrate, non-compliant products that have been detected by the Portuguese authority, INFARMED, I. P., from January 2018 to September 2023 are discussed, which were found to be potentially dangerous to human health and, therefore, withdrawn from the market.

A critical review to identify data gaps and improve risk assessment of bisphenol A alternatives for human health.

Bisphenol A (BPA), a synthetic chemical widely used in the production of polycarbonate plastic and epoxy resins, has been associated with a variety of adverse effects in humans including metabolic, immunological, reproductive, and neurodevelopmental effects, raising concern about its health impact. In the EU, it has been classified as toxic to reproduction and as an endocrine disruptor and was thus included in the candidate list of substances of very high concern (SVHC). On this basis, its use has been banned or restricted in some products. As a consequence, industries turned to bisphenol alternatives, such as bisphenol S (BPS) and bisphenol F (BPF), which are now found in various consumer products, as well as in human matrices at a global scale. However, due to their toxicity, these two bisphenols are in the process of being regulated. Other BPA alternatives, whose potential toxicity remains largely unknown due to a knowledge gap, have also started to be used in manufacturing processes. The gradual restriction of the use of BPA underscores the importance of understanding the potential risks associated with its alternatives to avoid regrettable substitutions. This review aims to summarize the current knowledge on the potential hazards related to BPA alternatives prioritized by European Regulatory Agencies based on their regulatory relevance and selected to be studied under the European Partnership for the Assessment of Risks from Chemicals (PARC): BPE, BPAP, BPP, BPZ, BPS-MAE, and TCBPA. The focus is on data related to toxicokinetic, endocrine disruption, immunotoxicity, developmental neurotoxicity, and genotoxicity/carcinogenicity, which were considered the most relevant endpoints to assess the hazard related to those substances. The goal here is to identify the data gaps in BPA alternatives toxicology and hence formulate the future directions that will be taken in the frame of the PARC project, which seeks also to enhance chemical risk assessment methodologies using new approach methodologies (NAMs).

Systematic Review of Quantitative Risk Quantification Methods in Construction Accidents

Construction accidents pose significant risks to workers and the public, affecting industry productivity and reputation. While several reviews have discussed risk assessment methods, recent advancements in artificial intelligence (AI), big data analytics, and real-time decision support systems have created a need for an updated synthesis of the quantitative methodologies applied in construction safety. This study systematically reviews the literature from the past decade, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A thorough search identified studies utilizing statistical analysis, mathematical modeling, simulation, and artificial intelligence (AI). These methods were categorized and analyzed based on their effectiveness and limitations. Statistical approaches, such as correlation analysis, examined relationships between variables, while mathematical models, like factor analysis, quantified risk factors. Simulation methods, such as Monte Carlo simulations, explored risk dynamics and AI techniques, including machine learning, enhanced predictive modeling, and decision making in construction safety. This review highlighted the strengths of handling large datasets and improving accuracy, but also noted challenges like data quality and methodological limitations. Future research directions are suggested to address these gaps. This study contributes to construction safety management by offering an overview of best practices and opportunities for advancing quantitative risk assessment methodologies.

An intuitive approach to cybersecurity risk assessment for non-governmental organizations

Purpose This study proposes a guided tool for cybersecurity risk assessment tailored for nongovernmental organizations (NGOs), enabling them to comply with cybersecurity policies despite limitations in security awareness, funding and expertise. Design/methodology/approach A digital transformation is indispensable for ensuring the sustainable operation of NGOs. Embracing a digital manifesto necessitates an awareness of cybersecurity risks, highlighting the critical need for a robust cybersecurity risk assessment methodology. Initial research phases revealed significant shortages in security awareness, funding and expertise. Consequently, this study introduces an intuitive approach tailored specifically for NGOs, supported by a customized tool designed to address their unique requirements. The NIST cybersecurity risk assessment framework and National Cyber-security Authority (NCA) were adopted to define the risk assessment approach. The efficacy of this approach is evaluated qualitatively through a case study involving three NGOs in Saudi Arabia, aimed at assessing their capability to utilize the tool effectively. Following the implementation, a Likert-scale survey gauged satisfaction among NGOs regarding the tool’s utility. Findings Results from the case study indicate high satisfaction, affirming its alignment with their operational needs and enhancement of compliance with NCA controls. Furthermore, the use of the tool enhances the awareness of NCA’s cybercity requirements and controls. Originality/value Based on theoretical and empirical grounds, this research proposes a novel design of security assessment framework tailored for NGO requirements and supported by initiative tool enabling complying with cybersecurity policies and enhances the awareness of cybersecurity controls.

Risk assessment for the surface water quality evaluation of a hydrological basin

This paper proposes a risk assessment methodology for evaluating the surface water quality of hydrological basins based on physico-chemical parameter concentrations. Considering the Douro River basin in Portugal and monthly recorded dissolved oxygen and conductivity parameter measurements in 18 water sampling stations from January 2002 to December 2013, the work intends to answer the research question of identifying the riskiest periods for water pollution in the year and classifying the water sampling stations in terms of risk for water pollution. The methodology consists first in determining the pollution risk implied by the physico-chemical parameters, based on the monthly water station measurements, using six different risk measures, namely mean, variance, loss probability, entropy, mean excess loss and value at risk. The risk values are ordered according to each risk measure and a final ranking is established through a ranking aggregation method. The final ranking permitted identifying the high risk period as ranging from May to October and the low risk period from November to April. Furthermore, July was classified as riskiest month concerning the dissolved oxygen concentration, and August as riskiest month regarding the conductivity levels. On the other hand, the ranking allowed classifying the water sampling stations, previously grouped in clusters, in terms of similar risk for water pollution: six sampling stations in the west of the basin formed the riskiest cluster in the dry period considering the dissolved oxygen concentrations, and four of those stations formed also the riskiest cluster concerning the conductivity levels.

Assessment of Cybersecurity Risks in Digital Twin Deployments in Smart Cities

Digital Twin (DT) technology has become a cornerstone of modern smart city infrastructure, providing real-time insights and operational efficiencies by creating a virtual replica of physical systems such as traffic networks, energy grids, and public services. While these advancements enable optimized urban management and improved decision-making, they also present new cybersecurity challenges that can potentially jeopardize the safety and reliability of critical infrastructures. This study addresses the cybersecurity risks associated with Digital Twin deployments in smart cities, focusing on threats such as unauthorized access, data manipulation, and hijacking of the DT models, which could result in service disruptions and compromise public safety. The research employs a comprehensive risk assessment methodology based on the NIST Cybersecurity Framework, where potential risks are identified, evaluated, and prioritized according to their severity and likelihood of occurrence. To mitigate these risks, a multi-layered security framework was developed, incorporating encryption mechanisms, robust access control, and an Artificial Immune System (AIS)-based anomaly detection model. The framework was tested through a simulated case study on a smart transportation system within a smart city environment, demonstrating its effectiveness in preventing data tampering and detecting unauthorized access. The results indicate that the proposed security model reduced data manipulation incidents by 35%, decreased response times for threat detection by 25%, and improved overall system resilience by 40%. These findings underscore the critical need for proactive cybersecurity strategies in ensuring the secure and resilient deployment of Digital Twin technologies in smart cities. The study concludes by emphasizing the importance of continuous security monitoring and adaptive threat management to safeguard smart city ecosystems from evolving cyber threats

Scientific substantiation of the maximum permissible concentration of the pharmaceutical substance osimertinib mesylate in the air of the working area

Introduction. Osimertinib, a 3rd generation epidermal growth factor receptor tyrosine kinase inhibitor, is currently the only drug registered for the treatment of metastatic non-small cell lung cancer in patients with a positive T790M mutation status. The production of osimertinib mesylate is planned on the territory of the Russian Federation, which necessitates research to substantiate the hygienic standard for the aerosol content of the substance in the air of the working area. Conducting research to substantiate the maximum permissible concentration of a substance requires significant material and time resources, while using the results of preclinical and clinical studies, mathematical modeling of processes, and risk assessment methodology allows for a comprehensive assessment of the substance, while significantly reducing the time and cost of work. The study aims to scientifically substantiate the maximum permissible concentration of the pharmaceutical substance osimertinib mesylate in the air of the working area using data from toxicological studies and mathematical modeling of the effects of the substance on humans in industrial conditions. Materials and methods. The materials used were domestic and international databases, reports, research protocols, scientific articles and monographs containing information on the physico-chemical and toxic properties, pharmacotherapeutic activity of osimertinib. Results. The specialists have conducted hygienic regulation of osimertinib, taking into account data on its toxicity, danger, pharmacotherapeutic activity, side effects, long-term consequences, pharmacokinetic studies and modeling. To substantiate the value of the maximum permissible concentration, the authors used the reference points: an inactive NOEL level of 1 mg/­kg/­day for general toxic effect, established in a 92-day experiment on rats with intragastric administration; the lowest observed level of adverse effects of LOAEL is 0.5 mg/kg/day for general toxic effect, established in a 180-day experiment on dogs with intragastric administration; the level that does not cause adverse effects of NOAEL is 10 mg/kg/day for general toxic effect, established in a 180-day experiment on mice with intragastric administration. Safe concentrations of osimertinib in the air of the work area were evaluated using reference points, including the pharmacological effect and the minimum daily therapeutic dose; toxicokinetic modeling of concentrations of a substance in the human body under production conditions and the level of minimal risk. Limitation. The study is limited to the review of open literature sources describing the toxicological/toxicokinetic characteristics of osimertinib mesylate. Conclusion. The most stringent indicators of safe exposure levels, established on the basis of pharmacological effect and toxicokinetic modeling in dogs, allowed us to recommend 0.005 mg/m3, aerosol, hazard class 1 as the maximum permissible concentration in the air of the working area for osimertinib mesylate. Ethics. This study did not require the conclusion of the Ethics Committee.

Safety Assurance of Maritime Autonomous Surface Ships

Abstract Safety of Maritime Autonomous Surface Ships (MASS) is inherently complex owing to the dynamic and unpredictable nature of the maritime environment. This is exacerbated by the pace of change in enabling technologies and their disruptive impact. Integral to the safety assurance of MASS is assessment and mitigation of risk. The International Maritime Organisation (IMO) defines Risk as “the combination of frequency and severity of the consequence”. The advent of software-controlled systems has introduced difficulties in quantifying frequencies; an issue which is more prevalent in the context of autonomy due to the complex interaction between control algorithms and the variabilities of the environment in which they are deployed. Within complex autonomous systems, therefore it is challenging to perform quantitative risk assessments using failure rates, which gives rise to a need for different techniques to assess risk. Novel risk assessment methodologies such as those presented in the European Maritime Safety Agency (EMSA) Risk Based Assessment Tool (RBAT) combined with conventional risk assessment techniques can offer a solution to this challenge. Compliance with legislation and standards is another cornerstone of safety assurance, which is also inherently difficult for MASS vessels owing to their having been developed for conventional vessels. A goal-based approach to legislation compliance could present an interim solution until the IMO goal-based Maritime Autonomous Systems (MAS) provides harmonisation across the industry. Whilst MASS Safety assurance is non-trivial, there are solutions to many of the challenges faced; this paper examines the predominant challenges and presents potential solutions.